10. Gender, Pregnancy and Breast-Feeding

Consensus:

It is ethically required to include both genders in preventive HIV vaccine trials, unless a scientific rationale warrants otherwise. If there is any consideration of enrolling pregnant or breast-feeding women in trials, then there must be adequate methodology to ensure that valuable data may be gained from their inclusion.

Controversy:

There was disagreement on whether women who are pregnant or breast-feeding should be enrolled in HIV vaccine trials. One argument was that including them provides important data on safety and efficacy that will not be gained otherwise. In addition, women are capable of understanding the risks to themselves and their fœtuses and should be able to make the choice of whether or not to participate, through providing informed consent. The opposing view is that the fœtuses and neonates should be protected from any potential harm as a result of participation in the trial, and that investigators have an obligation to exclude these women until adequate safety data is accumulated. Some argued that these data would not be accumulated, or would certainly be delayed, if these women were not included in the initial trials.

The role of the father in determining the involvement of a pregnant woman was identified as important, but not discussed in depth.