EDITORIALS
techniques of communication and is aware of available resource materials dealing with sexual matters related to the handicapped, including the mentally retarded.5 I stress the handicapped as a group because of the areas of overlap, such as special considerations for the motor handicaps which affect many of the mentally retarded.6 Sexual education and family planning services for the handicapped can be more effective if parents and teachers of the handicapped stress from earliest childhood on the "commonly accepted conventions in the relationship between boys and girls, women and men, and the individual's self-image as it relates to these conventions."7 Greater utilization of our public health services by all types of individuals should be a goal for all of us. We cannot be satisfied until our system of services has been extended to all in need, regardless of handicap, race, economic level, or age. Dr. David's article on family planning services for the mentally retarded provides a valuable lesson-some problems are not as great as they seem; their solutions are ignored not because of the facts in the case but because of the prejudices of society.
REFERENCES 1. David, H. P., Smith, J. D., and Friedman, E. Family planning services for persons handicapped by mental retardation. Am. J. Public Health 66:1053-1057, 1976. 2. Kempton, W., Gordon, S., and Bass, M. Love, sex, and birth control for the mentally retarded-A guide for parents. Planned Parenthood Association of Southeastern Pennsylvania, Philadelphia, 1971. 3. Kempton, W. Guidelines for planning a training course on human sexuality and the retarded. Planned Parenthood Association of Southeastern Pennsylvania, Philadelphia, 1973. 4. A Resource Guide for Sex Education for the Mentally Retarded. SIECUS and American Association for Health, Physical Education and Recreation, New York, 1971. 5. Jaslow, R. A modern plan for modern services to the mentally retarded: Expanding community services to the mentally retarded. Clinical Pediatrics, 7:80-82, 1968. 6. Bregman, S. Sexuality and the spinal cord injured. Sister Kenny Institute, Minneapolis, 1975. 7. Dybwad, G. Personal Communication, 1976.
Address reprint requests to Dr. R. I. Jaslow, Assistant Director for Health Services, Woodhaven Center (Southeastern State School & Hospital), 2900 Southampton Road, Philadelphia, PA 19154.
ROBERT I. JASLOW, MD
Privacy, Research, and the Health of the Public The broad ranging scrutiny of measures to protect the individual's right to privacy that is underway at the federal and local level has now focused attention on the confidentiality of medical and other records containing healthrelated data. The outcome could be restrictive legislative or regulatory actions by governmental agencies or independent decisions by health care providers and institutions that seriously impede the conduct of epidemiologic, health services, environmental, and occupational studies on many significant public health issues. On the other hand, the recognition of this possibility could result in efforts never previously considered necessary, to disseminate widely knowledge about the essential role of health record information in scientific research and the rigorous adherence to high ethical standards already required and monitored by Institutional Review Boards on Protection of Human Subjects. The end sought would be a new understanding of the value of research dependent on medical and related records and the need to continue to utilize these records under conditions that do not impede the research while protecting the confidentiality of the data. Efforts to make this case do not ordinarily occur except in response to what is perceived as an immediate danger. Such a response was evoked recently by the request of the 1050
Privacy Protection Study Commission,* established under the 1974 Privacy Act (P.L. 93-579), for reactions to policies and procedures being considered to protect the confidentiality of medical records.' Among the various provisions on which the Commission invited comment was the following principle: "4. No individually identifiable information should be released by the hospital, facility, agency or health care provider without the subject's express written consent. This consent must specifically state the information to be disclosed and the individual or organization to whom it is to be disclosed...." (Several exceptions are cited, none of which refers to research needs.)
Clearly, the intent of this principle should be supported but as it stands it would have a far reaching negative impact on many socially useful investigations, e.g., epidemiologic studies of risk factors for specific diseases, evaluation of new approaches for the early detection and treatment of disease, and research on the delivery of health care. This appraisal has been communicated to the Commission in various ways, including: 1) testimony at their public hearings in Los Ange*The Privacy Protection Study Commission's address is 2120 L Street, NW, Suite 424, Washington, DC 20506.
