Deception and Research: Ethics and Regulation

1. Deception and Research: Ethics and Regulation Franklin G. Miller, Ph.D. Department of Bioethics National Institutes of Health

2. Disclaimer • The views presented are mine and do not reflect the position or policy of the National Institutes of Health, the Public Health Service, or the Department of Health and Human Services.

3. Sources • Wendler D, Miller FG. Deception in the pursuit of science. Arch Intern Med 2004;164:597-600. • Miller FG, Wendler D, Swartzman L. Deception in research on the placebo effect. PLoS Medicine 2005;2(9):e262. • O’Neil C, Miller FG. When scientists deceive: applying the federal regulations. Journal of Law, Medicine & Ethics 2009;37:344-50.

4. Overview • Outline nature of deceptive research • Indicate why deception matters ethically • Discuss federal regulations • Present “authorized deception” approach • Recommend standards for discussing deception and safeguards in published articles.

5. Use of Deception • Deception frequently used in psychology, neuroscience, and behavioral research; less common in clinical research. • Purpose of deception is to promote scientific validity: • Obtain unbiased data about attitudes and behavior when truthful disclosure is considered likely to produced biased responses by subjects.

6. What is Deception? • Defining concept of deception is philosophically complex. • Working definition: deliberately misleading communication about purpose of research and/or procedures employed.

7. Typology of Deception • Misleading disclosure • Lack of accurate disclosure by withholding specific information about research • Misinforming subjects about the research • Distinct from disclosed concealment in double-blind placebo-controlled trials • Fake or rigged instruments or procedures

8. Typology of Deception • Misleading play-acting in experimental design: researcher, confederates • Covert procedures: e.g. observation behind one-way mirror • Covert research • Undercover observation • Staged experiment in public place

9. Milgram on Deception • “It is true that technical illusions were used in the experiment. I would not call them deceptions because that already implies some base motivation.” Quoted in Korn J. Illusions of Reality: A History of Deception in Social Psychology. State University of New York Press, 1997:p.104.

10. Irony of Deception in Science • Science aims to learn and communicate the truth. • Research may require deception to learn the truth about attitudes, motivations, and beliefs and their effects on behavior. • If so, then the end of learning the truth is pursued by the means of untruth.

11. Does Deception Matter? • Deception is prevalent in ordinary life and often considered justified to be polite and not hurt others’ feelings. • Why, then, should we care about deception in research? • In research, subjects are not being deceived for their own benefit. • They are deceived for the purpose of developing socially valuable knowledge.

12. Ethical Problems with Deceptive Research • Violates respect for persons • Manipulates people to do something that they otherwise might not want to do. • Violates right to choose what to do based on relevant information. • Deception may cause distress when discovered. • If use is not disclosed in advance, consent to research is not valid.

13. Is Deception Necessary? • Deception should not be used if non-deceptive alternatives are available. • Deception should not be used unless research has sufficient potential social value to justify risks associated with deception.

14. Does Debriefing Neutralize Deception? • Debriefing mitigates the harm and wrong of deception by explaining the rationale for the deception. • It does not cancel the violation of respect for persons. • Retrospective endorsement by deceived subjects is not the same as prospective informed consent.

15. Withdrawal of Data • Debriefing should include offer to withdraw data • Compensates for lack of prospective informed consent by giving subjects opportunity to control retrospectively whether their data are included in deceptive research

16. Waiver of Debriefing • Is debriefing always required? • Research for which debriefing is impossible • Concern that debriefing might be harmful • Contamination of the subject pool • Strong default for debriefing

17. Regulatory Authority • 45 CFR46.116(d) “An IRB may approve a consent procedure which does not include, or which alters some of the elements of informed consent . . . provided the IRB finds and documents that:

18. Regulatory Requirements • “(1) the research involves no more than minimal risk to the subjects; • (2) the waiver or alteration will not adversely affect the rights and welfare of the subjects; • (3) the research could not practicably be carried out without the waiver or alteration; and • (4) whenever appropriate, the subjects will be provided with additional pertinent information after participation.”

