NIH Update Joel Snyderman, Assistant Grants Compliance Officer, Division of Grants Compliance and Oversight Office of Policy for Extramural Research Administration, OER, NIH National Conference on College Cost Accounting (NACCA) Meeting October 4th, 2017

NIH is funded under the Continuing Appropriations Act, 2018 and Supplemental Appropriations for Disaster Relief Requirements Act, 2017 (Public Law 115-56), signed by President Trump on September 8, 2017 which funds the government until December 8, 2017. Funding is continued at 99.32 percent of the FY 2017 level. All FY 2017 legislative mandates remain in effect. See NOT-OD-17-124 for details.

FY 2018 NIH Grants Policy Statement The updated NIHGPS will be available on October 6, 2017 and will include the significant changes table. The revised Grants Policy Statement will be applicable to all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2017. Until publication, NIH will continue to publish interim grants policy changes through the issuance of NIH Guide Notices via the NIH Guide for Grants and Contracts. Stay tuned for additional information!!!

Biomedical Research Workforce Policy Updates

Research Career Development Salary Supplementation Update Significant Policy Change!! For effort not directly committed to a Career “K” award, NIH will allow recipients to devote effort, with compensation, on Federal or non- Federal sources as the Program Director/Principal Investigator (PD/PI) or in another role (e.g., co-Investigator). Recipients may devote effort while serving in these roles as long as the specific aims of the other supporting grants(s) differ from those of the “K” award. . See NOT-OD-17-094 for additional information.

Additional Guidance on “Full-Time Training” for NRSA Awards NIH recognizes that NRSA fellows and trainees may seek part-time employment incidental to their training program to offset their expenses. Therefore, NIH issued additional guidance clarifying that fellows and trainees may spend on average, an additional 25% of their time (e.g., 10 hours per week) conducting the following activities part time: Research Teaching, or Clinical employment As long as the activities do not interfere with, or lengthen, the duration of their research training. . See NOT-OD-17-095 for additional information.

Clinical Trial Reform Policy Reminders

NIH Clinical Trial Reform Overview Over the past couple of years, the NIH has launched a multifaceted effort to improve the quality and efficiency of the clinical trials that it supports. Specifically, the changes implemented during this effort aim to achieve the following: Enhance the application and award process Increase NIH’s ability to assess the merits and feasibility of clinical trial applications Improve oversight and transparency Increase sharing of clinical trial results. “To realize the benefits of a clinical trial, the data must be broadly shared quickly. The DHHS has released a regulation for registration and summary results reporting. The NIH will withhold clinical trial funding if the agency is unable to verify adequate registration and results reporting…” JAMA 2016 (online September 16, 2016)

NIH Definition of “Clinical Trial” On October 23, 2014, NIH published its revised definition of “clinical trial”: 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. NIH revised its definition of “clinical trial” for the following reasons: To make the distinction between clinical trials and clinical research studies clearer, and To enhance the precision of the information NIH collects, tracks, and reports on clinical trials. See NOT-OD-15-015 for additional information.

Funding Opportunity Announcements (FOAs) for Clinical Trials Effective for due dates on/after January 25, 2018 - All grant applications involving one or more clinical trials must be submitted through an FOA specifically designated for clinical trials. Clinical Trial-specific FOAs allow NIH to: identify proposed clinical trials ensure that key pieces of clinical trial-specific information are submitted with each application uniformly apply clinical trial-specific review criteria Learn more at https://grants.nih.gov/policy/clinical-trials/specific-funding-opportunities.htm See NOT-OD-17-043 for additional information.

New Human Subjects & Clinical Trials Information Form A primary component of NIH’s clinical trial reform is the creation of a new application form that: Consolidates human subjects, inclusion enrollment, and clinical trial information into one form Collects information at the study-level Uses discrete form fields to capture clinical trial information and provide the level of detail needed for peer review Presents key information to reviewers and staff in a consistent format Aligns with ClinicalTrials.gov (where possible) for future data exchange with ClinicalTrials.gov See NOT-OD-17-062 for additional information.

Single Institutional Review Board (sIRB) Policy for Multi-site Research Effective for due dates on/after January 25, 2018 – NIH expects that all multi-site studies which involve non-exempt human subjects research funded by the NIH, will use a single Institutional Review Board (sIRB) to conduct the ethical review required for the protection of human subjects. sIRB policy aims to: Streamline IRB review process to enhance research efficiency Reduce unnecessary administrative burdens and inefficiencies Learn more at https://grants.nih.gov/policy/clinical-trials/single-irb-policy-multi-site-research.htm See NOT-OD-17-076 for additional information.

NIH Policy on Dissemination of NIH-Funded Clinical Trial Information Effective January 18, 2017 – All NIH-funded awardees and investigators conducting clinical trials must register and report the results of their trial in ClinicalTrials.gov NIH dissemination policy: Extends previous HHS policies to apply to all NIH-funded clinical trials instead of defining a subset of “applicable clinical trials” Increases the availability of information to the public about clinical trials Learn more at https://grants.nih.gov/policy/clinical-trials/reporting/index.htm See NOT-OD-16-149 for additional information.

21ST Century Cures Update

Certificates of Confidentiality Section 2012 of the 21st Century Cures Act Requires the Secretary to issue CoCs to investigators or institutions engaged in: Biomedical Behavioral, or Other research in which identifiable, sensitive information is collected “Covered Information” Previously, NIH provided these protections through the issuance of Certificates only upon receipt and approval of an application. See NOT-OD-17-109 for additional information.

