January 19, 2017
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.
Just a few of the changes, and the HSO’s potential response, include:
|Change||HSO Response/Action Plan|
|New requirement for consent forms to provide potential research subjects with a better understanding of a project’s scope, including its risks and benefits, so they can make a more fully informed decision about whether to participate. The revised regulations require a concise explanation of the important aspects of the research at the beginning of the consent document, and include requirements for several additional pieces of information to be shared.||The HSO has already convened a working group, beginning this month, to discuss the informed consent and HIPAA authorization documents and process. That group will be tasked with offering a new informed consent template which complies with these requirements and facilitates greater understanding of research.||Requirement, in many cases, to use a single institutional review board (IRB) for multi-site research studies, similar to the NIH single IRB policy.||The HSO is already working hard to draft policies, procedures, and processes for local implementation of single IRB review. For more information on single IRB and the HSO’s efforts to prepare, click here.||Researchers who wish to collect identifiable data and/or identifiable biospecimens for future research will have the option to obtain broad consent, then rely on the broad consent for use of the data or specimens as an alternative to seeking an IRB waiver of the consent requirement.||The HSO working group on consent and authorization will offer a template for broad consent which complies with the revised regulations. Research use of deidentified data or biospecimens will continue to be considered non-human subjects research which does not require IRB approval or consent.||Establishment of new exempt categories of research based on the level of risk they pose to participants. For example, secondary research involving identifiable private information which is already protected by HIPAA (e.g. chart reviews involving recording of identifiable data) will be considered exempt, as will some research involving benign behavioral interventions such as playing games or solving puzzles.||HSO will address these changes in the coming year, with input from an advisory committee which includes members of the research community. See below for more information.||Removal of the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects. For example, research reviewed under an expedited procedure or greater than minimal risk research in data analysis only may no longer require annual or biannual renewal.||HSO will address this changes in the coming year, with input from an advisory committee which includes members of the research community. See below for more information.||Requirement that consent forms for certain federally funded clinical trials be posted on a public website.||HSO will provide guidance and education to the research community regarding this new responsibility in the coming year.|
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 (email@example.com) 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.
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