Refer to: Schultz AL, Pardee GP, Ensinck JW: Are research subjects really informed? (Informed Consent). West J Med 123:76-80, Jul 1975
In
Iformed
CONSENT
Are Research Subjects Really Informed? AMELIA L. SCHULTZ, PhD, GERALDINE P. PARDEE, MN, and JOHN W. ENSINCK, MD Seattle
To determine how adequately patients who participate as subjects for clinical investigation understand their commitment, 50 patients admitted to the Clinical Research Center of the University of Washington were interviewed. Their responses were compared with the detailed statements in the consent forms for the 23 specific protocols under which they were being studied. In spite of careful controls in accord with guidelines of a review committee, only half the patients were able to describe accurately their expectations of the studies to which they had given signed consent.
IN RECENT YEARS there has been increasing concern over the ethics of experimentation on humans. Accordingly, in the United States, the National Institutes of Health, under the Public Health Service of the Department of Health, Education, and Welfare, have set up guidelines for the protection of human research subjects in clinical (that is, biological, behavioral or psychological) re-
gators may be required to justify it before the
search. To, carry out these policies the Human Subjects Review Committee was formed at the University of Washington. Before a research project may be implemented it must be reviewed and the investi-
Methods
From the Departments of Medicine, Nursing and Social Service, t This study was conducted through the Clinical Research Center Facility of the University of Washington supported by National
University of Washington, Seattle.
Submitted, revised, May 6, 1975.
Unieprsinty Hospital,°UiAversiCthy Washinlgton, of
76
JULY 1975
*
123
*
1
committee. Our study concerned the criterion of informed consent, the "keystone of the protection of human subjects involved in research."' We wished to determine how well patients understood their commitment as research subjects.
Subjects were randomly selected among patients
admitted to hospital for the first time at the Clinical Research Center, a 16-bed facility supported by a grant from the National Institutes of Health. At the time, 100 projects were underway of p which 23 are represented in our sample. All patients consecutively admitted were studied, except
that one project was eliminated when it became Seattle, WA
98195:
apparent that further admissions would constitute
RESEARCH SUBJECTS
a disproportionately large sample, and five patients were dropped from the sample when we learned that the protocol under which they fell had not come under recent review by the Human Subjects Review Committee. Within an hour or two of their admission to the Center and their consent interview with the physician-investigator, the subjects were approached and the purpose of this study explained in a brief standard statement. Our questions were based on the following criteria for informed consent stipulated in November, 1971 by the Human Subjects Review Committee from National Institutes of Health guidelines.* 1. A description of the procedures to be followed, including an identification of those which are experimental. 2. A description of the attendant risks and discomforts. 3. A description of the benefits to be expected or the knowledge hoped to be gained. 4. A disclosure of appropriate alternative procedures that might be advantageous to the subject. 5. An offer to answer any inquiries the participant has concerning the experiment. 6. An instruction that the subject is free to withdraw at any time without penalty. 7. An assurance that the subject's identity will remain confidential. 8. A disclosure of what costs the subject may immediately or ultimately be forced to bear and
of the observers, 6 nonmedical, nonhospital-affiliated persons (one anthropologist, one saleswoman, one life insurance underwriter, one social service administrator, two housewives) were asked to rate the responses of ten patients to ten different consent forms, chosen at random from our sample. There were thus 60 judgments. Twenty-nine scores were exactly the same as those of the original observers, 13 were one step higher or lower, but within one of the two larger categories (adequate or inadequate). Eighteen scores were different: 13 higher, 5 lower. Since this difference of eight (13 percent) did not alter the interpretation of the overall results it seems reasonable to conclude that the scores recorded by the two authors interviewing were not significantly biased by their professional attitudes or their connection with the Clinical Research Center. Fifty consecutive new patients were studied in a 3½/2-month period in 1972. (During this time there was a total of 206 admissions.) Forty-one were adult patients, and the parent or parents of nine minors also were interviewed -and rated. All were judged to be of normal intelligence and hearing. Forty-nine patients had organic disease, one was a normal control. Patient Code Number
Date
what reimbursement of costs or otherwari comensaus etfcto c pe
tion he will receive. Each patient's response to the questions was recorded verbatim by one of the authors and the patient was then given a copy of the questionnaire (Figure I ) . To control for observer bias, the first ten interviews were attended also by another of the authors who independently rated the responses. The rank correlation coefficient between the two raters, using Spearman's Rank Correlation Coefficient, was 0.99, which was significant at a point greater than the 1 percent level with 8 degrees of freedom. Since there was thus essential agreement between the raters, subsequent interviews were handled by the first alone and the recorded responses were judged by both simulIn order to avoid bias on the part _______professional *Items I through 6, Department of Health, Education, and Welfare guidelines, were updated in August 1974, without significant change in the .criteria; 7 and 8 were added by the Human Subjects
wllin to answer a series of questions relating to how well you understand the form that you
have just signed? 2. Why did you doctors going to do in the studies? 3. What are yourvolunteer? 4. What are they trying to learn? 5. What were you told about the possible risks? 6. What are the benefits of the study? 7. Are any of these procedures experimental?
