Today, the Department of Health and Human Services published revised regulations on the protection of human subjects in research (Final Rule). The regulations governing research with human subjects, which mandate IRB review, were originally published by HHS and FDA in 1981, and adopted by 15 federal agencies in 1991. Now known as the Common Rule, they have remained largely unchanged since that time, despite a myriad of changes to the conduct of research since their initial publication. The publication of the revised Common Rule has been highly anticipated for several years and marks an ongoing effort to balance protection of human subjects with the changing demands of research.
Human research protection program (HRPP) administrators around the country, including those at the IU Human Subjects Office (HSO) have been anticipating and preparing for new regulations since a Notice of Proposed Rulemaking was published in September, 2015. IU offered feedback on the proposed rule at that time via the request for public comment. The final rule published today offers significant changes from the current regulations while still upholding the tenets of the Belmont Report.
Changes are significant but valuable
The revised regulations seek to strengthen protection of human subjects while decreasing administrative burden. Several of the changes reduce or remove requirements for low-risk research, while others offer additional flexibility within the current framework.
Click to read the HHS.gov Press Release and Final Rule full content
Most changes are required to take effect by January 20, 2018
With the exception of the single IRB requirement, which has a three-year implementation timeline, the revised regulations will be effective January 20, 2018. Between now and then, while there is the potential for incremental changes, the HSO and the IU IRBs will continue to operate largely under the pre-2017 regulation, in accordance with existing IU SOPs and Guidance, as should you.
As noted above, HSO will be working closely with institutional leadership and members of the research community over the next year to redefine the IRB process and draft revised policies and procedures. We will provide regular communication about our progress, as well as education and training, throughout 2017 until the effective date in January, 2018.
The future is still uncertain
While the revised Common Rule has been published, its long-term fate is still uncertain. The new presidential administration could take action to overturn the revised regulations and there is no way to predict whether this will happen. Regardless of the eventual standing of the regulations, HSO is committed to implementing improvements to the local IRB process and will continue our efforts to utilize regulatory flexibility and implement changes, as allowable, even if the revised regulations never take effect.
Further, there are a number of contingencies to consider in regards to planning for the implementation. In particular, the IU HRPP is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), and is consequently obligated to adhere to specific AAHRPP standards, which have not yet been adjusted in response to the Final Rule. Additionally, the FDA regulations have not yet been revised to allow for alignment with some of the provisions of the Final Rule.
We want YOU!
The new regulations mark a new era in human subjects research and we want the IU and affiliate research community to be engaged in the implementation process. The HSO is looking for volunteers from all areas and aspects of research to serve on an advisory committee which will provide input on IRB initiatives, including implementation of the revised Common Rule. The committee will serve as a sounding board for HSO and provide a standing opportunity for HSO to solicit feedback and input from the research community.
If you’d like more information or are interested in serving, please contact Leslie Albers (lealbers@iu.edu) with your contact information, role in the research community, and information about any unique perspective you can provide to the group, by March 1, 2017. We will select an appropriate number of individuals such that the majority of research interests are represented.
