Medical and Pediatric Oncology 7: 173-178 (1979)
Patient Recall of Informed Consent 6.J. Kennedy, MD, and Anne Lillehaugen, RN Section of Medical Oncology, Department of Medicine, University of Minnesota Medical School, Minneapolis
The protection of human subjects in research is a shared responsibility. The informed consent procedure was introduced to implement protection of the subjects. The contents of consent forms have been in dispute, and the impact of the procedure on the human subject has caused concern. It was demonstrated that patients with cancer have poor recall of the contents of a signed consent form. Key words: consent, informed, research, recall, patients
INTRODUCTION
The concept of “informed consent” has been added to clinical medicine as part of the major goal to improve health through research, and at the same time, protect the rights of those who participate in that research as subjects. The preoccupation with human experimentation is part of a broader and deeper societal concern with ethical and existential issues related both to biomedical progress and to the provision of medical care [l] . As a result, doctrines on informed consent and forms for patient signature have been written by lawyers, medical academicians, clinical investigators, and non-physicians concerned with individual rights, but written with a low level of input from those at the patient-doctor level. Under the National Research Act of 1974, institutional review boards (IRBs) were required for institutions receiving funds under the Public Health Service Act for research involving human subjects. One commitment of the boards was to determine whether legally effective informed consent is obtained from subjects placed at risk [2]. The American Medical Association developed a model state law that specifies what significant information about medical risks must be given to a patient to assure valid consent to a medical or surgical procedure [3]. Address reprint requests to Dr. B.J. Kennedy, Section of Medical Oncology, Department of Medicine, University of Minnesota Medical School, Minneapolis, MN 55455.
0098-1532/79/0702-0173$01,40 0 1979 Alan R. Liss, Inc.
174
Kennedy and Lillehaugen
The concept of informed consent is widely accepted because of the belief in the principle that human beings have the right t o determine what will happen t o themselves. Treating patients with advanced cancer today requires informing them of the diagnosis and presenting the possible benefits and risks of treatment. In experimental studies, it is necessary t o explain the nature of the investigational procedure, t o specifically elaborate the possible adverse reactions, and to show how these will be managed. The information concerning the risks of a procedure or therapy as well as its benefits is appreciated by the patient even though it might cause some anxiety [ 4 ] . Despite intensive efforts at improving informed consent procedures that fulfilled federal, state, and hospital requirements, in one study the patient’s knowledge o f goals of the study and life-threatening complications was insufficient t o enable intelligent patient decision-making [S]. An attempt to measure how well information is retained demonstrated that 80% of patients failed t o recall major parts of an informed consent interview four to six months later [ 6 ] . A multitude of consent forms has been prepared, criticized, and revised. One form offered was in a humorous vein [7] . Some contend that informed consent is a legalistic fiction that destroys good patient care and paralyzes the conscientious physician. Furthermore it has been asked whether the subject might be harmed rather than helped by the current consent procedure [8]. Oncologists are concerned at the number of consent forms developed for the many chemotherapy programs in the process of study. There is the danger of clinical investigation becoming so overburdened with external restraints that it would be abandoned [ 9 ] . The complexities the clinical investigator faces in preparing informed consent documents is illustrated by an amended HEW regulation requiring the inclusion of a clause stating whether or not the sponsoring institution has a mechanism to provide compensation for subjects who may incur physical injuries as a result of participating in biomedical and behavioral research [ 101 . What “physical injury” includes is not clear. In the process of developing consent forms for clinical investigations in medical oncology that would be approved by this institution’s IRB (“Committee on the Use of Human Subjects in Research”), a study was made of the process of acquiring patient signatures on a consent form and then later asking the same patients t o recall the contents of the form. It is recognized that the true value of a consent form depends upon the comprehension by the patients of the contents of the form, but even more important is the manner and personality of the professional who explains the form t o the patients.
