PUBLIC HEALTH PRACTICE VS PUBLIC HEALTH RESEARCH: THE ROLE OF THE INSTITUTIONAL REVIEW BOARD

The Journal is to be commended for presenting another Health Policy and Ethics Forum (June 2004) just 2 years after grappling with similar controversies in July 2002. It is, however, disappointing to see that the public health community continues its special pleading to circumvent the protection of human research subjects required by federal regulation.1 The assertion that “primary intent” exempts public health research from institutional review board (IRB) oversight is arbitrary and unjustified.2 Intent to publish the results of innovative public health efforts is sufficient (if not necessary) to meet the regulatory definition of human subjects research. Attempts to evade the protection of federal regulations in the belief that the ends justify the means are worrisome indeed. While the loss of publishable data because of delays in the review process is unfortunate, it is not too high a price to pay for meaningful oversight and consistency.

The increased scrutiny given to therapeutic maneuvers in the research context is not yet applied to therapeutic innovation not destined to be used for generalizable knowledge. IRB oversight might, in fact, provide needed protection in some instances of creative but risky unpublished clinical innovation. In any case, the dilemma of distinguishing public health practice from public health research would be eliminated if all such undertakings were reviewed by an IRB to determine whether IRB jurisdiction is appropriate. Any policies promulgated to simplify the review process, particularly for minimally risky research, would be equally welcome for clinical investigations not performed as public health endeavors.

The Nazi doctors, too, were motivated by public health concerns when they exposed unconsenting prisoners to trauma, infections, fatal low air pressure, and freezing temperatures, simulating disasters in war. If we reject the “end justifies the means” rationale for medical research, it is to be hoped that the slippery slope will be left to history.