Working with NIH Program Officials: Pre-Award & Post-Award Shawn Gaillard, NIGMS and Francisco Sy, NIMHD 2013 NIH Regional Seminar, Baltimore, MD

OUTLINE NIH Overview Pre-award: Communication w/ Program Staff Post-award: Communication w/ Program Staff

NIH Overview

“To win the future, America needs to out-educate, out-innovate, and out-build the rest of the world.” President Barack Obama, Weekly Address February 5, 2011

U.S. Dept. of Health & Human Services Administration for Children and Families (ACF) Food and Drug Administration (FDA) Health Resources and Services (HRSA) Secretary of Health and Human Services Administration on Aging (AoA) Center for Medicare & Medicaid Services (CMS) Indian Health Services (IHS) National Institutes of Health (NIH) Agency for Healthcare Research and Quality (AHRQ) Centers for Disease Control and Prevention (CDC) Substance Abuse and Mental Health Services Administration (SAMHSA) Agency for Toxic Substances and Disease Registry (ATSDR)

National Institutes of Health NIGMS National Institutes of Health The mission of the NIH is to uncover new knowledge that will lead to better health for everyone by: Conducting research in our own laboratories (Intramural) Providing support for research outside of our labs (Extramural) Training future research investigators Communicating medical information to public Intramural Research R&D Contracts Research Centers Other Research All Other Training Mgmt & Support 3% 5% 6% Research Project Grants (RPG) 53% 10% 11% Annual Budget ~$31 Billion Fiscal Year 2013

27 Institutes and Centers (IC) NIGMS 27 Institutes and Centers (IC) Office of the Director National Library of Medicine Center for Information Technology Scientific Review Fogarty International Center National Institute of Arthritis and Musculoskeletal and Skin Diseases of Diabetes and Digestive and Kidney Diseases of Dental and Craniofacial Research National Institute on Deafness and Other Communication Disorders National Eye Institute National Heart, Lung, and Blood on Alcohol Abuse and Alcoholism National Cancer on Drug Abuse of Environmental Health Sciences of Mental Health of Neurological Disorders and Stroke of Allergy and Infectious Diseases National Center on Minority Health and Health Disparities on Aging of Child Health and Human Development National Human Genome Research of Nursing Research National Center for Complementary and Alternative Medicine for Research Resources Clinical Center National Institute of Biomedical Imaging and Bioengineering of General Medical Sciences no funding authority

NIH Extramural Research Dual Nature of NIH 8 NIH Extramural Research NIH Intramural Research ~ 6K scientists & researchers ~ 10% of NIH budget ~ 90K applications/year ~ 45K ongoing awards/year ~ 3K institutions > 300K scientists & researchers ~ 83% of the NIH budget

Pre-award: Communication w/Program Staff

NIH Application Process Overview Application to NIH NIH Application Process Overview Application to NIH via CSR CSR assigns to IC, SRG Summary Statement (SS) to Applicant SRG 1st level of Review 2nd level of Review = Council Fundable Not Fundable Applicant Notified and Given Feedback IC Makes Award Applicant Evaluates SS Progress Reports Revised Application (x1) Prepared Award Ends, Renewal Application Prepared Time to Talk w/ NIH Program Officer

Communication: Means to Funding Communicate with: NIH staff – esp., PROGRAM OFFICIALS Your Fellow Investigators Your Institutional Administrators

Applicant Institution Authorized Institutional Official TEAMS NIH Applicant Institution Review Officer Principal Investigator Authorized Institutional Official Program Officer Grants Management Administrator Sponsored Research Administrator

Program Official aka Program Director or Program Officer Both a Scientist and Administrator Responsible for the programmatic, scientific, and technical aspects of a grant

Program Official Responsibilities Provide technical assistance to applicants Observe scientific review meetings Discuss review issues with applicants Prepare funding recommendations Manage scientific research/training portfolios Review annual research/training progress of grantees Report scientific progress and program accomplishments Identify opportunities and needs of science specific to an Institute’s mission Communicate program priorities - Funding Opportunity Announcements (FOA) - Request for Applications (RFA)

Program Official (PO) Principal liaison between investigators & NIH Your most important contact Contact us early … Contact us often!

How to Meet a Program Officer? Meet PO at Your Favorite Scientific or Professional Meeting Institute Booths Mingling thru the Crowds Institute sponsored Workshops Ask your Colleagues Search NIH Institute Websites or Directory View names/contact info on FOAs and RFAs

Why Contact a Program Officer? To Direct You to: The appropriate Institute 24 Institutes have granting authority The appropriate Division/Office Basic, clinical, behavioral, translational, training The appropriate Program Official Extramural research portfolio

Must I Contact the NIH Before Applying? --- YES! Mandatory: Application with >$500K budget DC/year R13 Conference Grants Optional: When RFAs request a Letter of Intent Recommended: When you think about applying for ANY grant

Benefits of Making Contact To develop a relationship with a potential program official To assure that your application has a home (appropriate Institute)

Developing Your Application Search NIH RePORT http://projectreporter.nih.gov/reporter.cfm NIH Guide – FOAs and RFAs http://grants.nih.gov/grants/guide/index.html Search Institute Web Sites www.nih.gov/icd/ Contact Institute Staff http://ned.nih.gov/