8. Is there anything in the studies that you are concerned about? 9. Did you refuse to accept any part of the study that was asked of you? 10. Suppose you change your mind about going through with this. what do you think would study written up 11. How do you feel about having thehappen? and published in the medical literature? 12. How long will you be here? 13. Who pays for the cost of the study? 14. Are you being paid in any way?
15. If there were complications as the result of any of the procedures who would pay for your care? 16. Have you read the form you signed? 17. Do you have a copy of it? 18. What is the name of the doctor who explained the to you?
~~~~~~~~~~~~~study
19. Have you any questions about any of these matters? Figure 1.-uestionnaire Used in Patient Interviews
THE WESTERN JOURNAL OF MEDICINE
77
RESEARCH SUBJECTS
The analysis was carried out in two ways. First we made an immediate judgment of each patient's overall understanding, which we rated on a fourstep scale, based on the type and amount of information obtained from analysis of the first ten interviews. Second, each patient's specific responses were analyzed and rated according to how accurately and thoroughly they reflected statements in the consent form. The consent form was the basis for comparison, since what had otherwise transpired between patient and investigator was not accessible to evaluation.
Results Table 1 summarizes the overall ratings: 52 percent of all patients were judged to be adequately informed. In* retrospect, it appeared that the responses concerning what the, investigators were trying to learn and going do, what they were tryingtolearnand goingtotodo, what risks were likely weighed most heavily in our ratings. Final ratings in two categories, adequate or inadequate, sum up the data most clearly. The analysis of specific responses is shown in
+3 +2 +1 0
TABLE 1.-Overall Ratings of Adequacy of Patients' Information Number of Patients Rating Full, detailed ........... ....... 11 Adequate .................. 15 Adequately informed ................ 26 ............ 18 Partial ...... None, or incorrect........... Inadequately informed .24 TOTAL .50 .
TABLE 2.-Analysis of Specific Responses by Items from Human Subjects Review Committee Guidelines Percent of
Consents That Specify (Total 23)
Guidelines Procedures ................. 100 Purpose .................... 100 100 ,isks. Confidentiality .............. 91 Freedom to withdraw .91 Benefits ....................
87
.57
Costs
Percent of Adequately
Informed
Responses
(Total 50) 34 22 20 .. 32
dentiality.
Regarding freedom to withdraw, 16 patients stated that they could leave the study if they wished. Eighteen others refused to consider the possibility, feeling obligated to follow through. The item of costs is especially interesting since patients are much clearer on this point than the
items stated in the consents. While only 13 out of 23 consents (57 percent) mentioned expenses, 43 out of 50 patients (86 percent) could state corTABLE 3.-Effect of Reading Consent Form on Patients' Information Number of Patients
Number of Patients
86
Adequately
Inadequately Informed
Experimental aspects of 28 39 procedures* ........... . Alternative procedures* 4.5...not..at.all *These items do not apply to all consents. JULY 1975 * 123 * 1
neve osninvestigator pt!cmlx sarsl contacthbetween be the first direct may and patient. Nonspecific benefits are spelled out in 20 out of to be ex23 protocols as "expected," "possibly P ..6 half or to In addition, "not be expected." pected" of the protocols mention specific benefits. Nevertheless, only nine patients (18 percent) understood correctly. We asked how the patient would feel about publication of the results of the study without mentioning confidentiality as such. Almost without exception they were agreeable or enthusiastic. Only four mentioned that they expected confi-
18
"Questions answered" or "Adequate explanation given" 39
78
Table 2. Patients were best informed about costs and least well informed about benefits and risks. Such crucial items as procedures, purposes, risks and freedom to withdraw were understood only by about 25 percent of patients, on the average, though consent forms were thorough, specific and detailed on these matters. Table 3 shows that whether patients read the form made no appreciable difference in how well they retained information. Since the policy of the University of Washington's Clinical Research Center requires a patient's signature before any research procedure may be started, the investigator is usually called when the patient arrives and comes to discuss the project and obtain consent. Half the patients come frmoto onadmn r eerdseii callyufor thersarch o edresfbyrphysiciain hs from within whyiniththe hosthe comutyr.arth ~~~~~~~~~~the community rather than from
Informed
Form was read.
