Research Affairs: Researcher's Alert for October 21, 2015 http://myllu.llu.edu/syncall/communityhome/?communityId=6088 en-us Sun, 28 Apr 2024 07:44:10 -0700 SyncAll RSS 1.0 6088:23739 <![CDATA[IMPORTANT: NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications]]> Sherie Donahue Notice Number: NOT-OD-16-004
Release Date:   October 13, 2015

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 Instructions for individual fellowship applications will be incorporated into the general application guide and no longer maintained as a separate document.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

Topic

Change

Rigor and Transparency*

We are changing application requirements and review language to enhance reproducibility of research findings through increased scientific rigor and transparency. These changes will take effect for most research grant applications (including small business and complex research grant applications), but will not impact institutional training and individual fellowship applications until Phase II.

Changes include:

  • Updates to application guide instructions for preparing your research strategy attachment
  • Use of a new "Authentication of Key Biological and/or Chemical Resources" attachment (uploaded in Other Attachments section of R&R Other Project Information form)
  • Additional rigor and transparency questions reviewers will be asked to consider when reviewing applications 

See NOT-OD-16-011 and NOT-OD-16-012.

Vertebrate Animals*

We are removing redundancy with Institutional Animal Care and Use Committee review while meeting the requirements of the Public Health Service Policy on Humane Care and Use of Laboratory Animals.

Changes include:

  • Updated guidance on criteria to be addressed (description of procedures; justifications; minimization of pain and distress; and euthanasia)
  • A description of veterinary care is no longer required
  • Justification for the number of animals has been eliminated
  • A description and justification of the method of euthanasia is required only if the method is not consistent with AVMA Guidelines for the Euthanasia of Animals

See NOT-OD-16-006.

Note: This change does not apply to AHRQ applications.

Definition of Child*

We are redefining 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.

See NOT-OD-16-010.

Note: This change does not apply to AHRQ applications.

Research Training

We are updating requirements and instructions for several attachments on the PHS 398 Research Training Program Plan form to reflect recent policy guidance and reduce applicant burden.

Changes include:

  • "Recruitment and Retention Plan to Enhance Diversity" - applicants will be asked to focus on recruitment
  • "Human Subjects" - applicants must describe how the institution will ensure that trainees only participate in exempt human subjects research or non-exempt human subjects research that has IRB approval; no longer necessary to provide a list of potential grants trainees may work on and associated IRB information
  • "Vertebrate Animals" - applicants must describe how the institution will ensure that trainees only participate in vertebrate animal research that has IACUC approval; no longer necessary to provide a list of potential grants trainees may work on and associated IACUC information
  • "Progress Report" - requirement to report on publications that arose from work conducted by the trainee while supported by the training grant will be moved to the Just-in-Time process

*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

Topic

Change

Rigor and Transparency*

We are extending Phase 1 changes to include institutional training and individual fellowship applications.

We are adding a new "Authentication of Key Biological and/or Chemical Resources" attachment to the following forms in FORMS-D application packages:

  • PHS 398 Research Plan
  • PHS 398 Career Development Supplemental Form
  • PHS Fellowship Supplemental Form

New “Plan for the Instruction in Methods for Enhancing Reproducibility” attachment will be added to the PHS 398 Research Training Program Plan form in FORMS-D application packages.

Vertebrate Animals*

We are extending Phase 1 changes to include institutional training and individual fellowship applications.

See NOT-OD-16-006.

We are adding new questions regarding euthanasia to the following forms in FORMS-D application packages to replace the euthanasia criteria in the vertebrate animals section:

  • PHS 398 Research Plan
  • PHS Fellowship Supplemental Form

Note: These changes do not apply to AHRQ applications.

Inclusion Forms*

We are adding an optional PHS Inclusion Enrollment Report form to FORMS-D application packages.

The new form, with additional study descriptors, will replace the optional Planned Enrollment Report and Cumulative Inclusion Enrollment Report forms found in FORMS-C application packages.

We will provide more details about these changes prior to release of the updated forms.

Data Safety Monitoring Plans

We are adding a new “Data Safety Monitoring Plan” to the following forms in FORMS-D application packages:

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

This new attachment must be included with all applications involving clinical trials.

Although the requirement of a data and safety monitoring plan for clinical trials is not new, the use of a separate attachment to collect this information will emphasize its importance and facilitate systematic enforcement of its presence. 

