informed consent for psychological research: do subjects comprehend consent forms and understand...

Informed Consent for Psychological Research: Do Subjects Comprehend Consent Forms andUnderstand Their Legal Rights?Author(s): Traci MannSource: Psychological Science, Vol. 5, No. 3 (May, 1994), pp. 140-143Published by: Sage Publications, Inc. on behalf of the Association for Psychological ScienceStable URL: http://www.jstor.org/stable/40063086 .

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INFORMED CONSENT FOR PSYCHOLOGICAL RESEARCH: Do Subjects Comprehend Consent Forms and Understand Their

Legal Rights? Traci Mann

Stanford University

PSYCHOLOGICAL SCIENCE

Technical Commentary

Informed consent for participation in psychology experiments has received much discussion since publica- tion of the classic obedience study by Milgram (1963). It has rarely, however, been studied empirically. In con- trast, there is a large literature of experimental research on medical patients' informed consent (see Meisel & Roth, 1983, for a review). Findings from this literature cannot necessarily be generalized to psychology because medical research provokes very different expectations from its participants than does psychological research. Many subjects in medical research have an illness for which they are seeking treatment or expect to undergo an aversive medical procedure, whereas subjects in psychological research do not expect to be hurt physically.

There are, however, other serious risks to psychology experiments. For example, psychology subjects may have their self-esteem manipulated, their mood changed, or their abilities questioned. In addition, more and more psychologists are turning to medical techniques (such as magnetic resonance imaging, MRI, and computer- assisted tomography, CAT, scans) in their research. For these reasons, it is important in psychological research that subjects read and understand consent forms and understand their rights as research subjects.

According to the American Psychological Association (1992), psychologists must "inform participants of the nature of the research; they [must] inform participants that they are free to participate or to decline to participate or to withdraw from the research; they [must] explain the foreseeable consequences of declining or withdrawing; they [must] inform participants of significant factors that may be expected to influence their willingness to participate" (p. 1608). Research subjects have to understand this information to make an informed decision about whether they wish to participate in an experiment. Re- search is needed on the critical question of whether subjects in psychology experiments understand the information on consent forms.

Even though it is unknown whether subjects comprehend consent forms, researchers continue to add more information to them. In an analysis of consent form readability, Baker and Taub (1983) found that the average

length of consent forms for research in Veterans Admin- istration hospitals doubled over the 7-year time span from 1975 to 1982. They concluded that consent forms in- creased in length in order to include more information about subjects' rights in accordance with federal guide- lines. It is unclear, however, if these statements about rights, liability, and confidentiality are understood by research participants. Indeed, the quasi-legal language may cause research subjects to think they have signed a legal document designed to protect researchers.

This experiment compared psychology subjects' comprehension of two consent forms matched for readability level - a long, detailed form and a shorter, less detailed one. In addition, we looked specifically at the effective- ness of consent forms in conveying to subjects their legal rights by comparing subjects who had signed a consent form with subjects who had read an information sheet, but who had not signed a consent form.

METHOD

Subjects

Eighty-three Stanford undergraduate students par- ticipated for course credit in introductory psychology. Subjects were tested individually in one of three experimental conditions. There were 26 subjects in the long- consent-form condition, 27 subjects in the short-consent- form condition, and 30 subjects in the information-sheet condition.

Materials

Two consent forms and an information sheet were adapted from a standard consent form for an MRI scan. The long consent form was taken nearly verbatim from the standard form. The short consent form was constructed by removing most of the detail and redundancy from the long consent form. The information sheet was constructed by removing the signature line from the long consent form and changing the words "Consent Form" to "MRI Information Sheet" on the top of the form. In addition, two sentences that apply only to consent forms were removed from the information sheet. Both sentences pertained to the meaning of signing the consent

Address correspondence to Traci Mann, Department of Psychology, Building 420, Stanford University, Stanford, CA 94305; e-mail: mann@psy ch . Stanford . edu .

140 Copyright © 1994 American Psychological Society VOL. 5, NO. 3, MAY 1994




Traci Mann

form.1 Both consent forms and the information sheet had a 12th-grade reading level as assessed by the Fry readability formula (Fry, 1968). All forms were divided into sections labeled "Introduction," "Procedure," "Risks," "Benefits," "Confidentiality," "Rights," and "Compensation."