22
17
Total
39 1
Form read partly or
.4. 47511
TOTALS ..
26
24
50
RESEARCH SUBJECTS
rectly how they were to be covered. Clearly, many had learned from other sources that they would bear no costs of the research stay in hospital or any complications thereof. Thirty-two patients (64 percent) understood the length of stay, which 13 out of 23 consent forms (57 percent) spelled out. While no written document requires that investigators specify length of stay it is requested verbally by the Human Subjects Research Committee. Moreover, 57 percent of patients who signed consent forms that did nlot mention length of stay were nevertheless able to state how long they expected to be in hospital and proved to be accurate within 24 hours. Obviously, they had been told. We assume that length of stay is a neutral nonthreatening subject on which doctor and patient can communicate with ease and the fact that there will be no cost is information gladly given and received. Although it is expected that each subject will be given a copy of the consent form he signed, only ten patients in our sample had in fact received copies and five more had been promised copies. Similarly, the space for the name of a witness was frequently left blank. Such data show the limited policing capabilities of a review committee. We asked each patient to name the doctor who
talkedby invexpationswereb bytohepim.Twenty-tw 11 by an the principal investigator, given a
assistant on the project and 12 by a research fellow. It made no difference in the adequacy of patentinfrmaion patint nfomatin: roghl ougly haf alf i eah goup goup were adequately informed. Five patients who could not identify the doctor were all inadequately informedother in respects.
Informed respects, In the lin lightotheur of our findings, the inclusion of a the
inclusion
of
statement in a consent form such as "my questions have been answered" does not seem useful. Some patients point out that they did not understand enough to know what questions to ask. Additional facts came to light which cannot be quantified, but which bear on the matter of consent. Some patients were brought in for brief specific studies which did not require the full protocol, so items in the consent form were crossed out. Others were brought in under the protocol of a research group to which the investigators did not themselves belong, because it was broad enough to encompass the work that was to be done. That is to say, theinflexibilityof the present system was met by slightly irregular moves which did not jeopardize the patient but reflect the prob-
lems occasioned by practical situations which do not conform to a prearranged system. Discussion The discrepancy between the higher overall patient ratings (52 percent adequately informed) and the lower individual response ratings (average 35 percent adequate) requires explanation. Criteria for "adequately informed patient" are obviously less stringent that those for "adequately informed response." A patient may, indeed, accurately anticipate the circumstances of his research stay in hospital, but if his information comes from sources other than the consent form, it will not show as a correct response. Lack of patient comprehension may be accounted for by the format and content of consent forms, by the timing and manner of presentation and by circumstances in which the patient finds himself. Many consent forms lack clarity, are expressed in complex medical terms difficult for laymen to comprehend. In order to incorporate all items stipulated by the Human Subjects Review Committee, consent forms often become lengthy. Previous studies have shown that the shorter the form, the better the comprehension, and that a document is no substitute for dialogue." Seven independent judges were asked to rate the consent or difficulty44of (63 compre, hension. Of forms a totalforofease 70 judgments, percetwrehatefom wreastoudthat the were cent) y hard stand, 26 (37 percent) that they were hard to understand. Ideally, all should have been easy to understand. th n one-ti me , after- admission cons ent interview ~Theone-tise is far from ideal. Others have pointed out that the earlier the form is presented to the patient, the better4 and that "consent is not a one-time pro-
cess."8 An important aspect of the consent problem is the life situation in which the patient finds himself and his feelings about it. These can and, judging from patient's comments, frequently do interfere with their comprehension. We found most patients strongly motivated to be at the Clinical Research Center. Asked why they had volunteered, they gave one or more of the following reasons: "to help myself" 38, "to 'help others" 11, "because my doctor asked me to" 6. The fact that " . . . patients accede to about any request their physicians may make" has been alluded to in previous
studies."l Most published discussion of informed consent THE WESTERN JOURNAL OF MEDICINE
79
RESEARCH SUBJECTS
