1. Handling Research Misconduct Allegations At the Highest Institutional Level Alexander P. Runko, Ph.D. Scientist-Investigator Office of Research Integrity Division of Investigative Oversight U.S. Department of Health and Human Services April 15, 2016

2. Disclaimers  The information in this presentation does not constitute official HHS policy statements or guidance.  The views and opinions expressed in this presentation are solely those of the author and do not represent the official position of HHS, ORI, or its employees.  The information in this presentation is not a substitute for official policy statements, guidance, applicable law, or regulations. The Federal Register and the Code of Federal Regulations are the official sources for policy statements, guidance, and regulations published by HHS.

3. I. Protect the health and safety of the public II. Promote the integrity of U.S. PHS-supported research and the research process III. Conserve public funds Office of Research Integrity (ORI)’s Functions Respond to allegations of research misconduct Oversee institutional investigations, procedures and compliance with PHS policies Provide guidance to whistleblowers, institutional officials and the public Teach responsible conduct of research Administer PHS findings of research misconduct and administrative actions

4. Handling Research Misconduct Allegations At the Highest Institutional Level Receipt of Allegations Sequestration Integrity of the Scientific Record Conflicts of Interest International Participants

5. Complainants - Variety of Sources: Laboratory / InstitutionCollaborators / Co-authors Anonymous Blogs / Websites Journal editorsPeer reviewers ORI Funding agencies / organizations I. Receipt of Allegations  Record / transcribe interview  Relevant and material information  Meet directly with Complainant(s)

6. Challenges  Confidentiality Complainants informed their supervisor, departmental head, journal, colleagues or social media  Quality of information provided Where the f/f/p occurred and how it was discovered, digital/paper evidence/records  Communication Open for further comment or testimony, establish dialogue I. Receipt of Allegations Institutional policy on communication, emails, tweets -> Employee work rules Institutional policy on evidentiary standards, Training of RIO Institutional policy on employees’ cooperation

7. I. Receipt of Allegations  Assessment Time Jurisdiction/referral, sequestration, notice to Respondent(s)  Consultation Guidance from institutional officials, legal counsel, ORI or funding agency, IT staff for sequestration of records  Protection/Retaliation Relocate Complainant to a new lab or office Institutional policy on determination on how/if/when an Inquiry/Investigation is warranted Training of RIO, Compliance Director, IACUC, IRB, IBC (biosafety), other staff Institutional policy on good/bad faith allegations, restoration of reputation

8. AwareComprehensive I. Receipt of Allegations  Confidentiality  HR Policies  Trained Staff  Whistleblower Policy Timely  Responsive  Assessment Be prepared to A C T !

9. 42 C.F.R. § 93.305 II. Sequestration  Team RIO, IT staff, forensic experts, legal counsel, security, assistants, witness  Documentation Chain of custody forms - itemized/detailed (date, description, location, access) Signed receipts by Respondent  Time Early as possible after Assessment Before/during notice of allegations to Respondent(s)

10.  Secure storage of evidence Locked/protected Accessibility  Evidence Laboratory notebooks, binders, documents Personal and shared computers Laboratory instrumentation External hard drives and disks (thumb/flash/jump, CDs/DVDs, SD/memory cards) Email accounts / Servers  Anticipate additional research misconduct Expand the scope of the investigation beyond initial allegations Include other relevant research records for possible f/f/p  Anticipate sequestration of records from additional Respondents II. Sequestration

11. Challenges  Incomplete Sequestration Additional lab members, Respondents later identified  Additional records recognized later Core facilities (vivariums, animal records, purchasing records) Lab instrumentation / equipment (microscopes, HPLC, FACS, scintillation counters) Undocumented evidence, personal computer  Poor sequestration methods Non-forensic electronic copies, loss of metadata, corrupted files  Chain of custody deviations Unsecured evidence Evidence intentionally or negligently destroyed or lost II. Sequestration RIO Training : ORI BootcampGuidance to Investigation Committee RIO’s coordination with sequestration team & other staff (IACUC) Institutional policy on personal records/devices Training of sequestration team Institutional policy on sequestration

12. II. Sequestration AwareComprehensive  Staff training  Documentation  Additional misconduct  Additional Respondents Timely  Assessment  Collection

13.  Institutional policy on research records retention / data management III. Integrity of the Scientific Record  NIH policy Grantees must retain their records (and accessibility) for three years  PHS policy Research data is owned by the grantee institution, not the researcher  42 C.F.R. § 93.106 (b) Burden of proof. (1) The institution or HHS has the burden of proof for making a finding of research misconduct. The destruction, absence of, or respondent's failure to provide research records adequately documenting the questioned research is evidence of research misconduct where the institution or HHS establishes by a preponderance of the evidence that the respondent intentionally, knowingly, or recklessly had research records and destroyed them, had the opportunity to maintain the records but did not do so, or maintained the records and failed to produce them in a timely manner and that the respondent's conduct constitutes a significant departure from accepted practices of the relevant research community.

14. III. Integrity of the Scientific Record Challenges  Inadequate or failure to maintain laboratory records  Intentional or negligent loss or destruction of records Remedies  Mandatory training of PIs and staff Grants management guidelines  Institutional data retention requirements Professional and personal computers, emails, Cloud storage, Dropbox accounts  Audits / Institutional monitoring

15. III. Integrity of the Scientific Record AwareComprehensive  Management  Training Timely  Monitoring

16.  Identification of real, apparent or perceived conflicts of interest (COI) IV. Conflicts of Interest  Free from bias and of professional, financial, personal, or other substantial ties to the Respondent and Complainant Mentor / supervisor, collaborator, co-PI, co-author Inquiry / Investigation committees RIO and Institutional officials  Notice to Respondent and opportunity to object  Management 93.305 – Using a consortium or other person Confidentiality agreements & disclosure forms

17. IV. Conflicts of Interest Challenges  Risk of poor judgment, case integrity compromised  Violation of terms of awarded grants/contracts, institutional policies and Federal regulations Remedies  Institutional oversight of COI Unbiased review by institutional staff  Disclosure -> Review -> Management -> Enforcement

18. IV. Conflicts of Interest AwareComprehensive  Disclosure  Institutional review Timely  Management

19. Challenges  Language and culture barriers  Mentor-mentee relationships  Visa issues V. International Respondents / Complainants / Witnesses Remedies  Communication Establish and maintain dialogue Institutional policy on interpreters/translators  Collaboration & network Liaison offices / agents: Asia Pacific Research Integrity Network (APRI), ENRIO, ARIO World Conference on Research Integrity

20. www.wcri2017.org Theme: Accountability and Transparency

21. AwareComprehensive  Barriers  Communication V. International Respondents / Complainants / Witnesses Timely  Network

22. Handling Research Misconduct Allegations At the Highest Institutional Level Receipt of Allegations Sequestration Integrity of the Scientific Record Conflicts of Interest International Participants Be prepared to: Aware - Institutional Policies Comprehensive - Staff Training Timely - Assessment

23. Alexander P. Runko, Ph.D. Scientist-Investigator, Division of Investigative Oversight Office of Research Integrity U.S. Department of Health and Human Services 1101 Wootton Parkway, Suite 750 Rockville, Maryland 20852 Phone: (240) 453-8422 Email:Alexander.Runko@hhs.gov AskORI@hhs.gov Website: http://ori.hhs.gov