METHODS AND MATERIALS
All patients in the study were new admissions to the University of Minnesota Masonic Memorial Cancer Hospital, a 117-bed unit of the University of Minnesota Hospitals devoted to the study and care of patients with cancer. They had been admitted for the first time to the Medical Oncology Service (46 beds) and were undergoing initial evaluations of their cancer problems. The patients had been informed by their physicians of the nature of their cancers and their management plans. The routine diagnostic and therapeutic procedures had been discussed with the patients and consented t o in accord with the usual customs of medical practice. The study required that the patients be well enough to read. Patients admitted under emergency conditions, lethargic patients, and those with central nervous system lesions were all excluded. A comprehensive but compact consent form was designed to replace a previous form that was deemed too all-inclusive. The purpose of the new form was to cover those medical
Patient Recall of Informed Consent
175
procedures that are considered necessary and/or routine as part of Medical Oncology treatment, teaching, and research programs, but which are not necessarily regarded as standard procedures in the practice of medicine. An additional form was used for investigations of specific chemotherapy agents or procedures. A preliminary study was conducted of 25 patients (see Results). Because the revised and shortened form was not acceptable to patients, a new, third form was prepared and submitted for testing to 50 patients with a variety of neoplasms. It was designed to contain the simplest request deemed possible in a unit where almost every patient participates in, or is in contact with, teaching and research activities (see Results). On the day of admission or the following day, a research oncology nurse presented the consent form to the patient. It was explained that this form did not mean the approval of any research tests, drugs or procedures. The patients’ responses were recorded. The patient either signed immediately, deferred signing until later, or refused to sign. To evaluate the patients’ recall of the contents of the signed form, a follow-up study was conducted 5-7 days later. RESULTS 1. Preliminary Study
An initial consent form asked patients to approve the release and use, for research purposes, of data relating to the history, physical examination, and routine laboratory tests. Further, it provided approval for a blood sample for research, skin tests for immune status, special study of biopsy material removed for diagnostic purposes (eg, estrogen receptor of breast cancer nodules), photographs of lesions, and personality testing. The form was submitted to 25 patients. Five patients signed initially. One clearly did not understand it, and one was hesitant about the last paragraph which stated that research drugs would require a separate consent form. Three signed without question. Signing the form was deferred by 20 patients. Although 15 of the deferring patients eventually signed, 5 others refused to sign. It was concluded that the consent form was not appropriate. The nursing time required and the 20%patient refusal rate made the system impractical. Further study was undertaken of a less complex form. II. Consent With Follow-Up Recall
A simplified form was prepared which asked for approval to use for teaching and research purposes the information gained from the history, physical examination and routine laboratory examinations. In addition, one test tube (1Occ) of blood for research purposes was requested. One week later, each patient was tested on recall of the contents of the signed consent form. Of the 50 new patients given the consent form, 46 signed and 4 refused to sign. Three patients refused to sign because they were afraid of having unnecessary tests and procedures performed on them for the sake of research. They were not interested in giving their blood for research and expressed concern that their health would suffer if they lost more blood than was absolutely necessary. Of these three patients, one evaluated for leukemia was found to have a sinusitis with leucocytosis-no cancer. The other two received standard cancer chemotherapy. The fourth patient refused to sign because she denied she had cancer, and therefore felt that she would not need to be part of any cancer research study. She was treated for multiple myeloma.
176
Kennedy and Lillehaugen
Of the 46 patients who signed the consent form, 34 signed immediately and willingly. Many were willing to sign even before reading the form. Eight signed after they were reassured that they wouldn’t be “guinea pigs.” Three patients deferred signing for a day because they were not feeling well enough to read the form. They subsequently signed willingly. One patient deferred signing for a day, so that his son could read the form and approve it; the patient later signed willingly. A follow-up study of the patients’ recall of the contents of the consent form was conducted 5-7 days after they signed the initial form. A questionnaire was given to 40 patients. The questionnaire was not given to the four patients who refused to sign the consent form. Six patients were discharged before the questionnaires could be filled out. Two patients did not remember signing the consent form and were therefore unable to complete the questionnaire. One of these was initially quite ill when she signed. The following day she became semi-comatose. She improved, and later, when quite lucid, was unable to recall signing the form. The