Academic journal article IRB: Ethics & Human Research

Comprehension and Informed Consent: Assessing the Effect of a Short Consent Form

Academic journal article IRB: Ethics & Human Research

Comprehension and Informed Consent: Assessing the Effect of a Short Consent Form

Article excerpt

Although informed consent is a fundamental ethical requirement for research with humans, many studies indicate that research volunteers often do not understand critical aspects of the research in which they are participating, suggesting that the "informed" part of consent to participate is imperfectly realized. (1) For instance, a study of 287 adult cancer patients participating in clinical trials revealed that 70% of patient-subjects did not recognize the unproven nature of the study drug. (2) At the same time, concerns have arisen that the increasing length and complexity of consent forms are inhibiting information disclosure and impeding understanding. (3) Consequently, critics worry that the informed consent process does not accomplish the goal of adequately informing prospective participants about the nature of a study and its potential risks and benefits.

Several attempts at improving informed consent have been evaluated. (4) Some preliminary and small studies suggest that decreasing the length and complexity of consent forms may improve understanding, satisfaction with the informed consent process, or both. (5) However, not all studies found improvement. (6) Moreover, these studies have important limitations. Many used consent documents in hypothetical situations rather than in actual research studies. (7) Also, most of the consent studies involved participants who were receiving a study intervention for a disease or disorder (8) and thus may not apply to healthy volunteers who participate in phase I drug development research.

Another concern about the quality of informed consent is the fear that prospective research participants, preoccupied by the prospect of financial gain, will ignore details of the research provided during the consent process, yielding poor understanding of risks, benefits, and alternatives. Yet there are few data about the impact of financial motivations on volunteers' understanding of the studies in which they agree to participate.

To address some of these concerns, our study evaluated the effect of a shorter and simpler consent form on the comprehension and satisfaction of research participants. We hypothesized that study volunteers would have the same level of comprehension after reading either a standard or a concise consent form, and that they would be more satisfied with the concise consent form. We also hypothesized that comprehension might be affected by select volunteer characteristics, including financial motivations to participate in research.

Study Methods

This was a substudy of a phase I bioequivalence study involving healthy volunteers conducted by Pfizer at its Clinical Research Unit in New Haven, Connecticut. The study compared a new 80-milligram atorvastatin calcium chewable tablet to an 80-milligram commercial atorvastatin calcium tablet formulation. From October 2008 to January 2009, all of the healthy individuals who came to the Clinical Research Unit to consider enrolling in the atorvastatin study were invited to participate in the informed consent substudy; only adults (age 18 and over) who could give their own informed consent were included in either the atorvastatin study or the informed consent substudy.

Participants were randomized by date of their visit to the Clinical Research Unit to receive either the standard consent form or the concise consent form. Both contained the elements required by the federal regulations governing research with humans, which are intended to provide all the information necessary to make an informed, voluntary decision to participate. (9) Investigators from Pfizer wrote the standard consent form, and investigators from the Department of Bioethics at the National Institutes of Health Clinical Center wrote the experimental concise consent form. The consent forms differed substantially by their number of words, length and complexity of sentences, and readability level (Table 1). The difference in length between the two forms was accomplished by eliminating repetition and unnecessary detail and using more simplified language (Table 2). …

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