Health Law Update

Home | Health Law Update

<img class="alignright size-medium wp-image-3603" src="https://healthlawupdate.bakerhostetlerblogs.com/wp-content/uploads/sites/19/2016/04/science-iStock_000080822095_Full-198x300.jpg" alt="science iStock_000080822095_Full" width="198" height="300" />The research community has a full plate as it sifts through the final rule on the Common Rule issued last week. Many are now fully appreciating the December gift from the National Institutes of Health that granted an extension for developing policies to streamline multi-site studies under a single Institutional Review Board (IRB).

On December 16, 2016, the NIH officially notified the public that it will delay implementation of its policy to require domestic NIH-funded multi-site studies to use one IRB of record for ethical reviews of all other sites in the study. Originally, the policy was set to apply to all applications submitted on or after May 25, 2017. Based on numerous concerns voiced by the research community, NIH delayed the implementation date four months. The policy is now effective for all applications received on or after September 25, 2017. Ongoing, non-competing awards are not expected to follow the policy until the grantee submits a competing renewal application after the policy is in effect. For contracts, the policy applies to all solicitations issued on or after the effective date.

NIH’s policy is akin to policies issued by the National Cancer Institute and other NIH programs. Citing its effort to streamline administrative processes and create more reporting efficiency, NIH believes that a single IRB will ensure that the same study administered at multiple sites will be conducted in a more uniform manner, including less variation with informed consent and other key IRB documents. Researchers will be required to coordinate and determine the best site to submit to NIH for the record. NIH has issued a robust set of <a class="js-autopdflink" href="http://osp.od.nih.gov/sites/default/files/sIRB_Extramural_FAQs.pdf" target="_blank" rel="noopener">frequently asked questions</a> regarding the policy and its implementation. The changes to the implementation deadline did not result in any changes to the <a class="js-autopdflink" href="http://osp.od.nih.gov/sites/default/files/NIH_sIRB_Policy_Multi_site_Research_UPDATED2016.pdf" target="_blank" rel="noopener">policy</a>.

More Time to Streamline: NIH Extends Deadline for Implementation of Single IRBs for Funded Studies