assessing the ethics of ethics research: a case study

Assessing the Ethics of Ethics Research: A Case StudyAuthor(s): Franklin G. Miller and David WendlerSource: IRB: Ethics and Human Research, Vol. 26, No. 2 (Mar. - Apr., 2004), pp. 9-12Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3564232 .

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CASE STUDY, BY FRANKLIN G. MILLER AND DAVID WENDLER

Assessing the Ethics of Ethics Research: A Case Study

mpirical research on ethical issues in medicine and clinical research has grown dramatically in recent

years. The ethical assessment of this research, however, has received scant attention., This lack of ethical reflection likely derives, for the most part, from the fact that ethics-related research often relies on questionnaires and interviews to assess the attitudes and prefer- ences of patients, clinicians, research subjects, investigators, and members of the public. These surveys typically pose few, if any, risks of physical harm or discomfort.

However, as more ethics research is conducted, including experimental interventions, it is important to ensure that such research satisfies the ethical conditions that apply to all research with human subjects.2 In this article, we con- sider the ethics of ethics research by evaluating a specific study that was designed to assess individuals' decisions to enroll in clinical research.

Study Description

Investigators at the University of Vienna recruited 150

hospitalized patients who were "scheduled to undergo minor surgery with general anesthesia" for a study using deception designed to evaluate how the disclosure of risk of harm or discomfort influences patients' decisions to

participate in clinical research.3 Eligible patients were

randomly assigned to one of three sham studies that were ostensibly designed to assess wound healing. The first sham study was described as a benign intervention without pain or risk; the second sham study was described as posing considerable pain and discomfort; the third was described as carrying significant risk of

injury. Patients were informed that psychological testing and questionnaires about decisionmaking would be administered before participation in the wound healing studies. These surveys were designed to investigate the factors that influenced individuals' decisions whether to

agree to enroll in the sham studies. After being randomized to one of the three sham

studies, patients received the appropriate written consent

form, which was read aloud to them. The consent forms were designed to deceive the patients into believing that the sham studies were real, describing in direct and clear

language the discomfort and risks posed by the studies. The forms also briefly mentioned the potential for medical benefit to the subjects.

Following the reading of the consent form, one of the

investigators answered any questions and then solicited individuals' consent. Participants were given only a few minutes to make a decision and "were not permitted to call or talk with relatives or friends and were told that their surgeons were unavailable for consultation." All but four patients approached agreed to go through the consent process and complete the psychological testing and questionnaires on the factors that influenced their decision whether to consent. Two subjects withdrew dur-

ing the survey phase and 61 agreed to participate in one of the sham studies.

After the surveys were completed, one of the investi-

gators immediately debriefed the subjects, explaining that the wound healing studies were all shams and

describing the rationale for the deception. Although the authors did not systematically assess patients' response to the deception, they report that:

most patients were surprised to hear about the deceptive nature of the trial during the debriefing. A few patients were initially distressed after hearing that no actual study would be performed, but most appreciat- ed the importance of the study once our purpose was explained to them.4

The University of Vienna Institutional Review Board

(IRB) approved the study. Interestingly, the published report of the study was accompanied by an editorial written by an ethicist.5 The editorial cited the importance of conducting research on informed consent in the peri- operative period, but did not comment on the use of

deception.

Risk in Ethics Research

R isk assessments in clinical research tend to focus on

the potential for physical harm. Although most ethics research poses essentially no risk of physical harm,

Franklin G. Miller and David Wendler, "Assessing the Ethics of Ethics Research: A Case Study," IRB: Ethics & Human Research z6, no. 1 (0zoo4): 9-12.

IRB: ETHICS & HUMAN RESEARCH MARCH-APRIL 2004

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this deceptive study of informed consent reveals that ethics research may pose other serious risks. The subjects were hospitalized patients awaiting surgery under general anesthesia. These patients were likely to be experiencing stress, and the invitation to participate in research involv-

ing discomfort or risk may have added to this stress, especially given the requirement that subjects make a

quick decision without consulting family, friends, or the

attending surgeon. In addition to the risks of provoking anxiety from the

artificially constrained informed consent process, this

study may have posed risks to subjects from the use of

deception itself. The authors of the study downplay this risk by declaring that "Deceptive studies per se do not distress research subjects."6 Although it may seem plausi- ble to assume that deception itself will not cause distress to subjects, the investigators' report that some of the

patients were distressed after being told about the deception belies this assumption. Moreover, data from the

only study of which we are aware that assessed the

impact of deception in clinical research found that 18 of

54 subjects were upset as a result of being deceived by clinical investigators.7 This finding is significant because it comes from a study that deceived subjects only about the purpose of a questionnaire, not about an entire study.

