The Ethics of
Inquiry
An introduction to
ethical issues in
the Scholarship of
Teaching and
Learning
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
Case study
 What potential issues/problems can
you see with this proposed study?
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How many potential problems can we can find
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
A Little History
 Nuremberg Doctors’ Trial (1946-47)
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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/
History
Tuskegee Syphilis Study (1932-72)
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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
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
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
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
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
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
Informed Consent-2
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This means that the person involved should have legal capacity
to give consent;
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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;
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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.
Informed Consent-3
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This latter element requires that before the
acceptance of an affirmative decision by the
experimental subject there should be made known
to him
1. the nature, duration, and purpose of the
experiment;
2. the method and means by which it is to be
conducted;
3. all inconveniences and hazards reasonably to be
expected; and
4. the effects upon his health or person which may
possibly come from his participation in the
experiment
A few ethical principles
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Privacy
Autonomy
Informed consent
risk/benefit (burdens/benefits)
• to subjects
• to society
• vulnerable populations
• truthfulness
Operative Ethical
Principles
The main operative principles mostly
come down to:
• Informed Consent
• Privacy
• Confidentiality
• protecting vulnerable populations
Fundamental Ethical
Principles
1. Respect for persons
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recognition of the personal dignity and autonomy
of individuals and special protection for those
with diminished autonomy
2. Beneficence (+ PNN)
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obligation to protect persons from harm by
maximizing anticipated benefits and minimizing
possible risks of harm
3. Justice
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fairness in the distribution of research benefits
and burdens
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).”
SoTL & the IRB
 students as human subjects
 Students as learners and subjects
 clinician/researcher
teacher/researcher conflicts
 IRB Levels of Review
1. Full review
2. expedited review
3. exempt
Students as subjects
A few potential issues
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
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?)
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)
Potential risks-1
“Possible risks [to student subjects]
include the following:
1. Breach of confidentiality, whether actual or
potential
2. Violation of privacy, even when confidentiality is
assured
3. Validation of inappropriate or undesirable
behaviors of subjects, perhaps based on
misunderstanding of the researcher’s intent
Potential risks-2
1. Presentation of results in a way that does not
respect (or agree with) the subjects’ interests
2. 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
3. Harm to subjects’ dignity, self-image, or
innocence as a result of indiscreet or ageinappropriate questions in an interview or
questionnaire”
- Robert Amdur and Elizabeth Bankert, Institutional Review Board
Management and Function, Jones and Bartlett, 2002 (pp 403-04)
Setting up NSCC’s
Human Subjects Review
Committee
1. HSRC’s goals & purpose
2. Procedures
3. Getting started
HSRC Mission & Goals
 To protect safety, rights and
welfare of human subjects (the
ethical imperative)
 Regulatory compliance with 45 CFR
46 (the legal imperative)
HSRC Procedures
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Procedures for SoTL proposals governed
by
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45 CFR 46
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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
Getting the HSRC started
 Volunteers:
later
time commitment at beginning, less
 Training:
• Special training next Wednesday
• Online trainings (Collaborative IRB
Training Initiative - CITI)
• IRB Forum listserv
• OHRP video
 Formalize policies and procedures
First Tasks
 Develop an informational website
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Templates
Materials
Readings
Announcements
 Planning meetings online (in FirstClass)
 Develop policies, procedures
 Plan how best to help SoTL researchers
Questions?
 Questions…
 Comments…
 Volunteers…
email tkerns@sccd.ctc.edu