Responsible Conduct of Research: Guidelines and Regulations

1. Responsible Conduct of Research:Guidelines and Regulations Office of Regulatory Research Compliance

2. Objectives: • To provide an overview of the Office of Regulatory Research Compliance and the role of institutional review committees; • To provide an overview of ethical guidelines and research regulations; • To discuss the importance of responsible conduct of research.

3. ABOUT THE OFFICE OF REGULATORY RESEARCH COMPLIANCE

4. About The Office of Regulatory Research Compliance (ORRC) Location: The Office of Regulatory Research Compliance (ORRC) 1840 Seventh Street, NW HURB-1, Suite 309 Washington, DC 20001 202-865-8597(O) 202-232-5286 (Fax) Yonette F. Thomas, PhD Associate Vice President for Research Compliance

5. ORRC Organizational Chart October 21, 2011

6. About The ORRC (cont.) The ORRC currently supports 5 federally mandated review committees: 1. Non-Medical Institutional Review Board (IRB) 2. Medical Institutional Review Board (IRB) 3. Institutional Animal Care and Use Committee (IACUC); 4. Institutional Biosafety Committee (IBC) [health and select agents needs to be added to this committee or a separate committee needs to be formed]; 5. Research Misconduct Committee (RMC) Pending: A Clinical Trials IRB; Institutional Radiation Safety Committee

7. About The ORRC (cont.) The Research Misconduct Committee (RMC) is a faculty peer review committee tasked with reviewing allegations of research misconduct • The Associate Vice President for Research Compliance is the Research Integrity Officer (RIO). • The work of this Committee is monitored by the Office of Research Integrity (ORI) within the U.S. Department of Health and Human Services (HHS).

8. Regulatory Committee Chairs

9. Function of the ORRC • ORRC supports HU in promoting ethical conduct of research and educating faculty and students about human subjects protections, responsible conduct of research, animal care regulations, and bio-safety. • ORRC has oversight of all research approved by an institutional review committee to ensure regulatory compliance and the protection of all human and animal participants involved in research.

10. IRB Metrics 2009-2011 • Non-Medical refers to all non-biomedical studies; • Medical refers to all biomedical studies. • **A Non-Medical IRB was created in March 2011.

11. IRB Metrics 2009-2011 (Jul-Dec) • Non-Medical refers to all non-biomedical studies; • Medical refers to all biomedical studies. • **A Non-Medical IRB was created in March 2011.

12. IRB Metrics 2011 Red = Non-Medical IRB Blue = Medical IRB • Non-Medical refers to all non-biomedical studies; • Medical refers to all biomedical studies. • **A Non-Medical IRB was created in March 2011.

13. Function of the ORRC (cont.) • The ORRC is available: 1. To assist faculty, students, researchers throughout all phases of the research protocol submission process. 2. To provide educational training on research misconduct. 3. To assist researchers in understanding appropriate regulations affecting their proposed research. • ORRC is required to foster the protection of all human participants and animals used in research.

14. Objectives: • To provide an overview of the Office of Regulatory Research Compliance and the role of institutional review committees; • To provide an overview of ethical guidelines and research regulations; • To discuss responsible conduct of research.

15. SPECIAL NOTE! NO HUMAN SUBJECTS RESEARCH, ANIMAL RESEARCH, OR RESEARCH INVOLVING BIOAGENTS AND RADIATION CAN BEGIN UNTIL IT HAS RECEIVED APPROVAL BY AN INSTITUTIONAL REVIEW COMMITTEE.

16. ETHICAL FOUNDATION OF HUMAN RESEARCH PROTECTION • Belmont Report • Ethical Principles

17. ETHICAL PRINCIPLES The “Belmont Report,” formally known as the Ethical Principles and Guidelines for the Protection of Human Subjects of Research, was written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

18. ETHICAL PRINCIPLES The Belmont Report identified the following three fundamental ethical principles that must be carefully considered to ensure the ethical practice of research involving human participants:

19. Respect for Persons

20. Justice

21. Beneficence

22. REGULATORY FOUNDATION OF HUMAN RESEARCH PROTECTION • History • Regulations • Policies • HIPAA

23. Significant recent events in research experimentation since the Hippocratic Oath. History

24. History (cont.) * Recent findings on Guatemala and Henrietta Lacks.

25. What regulations govern human subjects research? • Department of Health and Human Services (DHHS) • Food and Drug Administration (FDA) • Sponsors • Howard University Policies

26. What regulations govern human subjects research? (cont.) All research involving human subjects must adhere to DHHS regulation 45 CFR 46, also known as the COMMON RULE, unless the requirement is waived by the IRB.

