A new set of rules aimed at protecting Americans' medical information is unlikely to interfere with legitimate basic and clinical research. "For the average researcher in an academic medical center, this isn't going to change things," says Doug Peddicord, a policy analyst with the Washington DC-based American Federation of Medical Research. The rules were issued four weeks ago by the Clinton

Administration after Congress missed a self-imposed deadline to come up with a law to protect medical records from inappropriate snooping.

The rules take effect in February 2000, after a public comment period, and insurers, hospitals, physicians, and others who handle medical records will have two years to comply. Criminal and financial penalties can be levied on miscreants.

Patients can give consent for use of their information if they so wish, but otherwise, the rules apply to all electronic records. Paper records and non-identifiable information are not covered.

But if research involves a review of medical records, or data within those records that's identifiable, the investigator has to seek approval from an Institutional Review Board (IRB), or an equivalent entity established specifically to review privacy matters, says Peddicord.

To grant a consent waiver, an IRB will determine if the research cannot be done without identifiable information; if the research is of sufficient importance to outweigh the privacy intrusion; and that there are plans to protect identifiable information from improper use or disclosure, and to destroy the identifiers as soon as feasible.

Peddicord views the rules positively, saying they will enhance federal protection over all research, not just that conducted by government-funded scientists. "This actually extends, and in some ways improves the protections of the Common Rule over research that's essentially unregulated now," he says. However, the rules still could be amended by Congress. And state laws that are more stringent on privacy issues will not be superseded by these federal rules.