A questionnaire was designed to test subjects' knowl- edge of the information on the consent forms. All of the questions on the questionnaire could be answered from information that was present in both versions of the consent form and in the information sheet. The questionnaire contained 12 specific questions about the MRI procedure itself, including "What type of device will we use to study your brain?" "How does this device work?" "Are there risks to this procedure?" "What may be frightening about this procedure?" and "Are there any objects that could be damaged in this procedure?"

The questionnaire also contained 1 1 general questions about participation in research, including "Will you receive any compensation for participating in this study?" "What happens if you change your mind about wanting to be in this study?" "What could you do if you have a

complaint with this study, or if you want more information about it?" "Will your identity be revealed if we pub- lish this study?" and "If something goes wrong in this

experiment, and you are upset or hurt, can you sue the researchers?"

The subjects in this experiment were required to participate in six experiments as part of their course credit for introductory psychology. The general information was the same for all of the experiments being conducted that semester, so the subjects may have already encoun- tered much of it before participating in this particular study.

Procedure

When each subject arrived at the lab, he or she was informed that the study concerned the functional local- ization of memory in the brain, that the purpose of the

study was to learn where in the brain memories are stored, and that he or she would be asked to remember short lists of words while his or her brain activity was measured. The subject was then given a folder that contained either the long consent form, the short consent form, or the information sheet. The subject was in- structed to read the form while the experimenter left the room, supposedly to see if the MRI technician was ready for the subject. Actually, the experimenter left the room in order to remain blind to the experimental condition.

Table 1. Mean number of questions answered correctly in each consent-form condition

General questions Specific questions Condition n (out of 1 1) (out of 12)

Long form 26 5.50 6.65 (1.63) (2.51)

Short form 27 5.56 7.93 (1.55) (2.06)

Note. Standard deviations are given in parentheses.

After 1 min, the experimenter reentered the room, and if the subject was not yet finished with the form, waited until the subject had completed it. The form was then collected and set aside, so the subject could not refer to it later. Finally, the subject was given a copy of the questionnaire and told to fill it out to the best of his or her ability. The subject was told that the researchers wanted to make sure that he or she understood all the details of the upcoming procedure. After the subject had finished filling out the questionnaire, the experiment was termi- nated, and the subject was fully debriefed and reminded of his or her rights.

RESULTS

Comprehension of the consent forms was measured by totaling the number of questions subjects answered correctly on the consent questionnaire. The questionnaires were scored by a research assistant who was blind to the hypotheses and the conditions of the experiment. The mean numbers of questions answered correctly by subjects in the two consent-form conditions are shown in Table 1.

Subjects who received the short consent form correctly answered more of the specific questions than subjects who received the long consent form, t{5\) = - 2.02, p < .05. There was no difference in the numbers of general questions that were answered correctly by subjects in the two consent-form conditions, f(51) = -0.13, n.s.

Some questions were answered incorrectly by a majority of subjects, regardless of whether they read the long or the short consent form. These questions are listed in Table 2.

Responses to the question "If something goes wrong in this experiment, and you are upset or hurt, can you sue the researchers?" are listed by condition in Table 3.2

1. Both consent forms and the information sheet are available from the author upon request.

2. Subjects in the short- and long-consent-form conditions gave a similar pattern of responses to this question, so the two conditions are combined in the table.

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Informed Consent in Psychology

Subjects who signed a consent form were more likely to think they had waived their right to sue than subjects in the information-sheet condition, x2(2, N = 83) = 16.052, p < .005.

DISCUSSION

The data support three main conclusions. First, longer consent forms that attempt to describe a procedure fully may be comprehended less well than shorter forms that suppress some relevant details. Accordingly, federal regulations that require information to be added to already lengthy consent forms may end up reducing the amount of information subjects receive from consent forms. If a subject is to understand a consent form, the form should be as short and concise as possible.

