The Department of Health and Human Services has released its proposal to update the regulations that govern research involving human subjects (the Common Rule). The long-awaited Notice of Proposed Rulemaking (NPRM) explains the proposed changes and poses a number of questions for which the department is seeking public comment, to be submitted within 90 days of the NPRM’s publication. The Office of Human Research Protections (OHRP) plans to hold several webinars in the coming weeks to explain the changes as well as an in-person town hall meeting in Washington, DC in October.
The Common Rule has not been updated since 1991. The NPRM is the next step in a process that began in 2011 with the issuance of an Advanced Notice of Proposed Rulemaking (ANPRM) that asked for input. In response, COSSA, along with 21 other organizations, submitted a white paper that gave the perspective of the social and behavioral science community. The National Academies also issued a consensus report in 2014 that discussed proposed revisions to the Common Rule in the context of the social and behavioral sciences. A number of the proposed changes attempt to address concerns raised by the social and behavioral science community, particularly those that attempt to make the level of review proportional to the potential level of harm. The NPRM states the drafters’ intention to “more thoroughly addresses behavioral and social science research perspectives and the broader types of research conducted or otherwise supported by the other Common Rule agencies” and cites the consensus report as a source of guidance.
Summarized below are some of the major proposed changes that could affect social and behavioral science research. COSSA will continue to follow the issue and the reactions from throughout the social and behavioral science community.
Changes to the scope and applicability of the Common Rule
The NPRM includes specific examples of activities that are excluded from coverage under the common rule including:
- Non-research activities, which include program improvement activities; oral history, journalism, biography, and historical scholarship; quality assurance and quality improvement activities; and public health surveillance.
- Low-risk activities already subject to independent controls, like educational tests, survey procedures, interview procedures, or observation of public behaviors; research involving the collection or study of information that has already been or will be collected; and research conducted by a government agency using government-generated or -collected data.
The NPRM proposes streamlining the process for determining whether a study should be exempt from undergoing full institutional review board (IRB) review by having federal agencies create a web-based tool that can certify whether a study qualifies as exempt (although use of such a tool would not be mandatory). The NPRM also broadens the categories of research that would qualify as exempt, which would now include:
- Research conducted in established or commonly accepted educational settings involving normal educational practices.
- Federal research designed to study government programs.
- Benign interventions in conjunction with collection of data from adult subjects.
- Taste and food quality evaluation and consumer acceptance studies.
- Research involving educational tests, surveys, interviews, or observation of public behavior if information is identifiable or sensitive (subject to privacy safeguards).
- Secondary use of identifiable private information (subject to privacy safeguards).
- Secondary use/storage of biospecimens or identifiable private information (subject to privacy safeguards and requiring a broad consent for secondary research).
Changes to the informed consent process
To improve the process of obtaining and documenting informed consent, the NPRM would add new language to the regulations intended to “make sure that the most appropriate information is presented to prospective subjects in sufficient detail and in a format that is tied to understandability.” Where appropriate, the new regulations would add three elements of consent to the process: (1) inform subjects their biospecimens may be used for commercial profit and whether subjects will share in that profit; (2) inform subjects whether and how clinically-relevant research results, including individual results, will be disclosed; and (3) provide an option to consent or refuse to consent to potential future contact by investigators seeking additional information or participation.
The proposed regulations would require researchers to gain consent from subjects for storage, maintenance and secondary research use of biospecimens and identifiable private information. The NPRM recommends use of a broad consent form approving of unspecified secondary research use of such information.
Lastly, the updated regulations would require that copies of all consent forms from clinical trials be posted on a publically-available website shortly after the trial is closed for recruitment.
Changes to IRB operations
To facilitate studies conducted across multiple institutions, the NPRM would require that all U.S. institutions engaged in such cooperative research use a single IRB (as opposed to having each institution’s IRB review the study separately).
To assist IRBs in determining whether a study presents “minimal risk” and is eligible for expedited review, the HHS Secretary will publish a list of activities that should be considered minimal risk (to be evaluated and revised every eight years). The NPRM proposes that activities on the Secretary’s list be assumed to be eligible for expedited review unless the IRB determines the risk to be greater than minimal (a change to the default assumption).
The proposal would eliminate continuing review for all studies under expedited review (unless otherwise explicitly justified). Studies undergoing IRB review that have reached the analysis stage or are simply accessing clinical follow-up data would no longer need to be reviewed, so long as the investigators confirm this status annually with the IRB.