Fetal Research Needs Paternal Consent Unless Maternal Benefit Shown - HHS

Fetal research would be permitted with maternal consent alone if the study would also benefit maternal health, an HHS notice of proposed rulemaking states.

The proposed rule would modify regs issued at the end of the Clinton Administration that would have permitted research conducted on fetuses with only maternal consent.

HHS "proposes to require a father's consent (when the father is readily available) for participating in research that is directed solely at the fetus and that does not affect a mothers health," the notice states. "We believe that this approach is the most respectful of the parents' joint interest in their fetus' health."

"A father's consent would not be needed for a women to participate in a research activity that would benefit her health," HHS states.

HHS noted that the Clinton Administration's rule had indicated that paternal consent had been a barrier to participation in some cases. The January rule said that AIDS advisory panels had urged removal of the paternal consent provision.

The July 6 notice states that the concern can be addressed by the proposed maternal benefit provision. The Bush Administration had postponed the effective date of the rule to consider changes (¹ (Also see "HHS Modified Fetal Research Rule May Require Paternal Consent" - Pink Sheet, 21 May, 2001.)).

HHS proposes to use the term "neonate" to describe "a newborn for which a viability determination has not yet been made." The previous rule had used "fetus" to refer to newborns of uncertain viability. The term "fetus" would be defined as "an infant at the stage prior to delivery."

The notice clarifies that "neonates may be subjected to added risk only if the research is intended to enhance the particular neonate's probability of survival to the point of viability."

HHS will accept comments on the proposed regulation until Sept. 4.