MJPH November, 1976, Vol. 66, No. 1 1
EDITORIALS
les during June 1976 (at which Dr. Lester Breslow testified on behalf of the American Public Health Association and the Association of Schools of Public Health); 2) receipt of over 120 letters from researchers citing past contributions that would have been lost; and 3) a comprehensive statement from the Society for Epidemiologic Research. The SER document details the use of records in health research and draws attention to the fact that often "access to medical records is the necessary first step for identifying patients so that with their informed consent they can subsequently be interviewed and studied." A major recommendation advanced by SER, which reflects the view of many who have communicated with the Commission directly, is to include as an exception to the above principle-the availability of health records for epidemiologic and health services research and for treatment and program evaluation where there are adequate safeguards against unauthorized disclosures by the researcher. A distressing concomitant of the discussions about privacy are the misunderstandings about the existing provisions of the Privacy Act and concerns about future restrictive legislation that are beginning to affect the ability to do research that is dependent on medical record information. One wonders what the results would have been in the study reported by Neuhaus, Lyons and Payne in this issue of the Journal2 if it had been conducted under such a cloud. Although it required considerable effort, the investigators were able to obtain the cooperation of 64 per cent of the physicians in one area. It might be argued that this is not outstanding but participation by the physicians required several commitments. These included agreement to identify patients seen for specified conditions, endorsement of a letter to these patients requesting authorization to review their medical records, and then making the records available. Local conditions that were favorable at the time may have contributed to the achievement of about a two-thirds participation rate in this type of study (the authors note that in another community the investigation was dropped because of a very low response rate from providers), and researchers are only too well aware how volatile a local situation can be. Another intriguing aspect of the results reported is the return of signed authorizations by 64 per cent of the patients after only one mailing. This high a response to a minimum effort is exceptional, even considering the circumstances, and may well reflect a general acceptance by the public of the use of the medical record for research purposes. It
AJPH November, 1976, Vol. 66, No. 1 1
should be noted that in a climate of anxiety about releasing any information from the medical record, stage two, i.e., approaching the patient for authorization, might not be reached for more than a small proportion. Researchers have always had to face the task of obtaining the cooperation of individual providers, hospitals, and other institutions as well as the general public or particular patient groups. Success is affected by the auspices of the investigation, the interest and value associated with the study, and the burden placed on the respondent. But, the climate of the times can have a decisive influence on the response rate and where the medical record is involved a clearing of the air by statements that remove the cloud of uncertainty about the legality or ethics of cooperation is required to avoid the entry of a new obstacle. How the Commission acts on the matter will set a pattern. Considering the long record of responsible behavior by the scientific community one would expect the resolution to be consistent with the SER recommendation. The Commission will be submitting, by mid-1977, its report and recommendations to the President and Congress for legislation or other actions on many aspects of the privacy issue. As new opportunities for comment become available, it will continue to be important to respond with evidence on the benefits to both society and the individual that have resulted from the use of medical records for public health re-
search. Finally, the preoccupation with federal legislation should not deflect attention from related deliberations at the state and local levels. Strong presentations at the national level need to be paralleled by similar statements at other governmental levels when legislation is being considered.
SAM SHAPIRO
REFERENCES 1. Federal Register, Vol. 41, No. 92, May 11, 1976, pp. 19,265-
19,266. 2. Neuhaus, E., Lyons, T. F., and Payne, B. C. Patient responses to request for written permission to review medical records. Am. J. Public Health, 66:1090-1092, 1976.
Address reprint requests to Mr. Sam Shapiro, Director, Health Services Research and Development Center, and Professor of Health Care Organization, Department of Health Services Administration, School of Hygiene and Public Health, Johns Hopkins Medical Institutions, 624 N. Broadway, Baltimore, MD 21205.
