The Ethics of Inquiry

1. The Ethics of Inquiry An introduction to ethical issues in the Scholarship of Teaching and Learning

2. Case study • A sociology instructor wishes to evaluate a new teaching method • Experimental new teaching method: small group seminars, no formal lecture, independent study, plus he’s readily available for consultation • Has 2 sections of Soc 100, 30 students each • One section will be the subjects, one controls • Switch subjects & controls at mid-quarter • Both groups take same quizzes, exams & have same paper assignments • “I’m sorta hoping you won’t, of course, but everyone is free to quit the experiment any time” • Measures: quizzes, exams, papers

3. Case study • What potential issues/problems can you see with this proposed study? • How many potential problems can we can find

4. Case study • Could most of these problems be corrected? • Yes. Part of an IRB’s job is to help identify and fix issues like these

5. A Little History • Nuremberg Doctors’ Trial (1946-47) • Hypothermia survivability and effects • Bone healing • High altitude survivability and effects • Potability of treated sea water • How to effectively sterilize • Chemical burn effects • How quickly poison bullets kill • Typhus vaccine • Twins studies • http://www.ushmm.org/research/doctors/

6. History Tuskegee Syphilis Study (1932-72) • Several hundred black men in Macon County, AL • Originally a treatment/study (mercury rubs) • Subjects not informed when treatment stopped • Became “Tuskegee Study of Untreated Syphilis in the Negro Male” • (Weren’t actually “untreated,” though) • Penicillin available as treatment in 1943 • Provisions were taken to prevent Tuskegee subjects from getting penicillin • Formal apology (president Clinton) in 1997 http://www.pbs.org/newshour/bb/health/may97/tuskegee_5-16.html

7. History • Willowbrook hepatitis studies • Institution for “mentally defective persons” • Infecting retarded children with hepatitis (fed feces) • “They’ll get hepatitis anyhow. Better under controlled conditions.” • To study the course of hepatitis • Vaccine studies • Mid 1950’s to early ‘70s

8. History • Human radiation studies (100’s) 1944-74 • Several psychological/sociological studies • Milgram, obedience to authority,1967 http://learningat.ke7.org.uk/socialsciences/Psychology/PsyRes13/Milgram.htm • Zimbardo prison experiment at Stanford, 1971

9. Ethics Codes • The Nuremberg Code, 1947 • The Belmont Report, 1979, written in response to the exposé of both the Tuskegee Syphilis Study and U.S. human radiation experiments

10. Ethics Codes • World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects (1964,75, 83,89, 96,2000, 2002) • WHO/CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects

11. Informed Consent 1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion, and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment. Nuremberg Code, paragraph 1

12. Informed Consent-2 • This means that the person involved should have legal capacity to give consent; • should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; • should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision.

13. Informed Consent-3 • This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him • the nature, duration, and purpose of the experiment; • the method and means by which it is to be conducted; • all inconveniences and hazards reasonably to be expected; and • the effects upon his health or person which may possibly come from his participation in the experiment

14. A few ethical principles • Privacy • Autonomy • Informed consent • risk/benefit (burdens/benefits) • to subjects • to society • vulnerable populations • truthfulness

15. Operative Ethical Principles The main operative principles mostly come down to: • Informed Consent • Privacy • Confidentiality • protecting vulnerable populations

16. Fundamental Ethical Principles • Respect for persons • recognition of the personal dignity and autonomy of individuals and special protection for those with diminished autonomy • Beneficence (+ PNN) • obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm • Justice • fairness in the distribution of research benefits and burdens

17. Laws Federal Regulations (45 CFR 46) • “In 1974, Congress passed the National Research Act, which created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The National Commission wrote the Belmont Report, which provided the foundation for current federal regulations to protect human research subjects.The National Research Act required the government to publish regulations for the ethical treatment of human subjects, including obtaining informed consent, and called for oversight of research by Institutional Review Boards (IRBs).”

18. SoTL & the IRB • students as human subjects • Students as learners and subjects • clinician/researcher teacher/researcher conflicts • IRB Levels of Review • Full review • expedited review • exempt

19. Students as subjects A few potential issues

20. Students as subjects-1 • students are convenient, inexpensive and easy to recruit • potential coercion or undue influence (future courses, letters of recommendation, etc) • paying/compensating subjects (is giving course credit coercive?) • some college students are minors (state law applies) • confidentiality (extra care is required in a college community; IRBs should ask how names and data will be kept separate

21. Students as subjects-2 • Informed consent requires “time to consider” the request for participation (i.e.,informing and consent probably should not happen all in one class period) • Subjects must be free to withdraw from a study at any time (if the research is part of an ongoing course, how would a student’s withdrawal from a study affect their participation in the course? Course requirements?)

22. Students as subjects-3 • Requests to participate in a research project have less chance of being coercive or having “undue influence” if the request is less direct (made by someone other than the instructor?) • Need to be concerned about students with physical, psychological or developmental disabilities • If a research project is about a specific course and group of students, could subjects be considered identifiable? (affects whether a study would be exempt, or would require expedited or full review)

23. Potential risks-1 “Possible risks [to student subjects]include the following: • Breach of confidentiality, whether actual or potential • Violation of privacy, even when confidentiality is assured • Validation of inappropriate or undesirable behaviors of subjects, perhaps based on misunderstanding of the researcher’s intent

24. Potential risks-2 • Presentation of results in a way that does not respect (or agree with) the subjects’ interests • Possible harm to individuals not directly involved in the research but about whom data are obtained indirectly (secondary subjects), or who do not belong to the class or group from which subjects were selected • Harm to subjects’ dignity, self-image, or innocence as a result of indiscreet or age-inappropriate questions in an interview or questionnaire” - Robert Amdur and Elizabeth Bankert, Institutional Review Board Management and Function, Jones and Bartlett, 2002 (pp 403-04)

25. Setting up NSCC’sHuman Subjects Review Committee • HSRC’s goals & purpose • Procedures • Getting started

26. HSRC Mission & Goals • To protect safety, rights and welfare of human subjects (the ethical imperative) • Regulatory compliance with 45 CFR 46 (the legal imperative)

27. HSRC Procedures • Procedures for SoTL proposals governed by • 45 CFR 46 • RCW 42.48.020(1) "Release of Records for Research” • and ethics codes • To be established and formalized by the initial group of HSRC members

28. Getting the HSRC started • Volunteers: time commitment at beginning, less later • Training: • Special training next Wednesday • Online trainings (Collaborative IRB Training Initiative - CITI) • IRB Forum listserv • OHRP video • Formalize policies and procedures

29. First Tasks • Develop an informational website • Templates • Materials • Readings • Announcements • Planning meetings online (in FirstClass) • Develop policies, procedures • Plan how best to help SoTL researchers

30. Questions? • Questions… • Comments… • Volunteers… email tkerns@sccd.ctc.edu