U.S. federal regulations governing the protection of human subjects in research have been in existence for more than 30 years. The Department of Health, Education, and Welfare first published regulations for the protection of human subjects in 1974, and the Department of Health and Human Services (HHS) revised them in the early 1980s. To promote uniformity, understanding, and compliance with human subject protections, U.S. federal departments and agencies adopted the revised version of the regulations in 1991; subpart A of 45 Code of Federal Regulations (CFR) part 46 was created. This is often referred to as the “Common Rule” or “Protection of Human Subjects Regulations”.
The HHS regulations, 45 CFR 46, include 4 subparts:
- Subpart A, also known as the Federal Policy or the “Common Rule”
- Subpart B, additional protections for pregnant women, human fetuses, and neonates
- Subpart C, additional protections for prisoners
- Subpart D, additional protections for children
You can read about this “Common Rule” and the goal to “modernize, strengthen, and make more effective” in a previous blog.
Recently, the Office of the Federal Register pre-published the long-anticipated revisions to the Common Rule.
These revisions are intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. These revisions are also an effort to modernize, simplify, and enhance the current system of oversight.
This revised -rule will be effective on January 19, 2018; this is also the compliance date for this rule, except for cooperative research. The compliance date for cooperative research will be January 20, 2020.
Significant changes to the rule include:
- The 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.
- Requirements, in many cases, to use a single IRB for multi-institutional research studies. The proposal from the NPRM has been modified, however, to add substantial increased flexibility in now allowing broad groups of studies (instead of just specific studies) to be removed from this requirement.
- For studies on stored identifiable data or identifiable biospecimens, researchers will have the option of relying on broad consent obtained for future research as an alternative to seeking IRB approval to waive the consent requirement. As under the current rule, researchers will still not have to obtain consent for studies on non-identified stored data or biospecimens.
- The establishment of new exempt categories of research based on the level of risk they pose to participants. For example, to reduce unnecessary regulatory burden and allow IRBs to focus their attention on higher risk studies, there is a new exemption for secondary research involving identifiable private information if the research is regulated by and participants are protected under the HIPAA rules.
- Removal of the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects.
- The requirement that consent forms for certain federally funded clinical trials be posted on a public website.
The newly revised- rule does not include several of the proposed changes from the Notice of Proposed Rulemaking (NPRM), including the requirement that research with non-identified biospecimens be subject to the Common Rule, the category of "excluded" activities, and the expansion of the policy to cover clinical trials that are not federally funded.
Please share your thoughts with us on the new revisions to the Common Rule.