It is worth noting that the experience of distress is but one of the risks of deceptive research. The Vienna inves-

tigators conducted their deceptive study in a clinical set-

ting with patients who have a legitimate expectation of truthful communication, and are likely to rely on the

integrity of clinicians. The extensive deception used in this study, conducted by three physicians, a nurse, and a medical student, poses a risk of undermining subjects' trust in medical professionals, which could interfere with their future medical care or with their willingness to participate in future research. Such deception is also poten- tially corrupting for the researchers who may become

disposed to deceit in future research or in relationships with patients.

In the questionnaire study assessing the impact of

deception, 6 subjects reported after debriefing that they were sufficiently upset by the deception to refuse future research participation.8 This result suggests that debrief-

ing may not fully restore the trust that gets exploited in the conduct of deceptive research. Furthermore, wide-

spread recognition that clinical researchers sometimes

engage in deceptive research may undermine the public's trust in clinical research in general.9 Finally, by mislead-

ing and manipulating individuals in situations where

truthful communication is expected, deception violates

respect for the dignity and autonomy of persons. Recognizing the risks posed by deceptive clinical research raises the question whether the investigators could have taken any steps to reduce the risks of the present ethics

study.

Deception in Ethics Research

he most obvious way to minimize the risks of deceptive research is to allow the use of deception only

when scientifically necessary.10 The authors argued that

nondeceptive alternative research designs would not have been adequate. An investigation of the actual process of informed consent to clinical research would not have

permitted the randomized, controlled experimental conditions aimed at elucidating the influence of informed consent disclosures of risk and discomfort on patients' decisions to participate. The use of a deceptive invitation to sham studies allowed the construction of informed consent documents tailored to testing the research

hypothesis. In addition, the investigators rejected using hypothetical scenarios because the scenarios would not

accurately reflect decisionmaking in the real context of clinical research.

Granting the need for investigators in some studies to deceive subjects in order to answer their questions, can

they minimize the risks that deceptive studies pose? Many of the risks of deceptive research result from indi-

viduals, both subjects and the public in general, learning that particular studies are deceptive, and subjects have been deceived. Accordingly, one strategy to reduce the risks of deceptive research might be to recommend that

investigators conducting deceptive research not inform

subjects of its use and forgo the debriefing session after

subjects have completed the survey. This approach may be difficult to implement in stud-

ies of informed consent to sham protocols, as those who consent expect to be research subjects and will need to know that the research is not taking place. However, another comparable study of informed consent to two sham drug trials took this approach."* Patients who con- sented were informed that according to a review of their medical records they should receive standard care rather than participate in the trial of the investigational drug. In the article reporting the results of this study, the investi-

gators explained their decision to avoid debriefing as fol- lows: "Our concern that engendering mistrust might impact on future health care led us to conclude that immediate debriefing would be more risky than main-

IRB: ETHICS & HUMAN RESEARCH MARCH-APRIL 2004 10



taining the deception.""' Withholding from subjects the fact that they were

deceived presumably would eliminate the possibility of their being upset by the deception and the possibility that the deception might undermine their trust in the medical profession. In addition, refraining from inform-

ing subjects would reduce the extent to which the public will learn that some clinical research studies are deceptive. As a way of minimizing risks, there are several

problems with this approach, however.

First, failure to debrief will not completely keep the fact of deceptive studies from the public. The public will still learn, although to a lesser extent, of the conduct of

deceptive studies through reports of the results of stud-

ies, and possibly through comments made by the investi-

gators who conduct these studies. Since individuals will be unable to determine which studies are deceptive and whether the informed consent document presented to them is accurate, the failure to debrief subjects may ulti-

mately increase the potential of the deceptive study to undermine trust in research.

In addition, relying on the absence of debriefing to eliminate the ethical concerns with deceptive research assumes that the only harms or wrongs involve the possibility of subjects being upset and undermining the public's trust in clinical research. However, even when individuals are not informed, being deceived still may harm them. Deception in the context of clinical research involves a harm or wrong to subjects because it violates

respect for persons.13 Of course, debriefing subjects after they have been

deceived does not eliminate the deception itself.

Nonetheless, debriefing does allow subjects to under- stand accurately the nature of the study to which they contributed. Also, as some commentators have recom-

mended, the use of debriefing would allow subjects the

opportunity to remove their data if they decided that

they did not want to contribute to the deceptive study. 14 In the absence of debriefing, subjects are forced in a sense to contribute to the study, even though they did not give informed consent.

Recognizing the importance of debriefing, together with the fact that it does not eliminate all the ethical

problems with deceptive research, we have endorsed what we call "authorized deception."'s Specifically, investigators should be required to inform subjects prospectively that the study involves deception, without

telling subjects the exact nature of the deception.

