Under the revised Common Rule, a continuing review will no longer be required for:
- Most studies that qualify for the expedited review process (and meet one of the OHRP Expedited Review Categories)
- Studies that have completed subject intervention/interaction and research activity is limited to analyzing study data or involves only observational follow-up in conjunction with standard clinical care.
- Continuing may be required by the IRB on a case-by-case basis for research that meets the criteria above.
- FDA-regulated research must still undergo a continuing review at least annually, per FDA regulations.
- An administrative check-in form will be required for non-exempt research that is not subject to continuing review requirements.
NOTE: Ongoing research (approved prior to 1.21.2019) must still undergo a continuing review in 2019. The IRB may or may not transition ongoing research at the time of continuing review. This will be determined on a case-by-case basis.
Under the 2018 Rule (RCR), the requirements for informed consent will change.
The following requirements will be added:
- "Key Information" to be presented at the beginning of the consent form.
- New consent elements (required statements and additional statements when applicable to your research)
- Changes to waiver criteria and documentation.
The intent of the changes is to facilitate the participant's understanding of the proposed research. The new required elements will also ensure that participants understand how their data and biospecimens may be used.
A new consent template containing RCR requirements has been added to the Researcher's Toolkit. Click here to access the templates page.
The list of exempt categories expands from six to eight under the RCR. The categories have been given their own section in the regulations and can be found at 45 CFR 46.104.
Click here to access the list of Exempt Categories in the RCR.
Single IRB Review
This requirement affects federally-funded research that does not go into effect until January 2020. The NIH issued a single IRB review policy for NIH-funded policy, which has been in effect since January 25, 2018.
The HSC HRPP has a single IRB review process in place. Visit the Reliance Agreements page for more information!
CLICK HERE for a flyer summarizing RCR changes.