27. 45 CFR 46: The Common Rule • The Common Rule is a federal policy regarding Human Subjects Protection. The main elements include: • requirements for assuring compliance by research institutions; • requirements for researchers’ obtaining and documenting informed consent; • requirements for Institutional Review Board (IRB) membership, function, operations, review of research, and recordkeeping. • Revisions under consideration affecting informed consent, security and data collection. http://www.hhs.gov/news/press/2011pres/07/20110722a.html

28. What is HIPAA? • The Health Insurance Portability and Accountability Act, commonly known as HIPAA, is another piece of legislation that impacts the conduct of human subjects research. • Establishes national standards for the protection of private health information know as Protected Health Information (PHI). • PHI is defined as any individually identifiable health information that is created or maintained by a Covered Entity (CE) department.

29. HIPAA applies when:

30. Objectives: • To provide an overview of the Office of Regulatory Research Compliance and the role of institutional review committees; • To provide an overview of ethical guidelines and research regulations; • To discuss responsible conduct of research.

31. RESEARCH MISCONDUCT • Responsible Conduct of Research • Regulations and HU Scientific Misconduct Policy • Research Misconduct Tutorial • How to Report Alleged Research Misconduct

32. Responsible Conduct of Research • According to the Federal Office of Research Integrity, in general terms, Responsible Conduct in Research (RCR) is simply good citizenship applied to professional research activity. • Researchers should conduct and report their work honestly, accurately, efficiently, and objectively. • Research institutions (such as universities) are required by law to have policies that cover aspects of research for which the institution received funding.

33. Let us not Forget… Tuskegee Syphilis Study (1932-1972): • No informed consent • Participants are not informed of all known dangers. • Participants are not given a cure, even when the cure was widely known and easily available • Led to 1974 passage of the National Research Act.

34. What is Research Misconduct? • Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reported research results. • Fabrication is making up results and recording or reporting them. • 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. • Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit, including those obtained through confidential review of others’ research proposals and manuscripts.

35. HU Policy on Research Misconduct The federal regulations require Howard University, as a recipient of funding, to: • Define Research Misconduct • Outline procedures for reporting and investigating allegations of Research Misconduct • Provide protection for whistleblowers and persons accused of Research Misconduct http://www.provost.howard.edu/Documents/scimisconduct4.htm **This policy supersedes policy in the Faculty Handbook , Employee Handbook and/or Guidelines.

36. Reporting Alleged Misconduct & Adverse Events • The University must protect the complainant who has made an allegation in good faith, even if the allegation is not sustained. • It is the responsibility of the researcher to report adverse events and deviations from protocol immediately to the Office of Regulatory Research Compliance at 202-865-8597. • Reports of research misconduct can be made by calling the Office of Regulatory Research Compliance at 202-865-8597 or the University Whistleblower Hotline at 202-238-2479. Written communications should be directed to: interalauditor@howard.edu or HOTLINE Office of the Internal Auditor 2225 Georgia Avenue NW, Room 701 Washington, DC 20001

37. Research Misconduct: Possible Disciplinary Actions • Letter of reprimand • Suspension or termination of research • Removal from the particular research project • If a student, possible suspension or expulsion • If a staff member, possible termination of employment • If a faculty member, referral by the President to the Senate Committee on Faculty Tenure and Promotions for dismissal proceedings against the faculty member

38. Research Misconduct: Possible Disciplinary Actions (cont.) • Provost/SVP-Health Sciences may choose to notify: • Co-authors, co-investigators, collaborators • Professional societies and licensing boards • Editors of journals in which fraudulent research was published • Editors or journals or other publications, or institutions, etc, with which the individual has been affiliated, and • Where appropriate, criminal authorities. **The Research Integrity Officer is required to notify the ORI if there is a finding of research misconduct. The ORI may conduct an additional investigation.

39. Questions and Answers

40. The Office of Regulatory Research Compliance Location: The Office of Regulatory Research Compliance (ORRC) 1840 Seventh Street, NW HURB-1, Suite 309 Washington, DC 20001 202-865-8597 (Office) Yonette F. Thomas, PhD Associate Vice President for Research Compliance