questionnaire was fully completed by 38 patients. They all recalled signing the form. Signing the form did not upset them. They all understood the hospital was a teaching hospital; 37 patients said that they understood the form. Only one patient stated that she did not understand the consent form she had signed. The questionnaire asked whether the patient recalled approving the use of research drugs by the doctor; 19 patients (50%) checked yes, implying they had given permission to have research drugs used on them. Interviews with some of these patients suggest that they indeed thought they had approved research drug use. Only seven patients (18%) replied “no” to this question. Seven patients clearly did not remember, and five patients were not sure whether or not they had approved the use of research drugs. The next item asked whether the patient had given the doctor permission to do research fesrs. Twenty-three patients (60%) thought they had given permission to have research tests done. Only 12 stated they had not given permission. Three patients were either not sure or could not remember. After having completed the questionnaire, 12 patients discussed it further with the oncology nurse. They wanted to know if they had given permission for research drugs and tests. They felt it was very difficult to concentrate on anything on the day of admission because so many new things were happening to them. They all felt they probably had not understood the form or read it carefully. This contradicted their statement onthe follow-up form that they had understood. DISCUSSION
It is clear that obtaining informed consent from a patient is a complex process. The severity of the illness, the emotional state of the patient, the familiarity of the patient with the physician or institution, and the contents of the form are only a few of the variables in this encounter. Patients with advanced cancer have an even greater burden, since they are attempting to cope with the impact of a life-threatening disease. A study of the performance of IRBs considered the issue of informed consent [I 11. Informed consent is a major focus of activity of IRBs, and remains a problem. Apparently, most boards confine their attention to the paper forms used to document informed consent, rather than to the process by which informed consent is obtained. Sample consent forms under review tended to be incomplete, and too difficult for ordinary persons to understand. The IRBs performance study questioned patients who participated in research. Most subjects recalled giving consent for participation, but 10% did not understand that they
Patient Recall of Informed Consent
177
were to be involved in “research”. The most prevalent reason for subject participation in research was the expectation of extra medical, psychological, or educational benefits [ 111. Another study involved interviewing patients with malignant diseases as they participated in clinical research protocols [ 121 . All had signed an elaborately conceived consent form. The motivation to volunteer for the research was explored. The responses emphasized: 1) hope that the new treatment would control the disease; 2) altruism; 3) trust that the physician would only recommend an experimental treatment that would be of benefit. Potential risks and side effects were sometimes totally forgotten during the few days between the standard informed consent and the interviewing process. It is contended that the consent form must be recognized for what it is: nothing more than evidence that informed consent has been obtained [13]. “The use of a jointly signed form that records the physician’s affirmation that he has personally informed the patient, and the patient’s acknowledgement of the receipt and understanding of such information would be of considerable value in supporting the concept that the physician-patient relation is mutual” [131 .Informed consent should always be viewed in terms of the direct discussion between the doctor and the patient; the only way to obtain informed consent is through a conversation [13]. In this process, education of the patient regarding cancer can be accomplished. This should be one of the goals of informed consent. One research group provided a videotaped information package in addition to the standard written explanation. It was contended that this provided the opportunity for uniform, repetitious presentation and the foundation for general understanding [14] . The risks and benefits of a proposed research study are presented t o patients of widely varying backgrounds, intelligence, and conceptual ability. No system exists to confirm the degree of information retained by the patient. In the current study, a few patients (8%) refused to sign what was thought to be a simple request and is, in fact, a request routinely approved by patients in most hospitals. Furthermore, the patients in the study had poor recall of the form signed in the recent past. Hence, the existence of a signed consent form does not assure that the patients have been truly informed, and certainly does not record that they comprehend what has been explained to them. The process of signing a consent form is a threatening experience for the patient. Explanation of the form and reassurance of the patient is a time-consuming process of individual patient education. It does provide an opportunity for the health team to introduce medical and cancer education and orientation to the patient’s illness and therapy. A copy of the consent form, when given t o the patient or the patient’s family, will aid in