Before You Submit – Talk to PO Organize your thoughts for productive conversation Grant Purpose: Want a grant from which IC to do what? Problem/Background: Explain why you to think this topic needs study. Demonstrate you know Institute priorities. Significance: Explain why this is important in the field. Question: What hypotheses will you test and what model will guide your hypotheses? Design/Analysis: What is the study design that will enable testing your hypotheses? What statistical approach? Team: Who will be the key participants (co-investigators and organizations) on the project? Miscellaneous: Other issues that may be relevant

… are not done after you submit your application Program Officials… … are not done after you submit your application

PO Attends Review Meeting Observes the review group meeting Is a liaison to Scientific Review Officer (SRO) (e.g., provide clarification of FOA to the panel, if requested by the SRO) Is able to answer your questions about the review (especially useful if your application is unscored)

Review Meeting Review Meeting (or called Study Sections) are managed by NIH personnel called Scientific Review Official who is a PhD-level professional with scientific background close to the expertise of the study section Each standing study section has 12 - 24 members who are primarily from academia As many as 60 - 100 applications are reviewed at each study section meeting

After Peer Review Applicants receive a Summary Statement (SS) Written Account of Essentially Unedited Critiques Overall Resume and Summary of Review Priority Score & Percentile Ranking Budget Recommendations Contact PO to inquire about likelihood of funding If you disagree with facts on SS; contact your Program Official (PO). PO may submit an appeal to Council (2nd level of review) PO- prepares funding recommendations

What Determines Funding? Scientific Merit (Review Group) Program Considerations (Program Official, Advisory Council, IC Director) Availability of funds

Impact Scores & Meanings Additional Guidance on Strengths/Weaknesses NIGMS Impact Scores & Meanings * URM as indicated in FOA. *^ Honors as defined by applicant institution, typically GPA Score Descriptor Additional Guidance on Strengths/Weaknesses 10 Exceptional Exceptionally strong , essentially no weaknesses 20 Outstanding Extremely strong with negligible weaknesses 30 Excellent Very strong with only some minor weaknesses 40 Very Good Strong but with numerous minor weaknesses 50 Good Strong but with at least one moderate weakness 60 Satisfactory Some strengths but some moderate weaknesses 70 Fair Some strengths, at least one major weakness 80 Marginal A few strengths and a few major weaknesses 90 Poor Very few strengths, numerous major weaknesses

Not Funded? Consult with program officer on possible next steps Respond to reviewer concerns Revise application and resubmit

Revise and Resubmit Write a clear Introduction section Address all criticisms thoroughly Respond constructively: don’t be argumentative, abrasive or sarcastic! Acknowledge and accept the help of reviewer comments

Post-award: Communication w/Program Staff

Funded, Now What? Notice of Award (NoA) Legally binding document Award data and fiscal information Grant payment info Terms and conditions of award Grantee accepts terms and conditions of award when draw down funds

PO: Grant Oversight Serve as resource and liaison Answer technical questions Monitor progress of study

PO: Grant Oversight – Progress Reports You Submit Annual Non-competing Renewals Monitor scientific progress Confirm policy adherence Evaluate changes in key personnel or levels of effort Communicate your exciting results

Annual Progress Reports Summary of your accomplishments Specific aims (as funded) Results (during reporting period) Significance Plans for next budget period List of publications generated by project Explain any changes in Human Subjects or Vertebrate Animal Research Report on gender and minority inclusion

Annual Progress Reports Due 60 days prior to budget period start date eSNAP - due date is the 15th day of the month preceding the month in which the current budget period ends Submit Preferred via NIH eRA Commons https://commons.era.nih.gov/commons/index.jsp or to Centralized NIH Receipt Point http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-04-063.html

Progress Report Checklist for PO   Program Looks to See : Is progress satisfactory? (If no, explain.) Add Comment Is there a change in the scope, goals, or objectives of the project? If yes, does this change benefit the project and is it approved? (If not, explain.) Is there a change in key personnel or their level of effort? (If yes, describe.) If there are changes/concerns in the Multiple PI leadership plan, is the new plan acceptable? Is there evidence of scientific overlap? (If yes, explain.) ….. If a progress report for a supplement is required, is progress reported and acceptable? Are there other issues that should be resolved prior to issuing an award? (If yes, provide details.) If any issues have not been resolved, should a restricted award be made?

PO: Grant Oversight – Actions Requiring Prior Approval Change in Scope Significant change in aims, methodology, approach, or other aspects of project objectives Reflects significant change from the project as reviewed and approved Examples: Change in specific aims Change to a different animal model Any change from the approved use of animals or human subjects Shift of research emphasis to a different disease area

PO: Grant Oversight – Actions Requiring Prior Approval Desired Change of Grantee Institution Program Official assesses: If Grant mechanism permits Progress to date Adequacy of new resources and environment Availability of expertise (key personnel) Potential problems (e.g., equipment) Contact NIH Program Officer early!

PO: Grant Oversight – Actions Requiring Prior Approval Desired Change in Status of PI Change of PI >25% change in PI effort PI absence of 90 days or more Note: A project cannot be converted from a single PI to a Multiple PI project during a non-competing phase

NIH Resource Web Links: Overview of Electronic Submission http://era.nih.gov/ElectronicReceipt/ Frequently Asked Questions http://era.nih.gov/ElectronicReceipt/faq.htm Avoiding Common Errors http://era.nih.gov/ElectronicReceipt/avoiding_errors.ht Office of Extramural Research Grants Home Page: http://grants.nih.gov/grants/oer.htm PHS2590 Progress Report (form pgs are PDF-fillable): http://grants.nih.gov/grants/funding/2590/2590.htm

Questions?