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Compliance In Focus
Posted by Melissa Wollerman on Thu, Dec 5, 2019

Revisions to the Common Rule; Part II

In a previous blog post, revisions to the Common Rule were to be implemented January 19, 2018; however, due to a Notice of Proposed The Common Rule (1991)-1Rulemaking (NPRM), the compliance date was delayed until January 21, 2019.

The Common Rule is a set of ethics that protect human subjects involved in research, developed and published by The Department of Health and Human Services. The goal of the revisions is to “modernize, strengthen, and make more effective” the Common Rule (also known as the “2018 Requirements” or the “2018 Rule”). The revised rule is intended to strengthen protections for people who participate in research while ensuring that the oversight system does not add inappropriate administrative burdens, particularly to minimal risk research, and to allow increased flexibility in maintaining today’s research environment.

4 major topics that have been revised in the rule include:

1.  Exempt Review: The Code of Federal Regulations identifies new and modifies several different categories of minimal risk research as being exempt from the rule. Although these categories are exempt from Federal Policy, they are not exempt from IRB review.

2.  Continuing review: May no longer be required for certain minimal risk studies and studies in data analysis or long-term follow-up; however, Investigators will continue to submit modifications, reportable events and termination reports per IRB requirements.

3.  Consent process and forms:

  • Key information – Included in the revised Common Rule is a statement that reads “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.”
  • Elements of Informed Consent – If research involves the collection of identifiable private information or identifiable biospecimens, a basic element of informed consent has been added that addresses the future use of identifiable private information or specimens.
  • Waiver of informed consent – In addition to the requirements effective prior to January 21, 2019 for a waiver for obtaining informed consent, a new requirement has been implemented that if the research involves identifiable private information or identifiable biospecimens, the research could not be carried out practically without using the information or specimen in an identifiable form.

4.  Single IRB Review: Previously put into effect on January 25, 2018, use of a single IRB for review of multi-site research for NIH funded studies is required. Scheduled to take effect on January 20, 2020, use of a single IRB review for multi-site research for studies funded by other agencies will also be required.

In many cases, the Common Rule revisions have not impacted ongoing research. If research was approved prior to January 21, 2019, study sites can continue to comply with the “pre-2018” rule; however, the IRB may request any of the aforementioned changes to be implemented at a particular site.

The Common Rule is codified in separate regulations by 15 Federal departments and agencies but to date, the FDA has not yet agreed to the new Common Rule and therefore changes outlined here will not be applicable to FDA regulated studies. The FDA does intend to harmonize its regulations with the revised Common Rule to reduce confusion and burden associated with complying with two different sets of human subject protections regulations, although the FDA has not yet announced when this will take place.

Was your research affected by the revisions to the Common Rule? If so, what revision brought change to your non FDA-regulated research?

The History of Clinical Research

Topics: History of Clinical Research, The Common Rule


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