National Institute of Health: Updates from NIH Regional Seminar 2017 Chanda Robe, MHA Senior Grant Administrator November 3, 2017

Executive Summary The following will be discussed: Release of the New Issue of the NIH Grants Policy Statement Revised for FY 2018 Where to find the Forms E Grant Application Package and Instructions Ways to identify a clinical trial study What is the Human Subject/Clinical Trials (HS/CT) Form page When the New Funding Opportunity Announcements with Forms-E application Packages will be Released Update on Research Performance Progress Report Reminders on Grants Policies

NIH Grants Policy Statement Issued for FY2018 Grants Policy Statement (NIHGPS) The NIH issued a new Grants Policy Statement (NIHGPS, rev. October 2017) on October 1, 2017. The changes are applicable to all NIH and cooperative agreements with budget periods beginning on or after October 1, 2017. While the revision does not introduce new material, it does clarify and modify certain policies. *A summary of significant changes that are within the October 2017 NIHGPS can be found here: https://grants.nih.gov/grants/policy/nihgps/Significant_Changes_NIHGPS_Oct2017.pdf NIH Grants Policy Statement See NOT-OD-18-005 for additional information

FORMS-E Grant Applications Forms and Instructions Forms- E must be used for due dates on or after January 25, 2018 Forms-E application packages Forms E Application Package Identify the right Funding Opportunity Announcement (FOA) Tip: Check your FOA at least 30 days before the due date for any updates Determine if your grant announcement accepts clinical trials All the Parent Announcements (PAs) will be reissued, check here frequently https://grants.nih.gov/grants/guide/parent_announcements.htm The Application Form Instructions for Forms E can be found here https://grants.nih.gov/grants/how-to-apply-application-guide.html Applications submitted using the incorrect application package for their dues date may be withdrawn and removed from funding consideration Submit Early! See NOT-OD-18-009 and NOT-OD-17-062 and NOT-OD-17-119 for additional information

FORMS-E Grant Applications Forms and Instructions Ways to identify if NIH considers your study to be a Clinical Trial? If “YES” to ALL of these question, your study is considered a clinical trial Does your study involve the following: Involve one or more human subjects? Involve one or more interventions? Prospectively assign human subject(s) to intervention(s)? Have a health-related biomedical or behavioral outcome? Impacts whether you need to: Respond to a clinical trial specific FOA Address additional review criteria specific for clinical trials Register and report your clinical trial in ClinicalTrial.gov Clinical Trial NIH Definition: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. With a broader definition, many more studies are classified as clinical trials. Why the changes to NIH-funded studies involving human subjects? Lack of transparency in results reporting; impedes scientific progress dishonors research participants wastes tax-payers’ research funding New NIH Clinical Trial Initiatives will help to : Maximize use of knowledge from clinical trials Facilitate clinical trials design and reduce duplication Promote dissemination of research information and results Foster responsible stewardship of public’s research investment Refer to the Decision Making Tool https://grants.nih.gov/ct-decision/ See NOT-OD-15-015 for additional information

FORMS-E Grant Applications Forms and Instructions Forms- E must be used for due dates on or after January 25, 2018 Forms-E application packages PHS Human Subjects and Clinical Trials Information Form Consolidates information from multiple forms e.g human subjects, inclusion enrollment and clinical trial information Presents key information to reviewers and agency staff in a consistent format For more information https://grants.nih.gov/policy/clinical-trials/new-human-subject-clinical-trial-info-form.htm Incorporates structured data fields Collects information at the study-level Aligns with clinicaltrials.gov Initially was throughout the narrative in the application. More standardization and information in one place of the application. Will be easier for reviewers. See NOT-OD-17-062 and NOT-OD-17-119 for additional information

FORMS-E Grant Applications Forms and Instructions Become Familiar with the New Human Subject/Clinical Trial Form Take a video tour of the new form

FORMS-E Grant Applications Forms and Instructions New Funding Opportunity Announcements New FOAs will post after October 25, 2017 with initial due dates on or after January 25, 2018 BUT Forms-E application packages will not be added to these FOAs until November 10, 2017 Clinical Trial Specific Parent R01 and Parent R21 FOAs will post in November NOT-OD-18-010 Three Types of FOAs Clinical Trials not allowed Clinical Trials required Clinical Trials optional e.g. P01 or specific Request for Application Double Check Section II Award Information FOA title (New FOAs only) Information on Funding Opportunity Announcements 3 Types of FOAs Clinical Trials Not Allowed – only accepting applications not proposing clinical trial(s) Clinical Trials Required – only accepting applications proposing clinical trial(s) Clinical Trials Optional – accepting applications that either propose or do not propose clinical trial(s) NIH encourages applicants to SUBMIT a WEEK EARLY to allow time to work through any unforeseen issues

FORMS-E Grant Applications Forms and Instructions Identify Appropriate FOA FOA Title (new FOAs only) FOA Section II. Award Information Link to decision tool to help you determine if you are doing a clinical trial.

