June 19, 2018: A Final Rule was published by the U.S. Department of Health and Human Services (HHS) and 16 other federal departments and agencies issuing a delay for an additional 6 months to the general compliance date for changes recently made to the revised Federal Policy for the Protection of Human Subjects (also known as the Common Rule). The Final Rule delays the general compliance date for the revised Common Rule to January 21, 2019. The Final Rule also contains limited application of three burden-reducing provisions that could be implemented during the additional 6-month delay. The Final Rule indicates the intent for Common Rule departments and agencies to issue key guidance documents for implementation of the 2018 Requirements. RCS will continue to monitor for additional guidance and updates. For the full text of the federal register notice, click here.
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 have been delayed until January 21, 2019 through an Interim Final Rule. For the full text of the federal register notice, click here.
Until January 21, 2019 institutions are required to comply with the pre-2018 Common Rule. RCS has reviewed our most recently developed and issued materials to ensure only those that continue to comply with the pre-2018 Common Rule are available to the research community. We will continue to keep the research community informed of any further information.
The information below and on the linked pages is consistent with the Common Rule revisions that were originally set to go live on January 19, 2018. We will update the information on this page as applicable to keep the UO research community informed. Additional updates will be posted on a regular basis, as implementation guidance is issued by the federal government.
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 webpage).
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.
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. See the Continuing Review Changes webpage for additional information.
NOTE: 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 research and determine if it can transition to comply with the revised Common Rule. See the Existing and Ongoing Research webpage for more information.
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. See the Exempt Review Changes page for additional information.
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. See the Exempt Review Changes page for additional information.
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. See the Informed Consent Changes webpage for additional information.
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.
- 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 email@example.com if you would like to be added to our Education and Outreach listserv.
Prior to the implementation date, Research Compliance Services (RCS) will host two Q&A sessions at the EMU. In addition, RCS is offering education sessions devoted to addressing questions related to existing and ongoing research. Faculty and staff may register for these sessions through MyTrack. Students can register by contacting our office at (541) 346-2510 or firstname.lastname@example.org.
- Drop-in consultation time dedicated to the Revised Common Rule:
- Thursdays: 2:00 pm - 4:00 pm
- PeaceHealth North Building (677 E. 12th Avenue), Consultation Room
- Thursdays: 2:00 pm - 4:00 pm
- Our office is holding numerous sessions of a workshop entitled Human Subject Research – What’s Changing?, focusing on the final rule, NIH Clinical Trials requirements, single IRB review, and more.
- 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.
- Collaborative Institutional Training Initiative (CITI) Program offers a wealth of resources on its website.