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The Federal Policy for the Protection of Human Subjects is known as "The Common Rule". This policy was recently updated and the newest version of policy goes into effect on January 21, 2019. All new studies that are approved by the IRB-HSR on or after January 21, 2019 must comply with the revised 2018 Common Rule. These applications must use the revised protocol and consent form templates (available in Protocol Builder December 1st). For more details on studies that were in process around this date, see the attached January 21st IRB update. Studies that were approved under the current (pre 2018) Common Rule will not be switched over to the revised 2018 Common Rule at this time.

The following revisions to the 2018 Common Rule (45CFR46, Part A) will become effective January 21, 2019 for any study approved on or after January 21, 2019:

Grant Reviews: The IRB-HSR will no longer be required to review the Grant Proposal if all studies funded by the grant are regulated under the Revised 2018 Common Rule (e.g. Department of Defense, FDA). Therefore, the IRB will remain responsible for reviewing grant proposals to the Department of Defense or the FDA. The Office of Sponsored Programs/ SOM Office of Grants and Contracts will provide Human Subject Research Protection Training certifications for all applications not reviewed by the IRB-HSR.

Continuing Review: Continuing review has been eliminated for all expedited studies and full board studies that are in data analysis. The IRB-HSR will continue to require annual update from study team. Study teams will receive notification from the IRB reminding them to submit required information similar to the current process used for Continuation Status Reports. Continuing Review will still be required for studies regulated by the FDA, funded by the Department of Defense or if the IRB requires the study to have a Certificate of Confidentiality.

Exempt Determinations: Several changes were made to the exempt criteria. The criteria that will be primarily used by biomedical researchers includes reviews of existing data ( e.g. medical records) that are collecting retrospective or prospective identifiable health information in which data is protected by HIPAA. These types of submissions will now fall under an exempt review category. The IRB must also perform a data security review: Data Security Plan and Privacy Plan required. This exemption does not apply to studies regulated by the FDA, funded by the Department of Defense or if the IRB requires the study to have a Certificate of Confidentiality.

Consent Form Revisions:

• Key Information: The consent form (or consent process, if there is no consent form) must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject in understanding the reasons why one might or might not want to participate in the research. The consent form template has been updated to include this new section.
• Posting Consent Forms: For each clinical trial regulated under the 2018 Common Rule and conducted or supported by a Federal department or agency that has signed on to the revised 2018 Common Rule, one IRB approved informed consent form used to enroll subjects must be posted to https://clinicaltrials.gov/ or https://www.regulations.gov/ 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 45CFR46.116(h). Posting the consent form is usually done by the sponsor or overall PI.
  Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

Four new required elements of consent:

1. Required for all studies that collect identifiable private information or identifiable biospecimens: A statement about whether subject's private information or biospecimens could be used for future research studies or distributed to another investigator for future research studies, with or without identifiers.
2. Required when appropriate to the study: A statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit.
3. Required when appropriate to the study: A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions.
4. Required when appropriate to the study: For research involving biospecimens, whether the research will (or might) include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

• Waiver of Consent Criteria (new criterion): If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format.
• Waiver of Documentation of Consent Criteria (new criterion): If the subjects are members of a distinct cultural group or community in which signing forms is not the norm, the research involves no more than minimal risk of harm, and there is an appropriate alternative mechanism for documenting that consent was obtained.