the process of patient and family education. Furthermore, additional educational materials can be provided to extend or reinforce this education. Continuing study of the response of patients to documentation of the informed consent doctrine is needed. The emotional impact on the patient is not well understood. The implications and innuendos communicated subtly at the time of signing, the anxieties introduced, the concern of the patients regarding research, the effect on physician-patient relationships, and the long term effect on the patient’s emotional state need further evaluation. The informed consent procedures that protect subjects should be retained. A statement describing the procedure and the general level of risk is reasonable, but detailed information might well be reserved only for those who specifically request it [8]. The protection of human subjects is a shared responsibility whereby the physicianinvestigator implements procedures designed to protect the human subject. Others contend that the responsibility for the protection of human subjects lies with, and only with, the
178
Kennedy and Ldlehaugen
physician-investigator [ 1 1] .The issue becomes one of credibility. The final product must be a reasonable balance between a trusting patient open to a new understanding of the process of health care and a compassionate, believable physician. We must avoid overburdening the clinical investigator with unreasonable external burdens as well as avoid adding another hazard to the health of the patient. ACKNOWLEDGMENTS
This research was supported in part by research grants CA-08832 and CA-19527 from the National Cancer Institute of the United States Public Health Service, the Masonic Memorial Hospital Fund, Inc., and the Minnesota Medical Foundation. REFERENCES 1. Fox RC: Introduction t o the cases. “Experiments and Research with Humans: Values in Conflict.” Washington, DC: National Academy of Science, pp 59-61,1975. 2. Code of Federal Rules and Regulations; Title 45, part 46: Protection of human subjects. Federal Register 39:18914-18920 (May 30), 1974. 3. LaForet EG: The fiction of informed consent. JAMA 235: 1579-1585,1976. 4. Alfidi RJ: Informed consent: a study of patient reaction. JAMA 216: 1325-1329,1971. 5. Muss HB, White DR, Michielutte R, Richards F 11, Cooper MR, Williams S, Stuart JJ, and Spurr CL: Written informed consent in patients with breast cancer. Cancer, to be published. 6. Robinson G, and Merav A: Informed consent: recall by patients tested postoperatively. Ann Thorac Surg 22: 209-212, 1976. 7. Middleton EB: Informed consent. JAMA 233: 1049, 1975. 8. Loftus E F and Fries JF: Informed consent may be hazardous to health. Science 204: 11,1979. 9. Bond DD, Thomas L: Future policy options and summary. “Experiments and Research with Humans: Values in Conflict.” Washington, DC: National Academy of Science, pp 209-222, 1975. 10. Code of Federal Rules and Regulations; Title 45, part 46: Informed consent-definitions amended to include advice on compensation. Federal Register 43:51559, (November 3) 1978. 11. Gray BH, Cooke RA, and Tannenbaum AS: Research involving human subjects. Science 201: 1094-1 101, 1978. 12. Kardinal CC, and Cupper HT: Hope, consent, and clinical research. Forum on Medicine 1: 48-49, 1978. 13. Vaccarino, JM: Consent, informed consent, and the consent form. N Engl J Med 298: 455.1978. 14. Barbour BL, and Blumenkrantz MJ: Videotape aids informed consent decision. JAMA 240: 2741-2742, 1978.
Patient Recall of Informed Consent 6.J. Kennedy, MD, and Anne Lillehaugen, RN Section of Medical Oncology, Department of Medicine, University of Minnesota Medical School, Minneapolis
The protection of human subjects in research is a shared responsibility. The informed consent procedure was introduced to implement protection of the subjects. The contents of consent forms have been in dispute, and the impact of the procedure on the human subject has caused concern. It was demonstrated that patients with cancer have poor recall of the contents of a signed consent form. Key words: consent, informed, research, recall, patients
INTRODUCTION
The concept of “informed consent” has been added to clinical medicine as part of the major goal to improve health through research, and at the same time, protect the rights of those who participate in that research as subjects. The preoccupation with human experimentation is part of a broader and deeper societal concern with ethical and existential issues related both to biomedical progress and to the provision of medical care [l] . As a result, doctrines on informed consent and forms for patient signature have been written by lawyers, medical academicians, clinical investigators, and non-physicians concerned with individual rights, but written with a low level of input from those at the patient-doctor level. Under the National Research Act of 1974, institutional review boards (IRBs) were required for institutions receiving funds under the Public Health Service Act for research involving human subjects. One commitment of the boards was to determine whether legally effective informed consent is obtained from subjects placed at risk [2]. The American Medical Association developed a model state law that specifies what significant information about medical risks must be given to a patient to assure valid consent to a medical or surgical procedure [3]. Address reprint requests to Dr. B.J. Kennedy, Section of Medical Oncology, Department of Medicine, University of Minnesota Medical School, Minneapolis, MN 55455.
0098-1532/79/0702-0173$01,40 0 1979 Alan R. Liss, Inc.
