As director of a consulting group that works with institutional review boards (IRBs) at universities, hospitals and commercial organizations in the United States, I disagree that commercial IRBs are unduly influenced by profits and are less thorough than their academic counterparts (Nature 476, 125; 2011).

Many of the IRBs enveloped in your critique are accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). The two IRBs censured by the US Food and Drug Administration, Essex and Coast, were not. AAHRPP accreditation is voluntary; organizations undergo a rigorous assessment of their policies and records, including on-site interviews to ensure compliance with federal regulations and AAHRPP standards.

For accreditation, IRBs must separate business decisions from ethical review, even though this is not federally mandated. For instance, independent IRBs accredited by the AAHRPP prohibit equity holders from serving as IRB members or participating in research review. Independent IRBs are constantly evaluated by sponsors, clinical research organizations, regulators and the AAHRPP. Profit is often reinvested in training in ethics and regulatory processes for IRB members and staff.

Absent from your Editorial was an acknowledgement that universities and hospitals can have a proprietary interest in their research; independent IRBs do not. I believe that additional scrutiny of all IRBs is needed: protecting human subjects in research overseen by a hospital or university IRB is just as important as protecting those in research reviewed by independent IRBs.