Key Dates
Release Date: November 8, 2016
Response Date: December 18, 2016  

Related Announcements
None    

Issued by
Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)

Purpose

With this time-sensitive Request for Information (RFI), the Office of Research Infrastructure Programs (ORIP) solicits comments from the biomedical research community about the significance of standard environmental conditions in facilities and laboratories for the scientific rigor of animal model experiments and the effects of such conditions on the reproducibility of related experimental outcomes.

Background

ORIP, located in the NIH Office of the Director’s Division of Program Coordination Planning, and Strategic Initiatives, supports programs that enable the advancement of science and enhance research funded by all NIH Institutes and Centers. In particular, these programs include the development and modernization of research facilities, and support resources that create, maintain, and distribute models of human diseases using animals and cultured cells. ORIP is interested to learn from the research community about the impact of variations in standard environmental conditions in facilities and laboratories on the experimental reliability and reproducibility of research which uses animal models.

The Guide for the Care and Use of Laboratory Animals (hence forth referred to as the Guide) published by the National Research Council of the National Academies provides guidance “to assist institutions in caring for and using animals in ways judged to be scientifically, technically, and humanely appropriate”. The Guide sets general standards and recommendations to achieve a performance baseline for the best quality care and maintenance of laboratory animals. For the purpose of this RFI, we refer to the Guide’s recommendations as standard conditions or best practices. Details of the implementation of these standards at different institutions typically somewhat vary as the oversight at a local level is provided by the Institutional Animal Care and Use Committee.

NIH-funded investigators rely on many types of animal species as models for biomedical research; including, but not limited to roundworms, fruit flies, African clawed frogs, zebrafish, mice, rats, and rhesus macaques. Depending on a particular animal species and the scientific questions under considerations, details on how the animal is managed and maintained may be necessary to adequately describe the relevant experimental biological variables. Specific environmental conditions such as temperature, light on /off cycles, light color, noise level, humidity, feed type and feeding protocols - all within standards for animal research facilities as outlined in the Guide - may differently affect animal responses depending on what research protocols are undertaken. In some cases, these environmental conditions may need to be controlled for and become a part of an experimental design; in other situations, their influences on experimental outcomes may not be that critical. Each animal species requires a different housing environment and is maintained according to different protocols to ensure that the standards of best care practices are met. These best practices allow for a range of environmental conditions (e.g., temperature ranges, light or noise levels) and some variation in care protocols (e.g., feeding regimens, socializing, type of bedding); different animal models may respond differently to the same variations of environmental conditions in the course of similar scientific investigations.

The animal research community encompasses many investigators with different scientific interests and expertise: researchers who rely on animals, researchers who develop new animal models, and researchers who work in animal research facilities. This RFI seeks input from these diverse groups, as their experiences and professional interests in the design, conduct, and analysis of different animal experiments may be complementary and point to different pressing issues associated with the influences of environmental extrinsic factors, the ability to control them, and the reliability of experimental results.

In particular, different communities and different individuals might have different preferences on how to tackle the volume of issues addressed by this RFI. Of interest is the perceived relative importance of different animal species in the context of the scientific rigor of animal research as well as the relative impact of different extrinsic factors. Also, opinions about specific scientific areas or experimental approaches which would require special attention with regard to extrinsic factors, might vary among different experts. ORIP is interested to learn about a set of priorities which could direct ORIP’s efforts to further strengthen the rigor of animal research and to increase reproducibility of outcomes, by better monitoring of and accounting for standard environmental conditions.

The issues addressed in this RFI are directly related to NIH efforts to enhance scientific rigor and transparency, as outlined in the NIH Director’s Notice NOT-OD-16-011. The goals stated in this Notice include rigorous experimental design, leading to robust and unbiased results for all NIH-supported research.

This RFI DOES NOT seek information about responses to stress, drugs, microbiome, and other similar special causes. This RFI DOES NOT seek information about the value of or the rationale for to use animals in research. Responses addressing such issues won’t be considered.

Information Requested

ORIP is interested to learn from the research community who uses or relies on animals, about the current knowledge and practices regarding monitoring of extrinsic environmental conditions, accounting for them in the experimental design, identifying their influences on experimental results, and sharing such information with other researchers. ORIP is also interested to learn from the members of the community about their views on priorities on addressing these issues; in particular, with regard to specific animal species, scientific thematic areas, experimental approaches, and the most dominant extrinsic environmental factors. The focus of this RFI is on standard environmental conditions and best care practices - as outlined in the Guide - for specific animal species, in the context of biomedical research. Any comments will be helpful and may include the following areas:

1. Current knowledge about the effects of standard environmental conditions (e.g., temperature, humidity, noise level, type of feed, feeding protocols, cycles of lights on/off, color of light, quarantine procedures) on the design and conduct of experiments using specific animal species as models for biomedical research (e.g., roundworms, fruit flies, African clawed frogs, zebrafish, mice, rats, and rhesus macaques), and on the reproducibility of experimental outcomes

a) Correlations between specific extrinsic environmental conditions and experimental outcomes
b) Biological mechanisms affected by standard environmental conditions in specific animal models as relevant to specific research areas (e.g., genomics, metabolomics, neuroscience, immunology, cancer research)

1. Missing knowledge about the effects of environmental conditions (e.g., temperature, humidity, noise level, type of feed, feeding protocols, cycles of lights on/off, color of light, quarantine procedures) on outcomes of specific experiments (e.g., gene expression investigations, cell-cycle regulation studies, measurements of drug responses, memory retention testing) using different animal species (e.g., roundworms, fruit flies, African clawed frogs, zebrafish, mice, rats, and rhesus macaques)
2. Current practices regarding monitoring, accounting for, and reporting influences of particular environmental conditions (e.g., temperature, humidity, noise level, type of feed, feeding protocols, cycles of lights on/off, color of light, quarantine procedures) on outcomes of specific experiments (e.g., gene expression investigations, cell-cycle regulation studies, measurements of drug responses, cell-cycle regulation studies, memory retention testing) in different scientific areas (e.g., genomics, metabolomics, neuroscience, immunology, cancer research) using specific animal species (e.g., roundworms, fruit flies, African clawed frogs, zebrafish, mice, rats, and rhesus macaques); strengths and deficiencies of these practices
3. Priorities for ORIP's decision making on how to proceed to strengthen the scientific rigor and to improve reproducibility of animal research experiments in the context of monitoring of and accounting for external standard environmental conditions, for the benefit of the animal research community; comment on priorities regarding animal species, scientific areas, experimental approaches, and extrinsic environmental factors
4. Effective approaches to disseminate to the broad research community, knowledge and practices about environmental factors which contribute to the rigor of experimental design and reproducibility of experimental outcomes of animal model research

Any comments about animal research, related to extrinsic environmental factors contributing to the rigor of experimental protocols and reproducibility of experimental outcomes

All interested parties are invited to respond and all responses are voluntary. It is optional for the responders to provide their professional position, expertise, and experiences. Similarly, it is optional for the responders to state types animals they are commenting about.

How to Respond

All responses to this RFI must be submitted on the website https://dpcpsi.nih.gov/FactorsRFI by December 18, 2016.

Responses to this RFI are voluntary. This RFI is for planning purposes only and should not be construed as a solicitation for applications or an obligation on the part of the Federal Government, the National Institutes of Health, or individual NIH Institutes or Centers. The government will not pay for the preparation of any information submitted or for the government’s use of that information.
The information provided will not be considered confidential. The NIH will use the information submitted in response to this RFI at its discretion; the submitted information will be reviewed by the NIH and shared with the NIH Institutes and Centers that have an interest in this matter. The NIH will not acknowledge receipt of information submitted or provide comments to any responder. No proprietary, classified, confidential, or sensitive information should be included in your response. The government reserves the right to use any non-proprietary technical information in any resultant solicitation(s), policies or procedures; responses to the RFI may be reflected in future funding opportunity announcements. The information provided will be analyzed, may appear in reports, and may be publicly shared on an NIH website.

Inquiries

Please direct all inquiries to:
Office of Research Infrastructure Programs
Email:  RFI-FACTORS@nih.gov

(1) what, when, and how data should be managed and shared; and,

(2) setting standards for citing shared data and software.

The complete RFI, as well as instructions on how to comment, can be found on the NIH OSP website.  NIH will consider all public comments before taking next steps.

Additional information about the importance of this RFI can be found in an “Under the Poliscope” blog published today by Dr. Carrie D. Wolinetz, NIH Associate Director for Science Policy.

For more information, please contact the NIH Office of Science Policy by email at SciencePolicy@od.nih.gov or by telephone at 301-496-9838.

Key Dates
Release Date:  November 7, 2016

Related Announcements
NOT-OD-16-134
NOT-OD-16-062    

Issued by
National Institutes of Health (NIH)

Purpose

The purpose of this Notice is to announce the process whereby recipients of Kirschstein-NRSA institutional training grant and individual fellowship awards supporting currently active postdoctoral trainees or fellows with 0, 1, or 2 years of experience as of December 1, 2016, will received increased stipends. The Notice also provides instructions for requesting one-time supplemental funding to cover the stipend increase.

As previously announced (NOT-OD-16-134), stipend levels for postdoctoral NRSA recipients with 0, 1 or 2 years of experience will be increased in furtherance of the NIH mission. This increase is distinct from a projected cost-of-living adjustment for postdoctoral stipends that is subject to the availability of FY 2017 appropriations.

Current NRSA stipend levels at years 0, 1 and 2 years of postdoctoral experience are shown below along with the amount of the increase for each career level. 

Process

In order to acknowledge the significant contributions of postdoctoral researchers to our research mission, eligible NRSA awardees may request supplemental funds as outlined below.  Specifically, recipients of Kirschstein-NRSA institutional training grant and individual fellowship awards supporting currently active postdoctoral trainees and fellows at levels 0, 1, and 2, ending after December 1, 2016, may apply for one-time supplemental funding to support the stipend increase using the Parent Announcement for Administrative Supplements to Existing NIH Grants, PA-16-287.

For Institutional Training Grants:

Applications may be submitted based only on the number of appointees at levels 0, 1, and 2. Applicants may not increase the number of appointees under the current award as a result of this supplemental funding notice.  Applications must remain consistent with the current experience level of each postdoctoral appointee, which cannot be adjusted as a result of this notice.

Applicants must be careful to accurately identify the number of postdocs at each level and request an accurate, corresponding supplemental dollar amount.  Applicants should only request funds to cover increases in stipends at these levels from December 1, 2016 up to the end date of the current period of appointment. 

Examples:

Institution A has 3 postdocs at Level 0, 1 at Level 1, and 2 at Level 2 with periods of appointment ending on January 31, 2017. Its supplemental funding request would be:

Institution B has 3 postdocs at Level 0, 1 postdoc at Level 1, and 2 postdocs at Level 2 with periods of appointment ending on August 31, 2017 for all except for the Level 1 postdoc, whose period of appointment ends earlier, on June 30, 2017. Its supplemental funding request would be:

Note: For periods less than a whole month (i.e., days and weeks) stipends should be prorated as appropriate.

Additionally, in the interest of providing additional funds as quickly as possible, recipients should not propose within the supplemental funding application any change to the grant that would otherwise require prior approval from the awarding Institute/Center.  Once a supplement has been issued, it will not be revised to account for any errors within an application.

Current NRSA awardees that meet the criteria above wishing to apply for this one-time supplemental funding must submit an application to the awarding IC as soon as possible, and applications will be reviewed as quickly as possible in an effort to issue these awards expeditiously.

Appointments of postdoctoral trainees at the Levels 0, 1, and 2 made via xTrain as of December 1, 2016 will reflect these new stipend levels.  Additional guidance will be forthcoming about adjustments to appointment records for currently active trainees at those levels.   

For Individual NRSA Postdoctoral Fellowships:

Applications may be submitted to cover projected stipend increases for individual NRSA postdoctoral fellows at levels 0, 1, and 2. Applicants should only request funds to cover increases in stipends for postdoctoral fellows at levels 0, 1 or 2 from December 1, 2016 up to the end date of the current budget year of the award. The subsequent Notice of Award (NOA) for the next budget year will reflect the FY 2017 stipend levels. 

Examples:

Individual fellowship budget year ends June 30, 2017.  Supplemental funding requests for fellows at career levels 0, 1 or 2 would be as follows:

Individual fellowship budget year ends August 31, 2017.  Supplemental funding requests for fellows at career levels 0, 1 or 2 would be as follows:

* For periods less than a whole month (i.e., days and weeks) stipends should be prorated as appropriate.

Current NRSA awardees that meet the criteria above wishing to apply for this one-time supplemental funding must submit an application to the awarding IC as soon as possible, and applications will be reviewed as quickly as possible in an effort to issue these awards expeditiously.

Reminder of Other Relevant Policies

For institutional training grants (T32, T90, TL1) and individual fellowships (F32), the stipend level for the entire first year of support is determined by the number of full years of relevant postdoctoral experience when the award is issued. Relevant experience may include research experience (including industrial), teaching, internship, residency, clinical duties, or other time spent in a health-related field beyond that of the qualifying doctoral degree. 

Kirschstein-NRSA support for postdoctoral research training is limited to three years. The presence of eight discrete levels of experience does not constitute an endorsement of extended periods of postdoctoral research training. The NIH provides eight postdoctoral stipend levels to accommodate individuals who complete other forms of health-related training prior to accepting a Kirschstein-NRSA supported position for research training. 

Inquiries

General inquiries about this notice may be directed to:

Division of Grants Policy
Office of Policy for Extramural Research Administration
National Institutes of Health
6705 Rockledge Drive, Suite 350
Bethesda, MD 20892
Phone: 301-435-0938
Email: GrantsPolicy@od.nih.gov

For any specific financial or grants management questions regarding the administrative supplement notice (PA-16-287) please contact the Grants Management Specialist or Grants Management Officer listed on the NoA of the most recent parent award.

