IRB Manual
      7.6 AIDS Research (includes research which will use HIV status as an inclusion or exclusion criterion)
   
(Note: Much of the material in this section was taken from the N.Y. State Psychiatric Institute IRB Manual and PHS policy documents)

See also: Section 5.4.2 - N.Y. State reporting requirements.


   

OMH, OPWDD and OASAS AIDS policies:

   
When research records involve identifiable HIV test results, great care must be exercised to protect the confidentiality of the data. If an audit is to be conducted on such research records, all identifiers should be stripped. If it is absolutely necessary for auditors to have access to identifiable information, (e.g. if the FDA needs to verify that a subject in a drug trial is not fictitious), the IRB should review the procedures and approve such access on a case by case basis. IRBs should consult with their appropriate counsel's office prior to granting such a request.

Every investigator who seeks to use HIV infection as a research exclusion criterion must address the following issues in their IRB application:

 
(1)    
The scientific rationale for the use of HIV status as an exclusion criterion.

   
This may relate to the scientific integrity of the research (e.g.. seeking to exclude from neuropsychological studies subjects who may have CNS involvement), or protection of participants (e.g.. unknown risks to participants with HIV infection of an investigational drug, which there is reason to believe are greater than the unknown risks to anyone else). The rationale must avoid both the appearance and reality of bias - e.g.. if CNS involvement is likely to confound research results, exclusion criteria would also address seizure disorders, Tourette's, Parkinson's, etc.

 
(2)   
Method proposed for determination of HIV status.

   
If HIV testing is part of the screening process the investigator is required (by State law) to provide pre-test and post-test counseling. Pre-test counseling must be done on a separate day from the proposed testing itself, and must include a detailed review of the risks as well as the benefits of testing and a discussion of how the test results will be handled, to whom they will be divulged, etc. The counselor should be trained in such HIV-test counseling. A consent form, approved by the N.Y. State Department of Health is required.

Alternatively, the investigator can ask the prospective subject whether he/she has been tested, and whether he/she is willing to share the test results with the investigator.

A detailed description of all procedures relating to HIV testing must be included in the protocol.

 
(3)   
Methods for protecting confidentiality.

   
Will HIV status be recorded at all? If so, where will it be recorded? Is it necessary to retain any identifying information about subjects who are excluded for this reason from the proposed research?  If so, why? If the investigator requests permission to record HIV status and to retain identifying information, what rigorous methods will be used to protect these records from subpoena or review by government regulatory agencies? (See section 5.2 confidentiality certificates).

 
(4)   

Clinical management

   
If a person is to be excluded from a study because he/she is seropositive, what will they be told, by whom, and what alternative options will be offered if the protocol involved treatment? This must be explained in detail.


7.6.1

PHS Supported Research Involving HIV Testing

   


"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." (see exceptions below)

Protocols submitted for PHS funding should include the following: "issues of confidentiality; the notification process; access to the information at hand; the specific timing between the initial test result and informing the individual; the structure for counseling of the seropositives; and provisions for transmitting this information to known sexual partners" (and needle sharing partners).

"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 to the requirement for notification of test results are listed below. If an exemption is sought under 2 or 3 below (for research funded or conducted by PHS) it must be specifically approved by the PHS Agency Head (or designee) and OHRP must be notified prior to or simultaneous with the request for Agency Head approval.

 

    Exceptions
     
 
(1)   
Pertaining to an Individual

   
When there are compelling and immediate reasons that justify not informing a particular individual that he or she is seropositive, e.g., indication 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 result notification would significantly impair collection of study information that could not be obtained by other means; and (d) the risk/benefit ratio to individuals, their partners, and society will be periodically reevaluate 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."
     
   


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