Protection of the right to informed consent to participate in research

BEHAVIOR THERAPY 9, 73--82

(1978)

Protection of the Right to Informed Consent to Participate in Research RICHARD B. STUART University of Utah The Nuremberg Code stresses the need for all research participants to be accorded the privilege of freely giving their informed consent to participation in research. Unfortunately, participants' signing a consent form does not guarantee that they were fully informed about the nature of the proposed study or that they understand the explanation which they were offered. Use of a three-part consent form which includes a complete description of the research, space for participants to describe the study of their own words, and several objective questions about key aspects of the study is advocated as one means of providing behavioral evidence that consent is truly informed. To test the usefulness of this form, introductory psychology students were asked to participate in an experiment through one of five different consent forms that described the experiment in varying levels of detail. More students volunteered when the description of the experiment did not mention use of aversive methods. Unfortunately, however, even with the three-part consent form, the data did not support the belief that those who agreed to participate fully understood the experiment.

Protection of the right to informed consent to participate in experiments was the critical issue at the Nuremberg trials and led to the Nuremberg Code, the Declaration of Helsinki, and countless other oaths to protect for all time the rights of subjects to give freely informed consent to participate in experiments. Yet Pappworth (1967) noted that violations of subjects' rights continued to be commonplace in biomedical research in the mid1960s and Kelman (1970) observed a few years later that deception had become "a standard feature in psychological experiments . . . a game, often played with great v i r t u o s i t y . . , used without q u e s t i o n . . , not as a Portions of this paper were originally presented as part of the author's presidential address before the Association for Advancement of Behavior Therapy, San Francisco, 1975, and at the 84th Annual Convention of the American Psychological Association, Washington, D.C., 1976. The author acknowledges the assistance of both Sylvan Wallach, C. W. Post University, and Alan O. Ross, SUNY at Stony Brook, who arranged for pretest and experimental subjects, respectively. Requests for reprints should be addressed to Richard B. Stuart, School of Social Work, University of Utah, Salt Lake City, UT 84112. 73 0005-7894/78/0091-0073501.00/0 Copyright © [978 by Association for Advancement of Behavior Therapy. All rights of reproduction in any form reserved.

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last resort but as a matter of course" (pp. 66, 68). Because violations of this fundamental right have continued into the 1970s, many agencies of the United States Government and other funding and professional organizations have sought to develop guidelines and codes that would make a reality of the guaranteed protection that remains one of the cardinal issues of our times. The Nuremberg Code (1946) established the followin_g criteria for voluntary consent: (l) the person must be legally capable of giving consent; (2) the consent must be obtained without any element of fraud, duress, force, or deceit; and (3) the person must be offered sufficient knowledge of the experiment to ensure his or her understanding of all of the anticipatable consequences of participation in the research. Unfortunately, the process of obtaining consent under these circumstances is highly complex. Barber (Note I) has pointed out that the groups undergoing the most radical experiments are generally those least free to refuse to participate. Davison and Stuart (1975) have therefore suggested a framework for the institutional analysis of research settings as a means of indexing guidelines for determining the level of protection necessary to ensure free participation. For certain kinds of nonobtrusive observations, no consent may be required. For others, the consent process must be monitored by both intrainstitutional and external review committees, while for still others, it can be argued that no level of protection could adequately guarantee preservation of the participants' rights. Just as signing a consent form is no guarantee that consent is voluntary (Gray, 1975), neither is explaining the experimental procedure a guarantee that the participant understands the experiment (Pappworth, 1967). For example, Epstein and Lasagna (1969) made this quite clear when they offered subjects three different levels of information about a proposed experiment. Only 35% of those who received the most information understood what they were being asked to do, while 67% of those receiving the least amount of information comprehended the experiment. Therefore, the mere fact that consent is solicited does not guarantee that it is freely given, and the mere fact that an explanation has been offered does not guarantee that it has been understood. In recognition of these facts, Miller and Wiliner (1974) have recommended use of a two-part consent form. The first part describes the experiment; the second part asks key questions probing the subjects' comprehension of the explanation. To this can be added a third part which also asks the prospective participants to describe the experiment in their own words. For persons whose judgment is competent, accurate answers to salient questions about the specifics of the experiment and a description of the procedures in their own words would provide strong evidence that

