Institutional Review Board (IRB)

1. Institutional Review Board(IRB) A mechanism to help insure the ethical treatment of human subjects in behavioral science research. Dean Owen, Faculty Seminar, 2 March, 2007

2. Disclaimer Colleagues and Students: I am not, nor do I claim to be, an expert in the field of bio-medical or behavioral science research ethics. Dean Owen 2 March, 2007 Dean Owen, Faculty Seminar, 2 March, 2007

3. Additional Warnings…… Avoid prolonged contact with skin Not to be taken internally No animals were harmed during the production of this presentation Dean Owen, Faculty Seminar, 2 March, 2007

4. Science has one goal…seeking knowledge and truth….but that search must be governed by rules of conduct and basic ethical standards…. This is especially true when the subjects are our fellow human beings….and this is the reason for the Institutional Review Board , the IRB Dean Owen, Faculty Seminar, 2 March, 2007

5. What is coming…. Why an IRB? Some history…. Basic principles of research ethics The role, scope, and function of an IRB………….. OK…got your walking shoes on?...let’s go….. Dean Owen, Faculty Seminar, 2 March, 2007

6. A brief walk through history… Herophilus (335-280 BCE), Father of Anatomy is said to have performed vivisections on more than 600 prisoners. Claudius Galenus of Pergamam (129-200CE), Galen performed many experimental procedures on wounded gladiators from the Roman Games and is regarded by many as the father of modern medicine. Humans as subjects.. Irishmen William Burke and William Hare in the early 1800s became infamous for their grave robbing business as a method to provide fresh cadavers to Edinburgh anatomy schools. Dean Owen, Faculty Seminar, 2 March, 2007

7. Dr Josef Mengele (1911-1979) was a German SS Officer and in the Nazi concentration camp Auschwitz performed hundreds of vivisections on prisoners. How long will it take for a 70kg male to die when submerged in a tank of ice water? Mengele gave us an answer……. And more recently… Dean Owen, Faculty Seminar, 2 March, 2007

8. 1932 in America • A series of research abuses starts in Tuskegee, Alabama. In one study on the natural history of untreated syphilis (sifilis), poor, black males are not informed of their disease and denied treatment even after a treatment is found in 1947. The abuses are revealed in 1972. Dean Owen, Faculty Seminar, 2 March, 2007

9. 1947: • Twenty-six Nazi physicians are tried at Nuremberg, Germany, for research atrocities performed on prisoners of war. This results in the Nuremberg Code, the first internationally recognized code of research ethics, issued by the Nazi War Crimes Tribunal. • The Nuremberg Code includes the principles of: • informed consent, • absence of coercion, • properly formulated scientific experimentation, • beneficence toward experiment participants. Dean Owen, Faculty Seminar, 2 March, 2007

10. We’re just about done! • 1964:Finland • The 18th World Medical Assembly meets in Helsinki, Finland, and issues recommendations to guide physicians in biomedical research involving human subjects.The Declaration of Helsinki becomes the basis for later boards of ethics and self-regulation by researchers. • 1974:The United States • The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research is established, and the National Research Act is passed by the U.S. Congress. Dean Owen, Faculty Seminar, 2 March, 2007

11. The National Research Act of 1974 prompted the establishment of Institutional Review Boards and required IRB review for all federally funded research with human subjects. Dean Owen, Faculty Seminar, 2 March, 2007

12. And Finally!!!! • 1979: • The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research published The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research -- a guide for U.S. research with human subjects. Dean Owen, Faculty Seminar, 2 March, 2007

13. Basic Principles of Ethical Research with Human Subjects Autonomy:Each person should be given the respect, time, and opportunity necessary to make his or her own decisions. Beneficence: Beneficence obligates the researcher to secure the well-being of all study participants. It is your responsibility to protect participants from harm, as well as ensure that they experience the possible benefits of involvement. Justice: Participants should not be selected due to class, socioeconomic status, or race unless justified by study objectives. (Extracted from the Belmont Report, 1979) Dean Owen, Faculty Seminar, 2 March, 2007

14. What Research Must Be Reviewed? All research conducted in the United States that involves: Human Subjects (living or deceased), Human Tissue, Records gathered on human subjects Dean Owen, Faculty Seminar, 2 March, 2007

15. New and continuing training requiredAt most colleges and universities researchers must complete a training program on research ethics BEFORE submitting a research proposal for IRB review. The emphasis of this training is on Informed Consent Dean Owen, Faculty Seminar, 2 March, 2007

16. Informed consentis about an individual’s understanding and willingness to participate in a study and not about signing a form. Dean Owen, Faculty Seminar, 2 March, 2007

17. Prospective participantsmust understand:1. the purpose of the study;2. the procedures used in the study;3. the potential risks and benefits of their involvement;4. the alternatives to participation. A vital part of this process is the opportunity to discuss any questions or concerns with a knowledgeable research team member. In addition, prospective participants must be given time to think about their decision and to discuss it ifnecessary with family,friends, or religious advisors. Dean Owen, Faculty Seminar, 2 March, 2007

