HHS Delays Effective Date for Common Rule Requirements
The U.S. Department of Health and Human Services (HHS) has extended the deadline for compliance with the requirements under the Federal Policy for the Protection of Human Subjects (Common Rule) to January 21, 2019 in order to give covered entities additional time to comply with the requirements.
In a final rule published on January 2017, HHS outlined revised requirements of the Common Rule. Important elements in the final rule included the following:
- 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 institutional review board (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 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.
- Requirement that consent forms for certain federally funded clinical trials be posted on a public website.
The revised Common Rule was originally scheduled to become effective in January 2018, but there have been several delays to the effective date. Organizations should continue to work towards implementing the revised requirements over the next six months for the new deadline of January 21, 2019. Until the new effective date, covered entities should continue to comply with the requirements of the pre-2018 version of the Federal Policy for the Protection of Human Subjects.
Want to read the full alert and receive alert emails?