The Reason for REB Review: Free and Informed Choice for Research ParticipantSubjects

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The Reason for REB Review Free and Informed
Choice for Research Participant-Subjects

• By Dr. Daphne Maurer
• Department of Psychology
• McMaster University

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Scope of Research Requiring Review

• Living Human Subjects

• Human Remains
• Cadavers
• Tissues
• Biological Fluids
• Embryos
• Foetuses

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Kinds of Research Methods Used

• Interviews
• Surveys
• Naturalistic observation
• Private papers
• Secondary use of data
• Students research

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Interviews on relationships

• Open-ended does not know what agreeing to
• Includes everything, pauses, smiles, break
• Social Context
• Hard to refuse or withdraw
• Loss of support at end
• Intimate
• Embarrassment over what revealed
• Disagreement with researchers interpretations
• Possibility of being charged

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Reason for REB ReviewResearcher REBArms
Length

• Primary perspective object of research
• Well-being of prospective subjects
• Most important answering research question
  (Also reputation within field, job, tenure,
  merit increase, book contract
• Academic tradition

• Primary perspective subjects of research
• Impartial

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The Tri-Council Policy Statement Ethical Conduct
for Research Involving Humans, Article 2.1

• (2) their free and informed consent has been
  given and is maintained throughout their
  participation in the research

• (a) Research governed by this policy may begin
  only if
• (1) prospective subjects, or authorized third
  parties, have been given the opportunity to give
  free and informed consent about participation,
  and

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Guiding Principles of the TCPS

• Respect for human dignity
• Respect for free and informed consent
• Respect for vulnerable persons
• Respect for privacy and confidentiality
• Respect for justice and inclusiveness
• Balancing harms and benefits
• Minimizing harm
• Maximizing benefit

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Issues About Consent to Think About

• Free?
• Informed?
• Choice?
• Maintained?

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The Tri-Council Policy Statement Article 2.2

• Free and informed consent must be voluntarily
  given, without manipulation, undue influence or
  coercion

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Free?Undue influence or coercion?

• From inducements
• From power relationships
• From adverse consequences of non-participation

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Problematic Power Relationships

• Therapeutic
• MD to patient
• Social Worker to client
• Counsellor to client
• Prisoner
• Teacher
• Adverse consequences of non-participation or
  withdrawal

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Free?Undue influence or coercion?

• Informed?
• Is information complete?
• Is information comprehensive?
• Maintained?

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Possible Harms

• Physical
• Psychological
• Social/economic
• Loss of confidentiality
• Legal

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Physical Harms

• Discomfort
• Pain
• Injury
• Disease

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Psychological Harms

• Loss of self-confidence or self-esteem
• Anxiety
• Regret or guilt
• Depression
• Altered behaviour

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Social/economic Harms

• Embarrassment
• Loss of respect by others
• Negative labeling
• Loss of wages or employability
• Disruption of family routine
• Loss of time

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Legal Harms

• Loss of confidentiality
• Creating liability for violation of the law
• Reporting child abuse if discovered
• Researchers assurance fails

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Informed?

• Complete information?
• Possible harms
• Special issues in qualitative research
• Possible breaches of confidentiality
• Partial disclosure
• Comprehensive information?
• Accessible explanation
• Competence of prospective participant

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Possible breaches of confidentiality

• Other participants e.g. Focus groups
• Illegal activity or threat to society e.g.
  child abuse, intent to murder, infectious disease
• Individuals identifiable in aggregate results

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Temporary exceptions to full disclosure

• i.e. consent not full informed

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The Tri-Council Policy Statement Article 2.1 (C)

• The REB may approve a consent procedure1 which
  does not include, or which alters, some or all of
  the elements of informed consent set forth above,
  or waive the requirement to obtain informed
  consent, provided that the REB finds and
  documents that

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The Tri-Council Policy Statement Article 2.1 (C)

• i. The research involves no more than minimal
  risk to the subject
• ii. The waiver or alteration is unlikely to
  adversely affect the rights and welfare of the
  subjects
• iii. The research could not practicably be
  carried out without the waiver alteration

• iv. Wherever possible and appropriate the
  subjects will be proved with additional pertinent
  information after participation and
• v. The waiver or altered consent does not involve
  a therapeutic intervention.

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Informed?

• Complete information?
• Possible harms
• Special issues in qualitative research
• Possible breaches of confidentiality
• Partial disclosure
• Comprehensive information?
• Accessible explanation
• Competence of prospective participant

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Comprehensible information

• Words or phrases Waggoner
• Sponsor Protocol Investigator
• Sequelae Subsequent care
• Baseline visit Double-blind Placebo
• Random (assignment) Efficacy
• Prorated (payement)

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Comprehensible information

• Style of presentation
• Flowchart, pictures, video
• Boldface and italics
• Software indices of reading difficulty
• Hochhauser
• Consent concepts
• Research
• Forseeable risks how far in the future?

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Informed?

• Complete information?
• Possible harms
• Special issues in qualitative research
• Possible breaches of confidentiality
• Partial disclosure
• Comprehensible information?
• Accessible explanation
• Competence of prospective participants

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TCPS Article 2.5 2.6 Incompetent Individuals

• Special Issues
• Ethical
• Legal
• Competence to participate is not all-or-nothing.
  Varies with
• Choice and circumstances
• Time

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Informed?

• Complete information?
• Possible harms
• Special issues in qualitative research
• Possible breaches of confidentiality
• Partial disclosure
• Comprehensible information?
• Accessible explanation
• Competence of prospective participants

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Potential benefits

• If there are no potential benefits to the
  prospective research participant, this must be
  explicitly stated
• Be transparent by respecting the dignity and
  autonomy of prospective subject

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Guiding Principles

• Free?
• Undue influence or coercion?
• Informed?
• Is information complete?
• Is information comprehensive?
• Conflict of interest?
• Maintained?

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Commercialization and conflict of interest

• Annotated model form The research consent form
  should describe any apparent, actual, or
  potential conflict of interest on the part of the
  researchers, their institutions or sponsors, and
  any possibility of commercialization of the
  research findings.

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Potential benefits

• If there are no potential benefits to the
  prospective research participant, this must be
  stated explicitly.

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Issues About Consent to Think About

• Free?
• Informed?
• Choice?
• Respect voluntary choice
• Whose choice is it? Risk to others
• Maintained?

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The Tri-Council Policy Statement, Article 2.1a
Research . May begin only if

• (2) their subjects free and informed consent
  has been given and is maintained throughout their
  participation in the research.

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Maintained?

• Undue influence or coercion to continue
• Informed of right to withdraw and consequences
• Data already collected
• Compensation
• Ongoing relationship with researcher