to hospital is first proposed to the patient.5 It is theoretical. To our knowledge, only four refershould be left with him to read, consider and disences report actual interviews with subjects3-6 and cuss with anyone he chooses. After a suitable time of these, only two3'4 are comparable to the present interval, and before he is admitted to hospital he study. The first report, from the Social Service Deshould be encouraged, in the presence of a witness partment of The Clinical Center, Bethesda, in who has no involvement in the study, to ask ques1954, focused on whether a patient understood tions, and only when both are satisfied, to sign. the research nature of the admission to hospital. It did not pinpoint his understanding of the speArguments have been advanced for the interview to be witnessed by a physician or a nonphysician, cific protocol under which he was admitted. Of 30 or both.'4 patients questioned 66 percent knew that they * The consent should consist of a simple blanwere research subjects.4 ket form, with headings on all important points The second study was carried out by Pardee in from the guidelines, details to be filled in by each 1964, at the Clinical Research Center, University investigator. A typical document might be proof Washington. Of ten patients interviewed, vided as a guide with a nonmedical editor made half did not know in advance the purpose or available to review the final wording. the proposed methods of the research for which 0 The format should cover all essential items, they were to be admitted; two remained unsure but allow for flexibility in case the progress of the after admission to hospital.3 Our results suggest project requires minor changes. This procedure that 20 years of concern and guidelines7 have not may obviate some of the ad hoc maneuvers that improved patients' comprehension of the forms investigators have resorted to. that they sign or the accuracy of their expecta* If a consent interview were filmed, the words tions as research subjects.12 and manner of the participants would become The Human Subjects Review Committee, in amenable to study and we would have the sother addition to evaluating the ethics and potential risks evidence" without which written consent is of of research, spends much effort in refinement of little value consent forms without positive results.7"0 In fact, REFERENCES the very length and complexity of the forms may 1. Federal Register, 36:221, 1973 be a major source of difficulty. In addition, the Ingelfinger FJ: Ethics of experiments on children (Editorial). J Med 288:791, 1973 N 2.Engl committee has no practical access to information 10 Expectations of StatedAdmission A Comparison 3. Pardee GP: Prior about actual experience with the forms to insure on aof Reto and Following Selected Patients search Ward. University of Washington School of Nursing, that the carefully worded documents will be read Seattle, 1964 4. Social Service Department, The Clinical Center: A Study on or understood by the patients. We concur with . the Attitude of Patients written Center. Bethesda, 1954 about Coming to the Clinical Research wntten previously expressed opinions that JAMA RJ: Informed consent-A study of patient reaction. consent unaccompanied by other evidence that 6. Schwartz AH: Children's concepts of research hospitalization. explanation has been given, understood, and ac~N Engl J Med 287:489-592, 1972 13 FJ: Informed (but uneducated) consent (EdiIngelfinger ..7. cepted is of little value .
Suggestions Growing out of our observations are suggestions, admittedly easier to state than to implement, for improving consent procedures. * The consent form should be presented at the beginning of the process, when research admission
80
JULY 1975 *
123 *
1
torial). N Engl J Med 287:465-466, 1972 8. Epstein LC, Lasagna L: Obtaining informed consent: Form or substance. Arch Intern Med 123:682-688, 1969 9. Savard RJ: Serving investigator, patient and community in research studies. Ann N Y Acad of Sci 169, Art 2:429-434, 1970 10. Melmon KL, Grossman M, Morris RC Jr: Emerging assets and liabilities of a committee on human welfare and experimen-
tation. N Engl J Med 282:427-431, 1970
11. Beecher HK: 274: i35441360, 1966 Ethics and clinical research. N Engl J
Med
HK: JAMA 12. Beecher Consent in clinical reality (Editorial). 195:34, 1966experimentation: Myth and 13. When is consent? (Lead article). Lancet, 7520, Oct 14, 1967
In
Iformed
CONSENT
Are Research Subjects Really Informed? AMELIA L. SCHULTZ, PhD, GERALDINE P. PARDEE, MN, and JOHN W. ENSINCK, MD Seattle
To determine how adequately patients who participate as subjects for clinical investigation understand their commitment, 50 patients admitted to the Clinical Research Center of the University of Washington were interviewed. Their responses were compared with the detailed statements in the consent forms for the 23 specific protocols under which they were being studied. In spite of careful controls in accord with guidelines of a review committee, only half the patients were able to describe accurately their expectations of the studies to which they had given signed consent.