Research Training

We are changing the research training data table format.

Changes include:

  • Reducing the number of tables from 12 to 8
  • Minimizing the reporting of individual-level information
  • Extending the tracking of trainee outcomes from 10 to 15 years

NIH’s xTRACT system to help applicants prepare the new tables will be available October 16, 2015.

See NOT-OD-16-007.

Appendix Policy

We are reevaluating the current appendix policy. A notice describing specific appendix policy changes will be issued by spring 2016.

New PHS Assignment Request Form 

We are adding an optional PHS Assignment Request Form to FORMS-D application packages to provide a consistent way to collect application referral information, including:

  • Awarding component (NIH institute) assignment preference
  • Study Section preference
  • List of potential reviewers in conflict, and why
  • List of scientific expertise needed to review the application
  •  

See NOT-OD-16-008.

New Font Guidelines

We are providing additional flexibility regarding the fonts allowed in PDF attachments included in grant applications.

Although we will continue to recommend specific fonts, we will also allow other fonts (both serif and non-serif) as long as they comply with specific type density and line spacing guidelines.

See NOT-OD-16-009.

Biosketch Clarifications

We are clarifying biosketch instructions.

Clarifications include:

  • Indicating that a URL for a publication list is optional and, if provided, must be to a government website (.gov) like My Bibliography
  • Allowing publications (peer-reviewed and non-peer-reviewed) and research products to be cited in both the personal statement and the contributions to science sections
  • Explicitly stating that graphics, figures and tables are not allowed

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

Resources:

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

]]> Wed, 21 Oct 2015 09:53:24 -0700 6088:23736 <![CDATA[Sex in the Laboratory: NIH expectations for gender representation in human and animal research]]> Anu Diekmann notice from the NIH will likely change how human subject research is planned, reviewed, and conducted.  Although women now account for...]]> Sex in the Laboratory: NIH expectations for gender representation in human and animal research

A recent notice from the NIH will likely change how human subject research is planned, reviewed, and conducted.  Although women now account for roughly half of all participants in NIH-supported clinical research, basic and preclinical biomedical research has focused on male animals and cells. 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 from the scientific literature, preliminary data, or other relevant considerations must be provided for applications proposing to study only one sex.

]]> Tue, 20 Oct 2015 14:28:19 -0700 6088:23735 <![CDATA[Updated Names of IRB Application Forms]]> Anu Diekmann "Minimal Risk Studies" "Standard" > "Clinical]]> Updated Names of IRB Application Forms

The following IRB application names have been updated on the IRB Toolkit for Investigators to clarify when to use them:

  • “Social Behavioral” > “Minimal Risk Studies”
  • “Standard” > “Clinical Trial”
]]> Tue, 20 Oct 2015 14:27:49 -0700 6088:23734 <![CDATA[Revised IRB Applicant Checklist]]> Anu Diekmann Revised IRB Applicant Checklist

The IRB Applicant Checklist has been updated to provide information about naming conventions for full board electronic submissions.  Further details about naming conventions are provided in this guidance document.

]]> Tue, 20 Oct 2015 14:27:06 -0700 6088:23675 <![CDATA[Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals]]> Sherie Donahue
Please see the important notice below from NIH regarding changes to the Vertebrate Animals Section of Grant Applications. These requirements, as applicable, will take effect for all grant applications except Fellowship (F series) and Training (T series) grants for due dates on or after January 25, 2016, and will take effect for all applications for due dates on or after May 25, 2016.
Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals

Notice Number: NOT-OD-16-006

Key Dates
Release Date:   October 13, 2015

Related Announcements
NOT-OD-16-004   

Issued by
National Institutes of Health (NIH)

Purpose

This Notice is to inform potential applicants and offerors that the requirements of the Vertebrate Animals Section (VAS) of grant applications, cooperative agreements and contract proposals has changed. The changes have been made to remove redundancy with Institutional Animal Care and Use Committee review while meeting the requirements of the Public Health Service Policy on Humane Care and Use of Laboratory Animals.

