Washington

US geneticists were warned last week by their professional body that they could be endangering their research if they ignore government regulations protecting the families of subjects involved in human genetics studies.

But the American Society of Human Genetics (ASHG) also suggested that researchers should learn to make use of waivers, or face the “enormously cumbersome and prohibitive” task of enrolling family members as human subjects, a burden that would “seriously impede medical research”.

In an alert sent out to its 6,700 members, the society drew attention to a recent case that led to the closure of federally funded research at Virginia Commonwealth University (VCU) in Richmond. The father of college-age twins had complained that a questionnaire sent to his daughter by a university geneticist invaded his privacy by asking hundreds of questions about his own physical and emotional health (see Nature 404, 114–115; 2000).

The Office for Protection from Research Risks (OPRR) of the National Institutes of Health ruled that the university's ethics board should have required the researcher to obtain informed consent not only from recipients of the questionnaire, but also from members of their families.

The alternative, said the OPRR, was that the ethics board should have formally waived this requirement by agreeing that the research posed minimal risk to the rights of other family members and could not be practicably carried out without the waiver.

The ASHG alert was posted by the society's immediate past president, Uta Francke, a professor of genetics at Stanford University. She says that before the VCU case she “didn't know a thing” about the federal regulations covering the collection of information about family members of human subjects, and assumed that many geneticists were equally ignorant. “To prevent any [incidents similar to the VCU case] in the future, our members need to be aware that these regulations exist,” she says.

The society's approach contrasts with the more critical stance of Francis Collins, the director of the National Human Genome Research Institute, who challenged the OPRR's application of federal rules at VCU, declaring his “deep concern” about its possible implications for genetics research.

The ASHG alert, in contrast, appears to embrace the ruling, declaring that “there are clear lessons to be learned” from it. In particular, it stresses that geneticists should know the conditions required for ethics boards to grant waivers of informed consent from family members.