AIDS UPDATE * SIDA: LE POINT
Guidelines on ethical and legal considerations in anonymous unlinked HIV seroprevalence research Federal Centre for AIDS Working Group on Anonymous Unlinked HIV Seroprevalence T his document provides guidelines on the ethical and legal considerations in anonymous unlinked human immunodeficiency virus (HIV) seroprevalence research. The guidelines are intended as a resource for researchers, grant reviewers, government agencies and institutional ethics committees. The Department of National Health and Welfare does not accept responsibility for their use in studies funded by other agencies. Anonymous unlinked HIV seroprevalence research ("blinded surveys") is the least biased method of estimating the extent of HIV infection in a population. Serum left over from that routinely collected for other purposes and permanently unlinked from any information that could identify individuals is tested for HIV antibodies. The accuracy of the estimated rate of HIV infection in the population depends on the random selection of the blood samples tested. The National Health Research and Development Program (NHRDP) and the Federal Centre for AIDS (FCA) released a joint Request for Research Proposals for National HIV Seroprevalence Studies in October 1988. Recognizing the importance of ethical and legal considerations in such research the FCA convened a multidisciplinary Working Group on Anonymous Unlinked HIV Seroprevalence Studies, which met Dec. 13 and 14, 1988. Partici-
pants included experts in ethics, law, medicine, theology, nursing, philosophy and public health. These guidelines reflect the deliberations of this expert group.
The Canadian situation In 1988 the Royal Society of Canada' recommended that "to replace assumptions with data ... epidemiological surveys be carried out to estimate the number of HIV-infected persons in Canada" and that "anonymous sample surveys, approved by institutional ethics or human experimentation committees, [be] the preferred avenue for achieving the goal of HIV epidemiologic surveillance". At its meeting on Oct. 19, 1987, the National Advisory Committee on AIDS recommended that the Department of National Health and Welfare be encouraged to obtain or support the collection of HIV seroprevalence data adhering to the following criteria: testing should be conducted anonymously on specimens obtained for other routine tests; only the demographic information attached to these specimens should be collected; and voluntary HIV antibody testing should be available to all subjects under conditions of informed consent, pretest and posttest counselling, and confidentiality.2 The Medical Research Council of Canada3 has
Working group participants: Kimberly Elmslie, chair, Bureau of Epidemiology and Surveillance, Federal Centre for AIDS, Ottawa; Fay
Campbell, Legal Services, Department of National Health and Welfare, Ottawa; Gerrit Clements, Legal Services, British Columbia Ministry of Health, Victoria; Bernard Dickens, Faculty of Law, University of Toronto; Catherine Hankins, coordinator, Centre for AIDS Studies, Montreal General Hospital; Thomas Mabey, Atlantic School of Theology, Halifax; Maurice McGregor, Conseil d'e'valuation des technologies de la sante du Quebec, Montreal; Betsy MacKenzie, Bureau of Epidemiology and Surveillance, Federal Centre for AIDS, Ottawa; Suzanne Nootens, Faculty of Law, University of Sherbrooke; Eugene Oscapella, Offices of Information and Privacy Commissioners ofCanada, Ottawa; David Roy, Centre for Bioethics, Clinical Research Institute of Montreal; Martin Schechter, Department of Health Care and Epidemiology, University of British Columbia, Vancouver; Sydney Segal, Department of Pediatrics, University of British Columbia, Vancouver; Susan Sherwin, Department of Philosophy, Dalhousie University, Halifax; Margaret Somerville, McGill Centre for Medicine, Ethics and Law, Montreal; Janet Storch, Department of Health Services Administration and Community Medicine, University ofAlberta, Edmonton. Reprint requests to: Ms. Betsy MacKenzie, Bureau of Epidemiology and Surveillance, Federal Centre for AIDS, 2nd floor, 301 Elgin St., Ottawa, Ont. KlA OL2 -
For prescribing information
see
page 679
CAN MED ASSOC J 1990; 143 (7)
625
prevalence research, provided that specific requirestated that "consent is generally unnecessary for prevalence research, provided that specific requireresearch undertaken, for example, upon surplus ments are met. blood, urine, tissue, and similar samples obtained for diagnostic or treatment purposes if the patient is not Rationale identifiable, and the requirements of the research do The working group agreed that the anonymous not influence the procedures used for obtaining the unlinked methodology would be the most scientifisamples". cally acceptable and feasible research design and would offer several advantages. The international situation * It would provide accurate estimates of the Unlinked HIV seroprevalence research began in prevalence of HIV infection because it would avoid the United States in 1986 with the use of serum left the self-selection bias inherent in all voluntary over from sentinel hospitals and neonatal metabolic studies. * It would be noninvasive. screening programs. The US Centers for Disease * It would ensure personal privacy because Control (CDC) now oversee a variety of such studies involving sentinel physicians, women's health cen- individuals could not be linked to HIV antibody test tres, sexually transmitted disease clinics, addiction results. * It would be