Anesth Analg 2003;96:319-320
© 2003 International Anesthesia Research Society
EDITORIALS
Missing the Informed in Consent
Jeremy Sugarman, MD, MPH, MA
Duke Center for the Study of Medical Ethics and Humanities, Departments of Medicine and Philosophy, Duke University, Durham, North Carolina
Address correspondence and reprint requests to Jeremy Sugarman, MD, Center for the Study of Medical Ethics and Humanities, 108 Seeley G. Mudd Building, Duke University Medical Center (Box 3040), Durham, NC 27710. Address e-mail to sugar001{at}mc.duke.edu
Empirical research on informed consent can serve to help evaluate and improve this critical protection for research participants. Indeed there is substantial literature describing evaluation of informed consent, although not much of this work has been conducted in the perioperative setting (1). Consequently, the study by Treschan et al.(2) reported in this issue of Anesthesia and Analgesia is a welcome addition.
To evaluate the extent to which the pain or risk associated with research affects the decision to participate in it, the investigators used a sham procedure in which they pretended that they were asking patients who were scheduled to undergo surgery with general anesthesia the next day to participate in a research project. Participants were randomly assigned to receive one of three versions of the sham protocol: control, increased pain, and increased risk. Among a variety of other measures, consent rates were recorded, and the participants’ understanding of the protocol was assessed. As might be expected, patients were less likely to decide to participate in research that posed increased risk or pain than the control protocol. Unexpectedly, perhaps, those who reported feeling pressure did not agree to participate, and increased understanding of the protocol was associated with increased agreement to participate.
Although somewhat counterintuitive, the findings that feeling pressure and not understanding the protocol were related to refusals to provide consent are somewhat reassuring, because these findings suggest that if these key parts of the informed consent process are not met, participation may not occur. In turn, even though these associations are not necessarily causal, they might serve to reinforce the ethical obligation of those seeking consent for participation in clinical research to avoid pressuring potential participants, to provide information about a research protocol in a manner most likely to be understandable to potential participants, and to then ensure their understanding before a decision to participate is made. Perhaps approaching the consent process in this way might redound not only into higher consent rates, but also that those who give consent do it freely and based on an adequate understanding of what is likely to occur.
However, not all of the findings in the study are quite so salutary. Quite troubling is that 9% of the patients who did not understand the protocol gave consent to participate. Although this accounts for the minority of those who elected to participate, uninformed consent is not an acceptable substitute for informed consent. Understanding critical aspects of the protocol is central to providing an autonomous authorization to participate, which is an ethical requirement for conducting most clinical research. Fortuitously, a solution to this finding also involves obtaining consent only after providing an understandable and adequate disclosure about the protocol. Fortunately, these decisions were for participation in a sham protocol, and therefore, actual clinical research without consent did not occur.
It is conceivable that the findings concerning understanding of the research and decisions to participate were largely based on the investigators’ reliance on scripted information about the pain or risk of the sham protocols as described in the consent form. Although patients were given the opportunity to study the consent documents and have their questions answered, additional information about the sham protocol was provided only if patients asked. Patients were then given a short time to decide whether to participate, and they were not permitted to involve others in their decision. Whereas such an approach brings a degree of scientific rigor to the consent study and may be indicative of how consent for research is obtained in some clinical settings, it is far from ideal. A more ideal process would involve eliciting patients’ understanding about proposed research and giving them ample time to decide, along with the help of others whose opinions they value. Obtaining consent for most clinical research should neither be restricted to scripted materials nor by time.
Nonetheless, despite this approach, the consent rate varied from 30% to 55% according to which of five investigators approached the patient to participate. Although there are insufficient data provided in the report to understand this finding, and as the authors suggest, the sample size does not permit a thorough analysis of it, this variability suggests how complicated informed consent can be and how unexpected attributes can influence the success of the endeavor.
Although it is relatively simple to come up with some prudent suggestions for enhancing the likelihood of obtaining valid informed consent, such as formally assessing whether patients understand the essential aspects of a research protocol and giving them an opportunity to consult with relatives and friends, it is also important to test ways of improving the informed consent process using rigorous methods of clinical research (3). Ideally, such research would be performed in actual clinical settings and would evaluate interventions that are sensitive to the realities of perioperative care and a robust conception of what constitutes meaningful informed consent.
Obtaining meaningful informed consent for clinical research in the perioperative setting can be especially challenging. For a patient to partake in the process, he or she must have adequate competency or decision-making capacity. This includes the ability to take in new information and use it to make a rational decision and then express that choice. However, in some perioperative situations, decision-making capacity can be compromised by acute illness or the administration of psychoactive drugs that can impair capacity. Further, patients may not be well positioned to make a voluntary decision, another key aspect of informed consent, simply because of their incipient dependence on an anesthesiologist and surgeon or the circumstances in which they were approached to give consent (such as in a preoperative holding area). In addition, some of the clinical information related to research participation may be new to patients, making it particularly difficult to describe adequately the proposed research endeavor. For nonelective surgery, there may be time pressure to proceed to surgery, thereby eliminating the possibility of having sufficient time for patients to consult with family, friends, or another clinician before deciding to participate. Each of these impediments needs to be overcome for informed consent to be meaningful.
Given these realities, a research agenda for developing and testing promising interventions should be developed and discussed. Clearly this agenda should examine ways of assessing the capacity to consent as well as the effect of location and the timing of recruitment. It should also attempt to determine the potential effects of the characteristics of the individual seeking consent, ways of improving disclosure of relevant information about research, and simple methods of ensuring that patients understand the information. Data from studies that examine these sorts of questions should help investigators meet their ethical obligations to obtain valid informed consent for clinical research.
References
- Sugarman J, McCrory DC, Powell D, et al. Empirical research on informed consent. Hastings Cent Rep 1999; 29: S1–42.[Medline]
- Treschan TA, Scheck T, Kober A, et al. The influence of protocol pain and risk on patients’ willingness to consent for clinical studies: a randomized trial. Anesth Analg 2003; 96: 498–506.[Abstract/Free Full Text]
- Lavori PW, Sugarman J, Hays MT, Feussner JR. Improving informed consent in clinical trials: a duty to experiment. Control Clin Trials 1999; 20: 187–93.[Web of Science][Medline]
Accepted for publication October 8, 2002.
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