Freely Given Consent
It appears obvious that coercing people into serving as research subjects is patently unethical and nothing that we as researchers would ever do. But consider the following situations:
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You are the local investigator in a multicenter trial to determine the usefulness of antibiotics in treating ulcers. You ask the next 30 patients attending your outpatient clinic who meet the criteria to participate in this study, assuring them that their future care will not be jeopardized if they refuse. To reimburse you for your time in filling out the required forms, you will be paid $500 for each person who completes the trial.
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To study the effects of immobility on muscle fibers, you want to have otherwise healthy volunteers wear a cast on their nondominant arm for 6 weeks. You advertise in the college newspaper and offer to pay subjects $150 a week.
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You want to compare the efficacy of heat therapy versus acupuncture in patients with rotator cuff injury. To improve compliance during the 10-week trial, you will remunerate subjects after they have completed all 20 sessions.
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It is hypothesized that allergic reactions can be classically conditioned by exposing subjects to an allergen in the presence of a previously neutral stimulus. You try this with 20 students enrolled in an introductory psychology class who must participate in 3 hours of studies to meet the course requirements.
CoercionEach of these studies, which are based on actual proposals, raises concerns about the subjects’ freedom to say “No.” Although reassured that refusal will not jeopardize their future care, patients may still have concerns that not participating in a study will anger their physician, resulting in second-rate care. This puts subtle pressure on them to sign up, despite any misgivings they may have about being in the study. Further, there is a power imbalance between the physician and the patient that raises at least the potential for abuse and a violation of the therapeutic alliance. To avoid this, whenever possible, clinicians should not enlist their own patients in studies but should delegate the task to another person (e.g., colleague, resident, nurse). On occasion, this may present a dilemma because the attending physician may be the person who could best explain the study to the potential subject and address any questions or concerns. In these circumstances, it would be best if the clinician informs the patient about the details of the study but leaves the room when consent is sought by the other person overseeing the experiment.
Although the use of indentured servants was officially abolished in the United States well over 100 years ago, pockets of it still exist in the form of psychology students, postdoctoral fellows, and laboratory technicians who supply a disproportionate amount of information about “human” behavior and blood for new assays. The reasons for this are obvious: these people are generally compliant and available, often in large numbers. However, the problems with using them are similar to those outlined in the previous paragraph. If participation in a certain number of studies is a course requirement, then refusing can lead to a lower grade. Technicians and fellows don’t want to jeopardize their current jobs or their chances of future ones by alienating their boss, who also may be the writer of a needed letter of reference. The American Psychological Association stipulates that students should be offered an alternative to participating in research studies, such as writing a paper. Laboratory supervisors should act like attending physicians and never ask people who are beholden to them to take part in an experiment or even to donate blood. To do otherwise would strain the freedom of refusal.
Payment to PhysiciansPaying a physician more than a token amount to enroll patients in a study and complete the required forms is problematic at the best of times. In some studies, these “bounty fees” can be as much as a few thousand dollars a patient, which far exceeds the remuneration for the time spent doing these tasks and raises the question of whose interests the physician is serving. If there is the slightest possibility that tests or other procedures will be performed to determine eligibility for a study and not because the patient requires them, or that diagnoses may be subtly modified to meet study criteria (as happened in a recent breast cancer trial), then ethical practice is jeopardized. Even worse is making the fee contingent on the patient completing the trial, which puts the doctor in a situation of even greater conflict of interest. There should not be any financial disincentive to a physician removing a patient from a trial because of adverse reactions; even the perception that this may occur should be avoided.
Payment to SubjectsIn a similar fashion, paying the subjects only after they complete a long series of procedures may put undue pressure on them to continue in the study after the point at which they would otherwise say “Enough, already.” From both a scientific and a logistic point of view, we would like all subjects who are enrolled to stay in the study until the end; otherwise, we as researchers are plagued with missing data, fewer subjects than we need, and threats to the validity of the study. However, these very real methodologic considerations should not override the subject’s freedom to withdraw at any time. One compromise is to pay patients on a sliding schedule, which is a larger amount the longer they stay in the study.
This raises the related issue of how much to pay subjects in the first place. We don’t work for free (although we may feel grossly underpaid and undervalued), so why should we expect strangers to volunteer their time for the benefit of our research? The delicate balancing act is to find an amount that would reimburse subjects for their time, effort, and discomfort but not so much that they would take risks or jeopardize their health simply for the money. In the real world, we do pay people more to do risky jobs that we wouldn’t do ourselves—build or paint bridges, repair industrial chimneys, or fight forest fires. In the world of research, however, we should not coerce people into participating in studies in which we ourselves would not enroll. In most places we’re familiar with, if subjects are paid at all, the going rate is slightly above the minimum wage (plus traveling and parking expenses, if required), but this can be increased slightly if some discomfort is involved, such as venipuncture or swallowing a nasogastric tube. However, in many clinical trials, patients are not paid for participating.
Content on this page was last changed on March 19, 2009.
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| 5476. | Streiner DL, Norman GR. PDQ Epidemiology. 2nd ed. Hamilton, Ontario: BC Decker Inc.; 1996. |