- The revised Common Rule was published in the Federal Register on January 19, 2017.
- An interim final rule delaying the implementation was published on January 22, 2018.
- The current final rule published on June 19, 2018. The effective date for the revised Common Rule is January 21, 2019.
Applicability
Seventeen federal agencies have adopted the revised Common Rule. The Food and Drug Administration (FDA) and Department of Justice (DOJ) have not signed on to the Common Rule at this time. Any research subject to FDA regulations or sponsored by either agency will continue under the current regulatory requirements.
Policies and Procedures
Several of the UAB IRB Policies & Procedures will be revised to reflect the Revised Common Rule.
These draft policies and procedures will be finalized and posted to the UAB Policies and Procedures Library by the Office of University Compliance.
Policy on the Protection of Human Subjects in Research
Policy on Expedited Review of Human Subjects Research
Procedure for Initial Review Using the Expedited Procedure
Procedure for Continuing Review of Research by the Expedited Procedure
Policy for Posting of Consent Forms for Clincial Trials to Public Federal Website
Procedure for Determination of Exemption from Human Subjects Regulations
Training
Topic | Description | Time/Location | Materials and Information |
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Overview | This session will provide an overview of the revised common rule. | November 26. 2018 | |
Informed Consent (SBER) | This session will focus on new informed consent requirements with an emphasis on social, behavioral, and education research (SBER). |
Thursday, January 3, 2019 10:00-11:00 Finley Conference Center |
Video Recording |
Exempt Research (SBER) | This session will focus on the revised exempt categories with an emphasis on social, behavioral, and education research (SBER). |
Monday, January 7, 2019 10:00-11:00 Finley Conference Center |
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Informed Consent (Biomedical) | This session will focus on new informed consent requirements with an emphasis on biomedical research. |
Wednesday, January 9, 2019 1:00-2:00 Finley Conference Center |
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Exempt Research (Biomedical) | This session will focus on the revised exempt categories with an emphasis on biomedical research. |
Wednesday, January 9, 2019 2:00-3:00 Finley Conference Center |
Video Recording |
Expedited Status Updates (ESU) | This session will focus on the Expedited Status Update (ESU) process. | Monday, January 14, 20191:00-2:00Online Only |
Major Areas of Change
Topic | Description | Current Information |
---|---|---|
Informed Consent | “Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.” | The revised sample consent form has been published on the Forms page of this website. The new form includes the concise summary and other language required by the Revised Common Rule (e.g. whole genome sequencing, identifiers associated with data and specimens, etc.) has been incorporated. Additionally, a document of sample concise summary tables is available on that page as well. This document provides examples for various study scenarios. |
Exempt Categories | There are new categories for exempt research and there have been modifications to some of the existing categories. | We are currently working on implementation plans for review of research under the new exempt categories, including the process of limited review. Exempt categories 7 and 8 apply only to broad consent and will not be utilized at this time. |
Continuing Review | Continuing review will no longer be required for research that qualifies for expedited review or for studies that initially required full board review once the research interventions/interactions with participants have been completed. |
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Broad Consent | There is an option for the use of broad consent from a subject for storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens. This option requires an extensive tracking mechanism. | UAB has elected not to implement this option at this time. |