Trends in the Research Environment Research Administrators Open - PowerPoint PPT Presentation

Trends in the Research Environment Research Administrator’s Open Forum Academic & Research Integrity February 11, 2020

Why Do I Care? • Trends in government actions impact sponsor terms and negotiations • Expectations on researchers are changing and need to plan for new administrative requirements that may be coming • Open communication allows us to better “connect the dots” and prevent unintended issues • Implications of non-compliance are becoming more serious OFFICE FOR Academic and Research Integrity 2

Trends to Watch Focus on Research Environment • OSTP Joint Committee of the Research Environment ( Request for Information-84 FR 65194) 1. Rigor & Reproducibility 2. Research Security 3. Fostering a Safe & Inclusive Environment 4. Addressing Administrative Requirements • JASON Fundamental Research Security Report & Recommendations (NSF) • NIH & NSF Anti-Sexual Harassment Policies • Sponsor terms and conditions-COI, Harassment, Research Misconduct OFFICE FOR Academic and Research Integrity 3

More Concrete Requirements Coming… National Academies of Sciences, Engineering, Medicine and Public Policy, “Fostering Integrity in Research” Recommendations (2017) ◦ Increase funding for data storage ◦ Encourage publishing of negative findings, all statistical tests performed ◦ Data & code sharing mandates ◦ Mentoring guidance NIH Rigor & Reproducibility Effort https://grants.nih.gov/reproducibility/index.htm OFFICE FOR Academic and Research Integrity 4

Enforcement is Increasing There are always laws… • False Claims Act • Recipient Obligations • Reverse False Claims Act • NIH Grants Policy Statement • General fraud & abuse • Grants Office of Mismanagement Inspector Federal & General/ Nonfederal Department Sponsors of Justice OHRP & Other Private FDA & Individual/ Institutional Entities Review Boards • Whistleblowers • 45 CFR Part 46 • 21 CFR Part 56 • Qui Tam Litigants, • Serious & • Journalists, Journals, Continuing Employers Noncompliance OFFICE FOR Academic and Research Integrity 5

Office of Inspector General False Claims Act (31 USC § 3729(a)(1)(A) & (B) An person who — (A) knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval; [or] (B) knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim[.] Liability for Institution , Not Individual Respondent. What did the “institution” know? When did the “institution” know it? TREBLE DAMAGES OFFICE FOR Academic and Research Integrity 6

Cases in Press: Willingness to Leverage FCA to Spur More Institutional Action • Research misconduct (Duke Case) • Failure to disclosure grants outside the U.S. (Van Andel Research Institute Case; Others pending) • Tighter oversight on payback options when compliance violation reported The warning bell has rung! OFFICE FOR Academic and Research Integrity 7