cost-effective. treatment facilities, prisons and emergency rooms, as Adoption of the anonymous unlinked methodolwell as a national nutrition survey.4 The CDC and the Office for Protection from ogy raises three important issues. First, individual Research Risks, National Institutes of Health, have informed consent would not be obtained. However, determined that anonymous unlinked surveys "that seroprevalence studies on populations of unidenticause no collection of information or specimens that fied people can be distinguished from testing on an would not otherwise be obtained for routine medi- individual basis. The working group agreed that it cal purposes and obtain no data which can be linked would be reasonable not to require individual into identifiable individuals can be considered blind- formed consent when testing leftover, permanently ed, or unlinked surveys, not involving 'human sub- unlinked serum for HIV antibodies. Second, HIV-seropositive individuals would not jects'. Since patient identifying information will not be linked to HIV test results, informed consent will be identified. The objective of the anonymous unlinked research design is to produce accurate seronot be required."5 In Britain the government funded the Medical prevalence estimates, a goal independent of volResearch Council in 1988 to conduct a variety of untary individual testing and subsequent contact tracing. The HIV antibody test is available to Cananonymous unlinked HIV seroprevalence studies.6 adians through the health care system and should be given under conditions of informed consent, pretest Purpose of HIV seroprevalence research and posttest counselling, and confidentiality. Third, there is a potential for indirect harm to Although monitoring the number of identified AIDS cases on a national basis provides one impor- groups or individuals - for example, through stigtant measure of the AIDS epidemic, such surveil- matization. This could be minimized by appropriate lance misses cases of asymptomatic HIV infection. research requirements and would be outweighed by Consequently, this information cannot be used to the benefits to the public of accurate HIV seroprevaassess current seroprevalence rates. Identifying and lence data. Such data would constitute an early monitoring changes in the prevalence of HIV infec- warning system to detect changes in the pattern of tion among Canadians are necessary steps in assess- spread of HIV infection in specific populations. ing the need for prevention programs, designing and Planning preventive or screening measures on the targeting such programs, evaluating their effective- basis of inaccurate, particularly low, estimates would ness, identifying priority groups for screening should bring greater harm to groups and individuals. a vaccine or early treatment be developed, and planning and allocating resources for future health Requirements for anonymous unlinked HIV and social service needs with respect to HIV infec- seroprevalence research tion and AIDS. The working group agreed that the following Consensus of the working group basic requirements must be met. * Universal access to individual voluntary testThe working group agreed that the related ethi- ing under prescribed conditions of informed consent, cal and legal concerns do not constitute an insur- pretest and posttest counselling, and confidentiality mountable barrier to anonymous unlinked HIV sero- would be a prerequisite. 626
CAN MED ASSOC J 1990; 143 (7)
* Only leftover serum routinely collected for other purposes would be used. * Records would be permanently unlinked before testing, so that it would be impossible at any time to identify individual test results. * No sample size small enough to identify individuals would be reported. * No information that might lead to the identification of individuals would be used. * The research would have to meet the approval of the relevant institutional ethics review committees. * The public would be made aware of the research. The working group also agreed on the following requirements related to communication issues. * Communication with the public should be clear and balanced. * Methods of informing the public about plans for anonymous unlinked research will vary from study to study. Researchers should be prepared to determine the most appropriate medium to use. Mass mailings, video recordings, toll-free telephone numbers, special seminars and ethnic language newspapers are all potential tools for informing the public. * Researchers would be responsible for anticipating to a reasonable extent the special communication needs of the population being tested. * Physicians should be informed through their provincial associations and colleges about unlinked HIV antibody testing and its nontherapeutic purpose. Voluntary individual testing remains an option
within the patient-physician relationship and would not be affected by this research. * The researcher's contact number should be readily available so that a physician or a patient, or both, can discuss the research in more detail. After learning more about the research some patients may request that their leftover serum not be included in the random selection of samples. Physicians must be informed of how this issue is addressed in the research protocol. * Researchers would be responsible for anticipating to a reasonable extent the potential for indirect harm to groups or individuals. Special interest groups should be involved in developing the communication plan for potentially sensitive research results.
