On behalf of the Consortium of Independent Review Boards, a non-profit US organization for ethical review of clinical research and protection of participants, I object to your suggestion that a US government proposal to overhaul institutional review board (IRB) regulations would increase the use of commercial IRBs that have an “unsettling incentive to approve trials” (Nature 476, 125; 2011).

You imply that independent IRBs put research subjects at risk. However, all review boards are subject to a high level of federal regulation and inspection. Inspections by the US Food and Drug Administration involve thorough site visits and assessment of policies, procedures and records.

Independent IRBs protect research participants by reviewing studies conducted by private clinics and community and academic hospitals. Without such IRBs, patient access to promising experimental treatments would be curtailed and research would be unduly protracted.

Consortium members commit to a code of ethics requiring them to protect the IRB from economic influences when reviewing research, minimize 'IRB shopping' and promote ethical marketing. The consortium also requires members to be accredited by independent bodies such as the Association for the Accreditation of Human Research Protection Programs (see Nature 477, 280; 2011).

The consortium believes that the proposed overhaul of the regulations warrants careful review, and urges the research community to focus on identifying substantive measures that support the highest standards for protecting human subjects in clinical research.

See also: Review boards: all need closer scrutiny