By Megan Anderson Brooks, Senior Policy Associate
The time to comment on an important proposed regulatory change that affects many NIH-funded researchers is fast approaching!
Streamlining scientific investigations is a goal on just about everyone’s mind including Chairman Fred Upton (R-MI) and Ranking Member Diana DeGette (D-CO) on the House Energy and Commerce Committee who outlined their plans for the greatly anticipated 21st Century Cures bill earlier this month. But now, the National Institutes of Health (NIH) is taking a major step toward reducing the administrative burden of clinical trials by incentivizing the use of a single Institutional Review Board (IRB) for domestic multi-site research.
On December 3, 2014, the NIH proposed a policy that will require, in most cases, that NIH-funded studies using multiple sites in the United States use a single IRB of record. Following the finalization of the policy change, it is expected that all participating sites in both pre-clinical and clinical research rely on a single IRB review at a designated lead site instead of conducting individual IRB reviews in each location. The goal of the policy change is to enhance efficiency and reduce the overall burden of IRB review in exchange for shifting a great deal of the responsibilities to a lead site. Investigators (the extramural applicant or the intramural principle investigator) will have the responsibility for identifying the lead IRB site which will be accountable for regulatory compliance at all participating sites.
Both the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) have issued guidances that encourage the use of single IRBs, however, NIH believes that too few institutions are adopting this approach, and thus, felt the need to propose new policies that appear to compliment the expectations of FDA and OHRP.[i] There are some documented benefits to using single IRBs. Single IRB has been shown to decrease approval times for clinical protocols and may be more cost-effective than multiple local IRB reviews.[ii] In addition, single IRBs may lead to enhanced protections for human subjects by reducing intra-institutional conflicts of interest.[iii] A great deal more research is required on the topic and there has been public concern about the feasibility of a single IRB overseeing site-specific tasks.[iv]
NIH’s proposed policy specifies that participating sites will still be responsible for meeting other regulatory obligations such as obtaining informed consent and the single IRB of record will be required to have mechanisms in place to address context-specific issues at each site during its deliberations. Further, NIH encourages the uses of mechanisms other than local IRB review to address site-specific issues, such as the involvement of ad hoc members or consultants with the necessary specialized knowledge, or allowing local sites to submit relevant information to the single IRB review. Understanding that many researchers will be unfamiliar with how to adopt a central IRB, the Clinical Trials Transformation Initiative has produced a “considerations document” that outlines how site-specific IRBs and a central IRB might interact in a multi-site clinical trial using a single IRB.
Importantly, the policy does not prohibit a local IRB from carrying out its own review, although, the participating site is expected to cover the cost. Additionally, exceptions will be made when appropriate. If a single IRB is unable to meet the needs of a specific population or where local IRB review is required by law, then the study will be exempt from this requirement. As an example, FDA-regulated research using a medical device is required to use local IRB review.
Comments on this policy change are due January 29, 2015 to the Office of Clinical Research and Bioethics Policy, Office of Science Policy at NIH.
[i] The Secretary's Advisory Committee on Human Research Protections (SACHRP) has previously made recommendations to harmonize FDA’s and OHRP’s views on single IRBs. http://osp.od.nih.gov/sites/default/files/resources/revisedlocalconstext.pdf
[ii] Wagner TH, et al. Costs and benefits of the National Cancer Institute Central Institutional Review Board . J Clin Oncol. 2010; 28:662-666. - See more at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-026.html#sthash.8z3JQ6D4.dpuf
[iii] Emanuel EJ, et al. Oversight of human participants research: identifying problems to evaluate reform proposals. Ann Intern Med. 2004; 141(4):282-291. - See more at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-026.html#sthash.8z3JQ6D4.dpuf
[iv] Use of Central IRBs for Multicenter Clinical Trials. Clinical Trials Transformation Initiative. Accessed December 19, 2014. http://www.ctti-clinicaltrials.org/what-we-do/study-start/central-irb