Revised Common Rule - The Office of the Vice President for Research

The Federal Policy for the Protection of Human Subjects, known as the Common Rule has undergone substantive revisions for the first time since its publication in 1991.

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 Documentation of Research Undergoing Intial or Continuing Review by the Expedited Procedure

Procedure for Continuing Review of Research by the Expedited Procedure

Roles and Responsibilities of the Institutional Review Board (IRB) and Office of the Institutional Review Board (OIRB)

Policy for Posting of Consent Forms for Clincial Trials to Public Federal Website

Policy on Determination of Human Subjects Research and Research Exempt from Federal Human Subjects Protection Regulations

Procedure for Determination of Exemption from Human Subjects Regulations

Training

Topic	Description	Time/Location	Materials and Information
Overview	This session will provide an overview of the revised common rule.	November 26. 2018	Video Recording Powerpoint Slides
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	Video Recording Powerpoint Slides
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	Video Recording Powerpoint Slides
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	Video Recording Powerpoint Slides

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.	The current final rule allows for institutions to implement this provision prior to the effective date of the entire Rule. We hope to roll this out for a limited number of expedited studies before the end of the calendar year. We will implement a system of checking in so that we can be aware of what protocols are active. Details will be forthcoming. The OIRB will communicate witth a PI when continuing review is no longer necessary. Continue to submit renewal materials until instructed otherwise by the OIRB.
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.

Guidance Documents

Definitions Comparison Chart

Exempt Comparison Chart

Draft Guidance for Expedited Status Update (ESU)