2018 Common Rule
The Department of Health and Human Services and 15 other federal agencies issued revisions to the regulations governing human subjects research (the Common Rule) on January 19, 2017 (referred to as the 2018 Common Rule). The final revisions to the Common Rule go into effect on January 21, 2019.
Studies initiated before January 21, 2019 will be subject to the pre-2018 Common Rule. As per the guidance issued by the federal government, the definition of an “initiated” study is one that has been approved by the IRB before January 21, 2019.
Federally funded studies submitted to the IRB prior to January 21, 2019 but not yet approved by the IRB
The study will be reviewed under the 2018 Common Rule. Being reviewed under the 2018 Common Rule should not delay review and approval of the research as most of the revisions in the 2018 Common Rule are designed to streamline the review process. Research teams are unlikely to experience significant difference in their review experience, with the exception of informed consent requirements. Detailed information about new consent requirements can be found below.
Non-federally funded studies submitted to the IRB prior to January 21, 2019 but not yet approved by the IRB
The study will be reviewed under the pre-2018 Common Rule.
Any studies, regardless of funding source, submitted to the IRB on or after January 21, 2019 will be reviewed under the 2018 Common Rule
Transitioning pre-2018 studies to 2018 studies
Institutions have the option to transition research submitted before January 21, 2019 to the new rule. At this time, GW does not plan to universally transition studies submitted before January 21, 2019 to the revised 2018 Common Rule. The IRB will work with researchers on a case-by-case basis if it appears that transitioning makes sense for a study initiated before January 21, 2019.
FDA regulated research
The Common Rule regulations are separate from FDA regulations. As the FDA regulations have NOT changed, research regulated by the FDA continues to require annual continuing review, even if the research is minimal risk.
Consent under the 2018 Common Rule
Under the 2018 Common Rule, informed consent must include discussion with prospective participants and an initial presentation of “key information,” designed to facilitate prospective participants’ or representative’s understanding of the research and the reasons why one might wish to participate or not. Currently there is no federal guidance on what exactly constitutes “key information.” This is due partly to the study specific nature of this requirement; the key information that a prospective participant needs to decide whether to enroll in a greater than minimal risk clinical trial will be different from the key information a prospective participant needs to decide whether to enroll in social/behavioral/educational research that is minimal risk.
However, there are five components that generally are considered to provide the necessary information required by the 2018 Common Rule. Please note that key information provided to participants is NOT limited to these five elements – researchers may include other types of information that they deem necessary and appropriate to include in the key information:
- That the prospective participant’s consent is being sought for research and that participation is voluntary,
- The purpose(s) of the research, the expected duration of participation, the research procedures to be followed, and any other important information about the research,
- The reasonably foreseeable risks or discomforts to the prospective subject,
- The benefits to the prospective participant or others that may reasonably be expected,
- Appropriate alternatives to the research, if any.
Changes to the elements of informed consent:
- If the research involves the collection of identifiable private information or identifiable biospecimens, a statement on whether the identifiers might be removed from the data/biospecimens and information that data/biospecimens that are not identifiable could be used for future research or distributed to other researchers,
- When applicable:
- A statement that biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit,
- A statement about whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so under what conditions,
- For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).
GW will not be utilizing a “broad consent” at this time
Due to lack of guidance from the federal government on broad consent, and the difficulties of tracking individuals who choose not to allow their data for future use, GW is not utilizing broad consent at this time. Researchers may continue to use data/biospecimens that are coded, or to request a waiver of consent for identifiable data/biospecimens as consistent with pre-2018 practices.
For more information
More information on Revised Common Rule from OHRP