Under the Revised Common Rule 2018 Continuing Irb Review is Required for

Single Patient Emergency Use

Revised Common Rule

Contents

• Transitioning Studies to the Revised Common Rule
• Revised Common Rule Requirements
• Resources

Transitioning Studies to the Revised Common Rule

The Common Rule is the informal name given to a set of human subjects regulations that was developed in the 1970s. It was adopted by almost all federal agencies that fund human subjects research – in other words, it is the set of regulations that they all have in common. The Common Rule describes responsibilities and requirements for Institutional Review Boards (IRBs), researchers, and the researcher's institution. Most academic institutions (including the UW) apply the Common Rule regulations to all human subjects research, even if the research is not funded by a federal agency. It was revised, effective January 21, 2019.

Studies that were approved in Zipline prior to January 21, 2019 are regulated by the Original Common Rule (OCR) and studies approved after that date are regulated by the Revised Common Rule (RCR). When viewing the top of the home page for a study in Zipline, the "Regulatory Authority" is listed as either "Pre-2018 Requirements" (OCR) or "2018 Requirements" (RCR).

There may be advantages and disadvantages to "transitioning" studies currently regulated by the OCR to regulation under the RCR. For example, while minimal risk studies generally do not require continuing review under the RCR, subjects may need to be re-consented with RCR-required consent information. One big factor to consider is whether transitioning a study from OCR to RCR will trigger the Single IRB requirement which is likely to require reworking existing IRB review arrangements and approvals.

Researchers who have read this webpage and think they might want to transition their studies from OCR to RCR should first contact their HSD staff team to confirm the study should be transitioned. The HSD staff team will provide next steps if they determine the study is a good candidate for transitioning to the RCR.

Revised Common Rule Requirements

Below is a list of requirements in the Revised Common Rule that were not required in the Original Common Rule.

Consent

These RCR consent requirements will need to be added to the consent process for newly enrolled subjects and/or if already enrolled subjects are being re-consented for some other reason (e.g., new procedures or information about the study; new phase of the research).

Change #1. Four new required elements of consent.

These new items of information must be included in the consent process and form (if there is a consent form) unless the IRB grants a waiver for not including them.

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.

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.
• A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions.
• 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).

Change #2. Key information.

The consent process and form (if there is a 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. This part of the consent form or process must be organized in a way that facilitates comprehension. It is generally not required if the consent form is less than 2000 words (not counting the signature section and investigator list).

Change #3. Criteria for granting a waiver of consent.

A new criterion has been added.

• No more than minimal risk to subjects.
• The research could not practicably be carried out without the waiver.
• The waiver will not adversely affect subjects' rights and welfare.
• The subjects will be provided with any additional pertinent information after participation.
• NEW 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.

Change #4. Criteria for granting a waiver of documentation of consent.

A third set of criteria has been added, meaning that there are three different reasons why a waiver of documentation of consent can be granted.

• The only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. OR
• The research involves no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. OR
• NEW 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.

Change #5. Posting of clinical trial consent form.

For each clinical trial conducted or supported by a federal agency that has signed the revised Common Rule, one IRB approved consent form used to enroll subjects must be posted on a publicly available federal website that is established as a repository for such consent forms. This is the responsibility of the researcher or the federal agency.

Continuing Review

Continuing Review is the requirement for the IRB to re-review a study and renew the IRB approval, after a specified time period. Under the Original Common Rule, almost all studies with IRB approval had to go through continuing review once a year or once every three years.

The change. The following types of studies no longer need to go through Continuing Review. However, Zipline will send a short automated "check-in" notification once a year.

• Studies whose initial application was reviewed by the "minimal risk" process, called expedited review
• Studies whose remaining research procedures consist solely of:
• Data analysis (including analysis of identifiable private information or identifiable biospecimens), and/or
• Obtaining clinical care data from records, for follow-up purposes

Exceptions. This does not apply to studies that are:

• Regulated by the Food and Drug Administration (FDA)
• Funded by the federal Department of Justice

Single IRB

The change. For studies that involve more than one institution or organization, the same IRB must conduct the review for all of the institutions. This "Single IRB" requirement was implemented on January 20, 2020 for most research funded by DHHS and all research that is funded by any of the other federal agencies that adopted the Revised Common Rule. Some DHHS funded studies qualify for limited exemptions if they have been approved by an IRB prior to January 20, 2020. Any potential advantages to transitioning from OCR to RCR (e.g., elimination of continuing review) are likely to be outweighed by the potential disadvantages of reworking existing IRB review arrangements and approvals that would be required by using a Single IRB.

Agencies that adopted the revised Common Rule:

Agency for International Development (USAID)	Department of Homeland Security
Central Intelligence Agency	Department of Housing and Urban Development
Consumer Product Safety Division	Department of Labor
Department of Agriculture	Department of Transportation
Department of Commerce	Department of Veterans Affairs (VA)
Department of Defense	Environmental Protection Agency (EPA)
Department of Education	National Aeronautics and Space Administration (NASA)
Department of Energy	National Science Foundation (NSF)
Department of Health and Human Services	Social Security Administration (SSA)

Resources

Revised Common Rule Introduction Video

Revised Common Rule Consent Changes Overview Video

Revised Common Rule Exemption Changes Video

Revised Common Rule Continuing Review Changes Video

Single IRB and Collaborative/Multi-site Research Overview Video

ConKey Information Requirement section of the GUIDANCE Consent

This guidance includes the purpose, and requirements for Key Information. Several examples of providing a Key Information Statement can be found in EXAMPLE Key Information.

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Source: https://www.washington.edu/research/hsd/revised-common-rule/