INFORMED CONSENT TO PARTICIPATE IN RESEARCH

75

the subject understood the exact nature of the proposed investigation. The signed consent form could also be used as behavioral evidence of the fact that the subjects' understanding of the experiment was accurate should his or her participation in the experiment be challenged at a later date (Stuart, Note 2). The three-part consent form, with the inclusion of an open-ended question about the experiment, was the subject of this study. The present purpose was to determine the impact of complete information upon subjects' willingness to volunteer and whether the form does appear to help subjects to make intelligent decisions about accepting or declining participation in a proposed investigation. METHOD Subjects. Two hundred forty-three students in one section of an introductory psychology course participated. Their mean age was 19.8 years; 55% were female and all but six were white. Half of the subjects were born in cities with over 500,000 inhabitants, 40% were first-born children, and most had two siblings, high school-educated mothers, and fathers with some college education. Finally, 42% were Catholic, 38% were Jewish, 20% were Protestant, and most reported attending religious services rarely or never. The subjects' average score on the Marlowe-Crowne Social Approval Scale was 14.8, which is very similar to the scores reported by Crowne and Marlowe (1964) for students on other campuses. Other measures of their attitudes and behaviors (Stuart, Note 3) indicated that they were similar to student participants in many other psychological experiments (MacDonald, 1972; Rosenthal & Rosnow, 1975). Procedure. Subjects were tested during their normal class meeting. They were greeted by their normal instructor who introduced the experimenter who, in turn, asked them to read carefully and answer the questions in forms being passed out to them. Five forms of the experimental protocol were used. To protect the credibility of the experiment, all students sitting in a row received the same form of the protocol. The order for distribution of the forms was determined in advance by random selection in blocks of five rows. Because the rows were not equally filled, the number of subjects receiving each of the forms was unequal: e.g., 27.2% received Form 1 while only 17.3% received Form 4. There were, however, no statistically significant differences in demographic characteristics between the students receiving each form. Following collection of the completed forms, the experimenter conducted the class, focusing on social psychological research strategies, the role of deception in this research, and the ethics of informed consent. This lecture/discussion constituted debriefing, during which time the students were informed that the experiment that had been described in the protocol would not be offered. Instrument. The instrument began with a brief statement by the experimenter asking students to read the protocol and to answer all questions whether or not they intended to volunteer for the experiment. To increase the authenticity of the request for volunteers, students were asked to sign their names to the form. Upon collection, the names were deleted and all questionnaires were processed anonymously. The first page of the questionnaire collected information about students' demographic characteristics. The second page of the instrument contained the main experimental manipulation. All five forms of the protocol mentioned an experiment that involved tasting different

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substances, use of multiple "taste reeducating" conditions, and random assignment to one of these conditions. All five forms also offered a stipend, and four of the forms mentioned the use of aversive procedures with an increasing level of specificity. Form I contained the following statement: Subjects are urgently needed for participation in an experiment concerning application of learning principles to the development of taste responses to sweet and salty substances. Participation will require approximately 40 to 50 minutes. The experiment involves tasting various substances before and after exposure to one o f several taste reeducating experiences; subjects will be asked to complete two brief written questionnaires. A stipend of $5.00 will be paid for participation in this experiment. Day and evening experimental sessions are open. All are done on an individual basis and, of course, your participation will be anonymous. The statements in italics were replaced with the following language in the subsequent versions of the form: Form 2: The following phrase was added: "some of which involve the use of aversive stimulation." Form 3: The following phrase was added: "some of which involve moderately painful electric stimulation." Form 4: The following phrase was added: "some of which involve the use of moderately painful electric stimulation. Students with histories of heart disease, circulatory ailments, diabetes, or other serious medical problems are advised not to participate." Form 5: Identical to Form 4 but the stipend for participation was raised to $20.00. The instrument continued by asking students to describe the proposed experiment in their own words, to indicate on a five-point Likert-type scale the degree of danger they believed to be associated with participation in the experiment, and how much they thought that they would suffer from not participating in this experiment. Subjects were then asked whether there were more than one condition, whether they would be assigned to these conditions by chance or according to their personal characteristics, and whether they would be willing to volunteer to participate in the experiment. The instrument concluded with additional questions which were intended to build further creditability for the taste experiment and to learn a bit more about those who did and did not volunteer.

