Title: The Reason for REB Review: Free and Informed Choice for Research ParticipantSubjects
1The Reason for REB Review Free and Informed
Choice for Research Participant-Subjects
- By Dr. Daphne Maurer
- Department of Psychology
- McMaster University
2Scope of Research Requiring Review
- Human Remains
- Cadavers
- Tissues
- Biological Fluids
- Embryos
- Foetuses
3Kinds of Research Methods Used
- Interviews
- Surveys
- Naturalistic observation
- Private papers
- Secondary use of data
- Students research
4Interviews 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
5Reason 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
6The 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
7Guiding 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
8Issues About Consent to Think About
- Free?
- Informed?
- Choice?
- Maintained?
9The Tri-Council Policy Statement Article 2.2
- Free and informed consent must be voluntarily
given, without manipulation, undue influence or
coercion
10Free?Undue influence or coercion?
- From inducements
- From power relationships
- From adverse consequences of non-participation
11Problematic Power Relationships
- Therapeutic
- MD to patient
- Social Worker to client
- Counsellor to client
- Prisoner
- Teacher
- Adverse consequences of non-participation or
withdrawal
12Free?Undue influence or coercion?
- Informed?
- Is information complete?
- Is information comprehensive?
- Maintained?
13Possible Harms
- Physical
- Psychological
- Social/economic
- Loss of confidentiality
- Legal
14Physical Harms
- Discomfort
- Pain
- Injury
- Disease
15Psychological Harms
- Loss of self-confidence or self-esteem
- Anxiety
- Regret or guilt
- Depression
- Altered behaviour
16Social/economic Harms
- Embarrassment
- Loss of respect by others
- Negative labeling
- Loss of wages or employability
- Disruption of family routine
- Loss of time
17Legal Harms
- Loss of confidentiality
- Creating liability for violation of the law
- Reporting child abuse if discovered
- Researchers assurance fails
18Informed?
- Complete information?
- Possible harms
- Special issues in qualitative research
- Possible breaches of confidentiality
- Partial disclosure
- Comprehensive information?
- Accessible explanation
- Competence of prospective participant
19Possible 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
20Temporary exceptions to full disclosure
- i.e. consent not full informed
21The 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
22The 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.
23Informed?
- Complete information?
- Possible harms
- Special issues in qualitative research
- Possible breaches of confidentiality
- Partial disclosure
- Comprehensive information?
- Accessible explanation
- Competence of prospective participant
24Comprehensible information
- Words or phrases Waggoner
- Sponsor Protocol Investigator
- Sequelae Subsequent care
- Baseline visit Double-blind Placebo
- Random (assignment) Efficacy
- Prorated (payement)
25Comprehensible 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?
26Informed?
- Complete information?
- Possible harms
- Special issues in qualitative research
- Possible breaches of confidentiality
- Partial disclosure
- Comprehensible information?
- Accessible explanation
- Competence of prospective participants
27TCPS 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
28Informed?
- Complete information?
- Possible harms
- Special issues in qualitative research
- Possible breaches of confidentiality
- Partial disclosure
- Comprehensible information?
- Accessible explanation
- Competence of prospective participants
29Potential 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
30Guiding Principles
- Free?
- Undue influence or coercion?
- Informed?
- Is information complete?
- Is information comprehensive?
- Conflict of interest?
- Maintained?
31Commercialization 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.
32Potential benefits
- If there are no potential benefits to the
prospective research participant, this must be
stated explicitly.
33 Issues About Consent to Think About
- Free?
- Informed?
- Choice?
- Respect voluntary choice
- Whose choice is it? Risk to others
- Maintained?
34The 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.
35Maintained?
- Undue influence or coercion to continue
- Informed of right to withdraw and consequences
- Data already collected
- Compensation
- Ongoing relationship with researcher