Dr. Smith from the Department of Dermatology at New Broom University Medical School has submitted a
ief 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 ca
y 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
ing 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 emba
assing for my patients to be “de
iefed” 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
eflect 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
ehavior when truthful disclosure is
considered likely to produced biased
esponses 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.
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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
ehind one-way mi
or
• 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
eliefs 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
elevant information.
• Deception may cause distress when
discovered.
• If use is not disclosed in advance, consent
to research is not valid.
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Is Deception Necessary?
• Deception should not be used if non-
deceptive alternatives are available.
• Deception should not be used unless
esearch has sufficient potential social
value to justify risks associated with
deception.
13
Does De
iefing Neutralize
Deception?
• De
iefing 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
• De
iefing 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 De
iefing
• Is de
iefing always required?
– Research for which de
iefing is impossible
– Concern that de
iefing might be harmful
– Contamination of the subject pool
• Strong default for de
iefing
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
isk 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 ca
ied
out without the waiver or alteration; and
• (4) whenever appropriate, the subjects will be
provided with additional pertinent information
after participation.”
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Queries about Regs
• Why should research as a whole be only
minimal risk, as distinct from those
esearch 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
enefits 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
– De
iefing 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
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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 cu
ent research
educes the comparability to previous
esearch.
25
Limitations
• Disclosure of deception may lead to
educed subject enrollment.
• Does AD compromise scientific validity?