National Research Act at 50: An Ethics Landmark in Need of an Update; The Hastings Center, July 12, 2024

Mark A. Rothstein and Leslie E. Wolf, The Hastings Center; National Research Act at 50: An Ethics Landmark in Need of an Update

"On July 12, 1974, President Richard M. Nixon signed into law the National Research Act, one of his last major official actions before resigning on August 8. He was preoccupied by Watergate at the time, and there has been speculation about whether he would have done this under less stressful circumstances. But enactment of the NRA was a foregone conclusion. After a series of legislative compromises, the Joint Senate-House Conference Report was approved by bipartisan, veto-proof margins in the Senate (72-14) and House (311-10).

The NRA was a direct response to the infamous Untreated Syphilis Study at Tuskegee whose existence and egregious practices disclosed by whistleblower Peter Buxtun were originally reported by Associated Press journalist Jean Heller in the Washington Star on July 25, 1972.  After congressional hearings exposing multiple research abuses, including the Tuskegee syphilis study, and legislative proposals in 1973, support coalesced around legislation with three main elements: (1) directing preparation of guidance documents on broad research ethics principles and various controversial issues by multidisciplinary experts appointed to a new federal commission, (2) adopting a model of institutional review boards, and (3) establishing federal research regulations applicable to researchers receiving federal funding.

This essay reflects on the NRA at 50. It traces the system of research ethics guidance, review, and regulation the NRA established; assesses how well that model has functioned; and describes some key challenges for the present and future. We discuss some important substantive and procedural gaps in the NRA regulatory structure that must be addressed to respond to the ethical issues raised by modern research."