Analyze the Deception case.
(Case is Attached)
Dr. Smith from the Department of Dermatology at New Broom University Medical School has submitted a brief protocol to the IRB. It takes the form of a letter, which reads as follows: “Dear IRB Director: As a dermatologist I’m very interested in implementation science. As you may know, one of the biggest problems in dermatology is adherence to topical regimens for conditions like severe acne. If patients are not adherent, but do not admit that to the physician, the physician may conclude that topical medication is ineffective for the patient and prescribe a steroid to be administered orally, with systemic effects that carry more serious risks of harm than accompany topical administration. It would be far better to limit systemic medications to those patients who are genuinely adherent but for whom topical medication is insufficiently effective. For this reason, I would like to determine how many patients lie about their adherence. This is easily determined by giving patients a tube of prescription ointment that has a “chip cap” which records when the tube is opened and squeezed. I will ask patients to keep a record of when they use the ointment, and will give them a notebook or a smartphone app in which to record their use. I will collect that record at every visit, and compare it with the chip readout, which will be collected via Bluetooth during their office visits. (They will be asked to bring the tube to each visit.) This is obviously a minimal risk intervention, and it is not possible to explain the study without biasing the results. In addition, it would surely be embarrassing for my patients to be “debriefed” and caught lying. For that reason I request a waiver of consent and ask for an exemption.” Dr. Jones, the IRB Director, has called a meeting of all the committee chairs and staff at NBUMS, which has 5 committees and a large staff in order to deal with a substantial research portfolio. Dr. Jones has circulated Dr. Smith’s letter with a cover memo that states: “I am uncertain how to reply to Dr. Smith’s request. I would like everyone to think about the issues that need to be addressed in determining how to respond. Please prepare a list of questions for our discussion next week, and do some research (even if it’s just a matter of looking at the regulations) and prepare your own answers, including your reasoned justifications for those answers. Your preparation will form the basis for the discussion in our meeting and help me determine how to respond.” deception_and_research-ethics_and_regulation_sachrp.ppt 10/1/13 1 Deception and Research: Ethics and Regulation Franklin G. Miller, Ph.D. Department of Bioethics National Institutes of Health 1 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. 2 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. 3 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. 4 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. 5 What is Deception? • Defining concept of deception is philosophically complex. • Working definition: deliberately misleading communication about purpose of research and/or procedures employed. 6 10/1/13 2 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 7 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 8 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. 9 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. 10 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. 11 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. 12 10/1/13 3 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. 13 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. 14 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 15 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 16 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: 17 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.” 18 10/1/13 4 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? 19 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 20 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. 21 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) 22 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. 23 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? 24 10/1/13 5 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. 25 Limitations • Disclosure of deception may lead to reduced subject enrollment. • Does AD compromise scientific validity?