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

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OFFICE FOR

Academic and Research Integrity

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

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OFFICE FOR

Academic and Research Integrity

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

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OFFICE FOR

Academic and Research Integrity

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

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OFFICE FOR

Academic and Research Integrity

Enforcement is Increasing There are always laws…

• 45 CFR Part 46
• 21 CFR Part 56
• Serious &

Continuing Noncompliance

• Whistleblowers
• Qui Tam Litigants,
• Journalists,

Journals, Employers

• Recipient

Obligations

• NIH Grants Policy

Statement

• Grants

Mismanagement

• False Claims Act
• Reverse False

Claims Act

• General fraud &

abuse

Office of Inspector General/ Department

• f Justice

Federal & Nonfederal Sponsors OHRP & FDA & Institutional Review Boards Other Private Individual/ Entities

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OFFICE FOR

Academic and Research Integrity

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

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OFFICE FOR

Academic and Research Integrity

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!