AEGiS-14IAC: A participants' bill of rights and responsibilities in HIV vaccine trials.

14th International AIDS Conference


Barcelona, Spain - July 7-12, 2002

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A participants' bill of rights and responsibilities in HIV vaccine trials.

Int Conf AIDS 2002 Jul 7-12; 14:(abstract no. G12543)

McCullough RA, Gibson T, Mariner D
HVTN CAB member CAVE, Washington, DC, United States

ISSUES: Development and deployment of an AIDS vaccine, likely still years in the future, will change the course of the AIDS epidemic. Clinical trials of candidate vaccines are an essential element of developing an AIDS vaccine and there are vital community issues to conduct ethical clinical trials. Community members of the HIV Vaccine Trials Network (HVTN) identified and addressed issues related to conducting ethical trials that protect participants' rights and describe their responsibilities, including informed consent, access to care for any research related injury, state of the art counseling, and availability of treatment for those who become infected with HIV during a trial. Descriptions: Community members from HVTN sites worked with investigators, their communities, and each other to develop, debate, and amend a Participants Bill of Rights and Responsibilities for use in all HVTN sponsored trials and worked successfully to adoption by the HVTN.

ISSUES: Participants in HIV/AIDS vaccine trials provide a valuable service to the effort to develop a safe effective AIDS vaccine. Those considering participation in a trial have the right to understand the risks and benefits of participation and to choose to participate or not in the trial and must receive risk-reduction counseling. Participants deserve and trial sponsors have an interest in providing care for any research-related injury. Community members developed and helped the HVTN adopt standards and the process may help address other vaccine trial issues in other settings and learned that a set of clear standards to protect participants in trials is necessary.

RECOMMENDATIONS: The participants' rights and responsibilities, outlined by community members of the HVTN and adopted by the HVTN, must become the minimum standard for all trial sponsors. These guidelines provide protection for and information to potential trial participants and provide some protection for sponsors, as well.

Keywords: AEGIS, AIDS Vaccines, Human Rights, Clinical Trials, HIV Infections, Informed Consent, Research Subjects, Acquired Immunodeficiency Syndrome, Research, HIV Seropositivity, GuidelinesKWDaegis,aidsvaccines,humanrights,clinicaltrials,hivinfections,informedconsent,researchsubjects,acquiredimmunodeficiencysyndrome,research,hivseropositivity,guidelines

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G12543

Copyright © 2002 - International AIDS Society (IAS). Reproduction of this abstract (other than one copy for personal reference) must be cleared through the IAS.