Additional Information

Note that the interpretation and implementation of the FLSA and the DOL overtime regulations are under the authority of the DOL and the courts. While NIH plans to raise its NRSA stipends for consistency with spirit of the DOL’s support for increased pay, as reflected in its recent revisions to the overtime regulations, the NIH takes no position on the applicability of the overtime regulations to a particular worker supported by NIH grants. Institutions should consult their own counsel and/or local Department of Labor office about the applicability of the overtime regulations and for information on overtime obligations.

They say I must upgrade as fast as I can, otherwise Commons may not run.

The time is near, warnings I hear, November 30^th fast approaching,

HTTPS to be secure, my browser I must be preparing;

But O Chrome! IE! Firefox!

               Supported you are by this Fed

      Versions I must check else my browser be dead.

Just a little nod to Walt Whitman as a reminder to check that you are using a compatible browser as eRA transitions to meet federal security guidelines. For more information, see the communication sent on October 26, 2016.

You may remember that early this year, January 22, to be exact, we introduced a new view of the Status Results screen for Principal Investigators (PIs). This new design grouped applications and awards into families. These groups can be expanded with a click, or left collapsed, giving you a more concise view of your data. The design is responsive, adjusting to various window sizes, and recently color coded to provide the most recent status of an application.

And now a new feature has been added. A set of buttons in the upper right corner lets you toggle between the newer look (Grouped View) and a more traditional look (Flat View).  In the Flat View you will see all of your applications and awards listed, organized in the traditional manner of columns: Application ID, Grants.gov Tracking #, Proposal Title, etc.

So not only is the world round, but now you get the best of both of them…Well, in Status Results anyway!

How many of you remember this little guy from your high school biology class? Oh, wait, look whom I’m asking!  But flatworms aren’t alone in being flat. Now your Status Results screen can be flat too!

You may remember that early this year, January 22, to be exact, we introduced a new view of the Status Results screen for Principal Investigators (PIs). This new design grouped applications and awards into families. These groups can be expanded with a click, or left collapsed, giving you a more concise view of your data. The design is responsive, adjusting to various window sizes, and recently color coded to provide the most recent status of an application.

And now a new feature has been added. A set of buttons in the upper right corner lets you toggle between the newer look (Grouped View) and a more traditional look (Flat View).  In the Flat View you will see all of your applications and awards listed, organized in the traditional manner of columns: Application ID, Grants.gov Tracking #, Proposal Title, etc.

So not only is the world round, but now you get the best of both of them…Well, in Status Results anyway!

If you were lucky enough to attend the NIH Regional Seminar conference in Chicago last month you may have heard Scarlett Gibb, Customer Relationship Manager for eRA Commons, discussing the new Final RPPR.

Tentatively scheduled for required use as of January 1, 2017, the Final RPPR report will replace the current Final Progress Report for Closeout. As you know, the Final Progress Report is not strictly formatted, and basically has some half a dozen topics that need to be addressed, including a statement of progress; list of significant results, inclusion report, if applicable; list of publications; as well as any award specific instructions. The report is then uploaded as a PDF through eRA Commons and submitted to the agency by the signing official.

As part of Uniform Guidance (UG), we transitioned to the Research Performance Progress Report (RPPR) back in October of 2014.

So, come 2017, the RPPR format will be extended to the Final Progress Report. One of the differences between RPPR and the Final RPPR is that not all sections will be part of the final report. For example, Section D – Participants; Section F – Changes; and Section H – Budget will not be part of the Final RPPR. Plus, instead of a PDF upload, the information will be entered into RPPR-like screens. The new screens will include a new Section I – Outcomes.

The transition date from the current Final Progress Report Process to the Final RPPR will be a strict one. The anticipated plan specifies that if you have a progress report due, and you want to use the old format, it must be submitted prior to January 1, 2017. Any final progress report submitted after January 1, 2017 will need to be submitted as a Final RPPR. Any other submission format will be rejected and you will need to resubmit in the Final RPPR format.

This is just an introduction to what is coming so you can be ready. And now a brief musical interlude… “They call him Flipper, Flipper, faster than lightning, No-one you see, is smarter than he, and we know Flipper…”

The purpose of this Notice is to inform NIH grant applicants, their mentors, and reviewers about three online video briefings the NIH Center for Scientific Review (CSR) will host in November and December 2016. CSR is the portal for NIH grant applications and their review for scientific and technical merit.

Each Briefing Will Have a Different Focus

• Fellowship and R01 grant applicants:  The first two briefings will provide these applicants key information that could help them better navigate the NIH peer review process. 
• Basic research grant applicants and reviewers: The third briefing will reaffirm NIH’s commitment to basic research and help applicants and reviewers better do their part in proposing and reviewing basic research.

All of the briefings will run from 2:00 to about 3:00 p.m. Eastern Time, including a 30 minute Q&A period.

How to Participate in the Briefing

• Go to www.csr.nih.gov/webinar to register for the briefing you wish to join. You will not need to download special software.  You will just need a reliable Internet connection and browser.
• Register by October 31 for November briefing
• Register by November 30 for December briefings

• Submit questions for the Q&A session before or during the briefing by sending them to the moderator at AskExperts@csr.nih.gov. 

• Go to www.csr.nih.gov/webinar on the day/time your briefing is scheduled.  Click on the link that will be provided there to view it.

View Archived Briefings and Past Webinars  

• View archived webinars and PowerPoint slides now on our webinar web page: Meet the Experts in NIH Peer Review webinars for R01, R15, Small Business, and Fellowship grant applicants as well as a webinar for university research administrators.
• View our 2016 Briefings and PowerPoints about a month after broadcast on our webinar web page.      

If you have general questions about the NIH application and review processes at other times, please visit the CSR or the NIH Grants and Funding websites. The NIH Information Service can address specific questions. 

Inquiries

Please direct all inquiries to:

Don Luckett    
Center for Scientific Review
Telephone: 301-435-1111
Email: AskExperts@csr.nih.gov

Grantees filling out a Research Performance Progress Report in eRA Commons are expected to list significant products developed with their grant in Section C of the RPPR, namely websites, technology and other products.

The product sections of the RPPR have been redesigned recently to help grantees better categorize the products arising from their grant.  A new scrollable menu lists 14 product categories under which to list the product(s): Audio or video; data or databases; research material; educational aids or curricula; evaluation instruments; instruments or equipment; models; physical collections; protocols; software; survey instruments; interventions (e.g. clinical or educational); new business creation and other.

After entering a description for one or more reportable products in a text box, the grantee can then select appropriate categories for the product using a scrollable menu.  Grantees are not limited to a single category per product; please select as many categories as appropriate for the product being reported.

In addition, grantees can turn to a new resource ‘Guide to Categorizing Products in RPPR’s Section C’ to find definitions, examples and distinctions to help them decide which categories are appropriate for their product(s). For instance, videos developed to elicit behavioral change, such as counseling or motivational videos, or to instruct patients, may also meet the definition of clinical intervention.

This menu can be found in all three subsections of Section C: websites (C.2), technology (C.3) and other products (C.5). Grantees who do not have a product to report can click on the ‘Nothing to Report’ checkbox.

eRA has been working on strengthening the security of its modules, web services and websites to the federally mandated ‘https only’ secure connection required for all federal agencies.

The ‘https’ connection offers “the strongest privacy and integrity protection currently available for public web connections,” the Office of Management and Budget wrote in mandating federal agencies adopt this standard by the end of 2016.

Effective November 30, 2016, all eRA modules (eRA Commons, ASSIST, IAR and iEdison), web services and websites will use ‘https only’ secure connections. 

What This Means for You

You may need to update your web browser to continue using eRA modules:

• With this policy, some browser versions will no longer work.
• Here is a list of browsers and versions that will still work properly following the update:

These three are also the browsers eRA uses to develop and test its modules for browser compatibility, as listed in the eRA Browser Compatibility statement. While lower versions are listed below, we encourage you to upgrade to the versions listed in our browser compatibility statement above to ensure you have an optimal experience when using eRA modules.

• Google Chrome®  version 4.0.211.0 and higher
• Firefox® version 4 and higher; with Firefox 17, Mozilla® integrates a list of websites supporting the new protocol
• Internet Explorer® 11 on Windows® 8.1 and Windows® 7 when KB 3058515 or higher is installed (Released on Windows Update in June 2015)

These four are the other browser versions that will work with the security upgrade, but are not included in the in the eRA Browser Compatibility statement:

• Chromium® 
• Opera®  version 12 and later
• Safari® as of OS X Mavericks
• Microsoft® Edge™ and Internet Explorer® 11 on Windows® 10

More information is available at https://https.cio.gov/ and OMB M-15-13.

Beginning with the January 25, 2017 application due date, NIH will change what post-submission materials are allowable, and will eliminate most appendix materials currently allowed in applications. In November 2016, NIH will update the application guide and all funding opportunity announcements to reflect the changes for due dates on or after January 25, 2017.

For more information click on the links or contact Cindy Dickson, x44571.

New Policy Eliminates Most Appendix Material for NIH/AHRQ/NIOSH Applications Submitted for Due Dates On or After January 25, 2017 – NOT-OD-16-129

Changes to the NIH/AHRQ/NIOSH Policy on Post-Submission Materials for Applications Submitted for Due Dates On or After January 25, 2017 – NOT-OD-16-130

For additional information contact Cindy Dickson, x44571 or cdickson@llu.edu

The new capability ­­in eRA Commons via the new Prior Approval tab – can be initiated by the Principal Investigator (PI) or SO, but can only be submitted by the SO.

For more information click on the link or contact Cindy Dickson, x44571.

For additional information contact Cindy Dickson, x44571 or cdickson@llu.edu

• submitting a prior approval request for an application with 500k or more in direct costs per budget period;
• submitting a prior approval request for a change of PI (and pre-award change of PI);
• no-cost extensions for institutions that have already submitted one; 
• eRA Commons will display the status if requests were approved or denied.

For additional information contact Cindy Dickson, x44571 or cdickson@llu.edu

More information can be found at: https://nexus.od.nih.gov/all/2016/07/31/your-one-page-guide-to-rigor-and-reproducibility/

To help new and established applicants submit better applications, CSR asked current and recent study section chairs to share their personal insights on producing a highly competitive NIH grant application. They responded with great enthusiasm.

For more information, see the full Science Magazine article at:

http://www.sciencemag.org/news/2016/06/nih-gets-2-billion-boost-senate-spending-bill

http://grants.nih.gov/grants/forms/biosketch.htm

You are also required to fill in the Assignment Request Form (Awarding component, study section, individuals who should not review and expertise needed) in the S2S tab of your LLeRA record. NIH receipt and referral staff will no longer look for assignment requests in the Cover Letter (do not include it in the Cover Letter), they are only looking in the PHS Assignment Request Form.

The NIH states, the “Cover Letter should still be used for any narrative information you want to relay to the receipt and referral staff, such as:

• Reason for late application
• Explanation of why a Subaward isn’t active in all periods of the proposed project
• Statements regarding agency approval documents (e.g., requests over $500,000)
• Intent to submit a video as part of the application (NOT-OD-12-141)
• Indication that the proposed study will generate large-scale human or non-human genomic data (NOT-OD-14-111 and NOT-OD-15-027)”

In addition, Authentication of Key Biologics and Chemical Resources, has its own upload tab in your Research Plan section—NIH suggest one page limit.  If your research involves biologics or chemical resources the NIH instructs to: “Briefly describe methods to ensure the identity and validity of key biological and/or chemical resources used in the proposed studies.

• Key biological and/or chemical resources may or may not be generated with NIH funds and: 1) may differ from laboratory to laboratory or over time; 2) may have qualities and/or qualifications that could influence the research data; and 3) are integral to the proposed research. These include, but are not limited to, cell lines, specialty chemicals, antibodies, and other biologics
• Standard laboratory reagents that are not expected to vary do not need to be included in the plan. Examples are buffers and other common biologicals or chemicals.”

If you are working on a multiple Principal Investigator proposal don’t forget the Leadership Plan and if you are submitting a Clinical Trial proposal you must compose a Data Safety Monitor Plan/Board. 

For additional information or clarification contact Cindy Dickson, x44571 or cdickson@llu.edu

The full text is found at http://science.sciencemag.org/content/351/6280/1405.1

More informatin can be found at NOT-OD-16-088

The NIH periodically updates grant application forms in order to remain current with the most recent form sets available through Grants.gov and approved by the Office of Management and Budget.

The forms that will likely affect you during your proposal development are:

• New “Authentication of Key Biological and/or Chemical Resources” http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-011.html
• New biographical sketch format page and clarifications: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-080.html
• Assignment Request Form (Used to direct funding component assignment preference, study section preference, individuals who should not review your application due to conflicts, and scientific areas of expertise needed to review your application)
• New Vertebrate Animals section added http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-006.html.
• Combined Planned Enrollment Report and Cumulative Inclusion Enrollment Report forms into a single form (for human studies)
• New “Data Safety Monitoring Plan” (NIH supported Clinical Trials)

If you have questions please do not hesitate to contact Cindy Dickson at cdickson@llu.edu or x44571.

    Grants Basics

    Grants Process Overview

    How to Apply

    Pre-Award Process

    Post Award Monitoring and Reporting

    Forms Library

For additional information visit: http://grants.nih.gov/grants/oer.htm

We have dramatically simplified Grants.nih.gov to help you find and understand the information you need more easily.  A LOT has changed. You may want to familiarize yourself with the site by poking around or taking a video tour so you know where to look when you need to find information quickly. Here’s a taste of what’s new:

• Interface for the NIH Guide to Grants and Contracts
• How to apply/application guide information
• Grants process overview
• Forms library
• Presentation of policy information
• and more…

If something doesn’t work as expected or if you can’t find information that used to be there, let us know by emailing the  OER Webmaster

FORMS-D Application Instructions Now Available – View the Transformation

Not only has our website changed, so has our whole approach to delivering application instructions.  View the video overview to learn about the new filtered views of the instructions for the various grant programs, and how the HTML version of the general guide has been organized. 

We’d love your feedback on the application guide, too!

Key Dates
Release Date:   February 25, 2016

Issued by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 

Purpose

NICHD is issuing this Notice to alert interested investigators to the availability of the NCS Vanguard Data and Sample Archive and Access System (NCS Archive). 

