• HIPAA Authorizations for Adults [Standard] [Dependency Treatment] (removed paragraph regarding diagnostic and laboratory tests)
• HIPAA Authorizations for Minors [Standard] [Dependency Treatment]  (removed paragraph regarding diagnostic and laboratory tests)
• LLU Waiver of Consent/Authorization (modified to fit longer IRB study number)
• Protocol Change Form (Word) (removed wording about formatting the form)

Call us at x44531 if you need any help navigating our website!

Check the institutional spam trap by logging into spamtrap.llu.edu with your institutional user name and password. Once logged in, you will be able to see messages that were caught in this filter and customize the filter settings on your account.

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

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.

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.

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. “

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.

KEY DATES
Application System Opens: May 23, 2014
Pre-Application Due: July 17, 2014, by 1 p.m., Eastern Standard Time
Pre-Application Decision: October 1, 2014
Full Application Due: November 20, 2014, by 1 p.m., Eastern Standard Time
Award Notification: On or around May 1, 2015
 

Details on all Funding Mechanisms ARE available at www.komen.org/RFA.  

KOMEN RELEASES RFA FOR RESEARCH PROPOSALS FROM YOUNG INVESTIGATORS: Now accepting pre-applications – Due July 17, 2014
 
1. Career Catalyst Research (CCR) Grants

• Eligibility: Applications are open to junior faculty members working at academic institutions who have no more than six years of experience within their faculty appointment
• Funding Level: Up to $300,000 over 2 years or $450,000 over 3 years.
• Training Requirements: Applicants/PIs must propose a mentor committee whose purpose is to provide the research, scientific, clinical, management, and leadership guidance necessary to foster the Applicant/PI’s career advancement. At least one mentor must be at the same institution as the PI and serve as the onsite representative for the entire mentor committee.
• Grant Intent: CCR grants provide support for hypothesis-driven research projects that have significant potential to advance our understanding of breast cancer, lead to reductions in breast cancer incidence and/or mortality, and move us toward the goal of a world without breast cancer.  These grants are intended to foster promising breast cancer researchers who are in the early stages of their faculty careers.

Two Research Focus Areas are included in this mechanism:

• CCR-Clinical Research – for clinical faculty proposing clinical research (as defined within the RFA); and
• CCR-Basic/Translational Research – for basic or clinical faculty proposing laboratory-based biomedical research. 

Postdoctoral Fellowships (PDF)

• Eligibility: Applications are open to postdoctoral fellows who have completed their doctoral degree and are at academic institutions, no more than 5 years after the date of their degree confirmation, or 5 years after completion of their residency (for physicians).
• Funding Level: Up to $120,000 over 2 years or $180,000 over 3 years.
• Training Requirements: Applicants/PIs must include a Lead Mentor who currently conducts breast cancer research at the same academic institution with the postdoctoral fellow.  The primary purpose of the Lead Mentor and Co-Mentor (if applicable) is to provide the research, scientific, clinical, management, and leadership guidance necessary to foster the Applicant/PI’s career advancement.
• Grant Intent: Seek to attract and support promising scientists who are embarking on careers dedicated to breast cancer research.  PDF grants provide support for basic research projects that have significant potential to advance our understanding of breast cancer, lead to reductions in breast cancer incidence and/or mortality, and move us toward the goal of a world without breast cancer.

Two Research Focus Areas are included in this mechanism:

• PDF-Clinical Research – for clinical faculty proposing clinical research (as defined within the RFA); and
• PDF-Basic/Translational Research – for basic or clinical faculty proposing laboratory-based biomedical research. 

 
3. Graduate Training in Disparities Research (GTDR) Grants

• Eligibility: Applications are open to researchers with a doctoral degree at academic institutions who are conducting breast cancer disparities research and are committed to support a training program with a minimum of 3 graduate students/trainees (those in a masters and/ or doctoral program) per year.
• Funding Level: Up to $135,000 per year for up to 3 years for a total of $405,000.
• Training Requirements: The proposed research training program should leverage the current training and research activities available at the applicant institution while also providing new training opportunities that are not currently offered. The program should provide a combination of didactic coursework and hands-on laboratory, clinical and/or public health research experience.  Strong preference will be given to programs that provide a solid plan for recruiting trainees from populations affected by disparities in breast cancer outcomes.
• Grant Intent: Intended to establish and/or to sustain a training program for graduate students who are seeking careers dedicated to understanding and eliminating disparities in breast cancer outcomes across population groups. By providing funding to outstanding training programs, Komen seeks to ensure that a diverse pool of highly trained scientists will emerge as the next generation of leaders in the field of breast cancer research