Transcript Research Ethical Principles - Office of Human Research

Considerations in IRB Approval
of Deception Research
Lee Booze-Battle, MPA(c), CIP
IRBMED, University of Michigan Medical School
Ann Arbor, Michigan
Terry VandenBosch, PHD, RN, CIP, CCRP
Office of Human Research Compliance Review
University of Michigan, Ann Arbor, Michigan
Deception Definitions: Consensus?
“Valid results cannot be obtained by telling
subjects the real purpose of the research”
“Absence of full disclosure does not
constitute intentional deception”
[incomplete disclosure or concealment]
Terms “deception” and “incomplete
disclosure” used, but not defined in OHRP
IRB Guidebook
History of Deception Methods in
Social Psychology
Per cent of deception studies in Journal of
Abnormal and Social Psychology
1921 5%
1948 9%
1968 51%
1975 69%
1983 50%
1994 31%
1996 42%
Minimize Risks to Subjects*
Deception methods used when justified by
study’s significant prospective scientific,
educational (APA), or applied value (APA &
regs)
Justify nondeceptive alternative procedures
are NOT feasible (APA explicit)
Deception should not unnecessarily expose
subjects to physical pain and severe
emotional distress (APA & regs)
*45 CFR 46.111 Criteria for IRB approval
Nondeceptive Alternatives not
Feasible
Obtaining sample in naturalistic setting takes
prohibitively long time
Observations in natural setting can not produce
standardized stimuli to evoke and/or compare
responses
Observation of covert or antisocial behaviors not
feasible
Laboratory measurements permit analysis of
observational data, physiological measures and
self-report
Minimize Risks to Subjects (con’t)
Negative and Positive subject responses
in research literature
Analyzing if the study is in the Subject and
Subject Pools’ “comfort zone”?
General considerations
The kind of failure to inform
The nature of the research
The topic on which people are deceived
Negative Responses to Deception
Embarrassment, sadness, shame, humiliation,
discomfort, less confidence in own judgment, describe
less value in the experiment than nondeceived subjects
Angry or annoyed with the investigator
– May not believe investigator in debriefing
– May not be willing to reveal emotional reactions to debriefing
investigator they hold responsible
Do negative responses affect study participation?
– Suspicions may affect subject’s behavioral study responses
Unanticipated Problem
– A report of research assistant “confederates” who had severe
negative emotions
Positive Responses to Deception
Some research literature reports, “Research
participants do not perceive that they are
harmed and do not seem to mind being misled”
Minor forms of deception in studies with “active
participation” result in positive reactions and
subjects are generally tolerant toward being
deceived, being caused physical discomfort, and
being treated inconsiderately by the
experimenter
“Less bored” with the experiment
General Considerations
Are behaviors evoked or observed different
than those encountered in daily life?
Debriefing-often the time of greatest risk
PI experience and resources to implement
“controls” for practices that decrease risk
Is PI in dual role of provider & researcher?
Subject pool, e.g., Vulnerable subjects
Kind of Failure to Inform
Not informed
Information concealed
Falsely informed
Consent to possible deception
(Forewarning)
Nature of the Research
Perception of the behavior
Privacy of the behavior
Behavior (natural vs. induced)
Degree of confidentiality
Topic of Deception
False information
Role deception (use of confederates)
Subject given false feedback about
themselves or about others
Unaware study in progress at time of
manipulation or measurement
Risks Reasonable in Relation to
Anticipated Benefits*
Paradox
– Autonomous decision vs. societal knowledge
– Rarely direct benefit of participation
– Investigators selecting methods that provide
for the greatest scientific validity and social
value may result in deception methods
*45 CFR 46.111 Criteria for IRB approval
Informed Consent Sought*
Can someone consent to deception research?
Must meet waiver criteria
– Minimal risk
– Not adversely affect subject rights and welfare
– Not practicable without waiver
Options for “Respect for Persons”
– Forewarning (consent to deception)
– Debriefing (not “deferred” or “retroactive” consent)
– Subject has option to remove data
*45 CFR 46.111 Criteria for IRB approval & waiver 45 CFR 46.116
Debriefing
Not always required
Aims
– Provide information about true goals and nature of
study
– Correct misconceptions about the research and about
subject’s own abilities
– Alleviate any experimentally induced harm
Successful Debriefing
–
–
–
–
Subjects believe the investigator about the deception
“Surface” negative reactions to desensitize
Does not lead to psychological discomfort
Counseling &/or resources, if applicable
What are “appropriate” responses
to any harm?
Best judgment of investigators and IRBs
No research evaluating the best ways to
debrief
No research on long term consequences,
if any, on deception research participation
No evidence of “spill over” effects to
trustworthiness of psychologists
Common IRB Questions
Review the study design
–
–
–
–
Is the study scientifically sound and does it have social value?
Could the research topic be conducted without deception?
Subject risks-Is the study in subject’s “comfort zone”?
May openly discuss IRB reviewer reaction to deception methods
as a whole and for the study under review.
Consider the risks and benefits for subjects and society
Review the informed consent process
– Is the informed consent document or process a part of the
deception? Is forewarning appropriate?
– Issue appropriate waivers.
If information is withheld from the subject, is there a
debriefing?
– Does the IRB agree with when, who and how debriefing occurs?
After being debriefed, will subjects have the opportunity to
withdraw their data from the study?
Special considerations for federally funded studies
– Is deception written in the grant?
Summary
Review of deception studies not
“proscribed”
Great variability in deception study
methods means each IRB must apply
careful analysis of risks and benefits to
each study
Options to mitigate risks for deception
studies exist, but have not been wellresearched
Resources
Belmont Report
OHRP Guidebook
APA Code of Ethics, 2002
Reference Literature
Reference List
American Psychological Association. (2002). Ethical Principles of
Psychologists and Code of Conduct: General Principles. Retrieved from
http://www.apa.org/ETHICS/code2002.html#general.
Fisher, C.B. (2005). Deception research involving children: ethical practices
and paradoxes. Ethics & Behavior, 15(3), 271-87.
Lawson, E. (2001). Informational and Relational Meanings of Deception:
Implications for Deception Methods in Research. Ethics & Behavior, 11(2),
115-130.
Miller, F.G., Gluck, J.P, Jr., & Wendler, D. (2008). Debriefing and
Accountability in Deceptive Research. Kennedy Institute of Ethics Journal,
18 (3), 235-251.
Miller, F. G., & Kaptchuk, T.J. (2008). Deception of Subjects in
Neuroscience: An Ethical Analysis. The Journal of Neuroscience, 28(19),
4841-4843.
Ortmann, A., & Hertwig, R. (2002). the Costs of Deception: Evidence from
Psychology. Experimental Economics, 5, 111-131.
Sieber, J.E., Iannuzzo, R., & Rodriguez, B. (1995). Deception Methods in
Psychology: Have they Changed in 23 Years? Ethics & Behavior, 5(1), 6785.
Wendler, D., & Miller, F.G. (2004). Deception in the Pursuit of Science.
Arch Intern Med, 164(6), 597-600.