The National Children’s Study Vanguard was a pilot study for a planned cohort study of environmental influences on child health and development.  Starting in 2009, the study enrolled over 14,000 participants in over 5,000 families in 40 locations throughout the United States and followed them through 2014.  It collected more than 14 million records and nearly 19,000 biological and 5,500 environmental primary samples from which a sample repository of over 250,000 items was created.   That information and material now will be available through the NCS Archive for approved research projects by qualified investigators.  The initial release consists of study data from 2009-2010.  Additional data and sample availability will follow in subsequent releases.  Note that due to its pilot nature, identical evaluations were not conducted on all participants over the course of the study.   

Additional information is available on the NCS web page of the NICHD public website and through the NCS Archive.

Inquiries

Please direct all inquiries to:
Jack Moye       
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-594-8624
Email: NCSArchive@s-3.net  

Recently I had the opportunity to make a new friend in Texas (shout out to Suzanne). We were talking about our pending forms update (FORMS-D) and she mentioned that there is some angst in the community about it. The truth is NIH grants policy and the application process are continuously changing and adapting to new requirements. New policies and form updates are par for the course. It’s the unknown that makes us anxious. If we know exactly what to expect and how to plan for a change, we can deal with it. So, this edition of Items of Interest is dedicated to reducing angst by removing the unknown and pointing out resources already available to help you plan ahead.

 
FORMS-D Application Changes

Let's start by talking about what’s changing with FORMS-D.

Although FORMS-D application guides will not be available until March 25,  NOT-OD-16-004 and the guide notices linked from it give you a pretty good idea of what to expect from a policy perspective. Since that notice was issued, we've delayed the rigor and transparency changes for individual fellowship and training FOAs (NOT-OD-16-034) and we won't be posting a new appendix policy right now, but the rest stands.

Curious about what the forms themselves will look like? This annotated form set provides a preview of the forms and how the new fields will be enforced. It displays the forms as they would show if you use Grants.gov's downloadable forms option for submission, but the same forms, form fields and guidance apply regardless of submission option even if the display is slightly different. You might also find this high-level list of FORMS-D pre-award form changes handy.

You’ll find most of the forms haven’t changed substantially. However, there has been a significant reorganization of fields on the following forms that you’ll want to become familiar with:

• PHS 398 Career Development Award Supplemental Form
• PHS 398 Research Training Program Plan
• PHS Fellowship Supplemental Form

FORMS-D Timing

Now let’s talk timing.

You must use FORMS-D for applications to due dates on or after May 25, 2016.  The choice of forms is determined by the actual due dates listed in the funding opportunity announcement, not the date you submit your application.

It is important that applications reviewed together use the same forms and instructions to provide consistent and fair review. Consequently, you can’t use FORMS-D for due dates prior to May 25 and you can't use FORMS-C for due dates on or after May 25. If you are submitting late for a due date before May 25, you must use FORMS-C. If you are submitting early for a due date on or after May 25 you must use FORMS-D.

We'll start posting FORMS-D in a few weeks. We'll post new funding opportunity announcements (FOAs) with FORMS-D packages for all parent, fellowship and career development announcements. We'll add FORMS-D application packages to all other active FOAs without reissue.

We will do our best to have the updated forms available 60 days prior to the first FORMS-D due date. Some reissued fellowship and career development FOAs may not be available a full 60 days in advance, but all will be available at least 30 days prior to their first due date.

Selecting the Correct Forms – FORMS-C vs. FORMS-D

For a short time during our transition between FORMS-C and FORMS-D, it will be possible to get through our electronic systems with the incorrect form version. During this period, NIH receipt and referral staff will check your form version after you submit as part of the manual validations they typically perform. If everything is OK, they will assign your application for further processing. If a problem is found, you will be notified that your application will not be accepted for funding consideration. You will not be allowed to submit a late application to correct the version of forms used.  

We’ll help you make good form choices by adding:

• Splash screens displayed when you click the “Apply” buttons in your FOA;
• Descriptions with FORMS-D packages to “Use for due dates on or after May 25, 2016”;
• ASSIST warning messages upon initiation of an application;
• Warning messages presented with your validation results upon submission; and
• Reminders in NIH Guide notices, Nexus articles, presentations and any other place we can think to put them.

But, ultimately it is up to you to choose correctly.

If you are working with applications that are already in progress and you want to verify which form set is being used, the “Do I Have The Right Forms For My Application?” resource describes how to tell FORMS-C from FORMS-D.

Administrative Actions & FORMS-D

Administrative supplement, successor-in-interest, and change of institution requests are non-competing so we don’t have the same concerns regarding fairness of review that are present with grant applications.

We have one successor-in-interest, one change of institution FOA and three administrative supplement parent announcements that will be reissued on May 25 with FORMS-D. We also have an additional eight administrative supplement FOAs that will be updated on May 25 to add a FORMS-D package to the existing FOAs without reissue (NOT-OD-16-068).

Any requests started on or after May 25 must use FORMS-D.  If you started a request using FORMS-C, make sure you complete the submission process by June 24 when our systems will stop accepting FORMS-C administrative supplement, successor-in-interest, and change of institution applications.

Continuous Submission & FORMS-D

Planning on submitting a R01, R21 or R34 application under our continuous submission policy in the coming months?

I indicated earlier that the due date you are submitting to determines your form package. For continuous submission, use the due date you would have been held to if not eligible for continuous submission.

• February/March 2016 due dates – use FORMS-C; your applications will be assigned to October council if you submit on or before April 16
• May 7, 2016 AIDS due date – use FORMS-C and complete your submission by May 23 to be assigned to October council (note this is an earlier cut-off than is standard)
• June/July 2016 due dates – use FORMS-D; you will be able to begin submitting FORMS-D applications as early as April 17 for January council

See NOT-OD-14-028 and NOT-OD-16-064 for more details.

Purpose

National Institutes of Health grants and cooperative agreements are subject to requirements intended to ensure that recipient organizations handle their Federal awards responsibly. Recipients are required to adopt and enforce policies that minimize the opportunity for improper research and financial conduct on the part of their organization, employees and collaborators.  In upholding the high ethical, health, and safety standards in both the conduct of the research it funds and the expenditure of public funds by its recipients, NIH requires the signature of the AOR on the application as certification of compliance for the applicant organization.

The purpose of this Guide Notice is to inform NIH applicants and recipients that as of the effective dates reflected in table below, NIH will no longer accept forms or other documentation bearing generic departmental signatures or their electronic equivalent (e.g., Department of Sponsored Research).  All forms and documentation submitted to the NIH must reflect the name of the individual, electronic or otherwise, with the appropriate institutional authority to submit such information (i.e., Authorized Organizational Official (AOR), Signing Official (SO), Business Official (BO), Principal Investigator (PD/PI)). 

NRMN continues to offer a series of four intensive coaching programs to support investigators who are at a later training stage, specifically postdoctoral fellows and junior faculty. These programs are designed to enhance participants' career development, preparing them to meet each program's ultimate goal: the submission of strong research and research career development proposals for funding in the biomedical or biobehavioral sciences.

NRMN is accepting applications from two audiences:  

1. Postdoctoral Fellows & Junior Faculty - Apply to be a Mentee 

• Currently working on a grant proposal
• Planning to work on a grant proposal in the next year
• Read more about mentee opportunities here

 2. Experienced Faculty Investigators - Apply to be a Coach-in-Training 

• Interested in serving as a grant writing and professional development coach for individuals and groups
• Desire to learn and apply the proposal writing and coaching strategies used in the NRMN models
• Read more about coaching opportunities here

 Application deadlines for the various upcoming groups are March  28, 31, April 5, & May 6.

Program Features 

• Paid travel expenses for in-person meetings
• Token stipends for coaches that complete the training
• Networking with colleagues from across NRMN

'OMB No. 0925-0001 and 0925-0002 (Rev. 10/15 Approved Through 10/31/2018)'

Open the hyperlink below to access the current version, including instructions and samples.

http://grants.nih.gov/grants/forms/biosketch.htm

Purpose

This Notice provides guidance about the NIH Fiscal Operations for FY 2016 and implements the Consolidated Appropriations Act, 2016 (Public Law 114-113), signed by President Obama on December 18, 2015.  With the passage of the Act, NIH has $32.31 billion in budget authority or equivalent (program level), an increase of $2 billion over FY 2015.  The NIH will continue to manage its portfolio in biomedical research investments in a manner that includes recognizing applications from and providing special incentives for new investigators.

The following NIH fiscal policies are instituted in FY 2016: 

FY 2016 Funding Levels: Non-competing continuation awards that have already been made in FY 2016 were generally funded at levels below that indicated on the most recent Notice of Award (generally up to 90% of the previously committed level) as described in NOT-OD-16-002.  In general, such reductions will be fully restored, and non-competing continuation grants (research and non-research) including those that remain to be issued in FY 2016 will be made at the commitment level indicated on the Notice of Award.  Any exceptions will be posted at the site listed under "Additional Information" below.  Out-year commitments for continuation awards in FY 2017 and beyond will remain unchanged.  The NIH awarding Institutes/Centers (IC) will develop and post their fiscal policies consistent with overall NIH goals and available FY 2016 funds.

Ruth L. Kirschstein National Research Service Awards (NRSA):  Consistent with the 2016 Consolidated Appropriations Act and with the recommendations of the Advisory Committee to the Director regarding the Biomedical Research Workforce, the NIH will increase NRSA stipends by approximately 2 percent on average.  The full range of stipend adjustments for FY 2016 is described at NOT-OD-16-047. 

New Investigators: NIH will continue to support new investigators on R01 equivalent awards at success rates comparable to that of established investigators submitting new (Type 1) R01 equivalent applications.  Achievement of comparable success rates should permit the NIH to support new investigators in accordance with the policies established in FY 2009 and subsequent years as described at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-013.html and at http://grants.nih.gov/grants/new_investigators/index.htm. 

Salary Limits: Section 202 of the Consolidated Appropriations Act, 2016 prohibits payments for salaries under grants and other extramural mechanisms in excess of Executive Level II previously set at $183,300, and effective January 10, 2016, increased to $185,100.  See NOT-OD-16-045 for additional information. 

Other Legislative Mandates: Other statutory requirements are described in NOT-OD-16-044.

Additional Information:   Additional details on Fiscal Operations, including specific funding strategies for ICs will be posted at http://grants.nih.gov/grants/financial/index.htm.

Inquiries

Questions about specific awards may be directed to the Grants Management Specialist identified in the Notice of Award

The general responsibilities of investigators submitting genomic data sharing plans are listed below. More specific details of non-human and human genomic data sharing plans are found within the policy.

“Investigators seeking NIH funding should contact appropriate IC Program Official or Project Officer as early as possible to discuss data sharing expectations and timelines that would apply to their proposed studies.  NIH expects investigators and their institutions to provide basic plans for following this Policy in the “Genomic Data Sharing Plan” located in the Resource Sharing Plan section of funding applications and proposals.  Any resources that may be needed to support a proposed genomic data sharing plan (e.g., preparation of data for submission) should be included in the project's budget.  A more detailed genomic data sharing plan should be provided to the funding IC prior to award.  The Institutional Certification (for sharing human data), should also be provided to the funding IC prior to award, along with any other Just-in-Time information.  NIH expects intramural investigators to address compliance with genomic data sharing plans with their IC scientific leadership prior to initiating applicable research and are encouraged to contact their IC leadership or the Office of Intramural Research for guidance.  The funding NIH IC will typically review compliance with genomic data sharing plans at the time of annual progress reports or other appropriate scientific project reviews, or at other times, depending on the reporting requirements specified by the IC for specific programs or projects….

Genomic data undergo different levels of data processing, which provides the basis for NIH’s expectations for data submission and timelines for the release of the data for access by investigators.  These expectations and timelines are provided in the Supplemental Information. ”

In a March 2015 notice (NOT-OD-15-083), NIH reminded the research community that:

• Grant applications are expected to state in the cover letter that the studies proposed will generate large-scale human and/or non-human genomic data. 
  Applications proposing such research are expected to include a genomic data sharing plan.  Guidance on developing data sharing plans may be found here: http://gds.nih.gov/pdf/NIH_guidance_developing_GDS_plans.pdf.
  Applicants who wish to use controlled-access human genomic data from NIH-designated data repositories as a secondary user, to achieve the specific aim(s) of the research proposed, in the Research Plan of the application should:
  briefly address their plans for requesting access to the data, and
  state their intention to abide by the NIH Genomic Data User Code of Conduct. “

Additional information on the GDS Policy may be found at: http://gds.nih.gov/index.html.

https://m.era.nih.gov/cmb

This new mobile access means it will be significantly easier for PIs to track and manage grant applications and awards because the Status screen will be easily viewable on a range of devices such as tablets and smartphones. PIs can simply go to the eRA Commons mobile login page and provide their credentials as they normally would when accessing eRA Commons.

The mobile site is designed to provide the basic and necessary information PIs need to track their application submissions and awards. The status screen, resizable due to responsive design, provides a table of all their applications. The applications are grouped based on status, going from Received, Awarded, Pending, Withdrawn, to Not Funded. The column headings are Project Number, Status, Project Title and Date.

Each application can be expanded to show important information such as Priority Score, Percentile, Scientific Review Group (SGR) information and links to other resources, such as the application image and/or summary statement. There is also a Contact section that provides access to a PI’s assigned Scientific Review Officer (SRO), Grants Management Specialist (GMS) and Program Official (PO).

Additionally, at the top of the screen is a large search/filter field. When a PI simply starts to type in any information from any of the columns, the results will be dynamically updated as they type.

It is hard to believe 2016 is just around the corner. With the new year comes new forms and new grant policies (NOT-OD-16-004, NOT-OD-16-005).

Our updated application forms (we’ll be calling FORMS-D) must be used for applications for due dates on or after (but not before) May 25, 2016 and you’ll start seeing the updated forms and instructions showing up in funding opportunity announcements by March 25, 2016. You’ll be hearing a lot from me about FORMS-D between now and then.

