PHS Policies on Research Misconduct

1. PHS Policies on Research Misconduct Lawrence J. Rhoades, Ph.D. Office of Research Integrity, HHS Native American Research Centers for Health Program November 9, 2005

2. PHS Policies on Research Misconduct • Indian Health Service • National Institutes of Health • Centers for Disease Control and Prevention • Food and Drug Administration • Substance Abuse and Mental Health Services Administration • Agency for Healthcare Research and Quality • Health Resources and Services Administration • Agency for Toxic Substances and Disease Registry • Offices of Regional Health Administrators

3. PHS Policies on Research Misconduct Covers biomedical and behavioral research, research training and related research activities supported by PHS agencies Requires organizations seeking PHS support to file an assurance with the Office of Research Integrity (ORI) stating that the organization has established and will follow a policy for responding to allegations of research misconduct that complies with the PHS Policies on Research Misconduct.

4. PHS Policies on Research Misconduct • Code of Federal Regulations (42 CFR Part 93) • Published in the Federal Register, May 17, 2005, p. 28370 • Available on the ORI home page – http://ori.hhs.gov

5. Establish and Maintain Funding Eligibility • Submit initial assurance • Develop a policy for responding to research misconduct allegations • File the Annual Report on Possible Research Misconduct • Submit the policy to ORI for review upon request • Revise the policy when requested by ORI • Comply with the PHS regulation • Cooperate with ORI in investigations • Cooperate in implementing PHS administrative actions

6. Major Decisions • Policies vs procedures • Minimal vs useful • ORI Model Policy and Procedures • Small Organization Statement

7. Policies/Procedures: Issues to Address • Definition of research misconduct • Reporting allegations • Pursuing allegations • Maintaining confidentiality • Conflicts of interest • Appropriate expertise • Rights of respondents

8. Policies/Procedures: Issues to Address • Role of attorneys/advisors • Sequestration of data/records • Inquiry committee • Conduct of inquiry • Content of inquiry report • Investigative committee • Conduct of investigation • Content of investigative report

9. Policies/Procedures: Issues to Address • Protection of whistleblower • Sanctions • Appeals process • Restoring reputation of respondent • Interim administrative actions • Decision process/rules/maker(s)

10. Minimal vs Useful • To comply with PHS regulation to ensure eligibility for funding - Minimal • To efficiently/effectively respond to allegations of research misconduct - Useful

11. Allegations Minimal Allegations should be reported to the department head. Useful • Oral and/or written • What if the department head is involved? • What happens if whistleblower does not want to proceed? • Anonymous or identified

12. Allegations Information in allegation • Name of respondent(s) • Name of whistleblower(s) • Names of witnesses • Description of misconduct • Supporting documentation • Funding source • Grant number or title

13. Annual Report on Possible Research Misconduct • Submit by March 1 • Renews assurance and maintains funding eligibility • Provides contact information to ORI • Asks whether policy has been established • Asks about research misconduct activity • Number of allegations received • Number of inquiries conducted • Number of investigations conducted

14. Research Misconduct Defined • Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.

15. Fabrication Defined • Fabrication is making up data or results and recording or reporting them.

16. Falsification Defined • Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.

17. Plagiarism Defined • Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.

18. Informing research staff • Informs the institution’s research members about its policies and procedures for responding to allegations of research misconduct, and the institution’s commitment to compliance with the policies and procedures

19. Foster Responsible Conduct of Research (RCR) • Foster a research environment that promotes the responsible conduct of research, research training, and activities related to that research or research training, discourages research misconduct, and deals promptly with allegations or evidence of possible research misconduct.

20. RCR Defined The responsible conduct of research means the functioning of the research process meets the professional obligations of scientists and contributes to the perpetuation of science as a social institution held in high esteem.

21. RCR Education – Core Elements • Data acquisition, management, sharing, and ownership • Protection for human subjects • Animal welfare • Research misconduct • Conflict of interest and commitment • Mentor/trainee responsibilities • Publication practices and responsible authorship • Peer review • Collaborative science Source: PHS Policy on Instruction in the Responsible Conduct of Research - Suspended

22. ORI Website http://ori.hhs.gov