174
Kennedy and Lillehaugen
The concept of informed consent is widely accepted because of the belief in the principle that human beings have the right t o determine what will happen t o themselves. Treating patients with advanced cancer today requires informing them of the diagnosis and presenting the possible benefits and risks of treatment. In experimental studies, it is necessary t o explain the nature of the investigational procedure, t o specifically elaborate the possible adverse reactions, and to show how these will be managed. The information concerning the risks of a procedure or therapy as well as its benefits is appreciated by the patient even though it might cause some anxiety [ 4 ] . Despite intensive efforts at improving informed consent procedures that fulfilled federal, state, and hospital requirements, in one study the patient’s knowledge o f goals of the study and life-threatening complications was insufficient t o enable intelligent patient decision-making [S]. An attempt to measure how well information is retained demonstrated that 80% of patients failed t o recall major parts of an informed consent interview four to six months later [ 6 ] . A multitude of consent forms has been prepared, criticized, and revised. One form offered was in a humorous vein [7] . Some contend that informed consent is a legalistic fiction that destroys good patient care and paralyzes the conscientious physician. Furthermore it has been asked whether the subject might be harmed rather than helped by the current consent procedure [8]. Oncologists are concerned at the number of consent forms developed for the many chemotherapy programs in the process of study. There is the danger of clinical investigation becoming so overburdened with external restraints that it would be abandoned [ 9 ] . The complexities the clinical investigator faces in preparing informed consent documents is illustrated by an amended HEW regulation requiring the inclusion of a clause stating whether or not the sponsoring institution has a mechanism to provide compensation for subjects who may incur physical injuries as a result of participating in biomedical and behavioral research [ 101 . What “physical injury” includes is not clear. In the process of developing consent forms for clinical investigations in medical oncology that would be approved by this institution’s IRB (“Committee on the Use of Human Subjects in Research”), a study was made of the process of acquiring patient signatures on a consent form and then later asking the same patients t o recall the contents of the form. It is recognized that the true value of a consent form depends upon the comprehension by the patients of the contents of the form, but even more important is the manner and personality of the professional who explains the form t o the patients.
METHODS AND MATERIALS
All patients in the study were new admissions to the University of Minnesota Masonic Memorial Cancer Hospital, a 117-bed unit of the University of Minnesota Hospitals devoted to the study and care of patients with cancer. They had been admitted for the first time to the Medical Oncology Service (46 beds) and were undergoing initial evaluations of their cancer problems. The patients had been informed by their physicians of the nature of their cancers and their management plans. The routine diagnostic and therapeutic procedures had been discussed with the patients and consented t o in accord with the usual customs of medical practice. The study required that the patients be well enough to read. Patients admitted under emergency conditions, lethargic patients, and those with central nervous system lesions were all excluded. A comprehensive but compact consent form was designed to replace a previous form that was deemed too all-inclusive. The purpose of the new form was to cover those medical
Patient Recall of Informed Consent
175
procedures that are considered necessary and/or routine as part of Medical Oncology treatment, teaching, and research programs, but which are not necessarily regarded as standard procedures in the practice of medicine. An additional form was used for investigations of specific chemotherapy agents or procedures. A preliminary study was conducted of 25 patients (see Results). Because the revised and shortened form was not acceptable to patients, a new, third form was prepared and submitted for testing to 50 patients with a variety of neoplasms. It was designed to contain the simplest request deemed possible in a unit where almost every patient participates in, or is in contact with, teaching and research activities (see Results). On the day of admission or the following day, a research oncology nurse presented the consent form to the patient. It was explained that this form did not mean the approval of any research tests, drugs or procedures. The patients’ responses were recorded. The patient either signed immediately, deferred signing until later, or refused to sign. To evaluate the patients’ recall of the contents of the signed form, a follow-up study was conducted 5-7 days later. RESULTS 1. Preliminary Study
An initial consent form asked patients to approve the release and use, for research purposes, of data relating to the history, physical examination, and routine laboratory tests. Further, it provided approval for a blood sample for research, skin tests for immune status, special study of biopsy material removed for diagnostic purposes (eg, estrogen receptor of breast cancer nodules), photographs of lesions, and personality testing. The form was submitted to 25 patients. Five patients signed initially. One clearly did not understand it, and one was hesitant about the last paragraph which stated that research drugs would require a separate consent form. Three signed without question. Signing the form was deferred by 20 patients. Although 15 of the deferring patients eventually signed, 5 others refused to sign. It was concluded that the consent form was not appropriate. The nursing time required and the 20%patient refusal rate made the system impractical. Further study was undertaken of a less complex form. II. Consent With Follow-Up Recall
A simplified form was prepared which asked for approval to use for teaching and research purposes the information gained from the history, physical examination and routine laboratory examinations. In addition, one test tube (1Occ) of blood for research purposes was requested. One week later, each patient was tested on recall of the contents of the signed consent form. Of the 50 new patients given the consent form, 46 signed and 4 refused to sign. Three patients refused to sign because they were afraid of having unnecessary tests and procedures performed on them for the sake of research. They were not interested in giving their blood for research and expressed concern that their health would suffer if they lost more blood than was absolutely necessary. Of these three patients, one evaluated for leukemia was found to have a sinusitis with leucocytosis-no cancer. The other two received standard cancer chemotherapy. The fourth patient refused to sign because she denied she had cancer, and therefore felt that she would not need to be part of any cancer research study. She was treated for multiple myeloma.
