The highest ethical standards must be upheld when collecting behavioral or biological data on sexually transmitted infections (STIs), HIV or AIDS. Because of the stigma and human rights issues around HIV/AIDS, study participants may experience psychological, social, physical or economic harm, even when precautions are taken. Data collection protocols or procedures should include an explicit description of the measures that will be taken to protect the participants involved. In recent years, HIV/AIDS research has gotten increased attention, and large research and funding bodies are requiring improved and structured monitoring for all studies, especially those taking place in developing countries. While many of the data collection activities associated with HIV prevention, care and mitigation programming are not research per se, the principles underlying research hold true for all data collection activities involving human subjects.
The Nuremberg Code (1947) was the first widely recognized document to give guidelines for research with human subjects, with a particular emphasis on the importance of informed consent. This Code and a number of subsequent documents (see list of resources) now comprise the guidance for international ethics standards. The World Medical Association's Declaration of Helsinki (last revised in 2000 ) requires all experimental protocols to be reviewed by a specially appointed committee, known as an institutional review board (IRB), independent of the investigator or funding body. The U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, created in 1974, was tasked with identifying the underlying ethical principles for research involving human subjects. These are described in detail in the Belmont Report (1979) as:
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Respect for persons — Researchers must recognize the capacity and rights of all individuals to make their own choices and/or to make their own decisions.
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Beneficence — Requires that vulnerable populations are afforded additional protections because of their diminished autonomy. Respect for human subjects also requires that the risks of the research compare favorably to the benefits.
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Justice — Researchers must ensure that risks and benefits of data collection are distributed equally among the participants, and that recruitment and selection of participants are also distributed equally.
Ethical considerations for HIV/AIDS data collection
Conducting HIV-related studies poses particular ethical challenges given the urgency to find effective ways for preventing and mitigating the epidemic, and the stigma associated with being HIV-positive that can result in discrimination or harm. The need to document effectiveness–that is, to collect data–must be balanced with every effort to ensure the safety and protection of all participants in data collection activities.
Essential considerations include:
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Minimal risk: Health, psychological or social risks to participants should be minimized by using procedures that are consistent with sound research design and do not unnecessarily expose participants to risk. Risk to the study group as a whole should also be considered. For example, documented high rates of HIV or STIs in specific sub-populations may result in social or physical harm to the entire sub-population.
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Reasonable risks given the anticipated benefits: When possible, participants should benefit directly from their participation. For example, participants in an STI prevalence study consent to be tested for STIs with the understanding that they will be treated for any curable infections found. Likewise, participants in an HIV prevalence survey should be given the opportunity to know their HIV test results should they desire. In qualitative data collection, there are more likely to be benefits to communities than to individuals. Participants in focus group discussions, for example, should be advised on how the collected data will be used, and how the information may help to improve or design programs in their community.
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Equitable selection of participants: From the planning stages of data collection the purposes of the data collection and the setting in which the data will be collected must be considered. When some or all of the subjects are likely to be vulnerable to coercion or undue influence–such as children, prisoners, or brothel-based sex workers (SW)–additional safeguards are needed to protect the rights and welfare of these groups.
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Informed consent: Participants must be given information about the data collection using a format and language appropriate to their age group and level of education. Different methods for obtaining informed consent are selected based on the kind of data collection being undertaken, and the potential risks and benefits of that data collection to the participant. Documentation and procedures for obtaining informed consent in the research settings must be monitored. Because the understood or legal age of majority may differ by region, the local definition should be used to determine which participants are adults and which are children. Regardless of the method used, informed consent requires that participants receive:
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Explanation of the purpose for which the data are being collected, the expected duration of the participant's involvement, and a description of the procedures to be followed.
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Description of any reasonably foreseeable risks or discomforts.
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Description of any reasonably foreseeable benefits to the participant or others.
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Description of the measures to be taken to ensure the confidentiality of the participant's records.
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Explanation of compensation (if appropriate) and information about other medical assistance available to treat any injuries resulting from participation.
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Information about who can be contacted for questions about their rights as a participant or in the result of injury to a participant.
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Explanation that participation is entirely voluntary, refusal to participate will not result in a penalty or loss of benefits, participants may refuse to answer any questions, and that it is permissible to withdraw from the study at any time.
- Special provisions for vulnerable populations: HIV/AIDS/STI data collection increasingly involves vulnerable populations such as men who have sex with men (MSM), injection drug users (IDU), children and prisoners. Informing the community and soliciting their input for the proposed data collection presents an opportunity to get the community's support. For instance, orphaned children may be living with a relative or friend who is widely recognized as being responsible for the welfare of that child. For children in school, having the data collection approved in advance by school officials provides an additional assurance that the possibility of harm has been minimized. Care must be taken with the recruitment and participation of SW, MSM and IDU who, depending on the country, may participate in illegal or socially discouraged behaviors. Participants may be harmed if recruitment methods or procedures identify them as members of a particular group.
- Confidentiality: Strict measures must be taken to ensure confidentiality to the greatest extent possible because of the stigma associated with being HIV positive and with people who are HIV positive or identified as a member of a population participating in illegal or socially discouraged behavior that puts them at high risk of being HIV-infected. In qualitative or cross-sectional research it is often possible to record no names or personal information about participants at all. For surveillance or other biomedical research, a participant's identity can be protected by assigning a study number without ever recording names. Consideration must also be given to how the collected data will be stored, who will have access to it, and disposition of the data at the end of the study.
- Local IRB review and community participation: A review of procedures by a local IRB or the community in which the data will be collected provides additional assurance that the proposed methods are also appropriate to the sociocultural, environmental and economic situation of the selected populations.
Resources
- National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Department of Health, Education and Welfare.(1979). Belmont Report: Ethical Principles and Guidelines for Research Involving Human Subjects. Washington, D.C.: U.S. Government Printing Office. (2000 revision)
- World Medical Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects. 1964.
- Council for International Organizations of Medical Sciences (CIOMS). 1993 International Ethical Guidelines for Biomedical Research Involving Human Subjects.
