1. 1 HUMAN RESEARCH PROTECTIONS Daniel R. Vasgird, PhD, CIP Office of Research Compliance West Virginia University (304) 293-6094 drvasgird@mail.wvu.edu drvasgird@mail.wvu.edu

2. THE ESSENTIAL DILEMMA Human dignity and social justice in an economically and politically unbalanced world

3. 3 “The first step in the evolution of ethics is a sense of solidarity with other human beings.” Albert Schweitzer

4. 4 “Ethics primarily concerns the effects of our actions on others.” Randy Cohen

5. 5 DRAMATURGICAL FUNCTION OF IRBs To become the subject as much as possible

6. 6 "Of all the traits which qualify a scientist for citizenship in the republic of science, I would put a sense of responsibility as a scientist at the very top. A scientist can be brilliant, imaginative, clever with his hands, profound, broad, narrow-but he is not much as a scientist unless he is responsible." - Alvin Weinberg, The Obligations of Citizenship in the Republic of Science

7. 7 Perseverance and success, but for some increased: 1. 1. Risk for unintentional bias 2. 2. Willingness to cut corners 3. 3. Willingness to commit serious misconduct Consequences of ambition

8. 8 Gelsinger

9. 9 The research protection system fundamentally revolves around mutual trust.

10. 10 What is an IRB? An autonomous body at a private, public, or government institution charged with reviewing research proposals that will include human subjects to ensure compliance with federal regulations, institutional policy and ethical principles. Most often referred to as an Institutional Review Board (IRB)

11. 11 At this point in time the major responsibility for insuring ethical decision making in human research rests with the IRBs in terms of empowerment, flexibility and discretion.

12. 12 IRBs have ethical responsibility and legal authority.

13. 13 RESEARCH “Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” 46.102 (d)

14. 14 Research is the active application of curiosity and hope. It is a manifestation of those aspects of the human condition that seek security against mortality and greater understanding of our existential situation. Research is the active application of curiosity and hope. It is a manifestation of those aspects of the human condition that seek security against mortality and greater understanding of our existential situation.

15. 15 HUMAN SUBJECT “Human subject” means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. 46.102(f)

16. 16 Reasonable Expectations

17. 17 HISTORY OF HUMAN RESEARCH GONE AWRY Nazi Experiments (Nuremberg) Milgram Obedience Experiments Radiation Experiments Wichita Jury Taping Study Jewish Chronic Disease Cancer Study Thalidomide Tragedy Syphilis Experiment (PHS, Tuskegee) Jesse Gelsinger

18. 18 NUREMBERG CODE The Nuremberg Code is primarily remembered for the first sentence of the first of the 10 principles: “The voluntary consent of the human subject is absolutely essential.” It is to this statement that we trace the modern requirement for seeking the voluntary consent of research subjects.

19. 19 SYPHILIS STUDY (Tuskegee) Impact National Research Act (1974) - required federal regulations for the protection of human subjects required informed consent required review and monitoring of research by an institutional review board (IRB) - created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

20. 20 ETHICAL PRINCIPLES [BELMONT REPORT, 1979] (Product of Nuremberg, Helsinki and the National Research Act of 1974)  RESPECT FOR PERSONS  CONSENT, PRIVACY, CONFIDENTIALITY, I.E., AUTONOMY  INCREASED PROTECTION FOR THOSE WITH DIMINISHED AUTONOMY  BENEFICENCE  RISKS VS. BENEFITS  JUSTICE  EQUITY, FAIRNESS IN BENEFITS & BURDENS

21. 21 MAIN FUNCTION OF IRB REVIEW TO ASSURE THAT: RISKS ARE MINIMIZED AND REASONABLE IN RELATION TO ANTICIPATED BENEFITS. THERE IS INFORMED CONSENT. RIGHTS AND WELFARE OF SUBJECTS ARE MAINTAINED (i.e., Continuous).

22. 22 AUTHORITY OF IRB Requirement of review Approve, disapprove or modify Conduct continuing review –At any time and in person if desired –Must be done at least once per year Observe/verify changes Suspend or terminate approval

23. 23 Above all else, the IRB should strive to “do the right thing”.

24. 24 In sum, Empowerment, Flexibility and Discretion & Dramaturgical Function