Ethical dilemmas in retrospective studies on genital surgery in the treatment of intersexual infants.

Intersexual infants and infants with other genital abnormalities often receive genital surgery for sex assignment or for normalizing purposes.1 The wisdom and beneficence of these practices have been questioned by intersexual individuals, support groups, some doctors, and the media.2 Because the practices have been developed without long-term studies to evaluate them, pediatric urologists and parents of such children must face decisions with very little guidance from empirical support. In the face of ignorance about what is really the best medical response to intersexuality or genital abnormalities, some have argued for a moratorium on infant genital surgery until empirical studies are available.3 The urgent need for retrospective studies is now being recognized in medical journals.4 Because genital surgery may be appropriate and beneficent in some of these conditions, or in some degrees of these conditions, but not in others, retrospective studies must be devised to examine the degree of success of surgery for each of these conditions, or levels thereof. However, an ethical requirement of participation in retrospective studies is the informed consent of the research subjects, and procuring informed consent of potential participants seems to be impossible. Motivated by the beneficent concerns to prevent parental rejection, spare the child embarrassment, and ensure the success of sex reassignment, medical textbooks and authors of articles on the treatment of intersexuality have traditionally advocated withholding information from parents and their intersexual children.5–18 From the presence of scar tissue and abnormalities of their external genitalia, intersexuals know they have been operated on, but they do not know why or what exactly was done in the course of the surgery. Because they lack full knowledge and understanding of their medical conditions and histories, they cannot give truly informed consent to participate. Therefore, retrospective studies are both practically and ethically problematic. The dilemma is so onerous as to lead some to claim that these retrospective studies cannot be ethically justified.19 In their 1998 article, Kenneth Kipnis and Milton Diamond acknowledge that escaping the “epistemological ‘black hole’ that entraps parents, patients, and physicians in lies, secrets, and avoidable ignorance” will require integrity and courage on the part of pediatric practitioners, but they fully expect the profession to “rise to the occasion.” 20 The North American Task Force on Intersexuality (NATFI) under the direction of Ian Aaronson, urologist at the Medical University of South Carolina, has attempted to unify researchers at medical centers specializing in infant genital surgery to make meaningful retrospective studies possible. As a result of this cooperation, members have