IN RECENT YEARS there has been increasing concern over the ethics of experimentation on humans. Accordingly, in the United States, the National Institutes of Health, under the Public Health Service of the Department of Health, Education, and Welfare, have set up guidelines for the protection of human research subjects in clinical (that is, biological, behavioral or psychological) re-
gators may be required to justify it before the
search. To, carry out these policies the Human Subjects Review Committee was formed at the University of Washington. Before a research project may be implemented it must be reviewed and the investi-
Methods
From the Departments of Medicine, Nursing and Social Service, t This study was conducted through the Clinical Research Center Facility of the University of Washington supported by National
University of Washington, Seattle.
Submitted, revised, May 6, 1975.
Unieprsinty Hospital,°UiAversiCthy Washinlgton, of
76
JULY 1975
*
123
*
1
committee. Our study concerned the criterion of informed consent, the "keystone of the protection of human subjects involved in research."' We wished to determine how well patients understood their commitment as research subjects.
Subjects were randomly selected among patients
admitted to hospital for the first time at the Clinical Research Center, a 16-bed facility supported by a grant from the National Institutes of Health. At the time, 100 projects were underway of p which 23 are represented in our sample. All patients consecutively admitted were studied, except
that one project was eliminated when it became Seattle, WA
98195:
apparent that further admissions would constitute
RESEARCH SUBJECTS
a disproportionately large sample, and five patients were dropped from the sample when we learned that the protocol under which they fell had not come under recent review by the Human Subjects Review Committee. Within an hour or two of their admission to the Center and their consent interview with the physician-investigator, the subjects were approached and the purpose of this study explained in a brief standard statement. Our questions were based on the following criteria for informed consent stipulated in November, 1971 by the Human Subjects Review Committee from National Institutes of Health guidelines.* 1. A description of the procedures to be followed, including an identification of those which are experimental. 2. A description of the attendant risks and discomforts. 3. A description of the benefits to be expected or the knowledge hoped to be gained. 4. A disclosure of appropriate alternative procedures that might be advantageous to the subject. 5. An offer to answer any inquiries the participant has concerning the experiment. 6. An instruction that the subject is free to withdraw at any time without penalty. 7. An assurance that the subject's identity will remain confidential. 8. A disclosure of what costs the subject may immediately or ultimately be forced to bear and
of the observers, 6 nonmedical, nonhospital-affiliated persons (one anthropologist, one saleswoman, one life insurance underwriter, one social service administrator, two housewives) were asked to rate the responses of ten patients to ten different consent forms, chosen at random from our sample. There were thus 60 judgments. Twenty-nine scores were exactly the same as those of the original observers, 13 were one step higher or lower, but within one of the two larger categories (adequate or inadequate). Eighteen scores were different: 13 higher, 5 lower. Since this difference of eight (13 percent) did not alter the interpretation of the overall results it seems reasonable to conclude that the scores recorded by the two authors interviewing were not significantly biased by their professional attitudes or their connection with the Clinical Research Center. Fifty consecutive new patients were studied in a 3½/2-month period in 1972. (During this time there was a total of 206 admissions.) Forty-one were adult patients, and the parent or parents of nine minors also were interviewed -and rated. All were judged to be of normal intelligence and hearing. Forty-nine patients had organic disease, one was a normal control. Patient Code Number
Date
what reimbursement of costs or otherwari comensaus etfcto c pe
tion he will receive. Each patient's response to the questions was recorded verbatim by one of the authors and the patient was then given a copy of the questionnaire (Figure I ) . To control for observer bias, the first ten interviews were attended also by another of the authors who independently rated the responses. The rank correlation coefficient between the two raters, using Spearman's Rank Correlation Coefficient, was 0.99, which was significant at a point greater than the 1 percent level with 8 degrees of freedom. Since there was thus essential agreement between the raters, subsequent interviews were handled by the first alone and the recorded responses were judged by both simulIn order to avoid bias on the part _______professional *Items I through 6, Department of Health, Education, and Welfare guidelines, were updated in August 1974, without significant change in the .criteria; 7 and 8 were added by the Human Subjects
wllin to answer a series of questions relating to how well you understand the form that you
have just signed? 2. Why did you doctors going to do in the studies? 3. What are yourvolunteer? 4. What are they trying to learn? 5. What were you told about the possible risks? 6. What are the benefits of the study? 7. Are any of these procedures experimental?