RESULTS Does the increased information about the study that prospective subjects receive through use of the expanded consent form deter their participation? Data relevant to this question are found in two places. First, as seen in Table 1, subjects did show a statistically significant decrease in their willingness to participate as the experiment was described in increasing detail. This trend was reversed, however, when the stipend was increased from $5 to $20 indicating that the willingness to endure pain can be bought. These findings were consistent across subjects regardless of their demographic characteristics. When subjects' awareness of details of the experiment was taken into account using their open-ended descriptions of the experiment, it can be seen in Table 1 that a specific awareness of aversion was the only condi-

77

INFORMED CONSENT TO PARTICIPATE IN RESEARCH TABLE 1 STUDENTS' WILLINGNESS TO PARTICIPATE IN THE EXPERIMENT WHEN OFFERED VARYING AMOUNTS OF INFORMATION GIVEN AND PERCEIVED Agreeing (124) Information condition

Number

Information given 1. Low information, $5 2. Aversion, $5 3. Shock, $5 4. Shock, warning, $5 5. Shock, warning, $20 Students' description Taste only Taste, 2+ condition Taste, 2+ condition, random assignment Taste, aversion Taste, 2+ conditions, random assignment, aversion Students' perception of danger Highest level of danger Second level Third level Fourth level Lowest level Students' belief that would suffer from participating Felt they would Felt they would

Refusing (113)

Percentage

Number

Percentage

52 26 16 11 19

78.8 59. I 35.6 26.2 41.3

14 18 23 31 27

21.2 40.9 64.4 73.8 58.7

25 65

59.5 50,0

17 65

40.5 50.0

19 10

73.1 34.5

7 19

26.9 65.5

2

100.0

0

0

9 11 2I 4I 40

22.5 30.6 47.7 67.2 76.9

31 25 23 20 12

77.5 69.4 52.3 32.8 23.1

×2

39.90**

(df = 4)

11.15"

(df = 4)

39.51"*

(df = 4)

they not suffer not

30

69.8

13

30.2

6.56

93

48.2

100

51.8

(df= 1)

Students' understanding about number of conditions in experiment Only one More than one

14 108

45.2 53.2

16 95

54.8 46.8

(dr = 1)

Students' understanding about basis of assignment to multiple conditions By personal characteristic Random assignment

17 104

51.5 52.3

16 95

48.5 47.4

(df = I)

Suffer

* p < .05.

** p < .001.

.70

.01

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RICHARD B. STUART

tion that led a majority of subjects to decline participation, with the exception of the only two subjects who correctly described all four aspects of the proposed study. The extent to which the three-part consent form did help to improve subjects' understanding of the proposed research was measured in two ways: by asking subjects to offer open-ended descriptions of the experiment and by asking them to answer questions about the research. Eight of the 237 subjects failed to offer a description of the experiment in their own words. Among the subjects who did write such descriptions, all four elements of the study were relevant to the 72.2% who had received Forms 2, 3, 4, or 5 of the protocol. Yet only two of these 171 subjects included all four of the elements in their descriptions and only 13.5% mentioned use of aversive stimulation specifically. Turning to subjects' answers to objective questions about the experiment, as seen in Table 1, volunteerism was inversely related to the subjects' belief that participation would be dangerous. In addition, 18% of the students believed that they would suffer if they did not participate in the experiment. Anecdotal comments written by many of these students indicated that they felt that they would miss out on a learning opportunity or the chance to earn extra pocket money; none indicated that their nonparticipation would lead to a serious penalty. Of those who did assign a negative value to nonparticipation, over two-thirds did agree to participate. However, those who did not believe that nonparticipation would be penalized were about equally split in their willingness to join the experiment. Finally, almost 13% indicated that the study consisted of only one experimental condition while 14% stated their belief that assignment to experimental conditions would be based upon their personal characteristics as opposed to assignment on a random basis. (Among these students, 18 or exactly one-half of those who misunderstood one aspect also came to a false conclusion about the other.) As seen in Table 1, however, the students' decision to participate was not significantly influenced by their perception of multiple conditions and/or of the basis of assignment to these conditions.