Updated VAS Requirements
If live vertebrate animals are to be used, federal policy requires applicants to address the following criteria:

  • Description of Procedures. Provide a concise description of the proposed procedures to be used that involve vertebrate animals in the work outlined in the application or proposal. Identify the species, strains, ages, sex and total number of animals by species to be used in the proposed work. If dogs or cats are proposed, provide the source of the animals.
  • Justifications. Provide justification that the species are appropriate for the proposed research. Explain why the research goals cannot be accomplished using an alternative model (e.g., computational, human, invertebrate, in vitro).
  • Minimization of Pain and Distress. Describe the interventions including analgesia, anesthesia, sedation, palliative care and humane endpoints to minimize discomfort, distress, pain and injury.
  • Euthanasia. State whether the method of euthanasia is consistent with the recommendations of the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals. If not, describe the method and provide a scientific justification. 

Anticipated Implementation
These requirements, as applicable, will take effect for all grant applications except Fellowship (F series) and Training (T series) grants for due dates on or after January 25, 2016, and will take effect for all applications for due dates on or after May 25, 2016. For contracts, see individual Requests for Proposals (RFPs) for details.

Summary of Changes
The VAS criteria are simplified by the following changes:

  • A description of veterinary care is no longer required.
  • Justification for the number of animals has been eliminated.
  • A description of the method of euthanasia is required only if the method is not consistent with AVMA guidelines.

Application Review Criteria
As applicable for the project proposed, reviewers will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of procedures involving animals including species, strains, ages, sex and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for the euthanasia method if not consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals.

Resources
See the Vertebrate Animals Section webpage for more information on the VAS requirements. Here you will find a checklist, detailed instructions, plus links to worksheets.

Inquiries

For questions or further information, contact:

Office of Laboratory Animal Welfare (OLAW)
Telephone: 301-496-7163
Email: olaw@od.nih.gov

]]> Thu, 15 Oct 2015 08:04:26 -0700 6088:23674 <![CDATA[ Research 'Funder-mentals': Highlights and insights from the wonderland of UK research funding]]> Sherie Donahue The 'Research Fundermentals  Highlights and insights from the wonderland of UK research funding' blog offers a great great explanation of what it means for research to have impact, and how to capture that impact:

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

]]> Thu, 15 Oct 2015 07:51:59 -0700 6088:23559 <![CDATA[American Heart Association winter funding announcements and deadlines]]> Cindy Dickson American Heart Association Winter Funding Announcements and Deadline Dates

http://my.americanheart.org/professional/Research/FundingOpportunities/ForScientists/For-Scientists_UCM_316962_SubHomePage.jsp

Undergraduate Student Research Program
Midwest USRP | SouthWest USRP | Western States USRP
The purpose of this undergraduate research training program is to encourage promising students from all disciplines, including women and members of minority groups underrepresented in the sciences, to consider research careers while supporting the highest quality scientific investigation broadly related to cardiovascular disease and stroke.
Offered by: Great Rivers Affiliate
Career Stage: Making the decision – undergraduate student classified as junior or senior.

Predoctoral Fellowship
Helps students initiate careers in cardiovascular and stroke research by providing research assistance and training.
Offered by: Founders, Great Rivers, Greater Southeast, Mid-Atlantic, Midwest, SouthWest, and Western States Affiliates
Career Stage: Gaining credentials – doctoral student

Postdoctoral Fellowship
Helps trainees initiate careers in cardiovascular and stroke research while obtaining significant research results under the supervision of a sponsor or mentor; supports individuals before they are ready for some stage of independent research.
Offered by: Founders, Great Rivers, Greater Southeast, Mid-Atlantic, Midwest, SouthWest, and Western States Affiliates
Career Stage: Directed step - postdoctoral fellow

Mentored Clinical & Population Research Award (formerly Clinical Research Program)
Encourages early career investigators who have appropriate and supportive mentoring relationships to engage in high quality introductory and pilot clinical studies that will guide future strategies for reducing cardiovascular disease and stroke while fostering new research in clinical and translational science, and encouraging community- and population-based activities.
Offered by: Founders, Great Rivers, Greater Southeast, Mid-Atlantic, Midwest, SouthWest, and Western States Affiliates
Career Stage: Directed step/first independent step - master's degree. Healthcare professionals with a master's degree or certain doctoral degrees.