8. Is there anything in the studies that you are concerned about? 9. Did you refuse to accept any part of the study that was asked of you? 10. Suppose you change your mind about going through with this. what do you think would study written up 11. How do you feel about having thehappen? and published in the medical literature? 12. How long will you be here? 13. Who pays for the cost of the study? 14. Are you being paid in any way?
15. If there were complications as the result of any of the procedures who would pay for your care? 16. Have you read the form you signed? 17. Do you have a copy of it? 18. What is the name of the doctor who explained the to you?
~~~~~~~~~~~~~study
19. Have you any questions about any of these matters? Figure 1.-uestionnaire Used in Patient Interviews
THE WESTERN JOURNAL OF MEDICINE
77
RESEARCH SUBJECTS
The analysis was carried out in two ways. First we made an immediate judgment of each patient's overall understanding, which we rated on a fourstep scale, based on the type and amount of information obtained from analysis of the first ten interviews. Second, each patient's specific responses were analyzed and rated according to how accurately and thoroughly they reflected statements in the consent form. The consent form was the basis for comparison, since what had otherwise transpired between patient and investigator was not accessible to evaluation.
Results Table 1 summarizes the overall ratings: 52 percent of all patients were judged to be adequately informed. In* retrospect, it appeared that the responses concerning what the, investigators were trying to learn and going do, what they were tryingtolearnand goingtotodo, what risks were likely weighed most heavily in our ratings. Final ratings in two categories, adequate or inadequate, sum up the data most clearly. The analysis of specific responses is shown in
+3 +2 +1 0
TABLE 1.-Overall Ratings of Adequacy of Patients' Information Number of Patients Rating Full, detailed ........... ....... 11 Adequate .................. 15 Adequately informed ................ 26 ............ 18 Partial ...... None, or incorrect........... Inadequately informed .24 TOTAL .50 .
TABLE 2.-Analysis of Specific Responses by Items from Human Subjects Review Committee Guidelines Percent of
Consents That Specify (Total 23)
Guidelines Procedures ................. 100 Purpose .................... 100 100 ,isks. Confidentiality .............. 91 Freedom to withdraw .91 Benefits ....................
87
.57
Costs
Percent of Adequately
Informed
Responses
(Total 50) 34 22 20 .. 32
dentiality.
Regarding freedom to withdraw, 16 patients stated that they could leave the study if they wished. Eighteen others refused to consider the possibility, feeling obligated to follow through. The item of costs is especially interesting since patients are much clearer on this point than the
items stated in the consents. While only 13 out of 23 consents (57 percent) mentioned expenses, 43 out of 50 patients (86 percent) could state corTABLE 3.-Effect of Reading Consent Form on Patients' Information Number of Patients
Number of Patients
86
Adequately
Inadequately Informed
Experimental aspects of 28 39 procedures* ........... . Alternative procedures* 4.5...not..at.all *These items do not apply to all consents. JULY 1975 * 123 * 1
neve osninvestigator pt!cmlx sarsl contacthbetween be the first direct may and patient. Nonspecific benefits are spelled out in 20 out of to be ex23 protocols as "expected," "possibly P ..6 half or to In addition, "not be expected." pected" of the protocols mention specific benefits. Nevertheless, only nine patients (18 percent) understood correctly. We asked how the patient would feel about publication of the results of the study without mentioning confidentiality as such. Almost without exception they were agreeable or enthusiastic. Only four mentioned that they expected confi-
18
"Questions answered" or "Adequate explanation given" 39
78
Table 2. Patients were best informed about costs and least well informed about benefits and risks. Such crucial items as procedures, purposes, risks and freedom to withdraw were understood only by about 25 percent of patients, on the average, though consent forms were thorough, specific and detailed on these matters. Table 3 shows that whether patients read the form made no appreciable difference in how well they retained information. Since the policy of the University of Washington's Clinical Research Center requires a patient's signature before any research procedure may be started, the investigator is usually called when the patient arrives and comes to discuss the project and obtain consent. Half the patients come frmoto onadmn r eerdseii callyufor thersarch o edresfbyrphysiciain hs from within whyiniththe hosthe comutyr.arth ~~~~~~~~~~the community rather than from
Informed
Form was read.
