Fetal Research Requires Maternal Consent Only, HHS Final Rule Says

HHS-supported research involving pregnant women or fetuses prior to delivery requires only maternal consent under an HHS final rule, published in the Federal Register Jan. 17.

The rule modifies parental consent requirements "by permitting research with pregnant women or fetuses prior to delivery based on the consent of the woman or her legally authorized representative." Prior regulations required that the father's consent be secured.

By removing the requirement of paternal consent to research involving minimal fetal risk, the final rule permits the pregnant woman to be the sole decision-maker with regard to her participation in research, HHS said. The rule will become effective March 19.

"In some cases, the father's consent has been a barrier to participation in research of the woman or fetus prior to delivery," HHS said. The National Task Force on AIDS Drug Development, the Presidential Advisory Council on HIV/AIDS and the Institute of Medicine Committee have recommended that the consent of the father should not be a condition of the participation of a pregnant woman in research, HHS noted.

Although the consent of only one parent is required, if both parents are readily available, reasonable efforts should be made to provide all relevant information to both parents, HHS added.

Research involving fetuses (after delivery) of uncertain viability may proceed with the consent of either parent or, under certain circumstances, the consent of a legally authorized representative. However, "the research must hold the prospect of enhancing the probability of survival of the fetus to the point of viability or pose no risk to the fetus," the rule states.

Research involving a nonviable fetus should only proceed with the consent of both parents (unless one is unavailable, incompetent or temporarily incapacitated), and the consent of a representative is expressly prohibited, the rule states.

The rule requires, as a prerequisite to research on pregnant women or fetuses prior to delivery that, "where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies, including studies on nonpregnant women" be conducted.