Subjects could give prospective authorization for deception by including language such as the following in the informed consent document:

You should be aware that the researchers have not accurately described certain aspects of this study. An independent ethics committee has approved the use of deception and has determined that it is necessary to conduct this research. The aspects of the study that have not been described accurately will be explained to you at the end of your participation.

The use of the authorized deception approach permits subjects to agree to being deceived. Thus, it allows individuals who might be particularly upset at being deceived to decline to participate, and allows others to consent to the deception, likely reducing the chances that the deception will cause distress or undermine their trust in physicians.

Importantly, the use of authorized deception would not eliminate the risks posed by deceptive research, including the informed consent study. The conclusion that ethics research can pose serious risks highlights the

importance of assessing its value to ensure that the

potential benefits of the study justify the risks of the research.

Case Assessment

TO justify the risks and burdens imposed on subjects,

I human subjects research must offer the potential for sufficient value.'6 The value of clinical research studies on new drugs to improve health or health care typically is obvious. This may be less clear in the case of ethics research. Therefore, an important part of assessing the ethics of ethics research will be to ensure that it offers sufficient anticipated social value to justify the risks and burdens imposed on subjects.

Learning about the factors that may influence decisions to participate in clinical research is valuable for

assessing the adequacy of informed consent and improv- ing the consent process. However, it is unclear whether this particular deceptive study of informed consent had the potential to help significantly in suggesting how the

process of informed consent might be improved. The authors did not recommend any reforms to the informed consent process based on their study findings. In addi-

tion, it is not clear how information about the extent to which individuals make decisions to enter research based on the risks might influence the conduct of clinical research.

For the most part, the sorts of decisions that subjects


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make do not determine the risks of clinical research studies. Instead, the risks are a function of the assessment of the interventions, together with an assessment of what risks are ethically appropriate in the context of clinical research. For instance, it is not clear how a finding that individuals are more averse to risks of physical harm ver- sus the potential for serious discomfort might affect the conduct of clinical research. In either case, it is essential to minimize both risks as much as possible, consistent with valid scientific design.

Finally, the value of research was open to question in view of the artificially pressured informed consent

process that required patients to make a rapid decision whether to participate in the research without having the

opportunity to think it over and discuss this with others. Because this consent process differs from normal and desirable research practice, the generalizability of the

findings about informed consent is in doubt. These considerations suggest that the social value of

this deceptive research was questionable. Yet, the results of this study, combined with the results of future studies, may offer unforeseen ways to improve the informed consent process for clinical research. This conclusion is

important because the value of human subjects research, including ethics research, must justify the burdens and risks imposed on subjects. Studies of speculative value are not inherently unethical; however, it seems clear that at best the benefits of such studies can justify only very minimal risks.

We have argued that, as designed, the deceptive informed consent study posed greater than minimal risks. It posed the potential for serious distress to sub-

jects, and the potential to undermine subject and public trust in both research and clinical care generally. Although the research article reported IRB approval, it seems unclear that the social value of the research justified these risks.

In addition, we argued that the investigators could have used authorized deception, informing subjects of the use of deception upfront and obtaining their consent to its use. The use of authorized deception would have

significantly decreased the risks of this study. It would have warned subjects of the use of deception, allowing those bothered by deception to decline enrollment.

Furthermore, by making clear to subjects that deception was being used, authorized deception would have elimi-

nated, or at least reduced, the potential for this ethics

study to undermine trust in research and researchers.

Alternatively, as mentioned above there are almost no data on the impact that deception in clinical research has on subjects. There is a need for such data in order to assess the ethical appropriateness of deceptive research, particularly in cases where the IRB determines that inves-

tigators cannot use authorized deception. By collecting systematic data on the impact the deception had on sub-

jects, the deceptive informed consent study would have offered significantly more social value that might have

justified the risks to subjects. Either way, the present study highlights the importance of assessing the ethics of ethics research. Investigators should minimize risks and ensure that the social value of the research justifies the risks and burdens to subjects.

Acknowledgments We thank Ezekiel Emanuel and Alex Rajczi for helpful

comments on an earlier draft of this paper. Disclaimer: The ideas and opinions expressed are the authors' own and do not represent the position or policy of the National Institutes of Health, Public Health Service, or Department of Health and Human Services.

N Franklin G. Miller, PhD is Head, Unit on Clinical Research in the

Department of Clinical Bioethics, National Institutes of Health and

Special Expert, National Institute of Mental Health Intramural Research Program and David Wendler, PhD is head of the Unit on Vulnerable Populations in the Department of Clinical Bioethics at the National Institutes of Health.

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