DISCUSSION Subjects in this research appeared to be less willing to volunteer to participate in an experiment when they knew the details of the experiment including the fact that it included the use of electric shock. Students quite naturally consider shock to be aversive (Farr & Seaver, 1975), and they have been found to decline participation when they know that methods that they consider to be aversive are part of the experimental procedure. For example, Berscheid, Baron, Dermer, and Libman (1973) asked sub-

I N F O R M E D C O N S E N T T O P A R T I C I P A T E IN RESEARCH

79

jects whether they would participate in a range of experiments including social stress (Milgram, 1963) and holding their hands in ice water (Barber & Hahn, 1962). Predictably, subjects indicated that they would not participate in those studies that they considered to be highly aversive, although discussion of the rationale behind the procedure did influence some to reconsider. This research also showed that the three-part consent form is n o t a necessarily valid measure of subjects' understanding of the experiment. In the open-ended portion of the form, only one of every seven subjects, for whom it was relevant, cited the use of shock in the proposed research. In the objective section of the form, 18% gave clearly erroneous answers to questions about salient elements of the experiments. The omissions and inaccuracies could be attributable to the fact that students took the task too lightly or they may have genuinely misunderstood what they were being asked to do, The fact that only 19 questionnaires contained one or more incomplete or unscorable answers (13 of these being deficient in one item only) and the fact that subjects' responses to questions concerning their social behavior and attitudes fell well within the observations made in other studies both suggest that the task was taken seriously. Therefore, it is reasonable to assume that many of the freshmen and sophomore subjects did not fully understand some important aspects of the task that they were asked to perform in considering participation in the proposed study. Gray (1975) similarly found that participants in one study that he reviewed misunderstood what was happening to them. He interviewed women who had been participants in a double-blind drug investigation. He asked them to describe the research and found that 39% did not even know that they were research subjects while most of the others did not understand one or more important features of the research despite the fact that all had signed approved forms agreeing to their participation. Several factors can influence a subjects' failure to understand the experiment in which he or she participates. Deception on the part of the investigator is one possible cause although abuses such as those cited by Pappworth (1967) are rare. Subjects' inattention and/or genuine failure to understand are other possible causes. In addition, demand characteristics of the consent-securing process and subjects' psychological barriers to declining participation can obstruct this process (Katz, Capron, & Glass, 1972). Thus, the potential for subjects' misunderstanding is great. If the dictates of the Nuremberg Code are to be reality, the burden of proof that the consent of all subjects was freely given must be the responsibility of the researcher. It is the responsibility of research review panels to make certain that researchers do protect the human rights of their subjects in this way.

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It is possible that the full disclosure of research procedures that this protection demands may deter some subjects from participating. It is also possible that disclosure of the experimental methods may affect the validity of certain findings. For example, Levy (1967) and Resnick and Schwartz (1973) found that subjects who were aware of the fact that they were participating in a verbal conditioning study performed differently than did naive subjects. Moreover, subjects sometimes withheld from the investigators the fact that they were privy to this biasing information (White & Schumsky, 1972). Use of full disclosure may therefore preclude the procurement of subjects for some studies, or it may introduce a sufficiently strong potential bias into other studies to require their abandonment. Nevertheless, the human rights of subjects must be valued more than the findings of research that can only be completed through violation of these rights. For their part, human subjects review panels are charged with enforcing some 39 diverse codes of research ethics (Beecher, 1970) and many of the panels are overworked and understaffed (Barber, Lally, Makaruska, & Sullivan, 1973). Nevertheless, it is likely that these panels will have to take a more active role in guaranteeing respect for subjects' rights, much as researchers must take greater pains to achieve the same end. A fivestep procedure can be used as one way of making this protection a reality. (1) Experimenters could be required to submit complete descriptions of their methods for review along with an exact replica of the forms and procedures to be used in subject recruitment. (2) The review committee could then verify the accuracy with which subjects can be expected to understand the nature of the proposed study. When the study involves the use of particularly invasive or aversive procedures, the committee might ask the investigator to collect data showing that subjects do fully comprehend the study and the possible effects of participating in it. (3) The experimenter could then present the three-part consent form to prospective participants. Any relationship with those who refuse to participate would be terminated at this point. Discussions could then be held with any who did participate but whose forms did not reflect a precise understanding of the research. Their participation would be restricted until their understanding of the experiment was complete and accurate. (4) The completed forms could then be filed for possible review by the overseeing panel. (5) The panel could monitor the experiments under its jurisdiction on an acceptable sampling basis, reviewing completed consent forms in some investigations and interviewing selected participants in these and/or other studies (Gray, 1975). This is an exhaustive procedure. If adopted, it would doubtlessly slow

