The Ethics of Inquiry

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The Ethics of Inquiry

• An introduction to ethical issues in the
  Scholarship of Teaching and Learning

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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 hes 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
• Im sorta hoping you wont, of course, but
  everyone is free to quit the experiment any time
• Measures quizzes, exams, papers

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Case study

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

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Case study

• Could most of these problems be corrected?
• Yes. Part of an IRBs job is to help identify
  and fix issues like these

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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/

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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
• (Werent 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/tuskeg
  ee_5-16.html

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History

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

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History

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

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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

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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

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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

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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.

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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

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A few ethical principles

• Privacy
• Autonomy
• Informed consent
• risk/benefit (burdens/benefits)
• to subjects
• to society
• vulnerable populations
• truthfulness

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Operative Ethical Principles

• The main operative principles mostly come down
  to
• Informed Consent
• Privacy
• Confidentiality
• protecting vulnerable populations

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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

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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).

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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

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Students as subjects

• A few potential issues

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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

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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 students withdrawal from a
  study affect their participation in the course?
  Course requirements?)

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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)

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Potential risks-1

• Possible risks to student subjectsinclude 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 researchers intent

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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)

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Setting up NSCCs IRB

• IRBs goals purpose
• Procedures
• Getting started

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IRB Mission Goals

• To protect safety, rights and welfare of human
  subjects (the ethical imperative)
• Regulatory compliance with 45 CFR 46 (the legal
  imperative)

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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

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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

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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

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Questions?

• Questions
• Comments
• Volunteers email tkerns_at_sccd.ctc.edu