1. Communicating With Your Program Director : Understanding the Who, Why & How Elisa Woodhouse Division of Cancer Biology New Grantee Workshop March 18, 2015

2. What do Program Directors do? I. Pre-Award Phase: o Advise scientists on grant applications o Attend study section reviews o Advise applicants on summary statements and resubmissions o Resolve issues on scientific overlap, budget, human/animal subjects and other IRG concerns, foreign applications/foreign components o Manage appeals o Work with grants management specialists on making awards

3. What do Program Directors do? II. Post-Award Phase: o Monitor progress of research grants o Review and approve annual progress reports o Report major advances to NCI/NIH leadership o Identify gaps/needs/opportunities in the cancer research arena o Monitor compliance of regulations, policies, special terms of the award o Contact point for requests of administrative supplement funding

4. What does the NIH need to know about you? Information about you, the PI: via the “Personal Profile” section of eRA Commons –Your name, your degrees, your institution, your department, your academic rank, your address, your phone number, your email, etc. –Important to keep the information current.

5. What does the NIH need to tell you? –Status updates on your applications and grants, via the “Status” section of eRA Commons Documents received/accepted, study section assignment, study section SRO, NIH IC assignment, NIH Program Director/Officer, score, Summary Statement, Notice of Grant Award, etc. You can follow the status of an application as it moves through the system.

6. What does NIH need to know about your research? About your progress (both published and unpublished) over the most recent funding period. Progress reports are required annually to document grantee accomplishments and compliance with terms of award. It is important that the progress report be submitted on time! They describe scientific progress, identify significant changes, report on personnel, and describe plans for the subsequent budget period or year. I’ll highlight elements of the scientific write-up.

7. What’s “Normal” for an R01 Progress Report? Most are about 2-5 pages Most list and follow order of Specific Aims Some have figures, some don’t All discuss successes, some discuss problems/failures Publications (We will talk more about this!) Most take the PI a day or two to prepare --not an hour and not a week

8. What’s “Not Normal” for an R01 Progress Report? “Too much” data/progress -Is this really an accounting of just one year of progress? Does it make clear what is prior years’ vs. most recent year’s progress? -Is this really an accounting of progress from just this grant? Does it make clear whether some data come from other funding to PI’s lab, which may synergize with this project?

9. What’s “Not Normal” for an R01 Progress Report? “Too little” data/progress - Is this really an accurate account of PI’s total progress for the grant’s most recent year? Will require contact with PI to answer this. -If No, then PI needs to revise to provide sufficient information on progress, results, difficulties, etc. - If Yes, then PD and PI need to discuss problems PI is encountering, PI’s plans for getting back on track, what PD can do to help, etc., especially for New PIs. PD should explore/consider whether this is a recurring issue with this grant and/or PI.

10. What are some special cases? Grants requesting/proposing a change in scope –Significantly increasing the work proposed, due to rapid progress, new trainees, etc. –Significantly shifting the work proposed, due to new techniques, reagents, collaborators, etc. –Increases and shifts may require new IRB, IACUC, and/or biohazard approvals –Decreasing the work proposed, due to major budget cuts (normally occurs when the grant is initially awarded) These changes require pre-approval by the NIH

11. What are some more special cases? Grants with supplements requiring progress reports: -Administrative supplements, in response to a PA or initiated by PI: for new research opportunity within the scope of parent project -Diversity training supplements: for students, post-docs, junior faculty, re-entry -“Revision” supplements: major increase in scope and funding of grant; reviewed by study section, very rare Report should describe progress and plans, plus relationship to parent grant

12. NIH Public Access Policy The Policy implements Division G, Title II, Section 218 of PL 110-161 (Consolidated Appropriations Act, 2008) which states: The Director of the National Institutes of Health shall require that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine’s PubMed Central an electronic version of their final, peer- reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law. Key steps for awardees: 1) Deposit paper upon acceptance for publication 2) Cite article (using PMC number)

13. Evidence of Compliance Compliance codes in the RPPR and My NCBI report FundableNot Fundable Complete N/A (not applicable) PMC Journal In Process In process at NIHMS Non-compliant ◦ Awards will be placed on hold until grantees have demonstrated compliance ◦ For RPPRs, My NCBI is an integral part of the reporting process ◦Check public access compliance on My NCBI periodically ◦ Refer questions to the public access support center PublicAccess@mail.nih.gov

14. Having trouble submitting a report or updating your profile?  eRA Commons Helpdesk:  http://era.nih.gov/help/ http://era.nih.gov/help/  1-866-504-9552 or 301-402-7469

15. PIs are encouraged to: ◦ Let your Program Director know about scientific breakthroughs. ◦ Reach out to your Program Director if you have any concerns related to the project. ◦ As you develop new applications, you can discuss with your Program Director.

16. Thank you!