Some of our policy changes couldn’t wait (or didn’t need to wait) for our FORMS-D forms and will take effect for applications for due dates on or after January 25, 2016. We have new instructions for research and career development applications that specify what we want to see in terms of rigor to enhance the reproducibility of NIH funded research. We redefined the age of a child for the purposes of NIH's inclusion policy to individuals under 18 years old instead of under 21 years old. We also updated guidance for the vertebrate animal and training program plan sections of applications – including a reduction in data collection. Wow – reduction in data collection – that’s a rare and wonderful concept!  

We strive to have revised guidance available to you at least 60 days prior to the first due dates for which the changes apply. For January changes, that means by November 25, 2015 we’ll post an updated FORMS-C application guide. By that date, you will also see a link to revised review language in our active research and career development funding opportunity announcements.

There are certainly a lot of changes ahead, but it was the same last year and the year before that. We are constantly in a state of change and somehow it always seems to work out just fine.

Eyeballs Catch Stuff Systems Don’t

People have eyeballs. Systems typically don’t have eyeballs. People interpret situations and circumstances to make decisions. Systems take actions based on clearly defined rules. Why is this important? When checking application compliance against documented business rules, some checks can be easily automated and others are best left to actual people with eyeballs and cognition.

We talk a lot about showstopper errors identified by eRA systems that can prevent your application from moving on to our division of receipt and referral for NIH processing. We don’t often talk about the manual checks done by our staff once your application gets to them.

Here is some of the stuff our staff look for…

• Does the topic of the application fit NIH’s mission?
• Is the applicant eligible to apply? 

For example, if applying to the AREA (R15) program do the applicant organization and PI meet the eligibility requirements specific to that program?

• Does the application include all critical sections?

Our systems can tell if you attached a pdf document in a certain spot in the application, but can’t assess the content of that attachment. We’ve received all sorts of “unintended” attachments over the years from our own application guide instructions to a great recipe for cranberry margaritas (true story). To be fair, the recipe makes excellent margaritas (I’ll be making them again this holiday season), but it was a poor substitute for a research strategy.

• Does the application include information in inappropriate places to get around page limits?

We refer to the use of appendices and other non-page limited application sections to augment information in page limited sections as “overstuffing” your application (NOT-OD-11-080, NOT-OD-07-018). Your specific aims, research strategy, abstract, biosketches and other application attachments have page limits for a reason – to provide a fair and level playing field to convey information. We take that “fairness” thing pretty seriously around here.

• Was the application submitted on-time?

Unlike many agencies, NIH does not shut down the ability to submit to a funding opportunity announcement at 5:01 pm on a due date. We keep the submission door open and assess the circumstances of “late” submissions on a case-by-case basis. Staff check your cover letter submitted with your application for documented circumstances allowed under our late policy. They check to see if the application falls under our continuous submission policy. They also check to see if you ran into any system issues along the way and appropriately notified the eRA service desk to document them.

• Do you already have an application with essentially the same content under review?

Even under our latest submission rules which allow you to submit the same application again, you can’t have overlapping applications under review at the same time (NOT-OD-14-074).

• Does your application adhere to FOA-specific instructions in Section IV – Application and Submission Information?

Instructions in this section are often not systematically enforced, since they are exceptions from our general guidance. So, don’t rely on system checks to catch page limits and missing attachments documented in this section.

• If reference letters apply, were the correct number of reference letters received by the due date?
• Did you follow font and margin guidelines documented in the application guide when preparing all your attachments?
• If requesting over $500K in direct costs in any budget period, did you have institute permission to submit?
• If human embryonic stem cells are indicated, were all restrictions for their use met?

Although you may not have seen this particular list of checks before, I doubt there are a lot of surprises. The real takeaway here is that system checks are great (begin shameless plug – The Validate Application feature in ASSIST is awesome!  – end shameless plug), but they are not the whole story when it comes to assessing whether an application meets all the conditions to be accepted for review and funding consideration.

When submitting your application, don’t just think about getting through our systems. Stop to think how your application will hold up to the scrutiny of someone with eyeballs.

Mistakes Are Meant for Learning, Not Repeating – Biosketch Compliance

On November 5, NIH started sending email notifications to applicants indicating reviewers found one or more biosketches that did not comply with our current biosketch format (NOT-OD-15-032). Hundreds of letters have already gone out. If you’ve received one of these notifications, don’t panic. These letters are currently just warnings and require no action on your part. However, they do demonstrate NIH’s commitment to enforcing compliance with our biosketch policy.

What does it mean to have a compliant biosketch?

eRA systems ensure some biosketch rules are met by flagging errors upon submission. Applications that violate these rules won’t even move forward to NIH for consideration.

• A biosketch is attached for each and every Sr/Key person listed in the application
• Each biosketch is less than or equal to 5 pages
• Each biosketch attachment is in PDF format

But, there are additional rules you must follow to be compliant that aren’t systematically caught by eRA systems.

• Include each section (A - Personal Statement; B – Positions and Honors; C – Contributions to Science; D – Research Support or Scholastic Performance)
• Include no more than 5 contributions to science with no more than 4 citations per contribution
• Ensure that if you include the optional link to a full list of your published work in a site like My Bibliography that the URL is public, accessible without providing any login or personal information, and doesn’t link to websites that may violate page limit rules
  • Note: We will restrict this link to federal (.gov) sites beginning with applications to due dates on/after May 25, 2016 (NOT-OD-16-004)
  • Refrain from including information, such as preliminary data, that belongs elsewhere in the application
  • Follow NIH guidance on font type, font size, paper size, and margins (See section 2.6 of application guide)

Did you catch the part where I said “reviewers found” the non-compliant biosketches? We have provided instructions to our reviewers to flag any applications with biosketches that don’t follow current guidelines. Don’t make extra work for your reviewer – give them a clean application without the distraction of non-compliant formatting they have to write up.

Having trouble keeping up with NIH’s biosketch rules and getting your key personnel to follow them? Encourage people participating on your application to use SciENcv. Not only does SciENcv help manage biosketch information, it also creates perfectly compliant biosketches.

If you’ve received a warning letter, learn from your mistakes and don’t repeat them. Eventually, these warning letters will be replaced with notifications that applications have been removed from consideration. You’ve been warned (queue foreboding music in your head).

Thought for the Day

Gratitude can transform common days into thanksgiving,

turn routine jobs into joy,

and change ordinary opportunities into blessings.

–William Arthur Ward, writer

Sheri Cummins

Communications & Outreach

NIH Office of Extramural Research

cumminss@mail.nih.gov

NIH has recently announced that Rigor and Transparency must also be addressed in all progress reports (RPPRs) that are due on or after January 25, 2016. Specifically:

"By January 25, 2016, the Research Performance Progress Report (RPPR) instructions will be updated to include the following additional guidance for 6.2 Section B - Accomplishments, in addition to the existing instructions.  Progress reports submitted on or after January 25, 2016 that are initiated prior to the instruction updates may use the current forms while following these additional instructions.  The instructions that will address rigor are listed below for your convenience.

B.2 What was accomplished under these goals?

Include the approaches taken to ensure robust and unbiased results.

B.6 What do you plan to do for the next reporting period to accomplish these goals?

Discuss efforts to ensure that the approach is scientifically rigorous and results are robust and unbiased."

More information and background can be found in NOT-OD-16-031.

“Scientific and technological breakthroughs that have arisen from NIH-supported research account for many of the gains that the United States has seen in health and longevity,” said NIH Director Francis S. Collins, M.D., Ph.D. “But much remains to be done. This strategic plan will guide our efforts to turn scientific discoveries into better health, while upholding our responsibility to be wise stewards of the resources provided by the American people.”

The plan focuses on four essential, interdependent objectives that will help guide NIH’s priorities over the next five years as it pursues its mission of seeking fundamental knowledge about the nature and behavior of living systems and applying that knowledge to enhance health, lengthen life, and reduce illness and disability. The objectives are to:

1. advance opportunities in biomedical research in fundamental science, treatment and cures, and health promotion and disease prevention;
2. foster innovation by setting NIH priorities to enhance nimbleness, consider burden of disease and value of permanently eradicating a disease, and advance research opportunities presented by rare diseases;
3. enhance scientific stewardship by recruiting and retaining an outstanding biomedical research workforce, enhancing workforce diversity and impact through partnerships, ensuring rigor and reproducibility, optimizing approaches to inform funding decisions, encouraging innovation, and engaging in proactive risk management practices; and
4. excel as a federal science agency by managing for results by developing the “science of science,” balancing outputs with outcomes, conducting workforce analyses, continually reviewing peer review, evaluating steps to enhance rigor and reproducibility, reducing administrative burden, and tracking effectiveness of risk management in decision making.

“We are faced with extraordinary opportunities that demand exceptional attention if their promise is to be fully realized. Implementing these objectives will enable the more than 300,000 researchers supported by NIH across the nation and around the world to drive science further and deliver cures faster,” said NIH Principal Deputy Director Lawrence A. Tabak, D.D.S., Ph.D.

To inform development of the strategic plan, Dr. Tabak said NIH solicited input from a wide range of stakeholders through a Request for Information, which generated more than 450 responses; a series of interactive webinars, which attracted more than 750 participants; and meetings with 21 NIH advisory councils, including the Advisory Committee to the NIH Director.

The plan concludes with a bold vision for NIH, listing some specific achievements and advances that the agency will strive to deliver over the next five years. These aspirations include:

• Many thousands of cancer patients will experience enhanced survival from application of precision medicine.
• A candidate vaccine that induces a broad antibody-binding response to multiple strains of the influenza virus will be in clinical trials — a critical step toward a universal flu vaccine.
• NIH-supported research will develop effective, tailored behavioral and social interventions to promote health and prevent illness in populations that experience health disparities.
• Application of pharmacogenomics in real-world clinical settings will lead to improved outcomes in the use of several drugs.
• A pivotal efficacy trial of a novel HIV vaccine, expected to begin in the Republic of South African in 2016, will confer at least 50% protection against the acquisition of HIV.
• NIH-supported clinical trials will show that at least a half-dozen interventions thought to be clinically beneficial actually have no value.
• Radical new methods for structural biology will revolutionize drug screening and optimization.
• NIH-supported research will directly contribute to FDA-approved therapies for at least a dozen rare diseases.
• Application of certain mobile health (mHealth) technologies will provide rigorous evidence for their use in enhancing health promotion and disease prevention.
• A wearable biosensor for monitoring blood-alcohol levels in real time will be developed and show efficacy for preventing alcohol-related injury and disease.
• Technologies to reverse paralysis and restore some normal functions will be available to spinal cord injury patients.
• Vaccines against respiratory syncytial virus will be field tested for efficacy, promising a solution for this leading cause of childhood pneumonias.
• Research on the artificial pancreas will lead to advanced trials showing significantly better management of diabetes, without dangers of hypoglycemia.
• NIH will be known as the model agency for applying the scientific method to itself — for learning and implementing in a rigorous way, how best to support biomedical research.

Over the next five years, NIH leadership will evaluate the agency’s progress in meeting the objectives laid out in the strategic plan, which will be a living document that will be open to refinements throughout its life-cycle.

The NIH-Wide Strategic Plan, Fiscal Years 2016–2020: Turning Discovery Into Health can be found at: http:///www.nih.gov/sites/default/files/about-nih/strategic-plan-fy2016-2020-508.pdf

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

Original story can be found at: http://www.nih.gov/news-events/news-releases/nih-unveils-fy2016-2020-strategic-plan

This notice (link below) informs the biomedical research community of updates to application instructions and review language intended to enhance the reproducibility of research findings through increased scientific rigor and transparency. These updates will take effect for most research grant applications (including small business and complex research grant applications) submitted for due dates on or after January 25, 2016. For research contracts, this policy will be effective for proposals received on/after January 25, 2016 and expected to result in contract awards in Fiscal Year 2017 and beyond. 

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-011.html

At an NIH Regional seminar this year the session on “Rigor and Reproducibility” received conspicuous attention.  According to the NIH, the advancement of science is based on “rigor in designing and performing scientific research, and the ability to reproduce biomedical research findings.”

Addressing the rigor and reproducibility of a research plan will become mandatory for applications submitted after January 25, 2016.  The seminar also reported the expectation for careful consideration of “relevant biological variables, such as sex, age, weight and any other factors affecting health or disease” and the requirement for “authentication of key biological and/or chemical resources.”

There are revised instructions for applications due on and after January 25, 2016:

1. The scientific premise of the proposed research (research plan)

Applicants must state the scientific premise that forms the basis for the proposed research question(s).  NIH expects applicants to describe the general strengths and weaknesses of prior research cited by the applicant, including the rigor of previous experimental designs, their examination of relevant biological variables and their authentication of key resources

2. Rigorous experimental design for robust and unbiased results (research plan)

Scientific rigor is the strict application of the scientific method to ensure robust and unbiased experimental design, methodology, analysis, interpretation and reporting. This requires full disclosure of experimental details so that others may reproduce and extend the findings.

3. Consideration of relevant biological variables (human and/or animal subjects)

Biological variables, such as sex, age, weight, and underlying health conditions are often critical factors affecting health or disease. NIH expects that sex as a biological variable will be factored into research designs, analyses, and reporting in vertebrate animal and human studies. Strong justification must be provided for applications proposing to study only one sex.

4. Authentication of key biological and/or chemical resources (other attachments)

Key biological and/or chemical resources include, but are not limited to, cell lines, specialty chemicals, antibodies and other biologics. These may differ between laboratories or over time, and may influence the research data and the ability to reproduce the results. Investigators must determine which resources used in their research fit these criteria and are therefore key to the proposed research.

The links below provide additional information on the principals and guidelines governing Rigor and Reproducibility, a training module and application instructions for your upcoming grant proposals.

https://www.nih.gov/research-training/rigor-reproducibility/updated-application-instructions-enhance-rigor-reproducibility

http://grants.nih.gov/reproducibility/index.htm

And eRA Commons is also embracing new technology by making eRA Commons mobile friendly. While still in development, we are exploring the best way to provide you with easy access to critical grant information from any smart phone or tablet.

