The Common Rule The Federal Policy for the Protection of Human Subjects, known as the Common Rule, outlines the regulatory requirements for IRB review and approval. The Revised Common Rule The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). These revisions took effect on January 21, 2019, and all new research receiving federal funding must comply with the Revised Rule. How Do I Comply with the New Rule? All Studies The research consent form must comply with the Revised Rule. Visit the IRB Forms page to find consent form templates that comply with the Revised Rule. They are denoted with “2018 Common Rule Compliant” at the end of their name. Researchers requesting a waiver of consent for access to or use of private identifiable information or identifiable biospecimens must explain why the research cannot practicably be conducted without the use of identifiers. Federally-funded Studies Clinical trials must post one IRB-approved informed consent form which was used to consent subjects to a publicly available Federal website within 60 days of the last study visit by any subject. Single-IRB review must be used for multisite research. Am I Required to Comply with the Revised Rule? New Projects Effective January 1, 2020, all new minimal risk research must comply with the Revised Common Rule, regardless of funding. Effective January 19, 2019 all new federally-funded research must comply with the Revised Common Rule. Existing Projects The revisions to the Common Rule will have no effect on greater than minimal risk research that is already IRB approved. All existing greater than minimal risk research may continue uninterrupted and must follow the Old Rule (the rule in effect before 2018). Investigators must continue to submit continuing review/progress reports before the administrative due date, as is the current practice. If an investigator wants the IRB to apply the Revised Rule to existing research that is not due for continuing review, the investigator may submit a modification to the IRB. If the study is open to enrollment or requires access to private identifiable data or specimens, changes may be required to comply with the Revised Rule. To modify a study to comply with the Revised Rule researchers must: Update the research consent form to comply with the Revised Rule. Visit the IRB Forms page to find consent form templates that comply with the Revised Rule. They are denoted with “2018 Common Rule Compliant” at the end of their name. Update the justification for a waiver of consent for access or use of private identifiable information or biospecimens by explaining why the research cannot practicably be conducted using anonymous or coded data or biospecimens. Posting of Clinical Trials Consent Forms For federally-funded research, the Revised Rule requires one consent form to be posted on a publicly available federal website for any clinical trial conducted or supported by a Common Rule department or agency. The consent form must be posted no later than 60 days after the last study visit by any subject. The consent form must have been used in enrolling participants in order to satisfy this new provision. The compliance date for this provision is January 21, 2019. At this time, two publicly available federal websites have been identified to satisfy the consent form posting requirement: ClinicalTrials.gov and a docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021). OHRP has launched a website explaining how to upload consent forms to the Federal Docket to satisfy the requirement for public posting at 45 CFR 46.116(h)(1) under the Revised Rule. HHS and other Common Rule departments and agencies are developing instructions and other materials providing more information to the regulated community about this posting requirement. Additional federal websites satisfying the Revised Rule’s clinical trial consent form posting requirement might be identified in the future. What is Broad Consent? The term “Broad Consent” as defined by the Revised Rule applies to consent for storage and secondary research of identifiable private information or biospecimens. This concept must be implemented on an institutional level and requires tracking of individuals who decline to provide consent. Because there is no guidance from OHRP and because of the implications of tracking individuals who do not provide consent and excluding their data from all future research, our institutions (Einstein and Montefiore) are not pursuing broad consent at this time. Investigators can continue to use biospecimens that are coded or to seek a waiver of consent for use of biospecimens with identifiers retained consistent with current practices. What About the Requirements for Single-IRB Review of Multi-Site Studies? The Revised Rule states that federally-funded studies where the study will be conducted at more than one domestic site must use a single IRB, unless the federal agency has documented that single IRB review is not required. The single IRB provision compliance date is January 20, 2020. Montefiore Einstein researchers do not need to comply with this provision at this time unless the study is federally funded. The NIH has documented specific requirements for when studies they fund must be reviewed by a single IRB. Additional information about NIH single IRB requirements can be found here. What About FDA-Regulated Research? The Common Rule regulations are separate from FDA regulations. The FDA regulations have NOT changed. The FDA still requires annual continuing review for FDA-regulated studies, even those FDA-regulated studies involving only minimal risk.