18. Example of Consent Process Dean Owen, Faculty Seminar, 2 March, 2007

19. The Institutional Review BoardPeer Review at Work Dean Owen, Faculty Seminar, 2 March, 2007

20. IRB Membership: • Size and composition of the board varies but is typically at least 7 members • Members are usually elected by their colleagues on the basis of their research experience and seniority • Members have typically undergone extensive additional training Bio/Medical and Behavioral Research Ethics. • Typically serve in a consultative, educative, and voluntary capacity. Dean Owen, Faculty Seminar, 2 March, 2007

21. IRB Review Criteria Risks to the subjects are minimized. Risks to the subjects are reasonable in relation to anticipated benefits. Selection of subjects is equitable. • Informed consent is: • a. sought from each prospective participant or his or her legally authorized representative, and properly documented. • b. Adequate preparation is taken to protect the privacy and confidentiality of subjects. Adequate provisions are made for the ongoing monitoring of the subjects' welfare. Dean Owen, Faculty Seminar, 2 March, 2007

22. IRB Review Criteria (Just a few of hundreds) • Is there adequate provision for an informed consent process? • Is the study adequately described in common language? • Are the benefits and risks clearly stated? • Are alternatives to participation clearly stated? • Is there adequate opportunity for consideration and discussion? • Is there some mechanism to insure that subjects understand? • Are there provisions for special categories of subjects? Dean Owen, Faculty Seminar, 2 March, 2007

23. IRB Process Dean Owen, Faculty Seminar, 2 March, 2007

24. IRB Process • Researcher submits a formal application for review. • The IRB assigns the proposal to one of the following categories: Exempt, Expedited or Full Review. (Risk and Informed Consent) • It is the IRB’s responsibility to determine into which category the proposed research falls….and all research proposals must be reviewed. • Following review, the IRB will issue approval and only then may the research project begin. Dean Owen, Faculty Seminar, 2 March, 2007

25. Risk To Subjects in Behavioral Science Research Research that may involve physical stress.(physical exertion with likely elevations in cardiac rate, pulmonary rate, blood pressure, electro stimulation etc.) Research that may introduce psychological stress.(uncertainty, doubt, anticipatory anxiety, reactive depression, anger, humiliation, ridicule, etc. Research that may involve invasions of privacy or measures of sensitive information in which subjects might be identified .(audio/video tapes of abuse descriptions, surveys of sexual behavior, prior or current drug use or other illegal behavior, etc.) Dean Owen, Faculty Seminar, 2 March, 2007

26. IRB Review Categories Exempt (no risk) Expedited review Full review • Research poses no significant risk to participants • Research is conducted within the normal work or school setting • Test or survey procedures involve NO identifying information • Not possible to link data to specific subjects • Disclosure would pose no risk of civil or criminal liability • Disclosure could not result in loss of financial status, employability or reputation…. • Uses existing data, documents or specimens where no identifying information could link data to subjects. (Archival Data) • Use of educational tests & cognitive tests such as aptitude and achievement measures. Dean Owen, Faculty Seminar, 2 March, 2007

27. IRB Review Categories Exempt Expedited Full Review Even if research qualifies for exempt status, informed consent is still required by IRBs if research results will be published or presented in a public forum….. Dean Owen, Faculty Seminar, 2 March, 2007

28. IRB Review Categories Exempt Expedited (minimal risk) Full Review • Research is of a type shown to pose no more than minimal risk to subjects and the protocol conforms to standard protocols commonly accepted for this type of study. (Identical to earlier approved studies) • Research represents a MINOR modification of a previously approved protocol with all safety provisions for the protection of human subjects fully intact. (Virtually identical to earlier approved studies) Dean Owen, Faculty Seminar, 2 March, 2007

29. IRB Review Categories Exempt Expedited Full Review (more than minimal risk) • Research involves the potential for more than minimal risk and the methods, techniques, and treatments are largely experimental. The determination of risk level is the responsibility of the IRB and not the researcher. • Full review will require the greatest degree of documentation and such reviews will typically require considerably longer periods of review, discussion, and deliberation before approval is granted. Dean Owen, Faculty Seminar, 2 March, 2007

30. Categories of Special Subjects These require careful planning… • Therapist/Client or Physician/Patient • Teacher/Student • Employers/Employees • Children • The Elderly • Anyone suspected of diminished capacity Dean Owen, Faculty Seminar, 2 March, 2007

31. Some things to consider….and some stories…… 16-PF and lying, cheating and stealing from students…..Making participation in a study part of the grading process….?? What is the age of majority in Turkey….is this a concern…yet? How will an IRB impact the rate, quality, quantity or progress of research? How do we model ethical behavior in our discipline and research efforts? How will my colleagues react to peer review of research proposals?. Coping with Egos and avoiding adversarial confrontations. Overcoming the “us against them” mentality…. Dean Owen, Faculty Seminar, 2 March, 2007

32. I hope these topics can generate some useful conversation and discussion among all of us….teachers and students alike! To complete human subjects compliance training please visit the following site: http://www.osp.cornell.edu/HSCompliance/index.html Teşekkürler Dean Owen, Faculty Seminar, 2 March, 2007