Changes to the Review Criteria Additional Review Criteria for FOAs that accept clinical trial Study Timelines Impact Research (R), Individual Career Development (K), Fellowship (F) and Training (T) Awards Read the FOA carefully and be sure your application addresses the review criteria appropriately Detailed Information on changes can be found here https://grants.nih.gov/policy/clinical-trials/review-criteria.htm In addition to the scored criteria significane, investigator, innovation, approach and environment. The NIH now has included additional review criteria for all mechanisms that are considered clinical trials. The timeline Additional for clinical trials Timeline is now included and NIH removed the requirement for milestones. One reason is because after feedback from a focus group, the PI never really new milestones until after the study is performed. See NOT-OD-17-118 and NOT-OD-17-121 and NOT-OD-17-122 and NOT-OD-17-123 for additional information

Research Performance Progress Report (RPPR) RPPR Overview Research Performance Progress Report (RPPR) Used for annual reporting Required by all NIH Agencies & AHRQ Refer to NOGA for other Federal Agencies or GMS Not required in No Cost Extension Year Final Research Performance Progress Report (FRPPR) Used as part of the grant closeout process, available for use in eRA Commons on January 1, 2017 NIH will no longer accept any of the old format Final Progress Report (FPR) for grant closeout. Interim-RPPR (Check with your specific Institute) Used when submitting a renewal (Type 2) application. If the Type 2 is not funded, the interim RPPR will serve as the Final RPPR for the project If the Type 2 is funded, NIH will treat the Interim-RPPR as the annual performance report for the final year of the previous competitive segment. Annual RPPR Interim RPPR Final RPPR Annual RPPR –describes a grant’s scientific progress, identify significant changes, report on personnel, and describe plans for the subsequent budget period or year. Interim RPPR – Use when submitting a renewal (Type 2) application. If the Type 2 is not funded, the Interim RPPR will serve as the Final RPPR for the project. If the Type 2 is funded, the Interim RPPR will serve as the annual RPPR for the final year of the previous competitive segment. The data elements collected on the Interim RPPR are the same as for the Final RPPR, including project outcomes. Changes made to the NIH Grants Policy statement where the Final Research Performance Progress Report: Removes previous NIH Type 2 policy, which allowed progress reports submitted in Type 2 applications to serve in lieu of a separate final progress report. NIH now requires that organizations submit an “interim-RPPR” while their renewal (Type 2) application is under consideration. In the event that the Type 2 is funded, NIH will treat the Interim-RPPR as the annual performance report for the final year of the previous competitive segment. If the Type 2 is not funded, the Interim-RPPR will be treated by NIH staff as the institution’s Final-RPPR. Final RPPR – Use as part of the grant closeout process to submit project outcomes in addition to the information submitted on the annual RPPR, except budget and plans for the upcoming year. See NOT-OD-17-022 and NOT-OD-17-085 and NOT-OD-17-037 for additional information

RPPR Overview Project Outcomes Requirement A new section of the RPPR specifically designed to be made publicly available by the agency Reporting in the Outcomes section is limited (by the federal-wide RPPR format) to 8,000 characters The Outcomes should provide a concise summary of the findings of the award written in lay language for the general public In an effort to increase transparency NIH will make the Outcomes data available in RePORTER *Only for the FRPPR and Interim-RPPR NIH requires recipients to report on Project Outcomes in Section I of the Interim and Final-RPPR. Therefore, in each scenario listed above, Project Outcomes must be provided by the recipient in order for the recipient to submit their final report in eRA Commons. Otherwise, eRA Commons will not allow recipients to submit the required report and recipients will be considered non-compliant. If a recipient fails to comply with this reporting requirement, NIH may take one or more enforcement actions, such as a decision to withhold a non-competing continuation award, consistent with NIHGPS Chapter 8.5.2.

RPPR Deadlines FRPPR Deadline Reminders Standard NIH Awards SNAP due 45 days prior to the start date and Non-SNAP first of the month preceding the month in which the budget period ends Fellowships Due 60 days (2 months) before the beginning of the next budget period Training Grants Due 120 days before the grant anniversary date Multi-year Funded (MYF) Due on or before the anniversary of the budget project period start date of the award AHRQ Due 3 months before the anniversary of the award NIH final reports due within 120 days from the end of the project period; AHRQ final reports due 90 days from end of project period RPPR Deadlines FRPPR Deadline Non-SNAP - approximately 60 days before the start of the next budget period SNAP - approximately 45 days before the start of the next budget period Multi-year funded - on or before anniversary date

Reminders NIH GRANT SUBMISSIONS Submit early! Correct any errors before due date View your application in Commons If you can’t VIEW it, NIH can’t REVIEW it!

Appendix

NIH Guide for Grants and Contracts: NIH Listservs NIH Guide for Grants and Contracts: Official publication for NIH Grant Policies, Guidelines & Funding Opportunities http://grants.nih.gov/grants/guide/listserv.htm Office for Human Research Protections (OHRP): http://www.hhs.gov/ohrp Office of Laboratory Animal Welfare (OLAW): http://grants.nih.gov/grants/olaw/references/list.htm eSubmission: Separate listservs available for scientists and administrators http://grants.nih.gov/grants/ElectronicReceipt/listserv.htm

Office of Extramural Research (OER) Web Page: Helpful NIH Web Pages Office of Extramural Research (OER) Web Page: http://grants.nih.gov/grants/oer.htm NIH Grants Policy Statement (Rev. 11/16): http://grants.nih.gov/grants/policy/nihgps/ NIH Extramural Nexus – newsletter for the extramural community: http://nexus.od.nih.gov/all/nexus-by-date/ Grant Application Basics: http://grants.nih.gov/grants/grant_basics.htm eRA Training: Video Tutorials http://era.nih.gov/era_training/era_videos.cfm How to Apply - Application Guide: http://grants.nih.gov/grants/how-to-apply-application-guide.htm

NIH Helpful Webpages Continued… Annotated SF424 (R&R) Application Forms (General and Small Business and Multi-project): https://grants.nih.gov/grants/how-to-apply-application-guide/resources/annotated-form-sets.htm Ten Checks to Help Avoid Common Application Errors: http://grants.nih.gov/grants/how-to-apply-application-guide/learn-how-we-check-your-application-for-completeness/avoiding-common-errors.htm Do I have the right electronic forms for my NIH application?: http://grants.nih.gov/grants/ElectronicReceipt/files/right_forms.pdf Self Help Resources page: http://grants.nih.gov/support/index.html