19. Queries about Regs • Why should research as a whole be only minimal risk, as distinct from those research procedures that are deceptively presented? • How can research employ deception without adversely affecting the rights of subjects?

20. Authorized Deception • Prospective subjects informed that a study will not be described accurately or that some procedures will be deceptive. • Soliciting prior authorization for deception makes deception compatible with valid consent. • Prospective subjects given fair opportunity to decide whether or not they want to participate in research involving deception. • Not informed consent

21. Suggested Consent Language • “You should be aware that the investigators have intentionally misdescribed certain aspects of the study. This use of deception is necessary to conduct the study. However, an independent ethics committee has determined that this consent form accurately describes the risks and benefits of the study. The investigator will explain the misdescribed aspects of the study to you at the end of your participation.” Miller FG, Wendler D. 2004.

22. Specific Example • “At some point we will provide your child with misleading information about one of the tasks. After that task is completed, however, we will explain to you and your child how your child was misled and why. We will also answer any questions that you or your child has about the task and the use of deception.” • The phenomenology and neurophysiology of affective dysregulation in children and adolescents with bipolar disorder (NIMH)

23. Virtues of Authorized Deception • Authorized deception (AD) makes process of deceptive research transparent. • Subjects informed that: • They will be misled or deceived • No important risks have been concealed • Independent committee has approved • Debriefing will occur.

24. AD and Regs • AD makes deceptive research with condition 2 of 45CFR46.116(d) • Alteration in elements of informed consent will not adversely affect rights of subjects • Is AD necessary to satisfy condition 2? • How about minimal risk deceptive research in a public place where there is no possibility of a consent disclosure?

25. Limitations of AD • Telling subjects that deception will/might occur may make them suspicious, thus possibly leading to biased data. • Using the AD approach in current research reduces the comparability to previous research.

26. Limitations • Disclosure of deception may lead to reduced subject enrollment. • Does AD compromise scientific validity?

27. Test of AD • Research on placebo effect • Conditioning paradigm with heat pain stimulus given to 40 healthy volunteers • Pain stimulus surreptitiously lowered following application of placebo cream described as a pain-relieving agent • Subjects randomized to standard disclosure without AD vs AD disclosure (based on Wendler and Miller 2004) Martin AL, Katz J. Pain 2010;149:208-15

28. Results of AD Test • Placebo effect observed in both groups • No significant difference in magnitude; hence no biasing of study results • No subjects in AD group declined to participate • During debriefing19 of 20 participants in AD group stated that they preferred this method of disclosure.

29. Upshot • AD does not necessarily bias study results • Generalizability is open to question • Experimental evidence that conditioning is stronger than verbal instruction in forming placebo responses • Not known whether similar results would have been obtained with a procedure aimed at producing placebo analgesia by verbal instruction alone.

30. Queries about AD • If AD is necessary to justify deceptive research can it be ethical to conduct a methodological experiment comparing AD with the standard approach to deception? • If in future research AD is found to compromise scientific validity, can deception without AD be justified?

31. Deceptive Research and Public Accountability • Published articles represent the public face of science. • Published articles should satisfy public accountability for violating respect for persons and informed consent by discussing the use of deception.

32. Current Practice • Deception often not mentioned • Inferred from description of study design and disclosure to subjects. • Articles reporting research using deception frequently state, “written informed consent was obtained”! • Use of debriefing often not mentioned.

33. Discussing Ethical Issues • Discussing key ethical issues in published articles promotes public moral accountability, just as discussing research methods promotes scientific accountability. Miller FG, Rosenstein DL. Reporting of ethical issues in publications of medical research. Lancet. 2002;360:1326-28.

34. Reporting Standards • Highlight Deception • Explain rationale for deception/lack of non-deceptive alternatives • Describe deviation from informed consent and whether authorized deception used • Describe use and nature of debriefing • Detailed discussion on journal website

35. Conclusions • Deceptive research pits scientific validity vs. respect for persons. • Burden of proof rests on justifying deception. • Deception should be minimized and used only when necessary in studies having considerable value. • Stringent safeguards are required, which should include authorized deception.