22
17
Total
39 1
Form read partly or
.4. 47511
TOTALS ..
26
24
50
RESEARCH SUBJECTS
rectly how they were to be covered. Clearly, many had learned from other sources that they would bear no costs of the research stay in hospital or any complications thereof. Thirty-two patients (64 percent) understood the length of stay, which 13 out of 23 consent forms (57 percent) spelled out. While no written document requires that investigators specify length of stay it is requested verbally by the Human Subjects Research Committee. Moreover, 57 percent of patients who signed consent forms that did nlot mention length of stay were nevertheless able to state how long they expected to be in hospital and proved to be accurate within 24 hours. Obviously, they had been told. We assume that length of stay is a neutral nonthreatening subject on which doctor and patient can communicate with ease and the fact that there will be no cost is information gladly given and received. Although it is expected that each subject will be given a copy of the consent form he signed, only ten patients in our sample had in fact received copies and five more had been promised copies. Similarly, the space for the name of a witness was frequently left blank. Such data show the limited policing capabilities of a review committee. We asked each patient to name the doctor who
talkedby invexpationswereb bytohepim.Twenty-tw 11 by an the principal investigator, given a
assistant on the project and 12 by a research fellow. It made no difference in the adequacy of patentinfrmaion patint nfomatin: roghl ougly haf alf i eah goup goup were adequately informed. Five patients who could not identify the doctor were all inadequately informedother in respects.
Informed respects, In the lin lightotheur of our findings, the inclusion of a the
inclusion
of
statement in a consent form such as "my questions have been answered" does not seem useful. Some patients point out that they did not understand enough to know what questions to ask. Additional facts came to light which cannot be quantified, but which bear on the matter of consent. Some patients were brought in for brief specific studies which did not require the full protocol, so items in the consent form were crossed out. Others were brought in under the protocol of a research group to which the investigators did not themselves belong, because it was broad enough to encompass the work that was to be done. That is to say, theinflexibilityof the present system was met by slightly irregular moves which did not jeopardize the patient but reflect the prob-
lems occasioned by practical situations which do not conform to a prearranged system. Discussion The discrepancy between the higher overall patient ratings (52 percent adequately informed) and the lower individual response ratings (average 35 percent adequate) requires explanation. Criteria for "adequately informed patient" are obviously less stringent that those for "adequately informed response." A patient may, indeed, accurately anticipate the circumstances of his research stay in hospital, but if his information comes from sources other than the consent form, it will not show as a correct response. Lack of patient comprehension may be accounted for by the format and content of consent forms, by the timing and manner of presentation and by circumstances in which the patient finds himself. Many consent forms lack clarity, are expressed in complex medical terms difficult for laymen to comprehend. In order to incorporate all items stipulated by the Human Subjects Review Committee, consent forms often become lengthy. Previous studies have shown that the shorter the form, the better the comprehension, and that a document is no substitute for dialogue." Seven independent judges were asked to rate the consent or difficulty44of (63 compre, hension. Of forms a totalforofease 70 judgments, percetwrehatefom wreastoudthat the were cent) y hard stand, 26 (37 percent) that they were hard to understand. Ideally, all should have been easy to understand. th n one-ti me , after- admission cons ent interview ~Theone-tise is far from ideal. Others have pointed out that the earlier the form is presented to the patient, the better4 and that "consent is not a one-time pro-
cess."8 An important aspect of the consent problem is the life situation in which the patient finds himself and his feelings about it. These can and, judging from patient's comments, frequently do interfere with their comprehension. We found most patients strongly motivated to be at the Clinical Research Center. Asked why they had volunteered, they gave one or more of the following reasons: "to help myself" 38, "to 'help others" 11, "because my doctor asked me to" 6. The fact that " . . . patients accede to about any request their physicians may make" has been alluded to in previous