There are two approaches to provide this functionality to you:

1. Develop dedicated applications (apps) designed to work with eRA Commons
2. A flexible web-based tool

And like all things, each approach has its pros and cons. Based on the analysis by the development group and management, the team has chosen to use the flexible web based tools approach. The advantages to this approach are numerous, but here are two of the key ones:

1. The developers create one application for web browsers vs. a minimum of 2 separate apps for specific operating systems (Apple and Android).
2. No need to worry about licensing and other distribution issues of having to go through 3^rd party application “stores.”

The current mobile prototype interface provides Principal Investigators with the ability to track an application submission. They can view the status of the application, score and percentile information, Scientific Review Group (SRG) data.  Additionally they can review the grant image and view their summary statements. There are already discussions and plans for expanding the mobility functionality to Signing Officials to access reports, manage accounts, etc. Pretty exciting stuff! 

If you are a Principal Investigator and would like to help us fine tune the features, I invite you to contact Scarlett Gibb, Customer Relationship Manager for eRA Commons.  She will provide you with the necessary information to help test and provide feedback on this new interface.

And as I think of my daughter and my childhood, I realize my Dad never had a TV without a remote control. I was the remote control… “Joe, put on Bowling for Dollars!” “Joe, change the channel to Walter Cronkite.” “Joe, turn the volume up.”

Issued by: National Institutes of Health (NIH)
Agency for Healthcare Research and Quality (AHRQ)

Purpose

This notice informs the biomedical and health services research communities of planned changes to policies, forms and instructions for grant applications submitted in 2016.

The planned changes focus on the following areas:

• Rigor and transparency in research
• Vertebrate animals
• Inclusion reporting
• Data safety monitoring
• Research training
• Appendices
• Font requirements
• Biosketch clarifications

Some of the new policies require additional data collection and updates to our application forms. We have received approval from the Office of Management and Budget to make the needed form updates and we expect to have system support and guidance for these updates in place by March 25, 2016 (NOT-OD-15-146).

In order to move forward with the subset of policies which must remain consistent for all research applications in a funding year, we will implement the policy and guidance changes in two phases.

• Phase 1: Implements a subset of the policy changes using existing (FORMS-C) forms and updated instructions and will impact due dates on or after January 25, 2016.
• Phase 2: Completes the implementation with the introduction of new (FORMS-D) forms and instructions and will impact due dates on or after May 25, 2016.

Implementation

Policy & Guidance Changes - Phase 1

Timing
Effective for applications submitted for due dates on or after January 25, 2016

Application Forms
FORMS-C (current forms; already available)

Instructions
By November 25, 2015, we will update the general and small business (SBIR/STTR) application guides used with FORMS-C application forms. Instructions for individual fellowship applications will be incorporated into the general application guide and no longer maintained as a separate document. These application guides must be used for due dates on or after January 25, 2016, and before May 25, 2016.

Changes

*Policy also applies to contracts. See individual contract Requests for Proposals (RFPs) for details.

Policy & Guidance Changes - Phase 2

Timing
Effective for applications submitted for due dates on or after May 25, 2016

Application Forms
Our updated forms, identified by a Competition ID of "FORMS-D", must be used for all applications submitted for due dates on or after May 25, 2016.

All active Funding Opportunity Announcements (FOA) will be reissued or updated to include "FORMS-D" forms at least 60 days prior to the first due date on or after May 25, 2016.

We will reissue parent announcements, administrative supplements, research training, career development, individual fellowship and multi-project FOAs that include "Indiv Career Dev", "Inst Career Dev" or "NRSA Training" component types.

We will add FORMS-D application packages to all other active research FOAs (i.e., update existing FOAs; no reissue).  FORMS-C application packages will be set to expire after the May 7, 2016 AIDS due date. During a short transition period, you will need to select the appropriate application package based on due date.

Instructions
By March 25, 2016, we will provide new application guides to be used with FORMS-D application forms for due dates on or after May 25, 2016.

Changes

* Policy also applies to contracts. See individual contract Requests for Proposals (RFPs) for details.

Resources:

• High-level list of FORMS-D pre-award form changes
• Do I Have the Right Form Version For My Application?
• Form Update 2016 - Frequently Asked Questions

Related Announcements
NOT-OD-16-012
NOT-OD-16-011
NOT-OD-16-010
NOT-OD-16-009
NOT-OD-16-008
NOT-OD-16-007
NOT-OD-16-006
NOT-OD-16-005
NOT-OD-15-146
NOT-OD-15-112

http://fundermental.blogspot.com/2015/10/impact-what-works.html#more

Notice Number: NOT-HD-15-028

Key Dates
Release Date:   August 20, 2015

Issued by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)  

Purpose

This Notice serves to announce the launch of the NICHD Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from NICHD-funded research studies for the purposes of secondary research use.

NICHD DASH is available for NICHD-funded extramural and intramural investigators to house research data from studies when such data are ready for sharing as per the NIH Data Sharing Policy and the NIH Genomic Data Sharing Policy or in accordance with some other policy or interest.

NICHD DASH is a publicly accessible website. All users may browse and view information about studies and data archived in NICHD DASH. Users who are interested in submitting or requesting study data must register for a free account.

The Resources section of the website includes the NICHD DASH Policy, the NICHD DASH Data Use Agreement, a tutorial, answers to frequently asked questions, and other supplemental materials to orient new users.

By supporting data sharing through NICHD DASH, NICHD aims to accelerate scientific findings and improve human health.

Inquiries

Please direct all inquiries to:

Rohan Hazra, M.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6868
Email: hazrar@mail.nih.gov

Issued by
Center for Scientific Review (CSR)

Purpose

The purpose of this Notice is to inform new NIH applicants, their mentors, and grant administrators at their institution about two upcoming webinars the NIH Center for Scientific Review (CSR) is hosting in November 2015.  These webinars are designed to give participants useful insights into our application submission and peer review processes.  CSR is the portal for NIH grant applications and their review for scientific and technical merit.

Each Webinar Will Have a Different Focus

All of the webinars will run from 2:00 to 4:00 p.m. EST, including a 30 minute Q&A period.

Viewers Will See Presentations by Five CSR/NIH Experts

• The Review of Your NIH Grant Application Begins Here
• What You Need to Know about Application Receipt and Referral
• How Your Application Is Reviewed
• Key Things to Know About the NIH Grants Program  
• Jumpstart Your Career with CSR’s Early Career Reviewer Program (R01 webinar only)

How to Participate in the Webinar

• Go to www.csr.nih.gov/webinar to register for the webinar you wish to join by Monday, October 29.  You will not need to download special software.  You will just need a reliable Internet connection and browser.
• Submit questions for the Q&A session before or during the webinar by sending them to the moderator at AskExperts@csr.nih.gov. 

• Go to www.csr.nih.gov/webinar on the day/time your webinar is scheduled.  Click on the link that will be provided there to view it.

View Archived Webinars  

• View archived webinars and PowerPoint slides now: Our 2014 Meet the Experts in NIH Peer Review webinars for R01, R15, Small Business and Fellowship grants are available via our webinar webpage. 
• View our 2015 Webinars and PowerPoints about a month after broadcast: They will be posted on our webinar webpage.     

If you have general questions about the NIH application and review processes at other times, please visit the CSR or the NIH Grants and Funding websites. The NIH Information Service can address specific questions.  

Inquiries

Please direct all inquiries to:

Don Luckett    
Center for Scientific Review
Telephone: 301-435-1111
Email: AskExperts@csr.nih.gov

Issued by
National Institutes of Health (NIH)

Purpose

The National Institutes of Health (NIH) is informing the research community that it will not fund research in which human pluripotent cells are introduced into non-human vertebrate animal pre-gastrulation stage embryos while the Agency considers a possible policy revision in this area.

Background

The field of regenerative medicine, largely through the use of human pluripotent cells, has progressed to the stage in which some scientists are considering employing early stage animal embryos to grow human tissue and organs. Currently, the NIH Guidelines for Human Stem Cell Research (http://stemcells.nih.gov/policy/pages/2009guidelines.aspx) include the following section that pertains to this type of research:

“Section IV. Research Using hESCs and/or Human Induced Pluripotent Stem Cells That, Although the Cells May Come from Eligible Sources, is Nevertheless Ineligible for NIH Funding”

This section governs research using hESCs and human induced pluripotent stem cells, i.e., human cells that are capable of dividing without differentiating for a prolonged period in culture and are known to develop into cells and tissues of the three primary germ layers. Although the cells may come from eligible sources, the following uses of these cells are nevertheless ineligible for NIH funding, as follows:

• Research in which hESCs (even if derived from embryos donated in accordance with these Guidelines) or human induced pluripotent stem cells are introduced into non-human primate blastocysts.
• Research involving the breeding of animals where the introduction of hESCs (even if derived from embryos donated in accordance with these Guidelines) or human induced pluripotent stem cells may contribute to the germ line.”

Given the rapid expansion of potential research models employed beyond the scope described above, NIH would like to undertake a deliberative process to evaluate the state of the science in this area, the ethical issues that should be considered, and the relevant animal welfare concerns associated with these types of studies.

Implementation

Effective with the date of this Notice, NIH will not fund any new or competing grant applications or contract proposals for research in which human pluripotent cells are introduced into non-human vertebrate animal pre-gastrulation stage embryos. This policy will be in place until NIH issues a subsequent policy notification.

• Current research funding: NIH will not consider requests for administrative supplements or revisions to any grants or modification to R&D contracts that include costs for or involve research introducing human pluripotent cells into non-human vertebrate animal pre-gastrulation stage embryos. Ongoing NIH awards will be addressed with the awardees on a case-by-case basis.
• Peer reviewed competing applications:  Any grant applications previously submitted to the NIH and already reviewed (through both the initial and Council levels of review) which propose to introduce human pluripotent cells into non-human vertebrate animal pre-gastrulation stage embryos will be held for funding decisions until NIH has issued a policy notification.  At that time, highly ranked applications can be modified, as necessary, to comply with the policy notification to receive full consideration for funding.
• Competing applications/contract proposals pending submission and/or peer review:  NIH will not review applications or contract proposals for research proposing to introduce human pluripotent cells into non-human vertebrate animal pre-gastrulation stage embryos until NIH has issued a policy notification. 
• Once the policy notification is released, applicants for grants that have not completed initial peer review will have the opportunity to submit additional post-submission material to comply with the policy notification.  Provided that the additional material can be sent 30 days before the initial peer review meeting, those grant applications will be reviewed and considered for funding.  See NOT-OD-10-115 for instructions and details.
• Once the policy notification is released, offerors for R&D contract proposals shall not submit additional material or information addressing the issue related to this notice after the cutoff date for receipt of proposals, unless directed to do so by the Contracting Officer.
• Applications that completed initial peer review before issuance of this Notice will not proceed to Council review at this time.  R&D contracts that have completed peer review and have been determined to be in the competitive range before issuance of this Notice may proceed to negotiations.
• Alternatively, applicants may withdraw the application and submit again at the next available due date. 
• No contracts proposing research in which human pluripotent cells are introduced into non-human vertebrate animal pre-gastrulation stage embryos will be awarded until further notice.

Inquiries

For questions regarding a specific application, please contact the assigned NIH program officer.

For questions regarding a specific contract proposal, please contact the assigned NIH contracting officer.

General inquires about this change may be directed to:

Division of Receipt and Referral
NIH Center for Scientific Review
csrdrr@mail.nih.gov
301-435-0715

Or

NIH Review Policy Officer
Office of Extramural Research
ReviewPolicyOfficer@mail.nih.gov

• How to Prepare an NSF Proposal: The good, the bad and the ugly
• Excerrpts from the Current Issues at NIH presentation-- includes information on the 2015 budget, new guideance and policies, policy reminders, and
• SciENcv: Science Experts Network Curriculum Vitae
• Exceprts from 'Exploring the Alphabet Soup of Non-traditional Agreements: CDA, DUA,
  MTA, MOU, CA, TA, VSA'

Historically, all NIH funds awarded to LLU are in one pooled account managed by NIH.  LLU draws down against this account and receives income as expenses are accrued. 

As of October 1, 2015, NIH will use a subaccount (not the pooled account) for each grant awarded.

What does this mean?

NIH will transition awards currently in the pooled account to subaccounts between October 1, 2015 and September 30, 2016.

How will this be done?

• NIH will effectively break the single competitive segment into two shorter "administrative segments." 
• The project period end date will be revised to the existing budget period end date.
• A final Federal Financial Report (FFR) is due within 90 days. 
• All new and non-competing continuation awards issued between October 1, 2015 and September 30, 2016 will have a new NIH award number. 

How will my LLU projects be affected?

• A new Banner fund number (6xxxxx) will be created for awards issued between October 1, 2015 and September 30, 2016 and existing funds will be closed out.
• FFRs are to be submitted and funds carried over to the new award, as applicable.
• NIH-funded subcontracts issued to LLU will be invoiced and closed out as of the current contract end date.

Note: Progress Report submission and review dates will not change.

RAFM staff will contact you as awards are issued and if/when any action is required. Please feel free to contact us with any questions or concerns you may have.

Research Affairs Financial Management

(909) 558-4589 or ext. 44589 · rafm@llu.edu

For further information:

NOT-OD-14-103: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-103.html

FAQs: http://grants.nih.gov/grants/payment/faqs.htm

Where did the summer go?! I no longer have small children in my house (except when my grandson visits). Yet, I can certainly tell it’s back to school time. Temperatures are dropping. Days are getting shorter. Stores are stripped clean of, well, just about everything except Christmas decorations. And, of course, NIH is in full swing planning for grant administration changes for next year.

PHS Form Use Beyond Expiration Date

Have you ever noticed that potato rolls still taste fresh well after the date on the package? Well, perhaps we shouldn’t dwell on that thought. The point I actually want to make is that lots of things are still good after the date we stamp on them – even grant application forms. Some of you may have noticed our agency-specific (PHS) forms expired yesterday.

At least every three years, we are required to reassess our data collection needs, make any needed adjustments, and submit a data collection clearance request to the Office of Management and Budget (OMB). We are currently working through that process. Once we have OMB approval, we’ll issue notices in the NIH Guide for Grants & Contracts to tell you more about our pending changes and our implementation plans. In the meantime, continue to use the  current forms - despite the August 31, 2015 expiration date (NOT-OD-15-146). We’ll get fresh forms out to you as soon as we can (yes, “FORMS-D” is in our future). For now, the PHS forms are fresh enough.