References 1. Royal Society of Canada: AIDS: A Perspective for Canadians. Summary Report and Recommendations, Royal Society of Canada, Ottawa, 1988: 5 2. National Advisory Committee on AIDS: Minutes of meeting, Oct 19, 1987: 4 3. Medical Research Council of Canada: Guidelines on Research Involving Human Subjects, Medical Research Council of Canada, Ottawa, 1987: 26 4. Dondero TJ, Pappaioanou M, Curran JW: Monitoring the levels and trends of HIV infection: the Public Health Services HIV Surveillance Program. Public Health Rep 1988; 103: 213220 5. Centers for Disease Control: HIV Seroprevalence Survey in Childbearing Women: Testing Neonatal Dried Blood Specimens on Filter Paper for HIVAntibody (draft), 1988 6. British Information Services: News Release: Anonymous Blood Testingfor AIDS, Nov 24, 1988
Completing a medical education To be ill, or to undergo an operation, is to be initiated into the mystery of nursing, and to learn the comforts and discomforts of an invalid's life; the unearthly fragrance of tea at daybreak, the disappointment of rice pudding when you thought it was going to be orange-jelly, and the behaviour of each constituent part of the bedclothes. You know, henceforth, how many hours are in a sleepless night; and what unclean fancies will not let us alone. when we are ill; and how illness may blunt anxiety andfear, so that the patient is dull, but not unhappy or worried; and how we cling to life, not from terror of death, nor with any clear desire for the remainder of life, but by nature, not by logic. In brief, you learn from your own case many facts which are not in text-books and lectures: and your patients, in the years to come, will say that they prefer you to the other doctor, because you seem to understand exactly how they feeL I wish you therefore, young man, early in your career, a serious illness, or an operation, or both. For thus, and thus alone, may you complete your medical education, and crown your learning with the pure gold of experience. -
Stephen Paget (1855-1926)
CAN MED ASSOC J 1990; 143 (7)
627
Guidelines on ethical and legal considerations in anonymous unlinked HIV seroprevalence research Federal Centre for AIDS Working Group on Anonymous Unlinked HIV Seroprevalence T his document provides guidelines on the ethical and legal considerations in anonymous unlinked human immunodeficiency virus (HIV) seroprevalence research. The guidelines are intended as a resource for researchers, grant reviewers, government agencies and institutional ethics committees. The Department of National Health and Welfare does not accept responsibility for their use in studies funded by other agencies. Anonymous unlinked HIV seroprevalence research ("blinded surveys") is the least biased method of estimating the extent of HIV infection in a population. Serum left over from that routinely collected for other purposes and permanently unlinked from any information that could identify individuals is tested for HIV antibodies. The accuracy of the estimated rate of HIV infection in the population depends on the random selection of the blood samples tested. The National Health Research and Development Program (NHRDP) and the Federal Centre for AIDS (FCA) released a joint Request for Research Proposals for National HIV Seroprevalence Studies in October 1988. Recognizing the importance of ethical and legal considerations in such research the FCA convened a multidisciplinary Working Group on Anonymous Unlinked HIV Seroprevalence Studies, which met Dec. 13 and 14, 1988. Partici-
pants included experts in ethics, law, medicine, theology, nursing, philosophy and public health. These guidelines reflect the deliberations of this expert group.
