July 6, 2022

PUBLIC-PRIVATE DEBATE IN ETHICAL REVIEWS

Should research ethics boards be run for profit? Known as institutional review boards in the US, these have traditionally been staffed by volunteer committees of scientists and clinicians who are working in an institution. More and more, however, for-profit IRBs are being hired to conduct efficient, high-quality ethical reviews. The oldest of these, the Western Institutional Review Board, has been in business since 1968. Nonetheless, not everyone is happy with the idea. Critics say that for-profit IRBs have an inherent conflict of interest because they derive their income from clients who have a direct financial stake in obtaining approval.

A debate in the journal Public Library of Science between Ezekiel J. Emanuel, of the National Institutes of Health, and Trudo Lemmens, of the University of Toronto, and Carl Elliot, of the University of Minnesota, suggests that the issue will not be settled soon. Dr Emanuel complains that critics are blindly prejudiced against private enterprise. He says that outcomes — in terms of high quality reviews of protocols and monitoring of the safety of research participants — is what matters. A number of private IRBs have outstanding records while several scandals, including deaths, have occurred under the supervision of academic IRBs.

Trudo and Elliot oppose the trend towards commercialisation of ethics, especially for large pharmaceutical companies: “They are in a client-provider relationship with the commercial entities whose studies they review.” Delays in approvals by IRBs may affect profit margins. Furthermore, companies are free to shop around for an IRB which will give them an easy run. Recently, they point out, several commercial IRBs have been involved in controversial research practices. They agree with Emanuel that academic IRBs are also flawed, but insist that the way to fix the problem is “to clean up the conflicts of interest, not to institute a replacement in which such conflicts are built into the system.”