Second, the 53 subjects who signed consent forms for an MRI scan did so without understanding important as- pects of the experiment. Subjects answered only 60% of the specific questions correctly. These questions covered information crucial for deciding whether or not to participate in an experiment (e.g., risks, benefits, procedures). Because a consent is not considered valid unless the information on the consent form is understood (Beauchamp & Childress, 1989), subjects in this experiment did not give a valid consent.

In addition, subjects answered correctly only 50% of the general questions (which covered information they had presumably been exposed to in other experiments). Less than half of the subjects understood what the researchers would do for them if they got hurt, or could list even two of the four things their signature on the consent form meant. Only 39% of the subjects knew that the consent form included any information on what to do if one had complaints about an experiment, and only 1 of the 53

Table 2. Questions answered incorrectly by the majority of subjects

Percentage Question correct

What type of device will we use to study your brain? 38

How does this device work? 47 Are there risks to this procedure? 48 What can you do if the sound of the

machine bothers you? 45 What can you do if you have a

complaint about the study? 39 What will the researchers do for you if

you get hurt? 47 Name 2 of the 4 things your signature

on the consent form means. 20

Table 3. Responses to the question "Can you sue?" (in percentages)

Response

Don't Condition n Yes No know

Consent form 53 28 62 9 Information sheet 30 63 16 20

Note. Percentages do not add up to 100 because of rounding.

subjects was able to state the procedure for registering complaints about experiments. This last problem is par- ticularly serious because institutional review boards (IRBs) use feedback from subjects to determine whether an experiment can be continued safely. If no subjects complain when they are upset or hurt in experiments, IRBs may be led to believe that there are no problems, even when problems exist.

The third conclusion supported by the data is that the very act of signing a consent form caused subjects to believe that they had lost the right to sue the researcher, even for negligence.3 Subjects who signed a consent form thought they had lost their right to sue the experimenter, whereas subjects who read the same information but did not sign a consent form generally did not think they had lost this right.

According to the U.S. Department of Health and Hu- man Services (1983), "No informed consent, whether oral or written, may include any exculpatory language through which the subject is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the in- stitution, or its agents from liability for negligence" (5 CFR §46. 115). The consent forms used in this study were not in violation of this code. They stated explicitly that subjects who signed the forms were not giving up any rights to sue. Despite this explicit statement on the consent forms, subjects thought they had given up their right to sue. To rectify this problem will require more than a statement about rights on a consent form.

This research suggests an argument for the use of oral consent procedures. Simply signing a consent form made subjects think they had lost the very rights the consent form was designed to protect. Perhaps subjects who con-

3. Subjects who sign consent forms do not give up their right to sue researchers for negligence. They cannot, however, sue researchers for battery. Most people are not familiar with this unusual technicality of the law, and our subjects indicated that they were thinking about negligence suits, not battery suits.

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Traci Mann

sent orally but do not sign a legalistic form will not feel that they have lost their rights. Perhaps subjects simply need to be reminded after signing a consent form that they have not given up any rights by signing it, but have merely consented to go ahead with the research. Future research will examine whether oral procedures and re- minders are effective ways to overcome problems in informed consent.

Acknowledgments - This research was supported in part by a Na- tional Science Foundation Graduate Research Fellowship. The author thanks David Rosenhan for his help with this project.

REFERENCES

American Psychological Association. (1992). Ethical principles of psychologists and code of conduct. American Psychologist, 47, 1597-1611.

Baker, M.T., & Taub, H.A. (1983). Readability of informed consent forms for research in a Veterans Administration medical center. Journal of the Amer- ican Medical Association, 250, 2646-2648.

Beauchamp, T.L., & Childress, J.F. (1989). Principles of biomedical ethics. New York: Oxford University Press.

Fry, E.A. (1968). A readability formula that saves time. Journal of Reading, 11, 575-578.

Meisel, A., & Roth, L.H. (1983). Toward an informed discussion of informed consent: A review and critique of the empirical studies. Arizona Law Re- view, 25, 265-346.

Milgram, S. (1963). Behavioral study of obedience. Journal of Abnormal and Social Psychology, 67, 371-378.

U.S. Department of Health and Human Services. (1983). Protection of human subjects. Code of Federal Regulations, 45, §46.115.

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