The Canadian situation In 1988 the Royal Society of Canada' recommended that "to replace assumptions with data ... epidemiological surveys be carried out to estimate the number of HIV-infected persons in Canada" and that "anonymous sample surveys, approved by institutional ethics or human experimentation committees, [be] the preferred avenue for achieving the goal of HIV epidemiologic surveillance". At its meeting on Oct. 19, 1987, the National Advisory Committee on AIDS recommended that the Department of National Health and Welfare be encouraged to obtain or support the collection of HIV seroprevalence data adhering to the following criteria: testing should be conducted anonymously on specimens obtained for other routine tests; only the demographic information attached to these specimens should be collected; and voluntary HIV antibody testing should be available to all subjects under conditions of informed consent, pretest and posttest counselling, and confidentiality.2 The Medical Research Council of Canada3 has
Working group participants: Kimberly Elmslie, chair, Bureau of Epidemiology and Surveillance, Federal Centre for AIDS, Ottawa; Fay
Campbell, Legal Services, Department of National Health and Welfare, Ottawa; Gerrit Clements, Legal Services, British Columbia Ministry of Health, Victoria; Bernard Dickens, Faculty of Law, University of Toronto; Catherine Hankins, coordinator, Centre for AIDS Studies, Montreal General Hospital; Thomas Mabey, Atlantic School of Theology, Halifax; Maurice McGregor, Conseil d'e'valuation des technologies de la sante du Quebec, Montreal; Betsy MacKenzie, Bureau of Epidemiology and Surveillance, Federal Centre for AIDS, Ottawa; Suzanne Nootens, Faculty of Law, University of Sherbrooke; Eugene Oscapella, Offices of Information and Privacy Commissioners ofCanada, Ottawa; David Roy, Centre for Bioethics, Clinical Research Institute of Montreal; Martin Schechter, Department of Health Care and Epidemiology, University of British Columbia, Vancouver; Sydney Segal, Department of Pediatrics, University of British Columbia, Vancouver; Susan Sherwin, Department of Philosophy, Dalhousie University, Halifax; Margaret Somerville, McGill Centre for Medicine, Ethics and Law, Montreal; Janet Storch, Department of Health Services Administration and Community Medicine, University ofAlberta, Edmonton. Reprint requests to: Ms. Betsy MacKenzie, Bureau of Epidemiology and Surveillance, Federal Centre for AIDS, 2nd floor, 301 Elgin St., Ottawa, Ont. KlA OL2 -
For prescribing information
see
page 679
CAN MED ASSOC J 1990; 143 (7)
625
prevalence research, provided that specific requirestated that "consent is generally unnecessary for prevalence research, provided that specific requireresearch undertaken, for example, upon surplus ments are met. blood, urine, tissue, and similar samples obtained for diagnostic or treatment purposes if the patient is not Rationale identifiable, and the requirements of the research do The working group agreed that the anonymous not influence the procedures used for obtaining the unlinked methodology would be the most scientifisamples". cally acceptable and feasible research design and would offer several advantages. The international situation * It would provide accurate estimates of the Unlinked HIV seroprevalence research began in prevalence of HIV infection because it would avoid the United States in 1986 with the use of serum left the self-selection bias inherent in all voluntary over from sentinel hospitals and neonatal metabolic studies. * It would be noninvasive. screening programs. The US Centers for Disease * It would ensure personal privacy because Control (CDC) now oversee a variety of such studies involving sentinel physicians, women's health cen- individuals could not be linked to HIV antibody test tres, sexually transmitted disease clinics, addiction results. * It would be cost-effective. treatment facilities, prisons and emergency rooms, as Adoption of the anonymous unlinked methodolwell as a national nutrition survey.4 The CDC and the Office for Protection from ogy raises three important issues. First, individual Research Risks, National Institutes of Health, have informed consent would not be obtained. However, determined that anonymous unlinked surveys "that seroprevalence studies on populations of unidenticause no collection of information or specimens that fied people can be distinguished from testing on an would not otherwise be obtained for routine medi- individual basis. The working group agreed that it cal purposes and obtain no data which can be linked would be reasonable not to require individual into identifiable individuals can be considered blind- formed consent when testing leftover, permanently ed, or unlinked surveys, not involving 'human sub- unlinked serum for HIV antibodies. Second, HIV-seropositive individuals would not jects'. Since patient identifying information will not be linked to HIV test results, informed consent will be identified. The objective of the anonymous unlinked research design is to produce accurate seronot be required."5 In Britain the government funded the Medical prevalence estimates, a goal independent of volResearch Council in 1988 to conduct a variety of untary individual testing and subsequent contact tracing. The HIV antibody test is available to Cananonymous unlinked HIV seroprevalence studies.6 adians through the health care system and should be given under conditions of informed consent, pretest Purpose of HIV seroprevalence research and posttest counselling, and confidentiality. Third, there is a potential for indirect harm to Although monitoring the number of identified AIDS cases on a national basis provides one impor- groups or individuals - for example, through