It’s Time to Simplify Our Instructions

Recently I was explaining to a new team member our hierarchy of instructions. The conversation went something like this…

We have three application guides (general, small business and individual fellowship) and a separate supplemental instruction document that applies to all three. The general application guide has basic instructions for research grants with special sections for specific programs (training, career development, and multi-project) that augment the basic instructions. Our funding opportunity announcements have additional opportunity-specific instructions that supersede the application guides. We issue notices in the NIH Guide for Grants and Contracts when we change policies or need to provide corrections to instructions. The guide notices supersede and/or clarify the funding opportunity announcement instructions.

…The expression on her face at the end of my explanation is hard to describe, but my basset hound looks at me the same way when I tell her not to bark at the cats. It’s an “are you serious right now?” look.

Our current application guide practices have worked for many years – they are functional, but certainly not optimal. If you’d like to help us improve our approach to instructions, we’d love to hear from you. Simply respond to our Request for Information: Strategies for Simplifying NIH’s Grant Application Instructions by September 25, 2015.

Same Great Service, Slightly Different Name

The eRA Commons Help Desk has a new name – eRA Service Desk (NOT-OD-15-147).  The new name reflects the expansion of the team’s role to support additional eRA services like ASSIST.

The contact information, hours of operation, and friendly service remain the same. If you’d like to provide feedback on service you received, you can always email the support management team at usbmgmt@od.nih.gov. Of course, we want to hear when you are unhappy so we have an opportunity to make things right. We also love to hear the happy stuff – that stuff makes our day!

Browsing eRA Systems

Did you know that eRA recommends Internet Explorer and Mozilla Firefox browsers for use with eRA systems like eRA Commons, Internet Assisted Review and ASSIST (see eRA browser policy)? Many other popular browsers work just fine, but those are the two browsers the eRA team uses to develop and test our systems. If you use a different browser and your screen doesn’t look quite right, try Internet Explorer or Firefox and see if the issue is browser related.

Also, be sure to upgrade your browser periodically. Internet Explorer version 6.0 users may run into issues following some maintenance over the weekend. Yes, there is already an Internet Explorer 11 and version 6 was released 14 years ago, but some of you (and you know who you are) don’t seem to believe in frequent updates. No judgement here, but if you were in front of me I’d be giving you my best “basset hound are you serious face” right now.

Some Other Stuff

*You may be interested in this SciENcv blog post.

* We’ve consolidated our listservs (NOT-OD-15-132). OK, so if you got this email, you are likely already subscribed, but you can still share the notice with your coworkers. And, if you just joined our listserv – welcome.

* There is still time to register for the 2015 NIH Regional Seminar on Program Funding and Grants Administration. Space in the pre-seminar workshops (including the half-day workshop on Grant Application Preparation & Submission given by yours truly and my good friend, Jessie) is nearly gone – so, act fast.

* August 26th was National Dog Day. I’m a bit late, but couldn’t resist the dog theme to mark the end of the dog days of summer. These are my two hound dogs, Dixie & Daisy. They bring such joy to my life. I hope you and your families (including the 4-legged members) had a great summer!

Take care,

Sheri 

Sheri Cummins

Communications & Outreach

NIH Office of Extramural Research

cumminss@mail.nih.gov

Dear Colleagues,

In order to advance the NIH mission, we are developing an NIH-wide Strategic Plan. The goal of this 5-year plan is to outline a vision for biomedical research that ultimately extends healthy life and reduces illness and disability. NIH senior leadership and staff have developed a proposed framework for the Strategic Plan that identifies areas of opportunity across all biomedicine and unifying principles to guide NIH's support of the biomedical research enterprise. The aim is to pursue crosscutting areas of research that span NIH's 27 Institutes, Centers, and Offices.

I invite you to review the framework in our Request for Information (RFI: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-118.html) and on the NIH website (http://www.nih.gov/about/strategic-plan), and to provide your feedback via the RFI submission site (http://grants.nih.gov/grants/rfi/rfi.cfm?ID=46).

We also will be hosting webinars to gather additional input. These webinars will be held in early to mid-August.

Your input is vital to ensuring that the NIH Strategic Plan positions biomedical research on a promising and visionary path. I appreciate your time and consideration in assisting us with this effort.  

Sincerely,

Lawrence A. Tabak, D.D.S., Ph.D.

Principal Deputy Director, NIH

Acting Director, NIMHD

From the Rock Talk blog:

I’m excited to let you know about a wonderful opportunity for our extramural research community that’s headed to the west coast this fall! For the first time in several years, the NIH Regional Seminar on Program Funding and Grants Administration will be offered in the western half of the United States. This 2-day event, with an optional pre-seminar workshop day, will take place in San Diego from October 14 to October 16, 2015. …. Continue reading →

Notice Number: NOT-OD-15-095
Release Date: April 15, 2015  

Issued by
National Institutes of Health (NIH)

Purpose

The purpose of this notice is to remind applicants, both investigators and grants office officials, that to be fair to all concerned the NIH needs to consistently apply standards for application compliance.

Policy

Be mindful that non-compliance can have serious consequences. NIH may withdraw any application identified during the receipt, referral and review process that is not compliant with the instructions in the SF424 (R&R) Application Guide, the Funding Opportunity Announcement, and relevant NIH Guide Notices.

Some examples of how this policy is applied to NIH applications include but are not limited to:

• Applications containing one or more biosketches that do not conform to the required format may be withdrawn (NOT-OD-15-032).
• Applications that do not conform to the page limit requirements because inappropriate materials have been included in other parts of the application may be withdrawn (NOT-OD-11-080).
• Applications submitted as new but containing elements of a resubmission or renewal application are noncompliant with the resubmission policy and may be withdrawn (NOT-OD-15-059).
• Applications submitted after 5 PM local (applicant organization) time on the application due date may be withdrawn (NOT-OD-15-039).

It is important to remember that these are just examples, and that all requirements specified in the SF424 (R&R) Application Guide, the Funding Opportunity Announcement, and relevant NIH Guide Notices are to be followed. When in doubt about compliance policy, contact NIH "Grants Info" or the Division of Receipt and Referral as listed below.

If an application is withdrawn because it does not conform to the application preparation and submission instructions, a letter will be placed in the eRA Commons Status page for that application.  The PD/PI and the AOR from the applicant organization will be notified by eRA Commons to access their account and view the explanatory letter.

Inquiries

Please direct all inquiries to:

Grants Info
Office of Extramural Research (OER)
National Institutes of Health
Telephone:  301-435-0714
Email:  grantsinfo@nih.gov

or

Division of Receipt and Referral
Center for Scientific Review (CSR)
National Institutes of Health
Telephone: 301-435-0715
Email: csrdrr@mail.nih.gov

Notice Number: NOT-OD-15-090

Key Dates
Release Date:   April 10, 2015

Issued by
National Institutes of Health (NIH)

Purpose

The purpose of this guide notice is to amend instructions for reporting publications in the Research Performance Progress Report (RPPR). Awardees are encouraged to electronically report any publications found in Table 1 of the RPPR which were previously reported using the paper 2590 process or as part of a competing renewal application. This transitional, one-time measure to report each publication electronically in the RPPR ensures that NIH systems can store all appropriate award-publication associations.   

Background

Current RPPR instructions direct awardees to report only those publications that have been accepted for publication during the reporting period. However, NIH can only systematically link publications to awards if those papers were reported to us electronically using RPPR or eSNAP. These definitive linkages have not been possible for publications reported on paper forms, such as the PHS 2590. Maintaining appropriate linkages between publications and awards enables electronic systems, such as My Bibliography, to automatically populate biosketches and reporting systems, such as RePORTER, to identify results of NIH supported research.

For more information and resources on the RPPR, please visit http://grants.nih.gov/grants/rppr/index.htm.   

Inquiries

Please direct all policy inquiries to:

Division of Grants Policy
Office of Policy for Extramural Research Administration (OPERA)
Telephone: 301-435-0949
Email: GrantsPolicy@od.nih.gov

Please direct all technical inquiries to:

eRA Commons Help Desk
Web ticketing system:  http://grants.nih.gov/support
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

http://grants.nih.gov/grants/policy/nihgps/nihgps.pdf.

Straight Talk About Application Requirements

I manage a small support team called Grants Info responsible for responding to grant-related email and phone inquiries. Team members spend the better part of their day helping folks navigate through our many grant resources and matching ‘people who have questions’ with ‘people who have answers’. One of the most popular inquiries we receive is “What exactly do you mean by ‘required’?” This question can, of course, apply to any policy or guidance we put out. Most recently, it has been asked in the context of the new biosketch.

NIH expects applicants and grantees to follow all documented policies and instructions. When completing your grant application you must follow announcement clarification and policy notices posted in the NIH Guide, follow instructions in the Funding Opportunity Announcement and follow the guidance in the application guide and supplemental instructions.  I know (better than most) that is easier said than done. The NIH puts out A LOT of grant information keeping my team very busy. J

So, when we say NIH “requires use of the new [biosketch] format for applications submitted for due dates on or after May 25, 2015” (NOT-OD-15-032), we mean…

All biosketches included in applications submitted for due dates on/after May 25, 2015 must be formatted per the instructions in the application guide (and repeated in online resources), including:

• Completing each section (A - Personal Statement; B – Positions and Honors; C – Contributions to Science; D – Research Support or Scholastic Performance)
• Including no more than 5 contributions to science with no more than 4 citations per contribution
• Ensuring that if you include the optional link to a full list of your published work in a site like My Bibliography that the URL is public, accessible without providing any login or personal information, and doesn’t link to websites that may violate page limit rules
• Refraining from including information, such as preliminary data, that belongs elsewhere in the application
• Following NIH guidance on font type, font size, paper size, and margins (See section 2.6 of application guide)
• Using PDF format for your biosketch attachments
• Limiting the length to 5 pages or less

The new biosketch policy is “required’ –officially compulsory, or otherwise considered essential; indispensable. Failure to follow the policy means NIH may withdraw your application from consideration (NOT-OD-15-095). The majority of the requirements listed above (all except the 5-page limit) would not be flagged until your application has already moved forward to NIH. If you don’t follow the instructions and our staff manually identifies a biosketch in your application as being non-compliant, then you won’t have the opportunity to correct it before the due date. In that context, is it really worth not following the instructions?

Updated Resources

We’ve been hard at work updating our resources for you. Here are some recently posted items you’ll want to be aware of . . .

• Application guides (notable changes)
• Annotated form sets
• New biosketch formats and samples
  The SF424 (R&R) forms page now includes both the old and new biosketch. After January 25, 2015 the old formats and samples will be removed. Until then, choose the format appropriate for your due date. Although we will be flexible in accepting either format before January 25, the new format is required on/after January 25.
• Biosketch FAQs
  

SciENcv Takes the Guesswork Out of Biosketches

On November 26, NIH confirmed that the biosketch format that has been piloted with specific Funding Opportunity Announcements (FOAs) over the last year will be expanded to all FOAs with due dates on/after January 25, 2015.  The guide notice (NOT-OD-15-024) and  Rock Talk blog post explain why the new format has been put in place so I won’t rehash that here. Instead, let’s talk logistics…

The easiest way to navigate the biosketch changes is to use the Science Experts Network Curriculum Vitae (SciENcv). SciENcv serves as an interagency system designed to create biosketches for multiple federal agencies. Support for NIH’s new biosketch format and NSF’s current format is expected later this month.

The SciENcv home page has plenty of resources to get you started, including: FAQs,  YouTube tutorial and support documentation.

I realize folks are sometimes leery of using new systems, especially with something as important as a grant application. You really need not worry. There are already over 8,000 profiles in SciENcv and NIH tests submissions with applications that include biosketch PDF attachments generated through SciENcv. I’m a trust but verify person myself. I’ve personally tested a few submissions with SciENcv biosketches and can confidently say “they work great with eRA systems”!

As we transition from one biosketch format to another, it really is the perfect time to let a tool take the guesswork out of your biosketch attachment. Pull together your information centrally and let SciENcv do the formatting for you.

Need help spreading the word within your institutions? You’re welcome to use the flyer our Grants Information team has brought to recent outreach events.

Commons IDs Required for Fellowship Sponsors

Our standard Fellowship due dates are just around the corner. Don’t forget to include the eRA Commons Username for the primary Sponsor designated on your competing Fellowship grant applications. See NOT-OD-14-129 for details.

For those of you keeping score…eRA Commons IDs are now required on competing grant applications for:

• Contact Project Director/Principal Investigator (PD/PI)
• Multiple PD/PIs (must use the PD/PI role)
• Fellowship Sponsors
• Component leads on multi-project applications

For all other Sr/Key personnel, including the Commons ID in the Credential field of the R&R Sr/Key Person Profile form is optional, though encouraged if you have the information handy.

New Applications = Fresh Start!

Now that the updated Resubmission policy (NOT-OD-14-082) has been in place for a while, applicant inquiries on it have settled to a dull roar. But, there is still one area where folks are stumbling a bit. If you choose to submit a subsequent New application following an unsuccessful submission, you may not reference any previous application in any part of the New application. Not in the specific aims. Not in the research plan. Not in the project summary. Not in the narrative. Not in the cover letter. Not in a reference letter. Not in a box. Not with a fox. You get the picture.

By all means use reviewer feedback to improve your application. Just keep it to yourself where you got the ideas for improvement. A New application is a fresh start.

In November, NIH released an eRA Commons tutorial video, Grants Closeout in eRA Commons, to outline the few actions that are needed to prepare and submit acceptable final reports to complete an NIH award. Neglecting to meet these modest but important requirements could have a negative downstream impact on other current or future awards.