studies."l Most published discussion of informed consent THE WESTERN JOURNAL OF MEDICINE
79
RESEARCH SUBJECTS
to hospital is first proposed to the patient.5 It is theoretical. To our knowledge, only four refershould be left with him to read, consider and disences report actual interviews with subjects3-6 and cuss with anyone he chooses. After a suitable time of these, only two3'4 are comparable to the present interval, and before he is admitted to hospital he study. The first report, from the Social Service Deshould be encouraged, in the presence of a witness partment of The Clinical Center, Bethesda, in who has no involvement in the study, to ask ques1954, focused on whether a patient understood tions, and only when both are satisfied, to sign. the research nature of the admission to hospital. It did not pinpoint his understanding of the speArguments have been advanced for the interview to be witnessed by a physician or a nonphysician, cific protocol under which he was admitted. Of 30 or both.'4 patients questioned 66 percent knew that they * The consent should consist of a simple blanwere research subjects.4 ket form, with headings on all important points The second study was carried out by Pardee in from the guidelines, details to be filled in by each 1964, at the Clinical Research Center, University investigator. A typical document might be proof Washington. Of ten patients interviewed, vided as a guide with a nonmedical editor made half did not know in advance the purpose or available to review the final wording. the proposed methods of the research for which 0 The format should cover all essential items, they were to be admitted; two remained unsure but allow for flexibility in case the progress of the after admission to hospital.3 Our results suggest project requires minor changes. This procedure that 20 years of concern and guidelines7 have not may obviate some of the ad hoc maneuvers that improved patients' comprehension of the forms investigators have resorted to. that they sign or the accuracy of their expecta* If a consent interview were filmed, the words tions as research subjects.12 and manner of the participants would become The Human Subjects Review Committee, in amenable to study and we would have the sother addition to evaluating the ethics and potential risks evidence" without which written consent is of of research, spends much effort in refinement of little value consent forms without positive results.7"0 In fact, REFERENCES the very length and complexity of the forms may 1. Federal Register, 36:221, 1973 be a major source of difficulty. In addition, the Ingelfinger FJ: Ethics of experiments on children (Editorial). J Med 288:791, 1973 N 2.Engl committee has no practical access to information 10 Expectations of StatedAdmission A Comparison 3. Pardee GP: Prior about actual experience with the forms to insure on aof Reto and Following Selected Patients search Ward. University of Washington School of Nursing, that the carefully worded documents will be read Seattle, 1964 4. Social Service Department, The Clinical Center: A Study on or understood by the patients. We concur with . the Attitude of Patients written Center. Bethesda, 1954 about Coming to the Clinical Research wntten previously expressed opinions that JAMA RJ: Informed consent-A study of patient reaction. consent unaccompanied by other evidence that 6. Schwartz AH: Children's concepts of research hospitalization. explanation has been given, understood, and ac~N Engl J Med 287:489-592, 1972 13 FJ: Informed (but uneducated) consent (EdiIngelfinger ..7. cepted is of little value .
Suggestions Growing out of our observations are suggestions, admittedly easier to state than to implement, for improving consent procedures. * The consent form should be presented at the beginning of the process, when research admission
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torial). N Engl J Med 287:465-466, 1972 8. Epstein LC, Lasagna L: Obtaining informed consent: Form or substance. Arch Intern Med 123:682-688, 1969 9. Savard RJ: Serving investigator, patient and community in research studies. Ann N Y Acad of Sci 169, Art 2:429-434, 1970 10. Melmon KL, Grossman M, Morris RC Jr: Emerging assets and liabilities of a committee on human welfare and experimen-
tation. N Engl J Med 282:427-431, 1970
11. Beecher HK: 274: i35441360, 1966 Ethics and clinical research. N Engl J
Med
HK: JAMA 12. Beecher Consent in clinical reality (Editorial). 195:34, 1966experimentation: Myth and 13. When is consent? (Lead article). Lancet, 7520, Oct 14, 1967
