July Updates

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To: Investigators and Staff

Re: IRB News, Changes in requirements and reporting

The following notice provides updates regarding the new Common Rule requirements, Recombinant DNA Advisory Committee review, and iRIS (IRB submission system) guidance.

New Common Rule Update: Requirement to publicly post consent forms

In January of this year, the HRPP announced that the federal policy for the protection of Human Research Subjects has been updated to better protect human subjects. One of the updates of this policy includes the requirement to publicly post clinical trial informed consent forms (Refer to 46.116(h)),

What studies are affected? Clinical trials initiated on or after January 21, 2019 that are federally conducted or funded by a Federal department or agency are required to comply with this requirement. Recipients of NIH funding subject to the Revised Common Rule and conducting a clinical trial as defined in 45 CFR 46.102(b) must submit one version of an IRB-approved consent form that was used to enroll participants in accordance with Section 46.116(h) after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol. Please note, if multiple consent forms were used for different participant groups, you are only required to upload one form, but may opt to upload multiple forms.

For studies that are registered on ClinicalTrials.gov, researchers may upload consent forms within their existing ClinicalTrials.gov study record. ClinicalTrials.gov only accepts English language consent forms however, so for studies that do not use English language forms, or are not required to register at ClinicalTrials.gov, consents must be submitted through the comment portal at Regulations.gov. For instructions on how to submit please see HHS.gov.

Resources

To learn more about these new requirements please review the following NIH guidance. Questions regarding applicability of this requirement may be directed to IRB@ucsf.edu, and technical questions about uploading forms to ClinicalTrials.gov should be directed to ct.gov@ucsf.edu. An FAQ will be developed and made available soon.

Discontinuation of Recombinant DNA Advisory Committee (RAC) Review

RAC Review

The NIH Office of Biotechnology Activities (OBA) has amended its reporting and review requirements and no longer requires RAC approval. RAC is a federal advisory committee that provided recommendations to the NIH Director related to basic and clinical research involving recombinant or synthetic nucleic acid molecules.

RAC is not required. Any recommendations resulting from the RAC review does not need to be included in the applications to the UCSF IBC and IRB. FDA and local review is still required. The HRPP website has been updated to reflect this new information. The iRIS application is currently being modified to remove references to this previous requirement.

iRIS Guidance

Email Links: Recent updates allow for the UCSF Human Research community to access tasks directly from email alerts generated by iRIS.

When receiving notices from iRIS you may click the links included in the emails. You will be automatically routed to your tasks. In most cases, the links only work when logged out of MyAccess. The system will prompt you to log-in to myAccess to review and respond to the task.

Guidance on Downloading & Printing your Current IRB Approval Packetis provided on the IRB’s iRIS Help Site here (requires MyAccess login), as several users find this feature useful.