Implementation of salary limitation for NIH grant and cooperative agreement awards and extramural research and development contract awards:

• No adjustments will be made to modular grant applications/awards or to previously established commitment levels for non-competing grant awards issued with FY 2015 funds.
• NIH competing grant awards with categorical budgets reflecting salary levels at or above the new cap(s) that are issued on or after the January 11, 2015 effective date, will reflect adjustments to the current and all future years so that no funds are awarded or committed for salaries over the limitation.
• For awards issued in those years that were restricted to Executive Level II (see Salary Cap Summary, FY 1990 – FY 2015), including competing awards already issued in FY2015, if adequate funds are available in active awards, and if the salary cap increase is consistent with the institutional base salary, grantees may rebudget to accommodate the current Executive Level II salary level and contractors may charge at the higher level. However, no additional funds will be provided to these grant awards and the total estimated cost of the contract will not be modified.
• An individual's base salary, per se, is NOT constrained by the legislative provision for a limitation of salary. The rate limitation simply limits the amount that may be awarded and charged to NIH grants and contracts. An institution may pay an individual's salary amount in excess of the salary cap with non-federal funds.
• The salary limitation does NOT apply to payments made to consultants under an NIH grant although, as with all costs, those payments must meet the test of reasonableness and be consistent with institutional policy.
• The salary limitation provision DOES apply to subawards/subcontracts for substantive work under an NIH grant or contract.

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-049.html

More details, including examples of reasons an application may or may not be accepted, can be found at NOT-OD-15-039.

NIH has released the stipend, tuition/fees and other budgetary levels effective for Fiscal Year 2014. Details can be found in Notice NOT-OD-14-046

2. Notice of Legislative Mandates in Effect for FY2014

As a reminder, legislative mandates that in effect for NIH funding for the fiscal year ending September 30, 2014 are listed below.
FY 2013 Legislative Mandates that remain in effect are as follows:

1. (1) Salary Limitation (Section 203)
2. (2) Gun Control (Section 217)
3. (3) Anti-Lobbying (Section 503)
4. (4) Acknowledgment of Federal Funding (Section 505)
5. (5) Restriction on Abortions (Section 506)
6. (6) Exceptions to Restriction on Abortions (Section 507)
7. (7) Ban on Funding Human Embryo Research (Section 508)
8. (8) Limitation on Use of Funds for Promotion of Legalization of Controlled Substances (Section 509)
9. (9) Dissemination of False or Misleading Information (Section (515(b))
10. (10) Certification of Filing and Payment of Taxes (Section 518)
11. (11) Restriction on Distribution of Sterile Needles (Section 522)
12. (12) Public Access to Scholarly Publications (Section 527)

More information can be found in Notice NOT-OD-14-053.

3. NIH Fiscal Policy for Grant Awards – FY2014

The NIH Fiscal Policy for grant Awards Includes FY2014 funding levels for non-competing continuations, Ruth L. Kirschstein National Research Service Awards, New Investigators, and Salary Limits. More information can be found in Notice NOT-OD-14-055.

Please come have lunch on Tuesday, May 13 at the Research Affair’s LUNCH SEMINAR.

The presentation will cover:

research phases1-mall business innovation research phases1-3

• Small business innovation research phases1-3
• STTRs, R-43, and R-44 grant
• U-grant and K-grants
• R01s
• R01 and R21 grants and equivalents
• Diversity pre-doctoral awards and supplements
• What NIH and the DOD are looking for in these grant mechanisms

Three distinguished presenters with deep knowledge on the topic will present:  Wolff Kirsch, MD; Carlos Casiano, PhD; and Andrew Crofton, PhD candidate

Don’t miss out.  Please RSPV now if you want to attend (and especially, if you want lunch)  Last time, we were "oversold" by 90%, so responding quickly is a good idea if this is of interest to you. 

click to  RSVP   (Please include your name and extension)

The New Biographical Sketch format is here!  Starting January 2015 reformat your biosketch to meet the new required format.

Update: New Biographical Sketch Format Required for NIH and AHRQ Grant Applications Submitted for Due Dates on or After May 25, 2015 - See more at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-032.html#sthash.hMBM887u.dpuf

NIH and AHRQ encourages applicants to use the newly published biosketch format for all grant and cooperative agreement applications submitted for due dates on or after January 25, 2015, and will require use of the new format for applications submitted for due dates on or after May 25, 2015.

Link to the new Biographical Sketch forms - http://grants.nih.gov/grants/funding/424/index.htm#format

Effective immediately, it is sufficient to outline the changes made to the Resubmission application in the Introduction attachment. The Introduction must include a summary of substantial additions, deletions, and changes to the application. It must also include a response to weaknesses raised in the Summary Statement. The page limit for the Introduction may not exceed one page unless indicated otherwise in the Table of Page Limits.
- See more at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-030.html#sthash.HNPs18qn.dpuf

The original announcement is found at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-030.html

What is SciENcv?

(From the FAQs) Science Experts Network Curriculum Vitae (SciENcv) is an electronic system that helps researchers assemble the professional profile needed for application of federal funds. SciENcv is a cooperative project requested by the Federal Demonstration Partnership (FDP), which is an association of academic research institutions and federal agencies. In collaboration with FDP, the product is being built by the National Center for Biotechnology Information (NCBI) at the National Institutes of Health under the aegis of an interagency workgroup composed of members from the Department of Defense, the Department of Energy, the Environmental Protection Agency, the National Institutes of Health, the National Science Foundation (NSF), The Smithsonian, and the United States Department of Agriculture.

SciENcv documentation: http://www.ncbi.nlm.nih.gov/sciencv

SciENcv YouTube video tutorial: http://youtu.be/PRWy-3GXhtU

Provide feedback to: info@ncbi.nlm.nih.gov

Take Notice!

If there is one concept that we are reminded about daily and that we try to remind you about, it is that the grant application and award process is complex.  Part of what makes it so complex is that it is highly dynamic; ever changing, adjusting and adapting to political, economic, and technological forces.  As a result we need to communicate critical changes with regards to processes and policy to you.  We accomplish this through a variety of the methods, such as Items of Interest newsletters (eRA and eSubmission), the Extramural Nexus, Dr. Rockey’s Rock Talk blog, etc.

The most formal method of communication is via Guide Notices.  Guide Notices (NOT) are official NIH announcements relating to a change in policy, procedure, form, or system.  Notices can be searched for at the NIH Guide.  And searches can be subscribed to via the recently added subscription service. Watch this tutorial to learn more about the subscribe feature.

You may wish to take note of these recent and/or important notices:

1. “Ruth L. Kirschstein National Research Service Award Individual Predoctoral Fellowship to Promote Diversity in Health-Related Research” applications (PA-14-148) now require the attachment, “Additional Educational Information” as part of the application.  This information is attached under the Other Attachments section of the application.  See Guide Notice NOT-OD-14-095 for more information.

2. Starting on October 17, 2014 the Research Performance Progress Report (RPPR) will be expanded to include all Type 5 Non-SNAP Progress Reports.  You can learn more about this requirement reading Guide Notices NOT-OD-14-092.

3. On a related note, please remember that starting in October 2014 (just a few weeks away!) eRA Commons Usernames for graduate and undergraduate student project roles will be required for both the PHS 2590 Non-Competing Continuation Progress Report and Research Performance Progress Report (RPPR). For more information on this change, you can read Guide Notice NOT-OD-13-097.

“Knowledge is of two kinds. We know a subject ourselves, or we know where we can find information on it.”

�?? Samuel Johnson

Everyone Wants to be Included

And conversely, no one wants to be left out. Inclusion Management System (IMS). It’s coming in October.  You may recall in the May eRA Items of Interest, I shared with you information about a new feature coming to eRA Commons that will be referred to as IMS.  IMS is replacing the existing Population Tracking System to ensure the appropriate inclusion of women and minority groups in clinical research. The Principal Investigator will be responsible for providing inclusion data for grants in an electronic format (instead of a fillable PDF attached to the application, the PI will complete a structured data form that will automatically populate IMS). These inclusion enrollment grant application forms were released in September, 2013. (NOT-OD-13-091).

Starting on October 17, 2014, inclusion data will be accessible in eRA Commons using IMS.  It should also be noted the submission of all RPPRs on or after October 17^th will need to use the link to the new IMS system (located in Section G.4.b of the RPPR) to report inclusion data, even if the report was due prior to October 17^th.  As we get closer to October 17^th, look for additional Guide Notices, messages, user documentation and possibly a video tutorial to assist in the transition to IMS.

Seek and Ye Shall Find…

Binoculars.  Binoculars are good for finding things.  Things that are outside. Binoculars are not good for finding things not outside. They are not good to leave on a picnic table. In Canada. After crossing into North Dakota.  Especially when they are your Dad’s binoculars.  That can make things difficult.

And like forgotten binoculars, we often hear about how difficult finding information on our web pages, User Guides, and other resources can be.  So here are some pointers, tips, and (hopefully) helpful suggestions.

1. Remember that each grants.nih.gov web page and each era.nih.gov web page has a key word search tool in the upper right corner.  While this technology is not new, what you might not know is that there is a team of folks who constantly analyze the trends of information people are searching for and make adjustments to the tool. These adjustments are designed get you to the results you want faster.

2. For most major components of eRA Commons, there is now Online Help.  You can access the help systems by going to the eRA Modules, User Guides, and Documentation page and clicking “Online Help” under each heading.  These systems also have a keyword search tool that looks at the contents of the entire help documentation for matches.

3. A little less obvious is the “Crtl-F” keyboard shortcut for Windows (“Cmd-F” on Mac). By pressing and holding the Crtl key and then pressing the F key, you will bring up a “search this page” feature built into the operating system of the computer.  This will work on word documents, PDFs, and web pages.  It will scan the text for the keyword and highlight it and/or allow you to scroll through each instance. 

Hopefully these little tips will help make it easier to find the information you need.  At least easier than my Dad had it... face red with anger, veins popping off his head, trying hard not to tear the steering wheel off the car when we had to pass through customs 3 times in one day! And just so you know, the binoculars were right there on the table, right where I left them!

Pop the Corn and Pull Up a Seat

So in another flashback, you may recall the March 2014 Items of Interest where I introduced three new tutorials on Understanding Status.  No?  I don’t blame you. The article is completely forgettable.  The tutorials, however, are not.

With that in mind, 4 new tutorials have joined the eRA Video Tutorials page:

Accessing the Notice of Award (SO & PD/PI)

Video 7 of the Status series examines how to access the Notice of Award (NoA) document when a grant application has received funding.    The NoA spells out all the details of the award, including amount of funding, and all the terms and conditions of the award.

Accessing Just In Time (SO & PD/PI)

Video 8 looks at how to access and submit Just in Time (JIT) information.  Frequently after an application has gone through the peer review process and before a funding decision is made, the assigned Institute or Center (IC) will request additional information such as IACUC, IRB, and/or Human Subject Assurances. Just in Time is the process of providing that information to NIH.

Change of Institution (SO & PD/PI)

Video 10 demonstrates how a Signing Official can access and submit a Relinquishing Statement (RS) as part of the Change of Institution process.  The Change of Institution process allows the grantee institution to give up, or surrender, a grant to another institution, who will take over the approved research project.  The Signing Official submits a Relinquishing Statement (RS) to Grants Management which initiates the Change of Institution request.

The Department of Medicine is pleased to be hosting a free research course from the National Institutes of Health (NIH), open to anyone interested in learning more about research:

“Introduction to the Principles and Practice of Clinical Research (IPPCR)”

http://www.cc.nih.gov/training/training/ippcr.html

The Introduction to the Principles and Practice of Clinical Research (IPPCR) is a supplemental course to train you on how to effectively conduct clinical research. The course focuses on the spectrum of clinical research and the research process by highlighting epidemiologic methods, study design, protocol preparation, patient monitoring, quality assurance, and Food and Drug Administration (FDA) issues. Other areas covered include data management and ethical issues, including protection of human subjects, building a budget, plus many special topics.

All are welcome to enroll. There is no fee for the course. You may view the course live, or via web-broadcast on your personal computer and at your own convenience. An optional, open-note exam from NIH will be given at the end of the course. All registered participants are eligible to take the exam to be awarded a Certificate of Completion from the NIH for the course.

The first session will be launched:

Tuesday, October 14, 2014

1:30 PM – 3:30 PM

LLU Medical Center A-Level Amphitheater

Thereafter, the live transmissions will take place twice weekly, on Mondays and Tuesdays from 2:00 – 3:30 PM at LLU Medical Center. See attached syllabus for more information. Please note: some meeting locations are TBD. An updated syllabus will be provided to registered students, indicating meeting locations.

You must register to gain access to the IPPCR course and materials, whether you plan to view the course remotely or in person during the live stream.

To register, please go to:

http://ippcr.nihtraining.com/register.php?remote_site=true

Select Loma Linda University under “Name of Organization” from the drop down menu, and fill in all required fields (with red asterisks next to them)

Registration closes on October 6, 2014 so please enroll prior to do this date. 

For more information, please email Azmina Ghelani, MPH at aghelani@llu.edu.

Undergraduate & Graduate Accounts in Commons

Is everyone getting younger?  Or am I just getting older?  Having passed the half century mark, I have become keenly aware that… I see young people.  And as eRA Commons has gotten older, it can be said that it, too, is starting to see young people.

Since August 15, 2013, the functionality to create accounts for students has been available.  However, as part of the NIH effort to improve data on the biomedical workforce (BMW), undergraduate and graduate students who participate in NIH-supported projects for at least one person-month of full-time work will eventually be required to have an eRA Commons account for reporti

Back in November of 2013, both the PHS 2590 Non-Competing Continuation Progress Report and Research Performance Progress Report (RPPR) started checking to see if graduate and undergraduate students' Commons User IDs were included in the report.  They aren’t quite mandatory at this point.  You will get a warning from the electronically submitted RPPR for students listed on the report, but who do not have a Commons name.

Starting in October 2014, Commons User IDs will be required for these students. NIH will not accept RPPRs or PHS 2590s that do not have this information.

For more information on Commons User IDs for students, read the August 2, 2013, Guide Notice and the Extramural Nexus article. As Dr. Rockey points out in her Nexus article, it will be critical for all students to create their personal profile in Commons as this information will eventually “reduce burden in the long run by pre-populating some reporting fields and forms.”  For more information on the Personal Profile, you can watch the Personal Profile Overview video.

