Revised Common Rule for Human Subjects Research

Overview

The human subjects rues are changing as of January 21, 2019. The federal Office of Human Research Protections (OHRP) has published the changes and the changes are referred to as the 'Revised Common Rule" or the "Final Rule."

What this means to you: Changes have been underway for the Mentor IRB system, institutional policies and templates in preparation for the Revised Common Rule. Some of the key items are mentioned below:

The proposed changes will only impact new protocols submitted on January 21, 2019 or some studies that have not yet been reviewed and approved. The IRB Manager will reach out to you if already have an IRB application in the queue for review and need to make any additional changes.

Key Changes

Exempt Research

The Revised Common Rule broadens the types of research that qualify for exemption. Several exempt categories have been revised and there are new categories of exemption. Researchers must submit to the IRB for a determination that activities are exempt from IRB review. Please see the new and revised exempt categories.

Continuing Review 

The Revised Common Rule removes the requirement for minimal risk research and for Full-Board research that is in long-term follow-up or data analysis only.  The Fordham IRB will still require an annual check-in to know if the research is ongoing or completed. In addition, the Fordham IRB may require continuing review for certain studies as determined by the committee. 

Even when continuing review is not required, researchers remain responsible for updating the IRB about adverse events and other unanticipated problems, seeking IRB approval for changes to personnel, protocol amendments, etc.. and informing the IRB when research is complete.

Informed Consent 

The Revised Common Rule requires changes to the structure and content of informed consent documents.

• The consent form 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 consent form must be organized and presented in a way that facilitates comprehension.
• The consent form as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject's or legally authorized representative's understanding of the reasons why one might or might not want to participate.
• Consent form must disclose any plans to conduct future research using information and/or biospecimens collected during the research.
• If applicable, consent form must disclose whether: a) subjects will share in commercial profit; b) clinically relevant research results will be returned; and c) research will or might include whole genome sequencing.

There have also been changes to the method of acceptable way of obtaining consent from participants and criteria for approval.

• Electronic consent is allowed,  and a written copy must be provided to participants.
• Changes in the waiver and alteration criteria for consent.
• If applicable, must post copy of IRB-approved version of the consent form that was used for enrollment purposes for each clinical trial conducted or supported by a federal department or agency. Acceptable sites are Clinical Trials.gov and a docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021).

Definitions

The Revised Common Rule contains updated definitions as well as newly defined terms.

Revised Existing terms

UPDATE! Definition of Human subject - Human subjects means a living individual about whom an investigator (whether professional or student) conducting research: obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

UPDATE! Definition of Research - Now deems what's NOT research:

• Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
• Public health surveillance  activities, including the collection and testing information or biospecimens, conducted, supported, requested , ordered, required, or authorized by a public health authority. 
• Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigating purposes.
• Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions. 

UPDATE! Definition of Vulnerable populations - the final rule no longer includes pregnant women or ‘‘handicapped’’ or physically disabled individuals as examples of populations that are potentially vulnerable to coercion or undue influence. The final rule uses the term ‘‘individuals with impaired decision making ability’’ to replace the term ‘‘mentally disabled persons.’’ 

UPDATE! Definition of Legally Authorized Representative - Legally Authorized Representative means an individual or body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. If there are no applicable law addressing this issue, legally authorized representative means an individual recognized by institutional policy as acceptable for providing consent in the nonresearch context on behalf of the prospective subject to the subject's participation in the procedure(s) involved in the research.

New Terms Added:

NEW! Definition of Identifiable biospecimen - a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen. 

NEW! Definition of Public Health Authority - an agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate.

NEW! Definition of Written or In Writing - refers to writing on a tangible medium (e.g., paper) or in an electronic format. 

New! Definition of Clinical Trial - 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.

NEW! Broad Consent is a new type of consent as an alternative to regular informed consent specifically for the storage, maintenance, and secondary research uses of identifiable private information and identifiable biospecimens. Use of broad consent is tied to the new exempt research categories 7 & 8.

NEW! Limited IRB Review is tied to exempt categories 2, 3, 7 & 8.Under exempt categories 2,3 & 8, limited IRB review requires that the IRB determines that the criteria for approval at 111(a)(7) is satisfied ; when appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. Under exempt category 7, limited IRB review also requires that the IRB determines that the proposed secondary research is within the scope of the broad consent and the requirements at .111(a)(8) are satisfied.

Single IRB

Multi-Site Research Using Cooperative Review and Single IRB (sIRB) Review (GOES INTO EFFECT on January 20, 2020) - More information to be posted soon.

Learn More

View Revised Common Rule Educational Materials at HHS.gov

View Revised Common Rule Q&A's at HHS.gov