|UNAIDS-Sponsored Regional Workshops to Discuss Ethical Issues in Preventive HIV Vaccine Trials (UNAIDS, 2000, 52 p.)|
|ENTEBBE, UGANDA, 27-29 APRIL, 1998|
Individual informed consent is necessary for those participating in preventive HIV vaccine trials. There are situations that make this difficult, and these require that special efforts be made, but in no case should anything be substituted for consent of the individual.
Situations that may make individual informed consent difficult include those in which an individual requires the approval of another person or group in order to make decisions, where there is coercion, and where there is a cultural tradition of sharing of risks and responsibilities. (Examples raised were marital relationships, parental control of women, and community, religious, and political influences.) Where these situations arise, effort may be required to educate a community and develop understanding prior to requesting informed consent of individuals. Where women are not permitted to act independently, they are still capable of providing valid informed consent.
In cases where it remains unlikely that adequate individual informed consent will be achieved (such as in the situations listed above, or in cases involving mental disability), exclusion from participating in HIV vaccine trials should result.
There was extensive discussion of the specific situation of discordant couples, as outlined in the case scenario. Should the HIV positive partner also be enrolled in the trial? The group generally felt that the partner should at least be included in the counselling, and that it may be preferable that the partner also provides informed consent. The potential for the HIV-positive partner to either coerce or discourage the HIV-negative partner to participate was raised. There may even be risk of harm to the volunteer incurred by the partner if the participant does not follow the wishes of the partner. The group agreed that in no case should unwilling individuals be enrolled in a trial in which they do not wish to participate. In addition, if they do wish to participate, but risk disapproval of the partner (and have accepted this risk in providing informed consent), then there is no ethical imperative to protect them from this disapproval in any way other than by providing adequate counselling and support.