Association-wide Fellow-to-Faculty Transition Award
This program provides funding for trainees with outstanding potential for careers as physician-scientists in cardiovascular or stroke research during the crucial period of career development that spans the completion of research training through the early years of the first faculty/staff position.
Offered by: Association-wide Research Program
Career Stage: Directed step - postdoctoral fellow

Scientist Development Grant
Supports highly promising beginning scientists in their progress toward independence by encouraging and adequately funding research projects that can bridge the gap between completion of research training and readiness for successful competition as an independent investigator.
Offered by: Founders, Great Rivers, Greater Southeast, Mid-Atlantic, Midwest, SouthWest, and Western States Affiliates
Career Stage: First independent step – instructor, assistant professor or other first academic appointment or equivalent

Western States Affiliate Medical Student Research Program
Encourages promising students, including women and members of minority groups underrepresented in the sciences, from all disciplines to consider research careers while supporting the highest quality scientific investigation broadly related to cardiovascular disease and stroke. The research opportunity will allow students to work for 8, 10 or 12 weeks with a faculty/staff member on any project broadly related to cardiovascular disease/function or stroke. The goal is to encourage students to consider a future academic career in this area.
Offered by: Western States Affiliat


Grant-In-Aid
Encourages and adequately funds the most innovative and meritorious research projects from independent investigators. 
Offered by: Founders, Greater Southeast, Mid-Atlantic, Midwest, SouthWest, and Western States Affiliates
Career Stage: First independent step, intermediate level or recognized investigator – instructor, assistant professor or other first academic appointment or equivalent, associate professor or equivalent, professor or equivalent. Applicants are expected to be independent investigators.

Mentor/AHA Mentee Award
This unique program funds mentors to work with AHA early career grantees who are:

  • working in new/difficult areas of inquiry or potential for new discovery,
  • underrepresented racial and ethnic groups in science, or
  • conducting research at NIH AREA-designated institutions.

AHA Programs for Winter 2016 Deadlines

 

Applications for the Winter 2016 programs listed below will be available in Grants@Heart in mid-November.  For strategically focused programs such as CVGPS and SFRN, check the program webpage for additional application information.

Several programs have a broad target audience. You should always refer to the program description for details.

 

Application Deadlines

Updated:Oct 1,2015
Important: the application deadline for Winter 2016 programs is 5:00 p.m. Central Time on the specified deadline day.

The institutional grants officer is responsible for submitting applications to the AHA.  It is recommended that the applicant factor in time to submit the application to the grants officer for them to submit the application to the AHA.  Early submission is encouraged.

Founders Affiliate - DEADLINE:  January 15, 2016 

  • Grant-in-Aid 
  • Mentored Clinical & Population Research Award
  • Postdoctoral Fellowship
  • Predoctoral Fellowship
  • Scientist Development Grant

Great Rivers Affiliate- DEADLINE:  January 12, 2016

  • Mentored Clinical & Population Research Award
  • Postdoctoral Fellowship
  • Predoctoral Fellowship
  • Scientist Development Grant

Greater Southeast Affiliate - DEADLINE:  January 15, 2016

  • Grant-in-Aid
  • Mentored Clinical & Population Research Award
  • Postdoctoral Fellowship
  • Predoctoral Fellowship
  • Scientist Development Grant

Mid-Atlantic Affiliate - DEADLINE:  January 12, 2016

  • Grant-in-Aid
  • Mentored Clinical & Population Research Award
  • Postdoctoral Award
  • Predoctoral Award
  • Scientist Development Grant

Midwest Affiliate - DEADLINE:  January 13, 2016

  • Grant-in-Aid
  • Mentored Clinical & Population Research Award
  • Postdoctoral Fellowship
  • Predoctoral Fellowship
  • Scientist Development Grant
  • Undergraduate Student Research Program**

Association-wide Research Program - DEADLINE:  January 13, 2016

  • Collaborative Sciences Award***
  • Fellow-to-Faculty Transition Award
  • Mentor/AHA Mentee Award
  • Merit Award
  • Strategically Focused Research Network*

SouthWest Affiliate - DEADLINE:  January 14, 2016

  • Grant-in-Aid
  • Mentored Clinical & Population Research Award
  • Postdoctoral Fellowship
  • Predoctoral Fellowship 
  • Scientist Development Grant
  • Undergraduate Student Research Program**

Western States Affiliate - DEADLINE:  January 14, 2016

  • Grant-in-Aid
  • Mentored Clinical & Population Research Award
  • Postdoctoral Fellowship
  • Predoctoral Fellowship
  • Scientist Development Grant
  • Undergraduate Student Research Program**
  • Medical Student Research Program**
]]> Thu, 08 Oct 2015 09:51:56 -0700