1051
techniques of communication and is aware of available resource materials dealing with sexual matters related to the handicapped, including the mentally retarded.5 I stress the handicapped as a group because of the areas of overlap, such as special considerations for the motor handicaps which affect many of the mentally retarded.6 Sexual education and family planning services for the handicapped can be more effective if parents and teachers of the handicapped stress from earliest childhood on the "commonly accepted conventions in the relationship between boys and girls, women and men, and the individual's self-image as it relates to these conventions."7 Greater utilization of our public health services by all types of individuals should be a goal for all of us. We cannot be satisfied until our system of services has been extended to all in need, regardless of handicap, race, economic level, or age. Dr. David's article on family planning services for the mentally retarded provides a valuable lesson-some problems are not as great as they seem; their solutions are ignored not because of the facts in the case but because of the prejudices of society.
REFERENCES 1. David, H. P., Smith, J. D., and Friedman, E. Family planning services for persons handicapped by mental retardation. Am. J. Public Health 66:1053-1057, 1976. 2. Kempton, W., Gordon, S., and Bass, M. Love, sex, and birth control for the mentally retarded-A guide for parents. Planned Parenthood Association of Southeastern Pennsylvania, Philadelphia, 1971. 3. Kempton, W. Guidelines for planning a training course on human sexuality and the retarded. Planned Parenthood Association of Southeastern Pennsylvania, Philadelphia, 1973. 4. A Resource Guide for Sex Education for the Mentally Retarded. SIECUS and American Association for Health, Physical Education and Recreation, New York, 1971. 5. Jaslow, R. A modern plan for modern services to the mentally retarded: Expanding community services to the mentally retarded. Clinical Pediatrics, 7:80-82, 1968. 6. Bregman, S. Sexuality and the spinal cord injured. Sister Kenny Institute, Minneapolis, 1975. 7. Dybwad, G. Personal Communication, 1976.
Address reprint requests to Dr. R. I. Jaslow, Assistant Director for Health Services, Woodhaven Center (Southeastern State School & Hospital), 2900 Southampton Road, Philadelphia, PA 19154.
ROBERT I. JASLOW, MD
Privacy, Research, and the Health of the Public The broad ranging scrutiny of measures to protect the individual's right to privacy that is underway at the federal and local level has now focused attention on the confidentiality of medical and other records containing healthrelated data. The outcome could be restrictive legislative or regulatory actions by governmental agencies or independent decisions by health care providers and institutions that seriously impede the conduct of epidemiologic, health services, environmental, and occupational studies on many significant public health issues. On the other hand, the recognition of this possibility could result in efforts never previously considered necessary, to disseminate widely knowledge about the essential role of health record information in scientific research and the rigorous adherence to high ethical standards already required and monitored by Institutional Review Boards on Protection of Human Subjects. The end sought would be a new understanding of the value of research dependent on medical and related records and the need to continue to utilize these records under conditions that do not impede the research while protecting the confidentiality of the data. Efforts to make this case do not ordinarily occur except in response to what is perceived as an immediate danger. Such a response was evoked recently by the request of the 1050
Privacy Protection Study Commission,* established under the 1974 Privacy Act (P.L. 93-579), for reactions to policies and procedures being considered to protect the confidentiality of medical records.' Among the various provisions on which the Commission invited comment was the following principle: "4. No individually identifiable information should be released by the hospital, facility, agency or health care provider without the subject's express written consent. This consent must specifically state the information to be disclosed and the individual or organization to whom it is to be disclosed...." (Several exceptions are cited, none of which refers to research needs.)
Clearly, the intent of this principle should be supported but as it stands it would have a far reaching negative impact on many socially useful investigations, e.g., epidemiologic studies of risk factors for specific diseases, evaluation of new approaches for the early detection and treatment of disease, and research on the delivery of health care. This appraisal has been communicated to the Commission in various ways, including: 1) testimony at their public hearings in Los Ange*The Privacy Protection Study Commission's address is 2120 L Street, NW, Suite 424, Washington, DC 20506.
