The U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) issued a statement in their January 2019 newsletter indicating that no more delays are planned to the full implementation and compliance date for the 2018 Revised Common Rule regulations.
The research community will need to comply with the Revised Common Rule as of January 21, 2019 for all newly reviewed human subject research. Studies approved or determined exempt prior to January 21, 2019 must continue to comply with the pre-2018 Common Rule regulations.
The U.S. Department of Health and Human Services and 16 federal agencies issued a final rule updating the Federal Policy for the Protection of Human Subjects (the “Common Rule”) that safeguards individuals who participate in research. Most provisions in the new rule were scheduled to go into effect July 19, 2018 but were delayed until January 21, 2019 through an Interim Final Rule. See the full text of the federal register notice for more information. Until January 21, 2019 institutions are required to comply with the pre-2018 Common Rule.
Changes to regulations governing human subjects research, as outlined in the Common Rule, 45 CFR 46, were issued by the Department of Health and Human Services (HHS) on January 18, 2017. The majority of rule changes will take effect January 21, 2019. The amended rules are the first significant changes to human subjects regulations since 1991. While some changes will reduce the burden on researchers and institutional compliance areas, some of the new requirements come with additional responsibilities.
- All existing studies approved or determined exempt by the IRB prior to January 21, 2019 will remain governed by the pre-2018 Common Rule. Amendments to and continuing review of these studies will be reviewed in accordance with the pre-2018 Common Rule unless and until transitioned to the revised Common Rule (see Existing and Ongoing Research).
- All new studies approved or determined exempt by the IRB on or after January 21, 2019 are subject to the revised Common Rule.
- The revised Common Rule does not apply to FDA-regulated and Department of Justice studies.
RCS has reviewed and updated all materials available for the UO research community to ensure these comply with both the pre-2018 Common Rule and the 2018 Revised Common rule.
There are five main categories of major regulation changes.
Continuing Review: For new studies approved or determined exempt under the 2018 revised Common Rule, continuing review will not be 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.
Please note that if a study was reviewed under the pre-2018 Common Rule and was determined to require continuing review, continuing review is still required to stay compliant. The revised Common Rule permits the IRB to review existing and ongoing research and determine if it can transition to comply with the revised Common Rule.
Exemptions: The revised regulations created new exempt categories and modified some existing categories. Exempt research is research involving no greater than minimal risk and falls into specific categories identified in the federal regulations. RCS has adapted the exempt determination process to align with the revised exemption categories and to streamline the review process.
Limited IRB Review: The revised regulations also incorporate an alternate path of review for studies otherwise qualifying for exemption but working with identifiable information or biospecimens. An IRB member must conduct limited IRB review for these studies. The focus of the review is limited to determining that the research design includes adequate provisions to protect participant privacy and confidentiality.
Informed Consent: The revised regulations include new process requirements for the content, presentation and organization of information so potential participants have all the information they need to make an informed decision. Consent forms will need to include key information at the beginning of the form and be presented at the outset of the consent discussion with participants to explain the research in an easy-to-understand and clear manner. Consent forms must be concise while also giving the full context of a study, including its risks and benefits. Consent forms will also need to include information regarding the potential for future use of de-identified data and biospecimens.
Clinical Trials: For federally-sponsored clinical trials, a requirement has been added that a copy of the consent form must be posted to a "publicly available, federal website" post-recruitment and no later than 60 days after the last study visit by any subject. The Office for the Protection of Human Subjects (OHRP) has posted detailed information and guidance on the Revised Common Rule's clinical trial informed consent form posting requirement.
Single IRB-of-Record (sIRB): 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. The IRB overseeing the research must be approved by the funding agency. The UO's plans for sIRB will be developed in the coming months.
What does this mean for me as a researcher?
- These changes do not immediately affect existing studies approved or determined exempt prior to January 21, 2019.
- Pending applications for new studies will need to be reviewed under the new regulations if approval or an exempt determination has not been made prior to January 21, 2019. Researchers may need to work with RCS staff to address any adjustments to protocol materials needed to achieve compliance with the revised regulations.
- Updated submission materials will be posted to the website. Researchers will need to check the website and ensure they are using the most currently available forms and information.
- Contact us at firstname.lastname@example.org if you would like to be added to our Education and Outreach listser
Where can I learn more?
- Our office is holding numerous sessions of two workshops focusing on the revised Common Rule:
- The Revised Human Subject Research Regulations: Overview and Q & A
- Exempt Research Under the Revised Common Rule
- The Office for Human Research Protections (OHRP), a division of HHS, is the lead agency who published the final rule. This site provides a news release and commentary on the revised common rule.
- The published version of the changes to the Common Rule in the Federal Register.
- Public Responsibility in Medicine & Research (PRIM&R) provides many helpful resources on their website. Also see PRIM&R’s Primer on the Revised Common Rule Q&A
- Collaborative Institutional Training Initiative (CITI) Program offers a wealth of resources on its website.