washington

A Republican senator has introduced in the US Congress a medical privacy bill that essentially preserves existing procedures for researchers seeking access to identifiable patient information. This is in contrast to a draft of the bill that would have imposed heavy restrictions on researchers and industry (see Nature 392, 6; 1998).

The new version of the bill, from Senator James Jeffords, lacks any requirement for increased scrutiny of Institutional Review Board (IRB) waivers of informed consent. Such waivers are currently allowed for researchers seeking access to identifiable records in cases where it would be impractical to carry out the research if informed consent had to be obtained.

Nor does the Health Care Personal Information Nondisclosure Bill eliminate — as the draft did — ‘expedited review’ for such projects, a procedure under which IRBs may designate a member to give prompt approval.

The bill has also dropped an extension, to the private sector, of protection rules for human subjects, including informed consent for use of identifiable records, that now apply only to federally funded scientists. Industry had said the requirement would be crippling.

“We have worked hard with researchers to make sure we have provided them with the tools necessary” to their work, Jeffords said. “I believe that we have accommodated [their earlier] problems.”