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

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

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
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. “Possible risks [to student subjects] include the following:
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 )

25. Setting up NSCC’s IRB
IRB’s goals & purpose
Procedures
Getting started

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

27. IRB Procedures
Procedures for SoTL proposals governed by 45 CFR 46 (& RCW?) and ethics codes
To be established and formalized by the initial group of IRB members

28. Getting the IRB started
Volunteers: time commitment at beginning, less later
Training:
Conferences (OHSU in May, etc)
Online trainings (Collaborative IRB Training Initiative)
Certification
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…