U.S. Department of Health and Human Services Issues New Regulations for Human Subjects Research

For the first time in over forty years, the U.S. Government has issued new regulations governing the use of human subjects in federally-funded research projects.

Generally referred to as “the Common Rule,”[1] these federal regulations were originally intended to enhance privacy protections for research participants and to establish ethical principles and guidelines for the use of human subjects in research. 

The new 543-page revised set of regulations represents years of debate over the appropriate ethical standards for human subjects research and includes many attempts to modernize and streamline the oversight process.  The regulations will go into effect on January 19, 2018 and include the following key revisions:

• Consent Forms – The revised regulations provide that prospective participants must be given all information that a “reasonable person” would want to have in order to make an informed decision about participation in the research. Additionally, the information must provide sufficient detail regarding the proposed research and must be organized in a way to facilitate a participant’s understanding of the research’s goals and objectives.  For clinical trials, researchers must also post online one version of the consent form used to enroll participants in all federally-funded clinical trials.
   
• Institutional Review Board (IRB) Oversight – The new regulations significantly ease administrative burdens for both researchers and IRBs.  Under the new regulations, new categories of research (e.g., social science interviews) will be exempt from IRB review based upon their risk profile.  Additionally, research involving only data analysis will no longer be subject to a continuing review protocol by an IRB.  Finally, the new regulations adopt a single IRB requirement for U.S.-based institutions engaged in multi-site research. 
   
• Secondary Research Purposes – While the new regulations do not dispense with the requirement of informed consent for the use of any identifiable data, the new regulations now permit researchers to seek a “blanket consent” from participants to cover the use of remaining or stored identifiable biospecimens (e.g., blood, saliva, tissues) for additional research, even if such future research projects are unknown at the time the consent is obtained.  This broad consent will replace the requirement that researchers must seek IRB approval to waive the consent requirement in order to use these biospecimens in future research.
   
• IRB Administration – The new regulations also dispense with the “check the box” option on the Federalwide Assurance (FWA) to voluntarily extend the Common Rule to all research conducted by an institution.  Similarly, institutions will no longer be required to designate one or more IRBs on the FWA and changes to the IRB roster will no longer need to be submitted to the funding agency.

While the majority of the research community has lauded the revisions as a boon for science and research, the proposed revisions were not without controversy.  One particularly controversial aspect was the proposal to apply the requirements of informed consent to non-identifiable biospecimens.  Current regulations permit researchers to use such biospecimens in research without informed consent, provided that such samples are not linked to specific individuals.  While the U.S Department of Health and Human Services expressed concern for individual autonomy over the use of such biospecimens, it reasoned that the current regulatory scheme adequately protects against the unauthorized use of such biospecimens and did not adopt the proposed regulation. 

MIT’s Committee on the Use of Human As Experimental Subjects (COUHES) serves as MIT’s IRB and reviews all research protocols involving the use of human subjects.  The new regulations will provide MIT’s IRB with the ability to streamline and enhance its oversight and review process, including its ability to collaborate with other institutions’ IRBs.  In response to the new regulations, COUHES will be revising its policies and procedures and expects to release updated guidance to the MIT community shortly.

[1] The regulations are colloquially referred to as the “Common Rule” as they were jointly adopted by fifteen different Federal departments and agencies to standardize the research protocols for human subjects research funded by those governmental entities.