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the process through which research is approved, executed, and monitored. It may even reduce the amount of research that is conducted and possibly eliminate certain kinds of research entirely. But it would make a reality of the essential guarantee of the protection of the human rights of research subjects, an end that is greater than any possible contribution of the delayed or abandoned projects that might be the casualties of this approach. Many questions remain concerning the consent-giving process. How much information about an experiment is too much for subjects to comprehend? What are some of the demand characteristics of experimental situations that might lead subjects to make decisions that are contrary to their own interests? How can experiments that currently involve deception be redesigned so that their objectives can be met in ways that are consistent with codes of research ethics? How can the three-part consent form or a related document be amended so that it leads to better understanding of the proposed experiment than was shown by the subjects in this research? What are the characteristics of experiments that subjects tend to consider to be contrary to their interests? How can review panels most efficiently and effectively monitor these projects? These are just some of the questions that must be answered in what has now become an important new area of investigation: research about the ethics of research practices.

REFERENCE NOTES 1. Barber, B. Prepared statement. Washington, D.C.: Senate Subcommittee on Health Hearings, The Problems of Human Experimentation, March 9, 1973. 2. Stuart, R. B. Prepared statement. Bethesda, MD: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 9, 1976. 3. Stuart, R. B. Protection o f the right to informed consent to participate in research. Paper presented at the 84th Annual Convention of the American Psychological Association, Washington, D.C., April 9, 1976.

REFERENCES Barber, B., Lally, J. J., Makarushka, J., & Sullivan, D. Research on human subjects: Problems o f social control in medical experimentation, New York: Russel Sage, 1973. Barber, T. X., & Hahn, K. W. Physiological and subjective responses to pain producing stimulation under hypnotically suggested and waking-imagined 'analgesia.' Journal o f Abnormal and Social Psychology, 1962, 65, 411-418. Beecher, H. K. Research and the individual: Human studies. Boston: Little, Brown, 1970. Berscheid, E., Baron, R. S., Dermer, M., & Libman, M. Anticipating informed consent: An empirical approach. American Psychologist, 1973, 28, 913-925. Crowne, D. P., & Marlowe, D. The approval motive. New York: Wiley, 1964. Davison, G. C., & Stuart, R. B. Behavior therapy and civil liberties. American Psychologist, 1975, 30, 755-763. Epstein, L. C., & Lasagna, L. Obtaining informed consent. Archives oflnternal Medicine, 1969, 123, 682-688.

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Farr, J. L., & Seaver, W. B. Stress and its comfort in psychological research: Subject perceptions of experimental procedures. American Psychologists, 1975, 30, 770-773. Gray, B. H. An assessment of institutional review committees in human experimentation. Medical Care, 1975, 13, 318-328. Katz, J., Capron, A. M., & Glass, E. S. Experimentation on human beings, New York: Russel Sage, 1972. Kelman, H. C. Deception in social research: In N, K. Denzin (Ed.), The values of social science. Chicago: Aldine, 1970. Levy, L. H. Awareness, learning, and the beneficent subject as expert witness. Journal of Personality and Social Psychology, 1967, 6, 365-370, MacDonald, A. P. Characteristics of volunteer subjects under three recruiting methods: Pay, extra credit, and love of science. Journal of Consulting and Clinical Psychology, 1972, 39, 222-234. Milgram, S. Behavioral study of obedience. Journal of Abnormal Psychology, 1963, 67, 371-383. Miller, R,, & Willner, H. S. The two-part consent form: A suggestion for promoting free and informed consent. The New England Journal of Medicine, 1974, 290, 964-966. Nuremberg Code. Journal of the American Medical Association, 1946, 132, 1090. Pappworth, M. H. Human guinea pigs: Experimentation on man. Boston: Beacon Press, 1967. Resnick, J. H., & Schwartz, T. Ethical standards as an independent variable in psychological research. American Psychologist, 1973, 28, 134-139. Rosenthal, R., & Rosnow, R. L. The volunteer subject. New York: Wiley, 1975. White, H. W., & Schumsky, D. A. Prior information and "awareness' in verbal conditioning. Journal of Personality and Social Psychology, 1972, 24, 162-165. RECEIVED: October 22, 1976; REVISED: February 22, 1977 FINAL ACCEPTANCE:March 7, 1977