The National Institutes of Health (NIH) just issued a policy statement to the effect that it expects all sites participating in multisite studies funded by NIH and involving non-exempt human subjects research to use a single institutional review board (IRB) to conduct the ethics review to ensure the protection of participants.
The stated policy, years in the making and consistent with long-time NIH thinking, is designed to enhance and streamline the process of IRB review and reduce inefficiencies, the agency says. “We’ve been hearing for years, and the scientific evidence bears this out, that the use of [multiple] IRBs can slow research without a consummate increase in protection,” says Carrie Wolinetz, PhD, NIH’s associate director for science policy.
If anything, there are sometimes so many chefs in the kitchen that no one notices when the pan’s on fire.
While patient groups have broadly cheered the measure, others, including some research institutions, have expressed wariness, Wolinetz admits. “They know they have a lot of work to do to get their [information technology] systems in order,” she notes. NIH will offer ideas, FAQs, and other tools to help research institutions meet these and other new challenges associated with the new policy edict, she adds.
The new policy applies to the domestic sites of NIH-funded multisite studies where each site will conduct the same protocol involving non-emempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program. However, it does not apply to career development, research training, or fellowship awards.
Check out our White Paper, Considerations for AMCs When Debating the Use of a Central IRB, to learn more about the main points of maintaining local IRB review and oversight of multisite trials versus outsourcing to a commercial IRB as the IRB of record.
It may be of interest to take a look at the experience gathered in Brazil with the use of a central IRB. Although not completely applicable to NIH rules, CONEP (the acronym in Portuguese for National Committee of Ethics in Research) is a single, central IRB operating within the Ministry of Health and responsible for reviewing all multicentric international studies run in the country. From 1996 until 2008 every site had to review and approve the protocols and then submit their approval to CONEP. In the last years, one coordinating site submits the study to CONEP after a local review process. If approved, other participating sites are informed and endorse central approval. Those who have some experience with CONEP know about the political and ideologic biases of their members but, even disconsidering these aspects that have hindered the process in Brazil, the experience with a central IRB is highly positive, if one considers that:
1. The total review turnaround time is decreased,
2. Only one set of questions is issued for each protocol (although a central IRB may be more conservative and inquiring than one would wish),
3. The learning curve of reviewers is more consistent (although “new reviewers” may be painful to deal with).
4. Once one knows what the committee wants to see in the informed consent, questions are minimized.
5. Protocol amendments may be implemented for all sites at once.
There are, however, some setbacks:
1. What if a study is not approved by the central IRB, what can be done? Go look for another committee?
2. What if a central committee has operational issues and delays approval?
3. No IRB is free from the political and ideologic biases. In Brazil, CONEP has not approved a significant number of protocols, leading to the exclusion of the country from the projects.