MJPH November, 1976, Vol. 66, No. 1 1
EDITORIALS
les during June 1976 (at which Dr. Lester Breslow testified on behalf of the American Public Health Association and the Association of Schools of Public Health); 2) receipt of over 120 letters from researchers citing past contributions that would have been lost; and 3) a comprehensive statement from the Society for Epidemiologic Research. The SER document details the use of records in health research and draws attention to the fact that often "access to medical records is the necessary first step for identifying patients so that with their informed consent they can subsequently be interviewed and studied." A major recommendation advanced by SER, which reflects the view of many who have communicated with the Commission directly, is to include as an exception to the above principle-the availability of health records for epidemiologic and health services research and for treatment and program evaluation where there are adequate safeguards against unauthorized disclosures by the researcher. A distressing concomitant of the discussions about privacy are the misunderstandings about the existing provisions of the Privacy Act and concerns about future restrictive legislation that are beginning to affect the ability to do research that is dependent on medical record information. One wonders what the results would have been in the study reported by Neuhaus, Lyons and Payne in this issue of the Journal2 if it had been conducted under such a cloud. Although it required considerable effort, the investigators were able to obtain the cooperation of 64 per cent of the physicians in one area. It might be argued that this is not outstanding but participation by the physicians required several commitments. These included agreement to identify patients seen for specified conditions, endorsement of a letter to these patients requesting authorization to review their medical records, and then making the records available. Local conditions that were favorable at the time may have contributed to the achievement of about a two-thirds participation rate in this type of study (the authors note that in another community the investigation was dropped because of a very low response rate from providers), and researchers are only too well aware how volatile a local situation can be. Another intriguing aspect of the results reported is the return of signed authorizations by 64 per cent of the patients after only one mailing. This high a response to a minimum effort is exceptional, even considering the circumstances, and may well reflect a general acceptance by the public of the use of the medical record for research purposes. It
AJPH November, 1976, Vol. 66, No. 1 1
should be noted that in a climate of anxiety about releasing any information from the medical record, stage two, i.e., approaching the patient for authorization, might not be reached for more than a small proportion. Researchers have always had to face the task of obtaining the cooperation of individual providers, hospitals, and other institutions as well as the general public or particular patient groups. Success is affected by the auspices of the investigation, the interest and value associated with the study, and the burden placed on the respondent. But, the climate of the times can have a decisive influence on the response rate and where the medical record is involved a clearing of the air by statements that remove the cloud of uncertainty about the legality or ethics of cooperation is required to avoid the entry of a new obstacle. How the Commission acts on the matter will set a pattern. Considering the long record of responsible behavior by the scientific community one would expect the resolution to be consistent with the SER recommendation. The Commission will be submitting, by mid-1977, its report and recommendations to the President and Congress for legislation or other actions on many aspects of the privacy issue. As new opportunities for comment become available, it will continue to be important to respond with evidence on the benefits to both society and the individual that have resulted from the use of medical records for public health re-
search. Finally, the preoccupation with federal legislation should not deflect attention from related deliberations at the state and local levels. Strong presentations at the national level need to be paralleled by similar statements at other governmental levels when legislation is being considered.
SAM SHAPIRO
REFERENCES 1. Federal Register, Vol. 41, No. 92, May 11, 1976, pp. 19,265-
19,266. 2. Neuhaus, E., Lyons, T. F., and Payne, B. C. Patient responses to request for written permission to review medical records. Am. J. Public Health, 66:1090-1092, 1976.
Address reprint requests to Mr. Sam Shapiro, Director, Health Services Research and Development Center, and Professor of Health Care Organization, Department of Health Services Administration, School of Hygiene and Public Health, Johns Hopkins Medical Institutions, 624 N. Broadway, Baltimore, MD 21205.
1051
