January 21, 2019 is the new effective and compliance date for the revised Common Rule
On June 18, 2018, guidance was released delaying the General Compliance Date for the revisions to the Common Rule (also known as the "2018 Rule"). This guidance does allow institutions to implement three specific burden-reducing provisions during the delay period. The UH Human Studies Program has opted to delay implementation of the burden-reducing provisions until the January 21, 2019 compliance date. More information may be found on the Department of Health and Human Services site here.
This notice follows and replaces a previous notice that set the compliance date at July 18, 2018:
On January 17, 2018, an interim final rule (IFR), titled Federal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human Subjects, was released. The IFR delayed the effective date and general compliance date of the revised Common Rule for six months. All provisions are covered except the cooperative research ("single IRB") provision, whose compliance date remains January 20, 2020.
To help the research ethics and oversight community understand and adapt to this change, please see the one-page guide, Delay of the Revised Common Rule: What Does It Mean For Me? which was developed by PRIM&R (Public Responsibility in Medicine and Research). Please refer back to this website for updates on UH's implementation of the revised Common Rule.
Summary of major changes
- Continuing Review: No longer required for some minimal risk research, including studies where the only remaining activity is the analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data.
- Exemptions - New categories and clarification of existing categories. Some exemptions may require "limited IRB review" (to ensure the protection and confidentiality of data), while others may qualify for "self-determination."
- Informed Consent - A new "Key Elements" section and a rearrangement of content is designed to facilitate a potential subject's decision to participate or not. Revised UH model consent forms are now posted on the HSP website. These model consent forms must be followed if your study is approved after July 19, 2018 although we encourage their use now.
- Single IRB-of-Record (sIRB) - IRB oversight for 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. See below for information about the NIH sIRB policy implementation, as well as other recent NIH policies related to clinical trials.
What to Expect
The new regulations do not impact studies approved prior to July 19, 2018. For new studies, expect to see:
- IRB application changes
- Revisions to the Informed Consent templates
- Human Research Protection Program (HRPP) General Policy Manual updates
- UH IRB standard operating procedure (SOP) updates
- A conservative approach as to when UH will be the sIRB, with IRB consultation recommended prior to application submission
For existing studies, the UH IRBs may choose to apply the new rules to minimize burden for investigators.
The UH Human Studies Program (HSP) and the 3 UH IRBs are working to collectively interpret the new Common Rule elements and update the University’s policies, business processes, and eProtocol system to accommodate the changes while maintaining a high level of subject protection. A Final Rule working group was established to propose needed changes.
Decisions made so far
- Informed Consent - Revised UH model consent forms are now posted on the HSP website. These model consent forms must be followed if your study is approved after July 19, 2018 although we encourage their use now.
- Exemptions - At this time, UH will not implement the new regulatory “Broad Consent” option as 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 Exemption categories 7 and 8, these new exempt categories will not be implemented.
- Single IRB-of-Record (sIRB) - 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 SmartIRB.
Posting Clinical Trial Consent Forms:
One of the changes implemented in the revised Common Rule: 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.
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 obligations 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).