June 10, 1988 Dear Colleague: The attached U.S. Public Health Service (PHS) Policy on Informing Those Tested About HIV Serostatus was signed by the Assistant Secretary for Health, Dr. Robert E. Windom, on May 9. The attached Policy refines and reiterates that which was set forth in the document "Guidelines for Institutional Review Boards for AIDS Studies," in OPRR Reports of December 26, 1984, (page 3). The 1984 Guidance remains policy, but the discussion concerning notification of seropositives (page 3, Procedures and Documentation of Informed Consent) is made more explicit by the May 9 policy attached here. OPRR has had numerous discussions about HIV-related protocols since 1984 which contributed to the development of this document which was prepared by a Working Group of representatives of all the PHS Agencies. This Policy applies to all intramural and extramural PHS activities, including both research and health services activities, domestic and foreign. It requires that where HIV testing is conducted or supported by PHS, individuals whose test results are associated with personal identifiers must be informed or their own test results and provided the opportunity to receive appropriate counseling unless the situation calls for an exception under the special circumstances set forth in the Policy. It will be important for Institutional Review Boards (IRBs) to adopt these provisions in their consideration of HIV-related protocols research. IRBs should address issues of obtaining informed consent, confidentiality, the notification process, the timeliness of informing individuals, and counseling of the individuals and others designated by the individual (e.g., sexual partners). We hope this information will be helpful. Any comments you have are appreciated. Yours sincerely, /S/ Charles R. McCarthy, Ph.D. Director, Office for Protection from Research Risks Office of the Director DATE:May 9, 1988 FROM:Assistant Secretary for Health SUBJECT:Policy on Informing Those Tested About HIV Serostatus TO: PHS Agency Heads I am transmitting to you the attached "Policy on Informing Those Tested About HIV Serostatus," developed by the Working Group on Ethical and Legal Issues Related to AIDS, PHS Executive Task Force on AIDS. I fully concur with this policy and ask that you disseminate it to appropriate staff in your Agency. The policy mandates that when HIV testing is conducted or supported by PHS, individuals whose test results are associated with personal identifiers must be informed of their own test results and provided with the opportunity to receive appropriate counseling. This policy applies to all intramural and all extramural PHS activities, including both research and service activities, domestic and foreign. In order to implement mandatory notification as defined in this policy, I ask that each Agency Head insure that both intramural and extramural Institutional Review Boards, adjudicating on HIV human subjects studies, design protocols for informing participants in studies involving HIV testing of their positive antibody status. The protocols should address: issues of confidentiality; the notification process; access to the information at hand; the specific timing between the initial positive test result and its confirmation; the timing between the test result and informing the individual; the structure for counseling of the seropositives; and provisions for transmitting this information to known sexual partners. I recognize that in some instances, specific agency needs should be addressed in developing the protocols. I appreciate your cooperation as we move to include this policy in PHS AIDS activities. /S/ Robert E. Windom, M.D. Attachment POLICY ON INFORMING THOSE TESTED ABOUT HIV SEROSTATUS Policy and Applicability It is the policy of the Public Health Service (PHS) that when HIV testing is conducted or supported by PHS, individuals whose test results are associated with personal identifiers must be informed of their own test results and provided with the opportunity to receive appropriate counseling. This policy applies to all intramural and to all extramural PHS activities, including both research and service activities, domestic and foreign. Individuals may not be given the option "not to know" the result, either at the time of consenting to be tested or thereafter. This policy does not apply to testing situations in which subjects consent to be tested but specimen results cannot be linked to individual subjects by anyone other than the subjects themselves. The PHS encourages testing facilities to advise test subjects to obtain test results and to abstain from risk behaviors. Exceptions 1. Pertaining to an Individual Where there are compelling and immediate reasons that justify not informing a particular individual that he or she is seropositive, e.g., indicating that an individual would attempt suicide, the particular individual need not be informed of HIV test results. When this exception is made to the policy of informing individuals, the details of the exception shall be documented by the responsible individuals at the testing facility. If this exception is involved in the context of a research study, the principal investigator shall promptly report the exception to the local Institutional Review Board (IRB) without identifying the individual. 2. Pertaining to Protocol Design Because circumstances may exist in which extremely valuable knowledge might be gained from research involving subjects who would be expected to refuse to learn their HIV antibody results, an exception included in the protocol design may be proposed to the IRB reviewing the research proposal. The IRB shall consider the particular circumstances of the research study, the characteristics of the target research subjects, and other factors, and may approve a testing procedure that would allow research subjects to participate without being informed of their individual results. In proposing such an exception, the investigator must demonstrate to the satisfaction of the IRB that (a) research subjects will be informed of their risk of infection; (b) research subjects will receive risk reduction counseling whether or not they receive their test results; (c) there is good reason to believe that a requirement for test notification counseling whether or not they receive their test results; (c) there is good reason to believe that a requirement for test result notification would significantly impair collection of study information that could not be obtained by other means; an (d) the risk/benefit ratio to individuals, their partners, and society will be periodically reevaluated by the IRB so that the study might be revised or terminated if it is determined that it is no longer justifiable to allow subjects to continue to participate without receiving their HIV test results. 3. Pertaining to Foreign Sites Activities conducted at foreign sites should be carefully evaluated to account for cultural norms, the health resource capabilities and official health policies of the host country. If a research protocol review is involved, the reviewing IRB must consider if any modification to the policy is significantly justified by the risk/benefit evaluation of the research. The IRB might wish to seek expert advice, e.g., local public health experts, in evaluation of these projects. Review of Exceptions The Agency Head (or designee) must specifically approve any proposed exception described under 2 or 3 above that is to be funded or conducted by the PHS agency whether a research activity or a service activity and whether domestic or foreign. For research activities under 2 or 3, IRB approval must be obtained before the approval of the Agency Head is sought. In addition, the Office for protection from Research Risks (OPRR), NIH, is to be notified of the requested exception prior to or simultaneous with request for approval for an exception from the Agency Head. Assessment of Current Activities Any ongoing PHS activity that currently provides for an option "not to know" shall implement this policy for all persons tested hereafter. Individuals tested prior to the issuance of this policy, whose inform consent was given under the condition that they may choose not to learn their test results, may continue to decline to be informed. Every reasonable effort should be made to encourage such individuals to learn their results, however, and the individuals should be counseled about risk behaviors. The appropriate Agency Head, and OPRR if a research activity is involved, shall be informed of such ongoing activities. In ongoing HIV-related research studies, no additional research subjects may be entered as participants without being required to be informed of their results unless exceptions are approved by the IRB and Agency Head, as described above. Counseling Any person tested for HIV infection should receive the results of his or her tests and counseling in a timely fashion from an individual qualified to provide test counseling and partner notification services.