stigtant measure of the AIDS epidemic, such surveil- matization. This could be minimized by appropriate lance misses cases of asymptomatic HIV infection. research requirements and would be outweighed by Consequently, this information cannot be used to the benefits to the public of accurate HIV seroprevaassess current seroprevalence rates. Identifying and lence data. Such data would constitute an early monitoring changes in the prevalence of HIV infec- warning system to detect changes in the pattern of tion among Canadians are necessary steps in assess- spread of HIV infection in specific populations. ing the need for prevention programs, designing and Planning preventive or screening measures on the targeting such programs, evaluating their effective- basis of inaccurate, particularly low, estimates would ness, identifying priority groups for screening should bring greater harm to groups and individuals. a vaccine or early treatment be developed, and planning and allocating resources for future health Requirements for anonymous unlinked HIV and social service needs with respect to HIV infec- seroprevalence research tion and AIDS. The working group agreed that the following Consensus of the working group basic requirements must be met. * Universal access to individual voluntary testThe working group agreed that the related ethi- ing under prescribed conditions of informed consent, cal and legal concerns do not constitute an insur- pretest and posttest counselling, and confidentiality mountable barrier to anonymous unlinked HIV sero- would be a prerequisite. 626
CAN MED ASSOC J 1990; 143 (7)
* Only leftover serum routinely collected for other purposes would be used. * Records would be permanently unlinked before testing, so that it would be impossible at any time to identify individual test results. * No sample size small enough to identify individuals would be reported. * No information that might lead to the identification of individuals would be used. * The research would have to meet the approval of the relevant institutional ethics review committees. * The public would be made aware of the research. The working group also agreed on the following requirements related to communication issues. * Communication with the public should be clear and balanced. * Methods of informing the public about plans for anonymous unlinked research will vary from study to study. Researchers should be prepared to determine the most appropriate medium to use. Mass mailings, video recordings, toll-free telephone numbers, special seminars and ethnic language newspapers are all potential tools for informing the public. * Researchers would be responsible for anticipating to a reasonable extent the special communication needs of the population being tested. * Physicians should be informed through their provincial associations and colleges about unlinked HIV antibody testing and its nontherapeutic purpose. Voluntary individual testing remains an option
within the patient-physician relationship and would not be affected by this research. * The researcher's contact number should be readily available so that a physician or a patient, or both, can discuss the research in more detail. After learning more about the research some patients may request that their leftover serum not be included in the random selection of samples. Physicians must be informed of how this issue is addressed in the research protocol. * Researchers would be responsible for anticipating to a reasonable extent the potential for indirect harm to groups or individuals. Special interest groups should be involved in developing the communication plan for potentially sensitive research results.
References 1. Royal Society of Canada: AIDS: A Perspective for Canadians. Summary Report and Recommendations, Royal Society of Canada, Ottawa, 1988: 5 2. National Advisory Committee on AIDS: Minutes of meeting, Oct 19, 1987: 4 3. Medical Research Council of Canada: Guidelines on Research Involving Human Subjects, Medical Research Council of Canada, Ottawa, 1987: 26 4. Dondero TJ, Pappaioanou M, Curran JW: Monitoring the levels and trends of HIV infection: the Public Health Services HIV Surveillance Program. Public Health Rep 1988; 103: 213220 5. Centers for Disease Control: HIV Seroprevalence Survey in Childbearing Women: Testing Neonatal Dried Blood Specimens on Filter Paper for HIVAntibody (draft), 1988 6. British Information Services: News Release: Anonymous Blood Testingfor AIDS, Nov 24, 1988
Completing a medical education To be ill, or to undergo an operation, is to be initiated into the mystery of nursing, and to learn the comforts and discomforts of an invalid's life; the unearthly fragrance of tea at daybreak, the disappointment of rice pudding when you thought it was going to be orange-jelly, and the behaviour of each constituent part of the bedclothes. You know, henceforth, how many hours are in a sleepless night; and what unclean fancies will not let us alone. when we are ill; and how illness may blunt anxiety andfear, so that the patient is dull, but not unhappy or worried; and how we cling to life, not from terror of death, nor with any clear desire for the remainder of life, but by nature, not by logic. In brief, you learn from your own case many facts which are not in text-books and lectures: and your patients, in the years to come, will say that they prefer you to the other doctor, because you seem to understand exactly how they feeL I wish you therefore, young man, early in your career, a serious illness, or an operation, or both. For thus, and thus alone, may you complete your medical education, and crown your learning with the pure gold of experience. -
Stephen Paget (1855-1926)
CAN MED ASSOC J 1990; 143 (7)
627