I hope I get over this “seeing” thing soon, because every time I see the couple that lives a few doors down from me, I find it hard to believe they’re married… looks more like they should be getting ready for prom… junior prom (sigh).

Choose Carefully, IamDaBomb

Related to the article above, please remind undergraduate and graduate students that eRA Commons User IDs are for the life of their scientific career.  So while “IamDaBomb,” “WillDoubleHelix4U,” or “2MoreResearch” seem clever and witty now, in 5, 10, or 30 years it will create a kind of “face-palm” moment.

A Commons User ID should not be specific to their current institution, as in don’t use the student’s institution email address or have the institution initials as part of the ID.  Principle Investigators (PI) may be affiliated with multiple institutions over their career and having a user ID related to an institution they are no longer associated with can be confusing. Undergraduate and graduate students should work together with their Signing Official or Account Administrator (AA) to create a Commons User ID that will be professional, appropriate and can be saved for future reference.

Signing off, from “1B2B3” (and if you get that reference… well, you’re awesome!)

Joe Schumaker

eRA Communications

Division of Communications and Outreach

NIH Office of Extramural Research

1. Check your publications. All publications that received funding from NIH must be submitted to PubMed Central and have a PMCID assigned. Not sure what this means? See http://publicaccess.nih.gov/policy.htm.

Still have questions? Call Sherie Donahue (x83911 or sdonahue@llu.edu). Past experience has shown that it usually takes two weeks for the publications to get through the approval and tagging process, so plan accordingly.

2. Commons IDs. All key personnel, postdocs, and graduate students must have Commons IDs and it will take time to gather this information. If a Commons account needs to be created forward the name, LLU email address and role for that person to Sherie Donahue (x83911 or sdonahue@llu.edu).

3. The PI must initiate the RPPR report in the NIH Commons and then route it in order for it to be approved and submitted. These two steps can only be completed under the PI's login. Therefore, when you have completed your progress report, route the RPPR to your financial analyst for review. Not sure who your analyst is? Call x44589. Another good tip is to send an email to your financial analyst when the report is routed to confirm sure he/she is in the office.

4. Complete and route the RPPR early, at least 2-3 business days before it is due. This gives the Research Affairs office time to review and submit it by the deadline.

Any other questions? Contact Sherie Donahue at x83911 or sdonahue@llu.edu.

Senior/Key Personnel: The PD/PI and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they receive salaries or compensation under the grant. Typically these individuals have doctoral or other professional degrees, although individuals at the masters or baccalaureate level may be considered senior/key personnel if their involvement meets this definition. Consultants and those with a postdoctoral role also may be considered senior/key personnel if they meet this definition. "Zero percent" effort or "as needed" is not an acceptable level of involvement for senior/key personnel.

Non-key Personnel: Personnel (such as research assistants) not contributing in a substantive, measurable way to the scientific development or execution of the project.

Other Significant Contributor (OSC): Individuals who have committed to contribute to the scientific development or execution of the project, but are not committing any specified measurable effort (in person months) to the project. These individuals are typically presented at “effort of zero person months” or “as needed” (individuals with measurable effort cannot be listed as Other Significant Contributors).

Consultant: An individual who provides professional advice or services for a fee, but normally not as an employee of the engaging party. Consultants also include firms that provide professional advice or services.

Now here is the tricky part, Consultants can be listed as Key, Non-key or Other Significant Contributors. Principal Investigators must carefully review the role of the consultant to decide which of the three categories a consultant falls into. If you have any questions on what role should be assigned, please contact Cindy Dickson or Sherie Donahue in Research Affairs.

Letters of support

Provide all appropriate letters of support, including any letters necessary to demonstrate the support of consortium participants and collaborators such as Senior/Key Personnel and Other Significant Contributors included in the grant application. Letters are not required for personnel (such as research assistants) not contributing in a substantive, measurable way to the scientific development or execution of the project.  Letters should stipulate expectations for co-authorship, and whether cell lines, samples or other resources promised in the letter are freely available to other investigators in the scientific community or will be provided to the particular investigators only. For consultants, letters should include rate/charge for consulting services and level of effort/number of hours per year anticipated.  In addition, letters ensuring access to core facilities and resources should stipulate whether access will be provided as a fee-for-service.  Do not place these letters in the Appendix. Consultant biographical sketches should be in the Biographical Sketch section.

Don’t Forget the eSubmission Basics

I had the privilege of spending some time last week with the eRA Commons Help Desk and posed the question - “If you could tell the applicant community one thing about application submission what would it be?” I was a bit surprised to hear the same key messages that we have been pushing for years. On the other hand, that’s why we consider them ‘the eSubmission basics’.

So, here’s a quick reminder…

• Watch out for form fields required by NIH that are not marked required on federal-wide forms (e.g. Credential for PD/PIs and Organization for all entries on R&R Sr/Key Person Profile form; primary site DUNS on Project/Performance Sites form).
• Use PDF format for all attachments. Follow PDF Guidelines.
• Submit early – days, not minutes – to allow time to correct unforeseen errors.
• Track your submission in eRA Commons. Email can be unreliable.
• Check your entire assembled application image in eRA Commons. If you can’t view it, we can’t review it!
• If federal system issues threaten your on-time submission you need to notify the help desk and follow the Guidelines for Applicants Experiencing System Issues.

JIT instructions

In the Commons, the instructions for the JIT is a link to a sample form with this information on the top: For instructions and information pertaining to the use of and policy for other support, see Other Support in the PHS 398 Part III, Policies, Assurances, Definitions, and Other Information. Page 6 of that document states:

‘Information on active and pending Other Support is required for Key Personnel, excluding consultants. For individuals with no active or pending support, indicate “None.” Neither the application under consideration nor the current PHS award for this project should be listed as Other Support. Do not include Other Support for individuals listed as "Other Significant Contributors" unless their involvement has changed so that they now meet the definition of "key personnel."’

RPPR instructions (Version 7.0 dated January 31, 2014) state:

“D.2.c Changes in other support.

Has there been a change in the active other support of senior/key personnel since the last reporting period?

If yes, upload active other support for senior/key personnel whose support has changed and indicate what the change has been. List the award for which the progress report is being submitted and include the effort that will be devoted in the next reporting period. “

www.ndriresource.org

The National Disease Research Interchange (NDRI) provides project-driven human biospecimen service to academic and corporate scientists for biomedical research. NDRI’s extensive recovery network has the experience and capability to provide nearly every human tissue and organ.   Our high quality biospecimens are commonly utilized to establish primary cell cultures and for rigorous molecular methodologies such as RNAseq.  Frequently requested biospecimens and delivery service options include:

• Whole heart, atrium, AV valve, SL valve, ventricle, and blood vessels
• Whole lungs, bronchus, lung lobe, trachea, and blood vessels 
• Intact organs and gross anatomical structures
• Region/ area-specific tissue samples
• Rapid biospecimen preservation and delivery intervals
• Shipped frozen, fixed or on ice in culture media with antibiotics

If you have any questions, please contact Thomas Bell at 1-800-222-NDRI, extension 247 or tbell@ndriresource.org. 

The three newest videos for your viewing enjoyment (and if not enjoyment, then at least you might learn something new from them) are:

Status for PD/PIs (PD/PI Only)

This video reviews the steps for accessing the features available to a Program Director (PD) / Principal Investigator (PI) in the Status module. The video also examines the search options and organization of the Status Result screen table.

Detailed Status Information (SO & PD/PI)

Video 5 of this series looks at the Detailed Status Information screen. The Detailed Status Information screen is the culmination of the latest information about your grant application, including critiques, scores, NIH contact information, award information, and more.

Accessing the Summary Statement (PD/PI Only)

Video 6 of the Status series looks at the steps a Principal Investigator (PI) takes to access the Summary Statement. Additionally, the video summarizes, at a high level, the review process for grant applications. It is this review process that generates an evaluative document called the Summary Statement.  Because the Summary Statement is considered an evaluation, it is only

What is Unicode compatible and why should investigators care? Unicode is a way that computers can understand all the modern characters of almost all the written languages in the world.

1. As a result of this upgrade, eRA systems will be able to accept Greek characters as they appear in the original scientific text submitted by grantees. For instance, Greek characters will now appear in progress reports without resulting in garbled text. 

2. Because Unicode will support Greek and other scientific characters, the attachments in  your application can be more accurately assigned for evaluation; reviewers will be able to better understand your goals and objectives; and NIH will be able to better categorize awards for reporting. Note that Grants.gov has not yet adopted Unicode, so until they do so you cannot use Unicode in any of the actual form fields.

IMPORTANT NOTE: Though investigators will be able to use special characters in information submitted directly into NIH systems, data fields in proposals submitted through Grants.gov are cannot contain special characters.

More information on this upgrade can be found at NOT-OD-14-071 (NIH Extramural Grant Systems Upgrade for Unicode Compatibility Means Memorial Day Weekend Downtime).

Table of Contents

Ten Steps—Outlined

Step 1: Conduct a Self Evaluation

Step 2: Find Your Niche

Step 3: Draft Specific Aims

Step 4: Identify a Study Section

Step 5: Size Up Your Specific Aims

Step 6: Outline Your Experiments

Step 7: Build Your Team

Step 8: Define Resources

Step 9: Nail Your Budget

Step 10: Write to Excite

Grant Writing for Success, NIH Peer Review; Mapping Your Career with NIH; Interacting with NIH Electronically; A Walk Through the SF424 (R&R); and Working with Program: PreAward and PostAward.  For more information, please see:

http://grants.nih.gov/grants/regionalseminars/Baltimore_2013/index.html

• Individual Research Career Development Award Programs (Ks), Institutional Training and Career Development Programs (Ts and Ds) and Individual National Research Service Awards (Fs) applicants will be required to use FORMS-C packages for due dates on or after January 25, 2014.

• Small Business programs (SBIR/STTR) applicants will transition to FORMS-C packages later in 2014, when we can combine these form changes with anticipated form changes relating to the Small Business Authorization Act.

Details of the form changes are documented at http://grants.nih.gov/grants/ElectronicReceipt/files/FORMS-C_Changes.pdf.

Full details can be found at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-074.html

NIH grantees with Streamlined Noncompeting Award Process (SNAP) and Fellowship awards are now required to use the Research Performance Progress Report (RPPR) format in the NIH eRA Commons, for awards with start dates on or after July 1, 2013. Progress reports for these awards submitted in any other format will not be accepted and must be resubmitted in the RPPR format. Note that noncompliance with these requirements will jeopardize the NIH’s ability to issue timely awards. Questions regarding the RPPR can be directed to Sherie Donahue (x83911, sdonahue@llu.edu).

What does this mean to you, the investigator? If you are planning to submit to NIH on or after September 25, work with Sherie Donahue (x83911 or sdonahue@llu.edu) and Cindy Dickson (x44571 or cdickson@llu.edu) to make sure you are using the correct funding announcement package.

Last year NIH said that they would not fund non-competing continuations unless all publications were compliant with the Public Access Policy, i.e., a full copy of the publication had been deposited in PubMed Central. Now NIH is adding language to the terms and conditions of new awards stating that if a grant is not compliant with the NIH Public Access Policy, all funds for the grant will be restricted with the exception of those costs associated with patient care and or animal care until that requirement is met. No research activities can occur during the restricted period and any salaries and fringe benefits paid during that time will be at the institution’s expense.

2. NIH to require NIH Commons IDs for Graduate and Undergraduate Students.

The requirement for all principal investigators and post docs to have an NIH Commons ID will now be extended to graduate and undergraduate students (NOT-OD-13-097). Graduate students listed on a current grant may request an NIH Commons account by sending an email to researchaffairs@llu.edu.

3. NIH has announce the availability of a Beta version of the Science Experts Network, (SciENcv).

This new electronic system will enable researchers to easily assemble the information (including expertise, employment, education and professional accomplishments) to populate an NIH biographical sketch (biosketch).  Initially, the goal of SciENcv is to reduce the burden associated with creating and maintaining federal biosketches while accommodating the need to describe scientific contributions.

Users can get to SciENcv by going to the NCBI sign-in page at https://www.ncbi.nlm.nih.gov/account/ where they will have the option to sign in using third-party accounts (for example, an eRA Commons account, a local institutional account through InCommon, or a Google account). Full documentation on how to use My NCBI is located at http://www.ncbi.nlm.nih.gov/books/NBK3842/.  Information on how to set up and use the SciENcv tool is located at http://www.ncbi.nlm.nih.gov/books/NBK154494/. 

The beta version of SciENcv will allow users to explore the system and create an NIH biosketch.   Users also are invited to identify features that need to improved or added to fully serve the needs of the research community.  Suggestions can be entered using the utility provided at info@ncbi.nlm.nih.gov.  A number of enhancements are already planned for future versions of SciENcv including the ability to generate biosketches for other federal agencies as well as other functionality listed below

• Generate and maintain multiple biosketches including those for NSF and other federal science agencies
• Describe the scientific impact of past discoveries
• Ingest data from additional external systems
• Control data exposure
• Transfer data to other systems
• Allow delegates to manage data

For more information: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-114.html

The course information, topics & objectives, and schedule can be found at http://www.llu.edu/assets/research-affairs/docs/nih_2012-2013_at_llu.pdf. This course is an invaluable tool for all who are interested in the design, conduct, and analysis of research.  The live transmission will take place at the LLU Medical Center locations described on the attached schedule.  Optional arrangements could be made for delayed viewing (within 72 hours after each lecture date) via the NIH lecture website if you are not able to attend in-class.  

You may register to attend the conference using the following login :  http://ippcr.nihtraining.com/register.php?remote_site=true , select Loma Linda University from the Name of Organization drop down list and then complete the Student Information, Contact Information, and Affiliation information sections.  

In addition to registering on the NIH  website, please also email Blen Eshete, MPH, at beshete@llu.edu with confirmation of your registration by Friday September 28^th. This is for internal logistical reasons i.e. to ensure availability of  sufficient course materials  ahead of each lecture and to facilitate all future course –related correspondences/updates.