176
Kennedy and Lillehaugen
Of the 46 patients who signed the consent form, 34 signed immediately and willingly. Many were willing to sign even before reading the form. Eight signed after they were reassured that they wouldn’t be “guinea pigs.” Three patients deferred signing for a day because they were not feeling well enough to read the form. They subsequently signed willingly. One patient deferred signing for a day, so that his son could read the form and approve it; the patient later signed willingly. A follow-up study of the patients’ recall of the contents of the consent form was conducted 5-7 days after they signed the initial form. A questionnaire was given to 40 patients. The questionnaire was not given to the four patients who refused to sign the consent form. Six patients were discharged before the questionnaires could be filled out. Two patients did not remember signing the consent form and were therefore unable to complete the questionnaire. One of these was initially quite ill when she signed. The following day she became semi-comatose. She improved, and later, when quite lucid, was unable to recall signing the form. The questionnaire was fully completed by 38 patients. They all recalled signing the form. Signing the form did not upset them. They all understood the hospital was a teaching hospital; 37 patients said that they understood the form. Only one patient stated that she did not understand the consent form she had signed. The questionnaire asked whether the patient recalled approving the use of research drugs by the doctor; 19 patients (50%) checked yes, implying they had given permission to have research drugs used on them. Interviews with some of these patients suggest that they indeed thought they had approved research drug use. Only seven patients (18%) replied “no” to this question. Seven patients clearly did not remember, and five patients were not sure whether or not they had approved the use of research drugs. The next item asked whether the patient had given the doctor permission to do research fesrs. Twenty-three patients (60%) thought they had given permission to have research tests done. Only 12 stated they had not given permission. Three patients were either not sure or could not remember. After having completed the questionnaire, 12 patients discussed it further with the oncology nurse. They wanted to know if they had given permission for research drugs and tests. They felt it was very difficult to concentrate on anything on the day of admission because so many new things were happening to them. They all felt they probably had not understood the form or read it carefully. This contradicted their statement onthe follow-up form that they had understood. DISCUSSION
It is clear that obtaining informed consent from a patient is a complex process. The severity of the illness, the emotional state of the patient, the familiarity of the patient with the physician or institution, and the contents of the form are only a few of the variables in this encounter. Patients with advanced cancer have an even greater burden, since they are attempting to cope with the impact of a life-threatening disease. A study of the performance of IRBs considered the issue of informed consent [I 11. Informed consent is a major focus of activity of IRBs, and remains a problem. Apparently, most boards confine their attention to the paper forms used to document informed consent, rather than to the process by which informed consent is obtained. Sample consent forms under review tended to be incomplete, and too difficult for ordinary persons to understand. The IRBs performance study questioned patients who participated in research. Most subjects recalled giving consent for participation, but 10% did not understand that they
Patient Recall of Informed Consent
177
were to be involved in “research”. The most prevalent reason for subject participation in research was the expectation of extra medical, psychological, or educational benefits [ 111. Another study involved interviewing patients with malignant diseases as they participated in clinical research protocols [ 121 . All had signed an elaborately conceived consent form. The motivation to volunteer for the research was explored. The responses emphasized: 1) hope that the new treatment would control the disease; 2) altruism; 3) trust that the physician would only recommend an experimental treatment that would be of benefit. Potential risks and side effects were sometimes totally forgotten during the few days between the standard informed consent and the interviewing process. It is contended that the consent form must be recognized for what it is: nothing more than evidence that informed consent has been obtained [13]. “The use of a jointly signed form that records the physician’s affirmation that he has personally informed the patient, and the patient’s acknowledgement of the receipt and understanding of such information would be of considerable value in supporting the concept that the physician-patient relation is mutual” [131 .Informed consent should always be viewed in terms of