Considerations in IRB Approval of Deception Research

1. 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

2. 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

3. 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%

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. Kind of Failure to Inform • Not informed • Information concealed • Falsely informed • Consent to possible deception (Forewarning)

11. Nature of the Research • Perception of the behavior • Privacy of the behavior • Behavior (natural vs. induced) • Degree of confidentiality

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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?

18. 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 well-researched

19. Resources • Belmont Report • OHRP Guidebook • APA Code of Ethics, 2002 • Reference Literature

20. 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), 67-85. • Wendler, D., & Miller, F.G. (2004). Deception in the Pursuit of Science. Arch Intern Med, 164(6), 597-600.