What is a CoC? A certificate of confidentiality applies to biomedical, behavioral, clinical or other research that collects or uses identifiable, sensitive information. The certificate protects researchers from involuntary disclosure (e.g. subpoenas) of names and other identifiable information about research participants. Certificates protect the data in perpetuity.

New CoC Policy Prior to 21st Century Cures, researchers chose whether to apply for a Certificate. In order to minimize the burden to researchers, NIH will now provide certificates automatically to any NIH-funded research (grants, contracts, cooperative agreements, other transaction awards and intramural research) covered by the Policy. Therefore, this Policy will be implemented as follows: Effective October 1, 2017, applies to research commenced or ongoing as of December 13, 2016. For new and non-competing awards, compliance with data protection requirements will become a term and condition of award for grants, via the NIH Grants Policy Statement.

New CoC Policy - continued NIH will continue to consider requests for Certificates for non-federally funded research. For the time being, NIH will continue to consider requests for Certificates for research within the scope of NIH’s mission funded or supported by other Federal Departments or agencies. Resources Additional information such as FAQs are available on the NIH Certificates of Confidentiality website. https://humansubjects.nih.gov/coc/index Guide Notice Open Mike Blog Questions can be sent to the CoC inbox. NIH-CoC-Coordinator@mail.nih.gov

21st Century Cures Administrative Burden Update Accelerating the discovery, development and delivery of 21st century cures and for other purposes. Relieves Administration Burden for Researchers: Financial Conflict of Interest (FCOI) Sub-recipient monitoring Financial Expenditure Reporting Procedures https://www.congress.gov/bill/114th-congress/house-bill/34

Protecting Life in Global Health Assistance (PLGHA)

Protecting Life in Global Health Assistance (PLGHA) On January 23, 2017, President Trump signed the Presidential Memorandum reinstating the 2001 Presidential Memorandum on the “Mexico City Policy”. Expands the policy to include US global health assistance: Directs “the Secretary of State to implement a plan to extend the requirements of the reinstated Memorandum to global health assistance furnished by all departments or agencies” . Under the expanded policy, “global health assistance” includes funding for international health programs, such as those for HIV/AIDS, maternal and child health, malaria, global health security, and family planning and reproductive health. See NOT-OD-17-083 for additional information.

Protecting Life in Global Health Assistance (PLGHA) (cont.) NIH will implement the requirements of Protecting Life in Global Health Assistance through terms and conditions of award for all applicable new PEPFAR grants and cooperative agreements and to existing awards when amended to add new funding. For NIH, this policy applies to Foreign NGOs (e.g., foreign private institutions) directly supported by or that are subrecipients of U.S. NGOs. This policy does not apply to U.S. NGOs ; Foreign governments (e.g., foreign public universities and public international (multilateral) organizations, such as the World Health Organization); and subrecipients of awards made to U.S. governmental institutions (e.g., public universities). Each organization will have the opportunity to indicate its agreement to abide by the terms of the new policy by accepting the provisions in its award. Foreign NGOs that agree not to perform or actively promote abortion as a method of family planning, or provide financial support to any other foreign non-governmental organization that conducts such activities, will remain eligible for global health assistance funding. The provisions for these PEPFAR awards may be found on: https://grants.nih.gov/sites/default/files/HHS%20Standard%20%20Provision_ProtectingLifeinGlobalAssist ance_HHS_May%202017.pdf .

Reminders: Regulatory and Compliance Requirements

HHS Regulations 45 CFR Part 75 – Public Welfare, Uniform Administrative Requirements, Cost Principles and Audit Requirements for HHS Awards Effective for all HHS awards made on or after December 26, 2014 http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75&rgn=div5 See NOT-OD-15-046 for additional information.

Compliance Requirements Cost Principles: 45 CFR Part 75, Subpart E (§ 75.400- § 75.477) Institutions of Higher Education (IHE), State, Local Governments and Indian Tribes, and Non-profit Organizations 45 CFR Part 75, Appendix IX Hospitals 48 CFR Subpart 31.2 (Federal Acquisition Regulation): For-Profit Institutions

Timely Progress Reports Annual progress reports = RPPR format Due dates 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 Searchable list to determine which progress reports are due: https://public.era.nih.gov/chl/public/search/progressReportByIpf.era

Timely Financial Reporting Federal Financial Report (FFR) (SF-425) Expenditure Data Annual (Non-SNAP Awards) FFR submitted no later than 90 days after the end of the calendar quarter in which the budget period ended. Final (SNAP and Non-SNAP Awards) FFR submitted within 120 days following the end of the project period.

NIH Closeout Requirements NIH Recipients Must Submit 3 Final Reports within 120 days of the project period end date: Final RPPR Final Federal Financial Report Final Invention Statement Unilateral Closeout (action of last resort)-closeout of an award without the receipt of acceptable reports from the recipient. HHS policy requirement - Unilateral closeout of awards if the final reports referenced above are not timely and acceptable.

Audit Requirements 45 CFR 75.501: 45 CFR 75.501(h) through (k): Institutions of Higher Education, States and Local Governments, and Non-Profit Organizations, including Non-Profit Hospitals 45 CFR 75.501(h) through (k): For-Profits Organizations, including For-Profit Hospitals NIH Grants Policy Statement: Foreign Organizations must follow the same requirements as For-Profit Organizations

Save the Date: 2017 NIH Regional Seminars Fall Regional Seminar Baltimore, MD October 25th – 27th See NOT-OD-17-073 for details.

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