Correspondence

Paternal Consent for Fetal Research

N Engl J Med 1993; 329:278July 22, 1993

Article

To the Editor:

Regulation 46.208 of the National Institutes of Health's Office for Protection from Research Risks states that fetal research is permitted only if both the father and the mother have consented to it. Aside from cases of rape, exceptions to this regulation are similar to those regarding research on children: paternal consent is not required if the father's identity cannot reasonably be ascertained or if he is not reasonably available.

This rule, although it seems to adhere to the principle of fetal beneficence, restricts women's participation in medical research. It begs the question of the status of the fetus by treating the fetus as a child. It is also inconsistent with abortion regulations, which do not require paternal consent. Imposing such a standard in the context of potentially beneficial research is dubious, at best.

One example of the impact of this rule involves trials of passive immunization of human immunodeficiency virus (HIV)-infected pregnant women with HIV antibodies to determine whether this technique reduces perinatal transmission of HIV. Although the method's efficacy remains to be determined, there is also evidence that the mother's immune status could be stabilized and the progression of her disease slowed.1 There could be risks, which have to be balanced against such potential benefits. It would be reasonable for a woman to decide whether or not to enter the study.

It appears unreasonable, however, to require a woman who has chosen to participate to discontinue participation if the father does not consent. Of course, the father's participation in the decision would be welcome, since paternal support and collaboration should be nurtured. Finally, however, a woman must be permitted to follow his advice as she sees fit when choosing for herself and her fetus.

To minimize the effects of this rule, some researchers make the mother responsible for determining the availability of the father. Although honorable, this approach bends the law and reflects a decision to sidestep an onerous federal regulation lest the study as a whole be threatened by regulatory agencies. It is time to reconsider and rescind these policies. Paternalism is no longer an acceptable attitude toward women who are asserting their reproductive freedom.

Howard L. Minkoff, M.D.
Jonathan D. Moreno, Ph.D.
State University of New York Health Science Center, Brooklyn, NY 11203

1 References

1. 1

   Vittecoq D, Mattlinger B, Barre-Sinoussi F, et al. Passive immunotherapy in AIDS: a randomized trial of serial human immunodeficiency virus-positive transfusions of plasma rich in p24 antibodies versus transfusions of seronegative plasma. J Infect Dis 1992;165:364-368
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Citing Articles (1)

Citing Articles

1. 1

   Steven R. Lindheim, Mark V. Sauer. (1998) Expectations of recipient couples awaiting an anonymous oocyte donor match. Journal of Assisted Reproduction and Genetics 15:7, 444-446
   CrossRef