the direct discussion between the doctor and the patient; the only way to obtain informed consent is through a conversation [13]. In this process, education of the patient regarding cancer can be accomplished. This should be one of the goals of informed consent. One research group provided a videotaped information package in addition to the standard written explanation. It was contended that this provided the opportunity for uniform, repetitious presentation and the foundation for general understanding [14] . The risks and benefits of a proposed research study are presented t o patients of widely varying backgrounds, intelligence, and conceptual ability. No system exists to confirm the degree of information retained by the patient. In the current study, a few patients (8%) refused to sign what was thought to be a simple request and is, in fact, a request routinely approved by patients in most hospitals. Furthermore, the patients in the study had poor recall of the form signed in the recent past. Hence, the existence of a signed consent form does not assure that the patients have been truly informed, and certainly does not record that they comprehend what has been explained to them. The process of signing a consent form is a threatening experience for the patient. Explanation of the form and reassurance of the patient is a time-consuming process of individual patient education. It does provide an opportunity for the health team to introduce medical and cancer education and orientation to the patient’s illness and therapy. A copy of the consent form, when given t o the patient or the patient’s family, will aid in the process of patient and family education. Furthermore, additional educational materials can be provided to extend or reinforce this education. Continuing study of the response of patients to documentation of the informed consent doctrine is needed. The emotional impact on the patient is not well understood. The implications and innuendos communicated subtly at the time of signing, the anxieties introduced, the concern of the patients regarding research, the effect on physician-patient relationships, and the long term effect on the patient’s emotional state need further evaluation. The informed consent procedures that protect subjects should be retained. A statement describing the procedure and the general level of risk is reasonable, but detailed information might well be reserved only for those who specifically request it [8]. The protection of human subjects is a shared responsibility whereby the physicianinvestigator implements procedures designed to protect the human subject. Others contend that the responsibility for the protection of human subjects lies with, and only with, the
178
Kennedy and Ldlehaugen
physician-investigator [ 1 1] .The issue becomes one of credibility. The final product must be a reasonable balance between a trusting patient open to a new understanding of the process of health care and a compassionate, believable physician. We must avoid overburdening the clinical investigator with unreasonable external burdens as well as avoid adding another hazard to the health of the patient. ACKNOWLEDGMENTS
This research was supported in part by research grants CA-08832 and CA-19527 from the National Cancer Institute of the United States Public Health Service, the Masonic Memorial Hospital Fund, Inc., and the Minnesota Medical Foundation. REFERENCES 1. Fox RC: Introduction t o the cases. “Experiments and Research with Humans: Values in Conflict.” Washington, DC: National Academy of Science, pp 59-61,1975. 2. Code of Federal Rules and Regulations; Title 45, part 46: Protection of human subjects. Federal Register 39:18914-18920 (May 30), 1974. 3. LaForet EG: The fiction of informed consent. JAMA 235: 1579-1585,1976. 4. Alfidi RJ: Informed consent: a study of patient reaction. JAMA 216: 1325-1329,1971. 5. Muss HB, White DR, Michielutte R, Richards F 11, Cooper MR, Williams S, Stuart JJ, and Spurr CL: Written informed consent in patients with breast cancer. Cancer, to be published. 6. Robinson G, and Merav A: Informed consent: recall by patients tested postoperatively. Ann Thorac Surg 22: 209-212, 1976. 7. Middleton EB: Informed consent. JAMA 233: 1049, 1975. 8. Loftus E F and Fries JF: Informed consent may be hazardous to health. Science 204: 11,1979. 9. Bond DD, Thomas L: Future policy options and summary. “Experiments and Research with Humans: Values in Conflict.” Washington, DC: National Academy of Science, pp 209-222, 1975. 10. Code of Federal Rules and Regulations; Title 45, part 46: Informed consent-definitions amended to include advice on compensation. Federal Register 43:51559, (November 3) 1978. 11. Gray BH, Cooke RA, and Tannenbaum AS: Research involving human subjects. Science 201: 1094-1 101, 1978. 12. Kardinal CC, and Cupper HT: Hope, consent, and clinical research. Forum on Medicine 1: 48-49, 1978. 13. Vaccarino, JM: Consent, informed consent, and the consent form. N Engl J Med 298: 455.1978. 14. Barbour BL, and Blumenkrantz MJ: Videotape aids informed consent decision. JAMA 240: 2741-2742, 1978.
