January 21, 2019 is the compliance date for the revised Common Rule
The U.S. Department of Health and Human Services and fifteen other Federal agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). The revised Common Rule is effective January 21, 2019. The revised Common Rule is also commonly referred to as the Final Rule or the “2018 Requirements.”
- Continuing Review: Continuing Review will no longer be required for most minimal risk research (Expedited studies), including studies where the only remaining activity is the analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data.
- Exempt Studies: New categories were added and there was clarification of certain existing exempt categories. Some exemptions may require “limited IRB review” (to ensure the protection and confidentiality of data). At this time, UH will not implement the new regulatory “Broad Consent” option for the informed consent process because of the additional tracking requirement required for participants who choose to “opt-out” of providing broad consent. Since this is required for the new exempt categories 7 and 8, these new exempt categories will not be implemented at UH. The exempt categories available for use by UH are listed in the IRB application through eProtocol.
- Informed Consent:
- The informed consent process must now begin with a new “Key Elements” section, which is a concise and focused presentation of key information that is most likely to assist a participant in understanding the reasons why they might (or might not) consider being in a study. Revised [UH model consent forms] are now posted on the HSP website. These model consent forms should be used if your study is approved after January 21, 2019, although we encourage their use now.
- A requirement was also added to include one of two statements about collection of private information or identifiable biospecimens for future research (either that identifiers might be removed and the de-identified information or biospecimens will be used for future research without additional informed consent from the subject; or that the subject’s information or biospecimens will not be used or distributed for future research studies even if identifiers are removed).
- There are also three (3) new requirements that should be addressed as relevant: 1) biospecimens, even if identifiers are removed, may be used for commercial profit and whether the subject will share in the profit; 2) whether clinically relevant results will be disclosed to participants; and 3) whether the research project might include whole genome sequencing.
- Single IRB Review (also called Cooperative IRB review): Most federally-funded collaborative research projects located in the U.S. will be required to use a single IRB (commercial, academic, or hospital-based) starting January 20, 2020. UH will continue to assess its criteria for whether UH will serve as the single IRB-of-Record or cede review to another institution or a commercial IRB. UH is now participating in a pilot program to track IRB review agreements between institutions. Contact the HSP Office for information on using this system, called SmartIRB. Please contact Victoria Rivera for more information about using SmartIRB.
- Posting consent forms for clinical trials: See below for further guidance on the new requirement to post the informed consent document for clinical trials to a federal website.
Continuing Review for Existing Studies
On a case-by-case basis, the UH Human Studies Program (HSP) will decide whether to transition existing Expedited or Full-Board studies to the revised Common Rule. If an existing study is transitioned to the revised Common Rule, this means that Continuing Review will no longer be required. The UH HSP will evaluate the need for continuing review at the time of the next amendment or scheduled continuing review submission for each existing study.
Studies eligible for transition to the revised Common Rule (therefore, no longer needing Continuing Review) will typically include:
- Expedited studies (with a few exceptions explained below)
- Full-Board studies in which interaction or intervention with participants has concluded and the study is not regulated by the U.S. Food & Drug Administration (FDA) or considered a “Clinical Trial” under the revised definition (see definition below)
Studies that will NOT be transitioned to the revised Common Rule (therefore, still requiring annual Continuing Review) will typically include:
- Studies regulated by the FDA;
- Studies that are considered a “Clinical Trial” under the revised definition (see definition below)
- Studies in which participants are still being enrolled;
- Studies in which enrollment has ended but the project still involves interaction or intervention with participants;
- Studies in which previous amendments or incident reports reveal a need for additional oversight;
- Studies in which the Principal Investigator (PI) has had a pattern of compliance concerns on existing or previous studies.
Continuing Review for New Studies
For new studies approved via Expedited review on or after January 21, 2019, the revised Common Rule will apply. Under the revised Common Rule, most Expedited studies will not require continuing review. The UH IRB expedited reviewer will determine the need for continuing review.
Some reasons for HSP to determine that continuing review of an Expedited study is still required even under the revised Common Rule include:
- The study is regulated by the FDA;
- The study involves additional regulatory oversight, such as conflict of interest (COI) management;
- The PI has had a pattern of compliance concerns on other studies;
- The study will be conducted internationally.
One of the changes implemented in the revised Common Rule is that the consent form for any clinical trial conducted or supported by a Common Rule department or agency must be posted on a publicly available federal website within a specific time frame (45 CFR 46.116(h)). The U.S. Dept. of Health and Human Services (HHS) and 16 other federal departments and agencies have announced where clinical trial consent forms may be posted. Under the revised Common Rule, a clinical trial is defined more broadly as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.”
The U.S. Department of Health and Human Services (HHS) and 16 other federal departments and agencies are announcing where clinical trial consent forms can be posted, as will be required by the revised Common Rule. No obligation to post such consent forms apply before January 21, 2019.
At this time, two publicly available federal websites that will satisfy the consent form posting requirement, as required by the revised Common Rule, have been identified: ClinicalTrials.gov and a docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021). HHS and other Common Rule departments and agencies are developing instructions and other materials providing more information to the regulated community about this posting requirement.
The revised Common Rule requires that for any clinical trial conducted or supported by a Common Rule department or agency, one consent form be posted on a publicly available federal website within a specific time frame. The consent form must have been used in enrolling participants in order to satisfy this new provision.
You can read more information about the revised Common Rule on the OHRP website (https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/index.html).