Sarah B. Galeli
Loyola University Chicago School of Law, J.D. 2020
The Common Rule, the Federal policy protecting human subjects of biomedical and behavioral research, was published in 1991. The process to update the policy has taken place over the last several years, leading to the final rule revisions which were effective as of July 19, 2018. After January 20, 2019, institutions are now permitted to implement the entirety of the revised Common Rule. Any institution receiving funds, supervision, or review from any of the twenty Federal Departments and Agencies that have codified the Common Rule must implement this revised rule in their compliance programs.
The Common Rule
A quick primer on the Common Rule: in 1979, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research wrote the Belmont Report. The report developed basic ethical principles for research involving human subjects. In the years following the Belmont Report, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) revised their agency regulations for research on human subjects to make them as compatible with the report as possible at the time.
In 1991, the Federal Policy for the Protection of Human Subjects (Common Rule) was published and subsequently codified by fifteen Federal departments and agencies. The HHS regulations contain subparts for the Common Rule: pregnant women, human fetuses and neonates; prisoners; and children involved in research conducted or supported by HHS. These regulations cover every agency under HHS and are similar to those rules codified by other Federal departments. The FDA’s Common Rule protections affect regulations on human subject protections, and Institutional Review Boards specifically protect human subjects participating in FDA-regulated clinical investigations. While historically fifteen departments and agencies codified the Common Rule, after the revision process twenty Federal departments and agencies have codified the revised version of the Common Rule.
Process Leading Up to the Revisions
In July 2011, the Federal government provided advance notice that it would be seeking comments on potential revisions to the Common Rule. The Common Rule had a history of mixed reactions, with many in the public finding informed consent and the ability to control their genetic information to be a controversial topic. This advance notice informed the public that comments on the Common Rule revisions had to be received by September 26th of the same year to be taken into consideration.
In September 2015, another public comment period was held through December 7th of the same year. The departments and agencies utilizing the Common Rule proposed revisions to “modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects” that went into place in 1991. These departments and agencies once again set this comment period for proposals toward better protections for human subjects involved in research “while facilitating valuable research and reducing burden, delay, and ambiguity for investigators”. The overall effort of these proposed rule changes was to modernize, simplify and enhance the system of oversight.
In January 2017, a public notice about the final rule implementing the revisions to the Common Rule was announced. The final rule “strengthens protections for people who volunteer to participate in research, while ensuring that the oversight system does not add inappropriate administrative burdens”. Notable changes included the flexibility the new provisions allowed and the change requiring consent forms to contain a brief explanation of the most important information for participants.
Throughout 2018, the revised Common Rule compliance date was delayed. First, for additional public comments, another setting out the effective date and general compliance date, and finally the general compliance date of the revised Common Rule was set for January 21, 2019. The final delay was caused by some minor changes in the text, but the delay period essentially meant that regulated entities, entities that facilitate biomedical and behavioral research on human subjects, were required to continue to comply with the pre-2018 version of the Common Rule until January 21. These entities were permitted to implement three “burden-reducing provisions” of the revised version for “certain research”. Now that the general compliance date has passed, regulated entities should be familiar with the revisions to the Common Rule and ensure their compliance with the rule.
The most notable changes in the revised version of the Common Rule are the expanded types of research exempted from the Common Rule, alterations to the continuing review requirement, changes to the informed consent requirements, an allowance for a single Independent Review Board (IRB) for research taking place in multiple facilities, and minor changes to IRB’s electronic submission system and ongoing research.
The revised Common Rule allows for more types of research to be exempt from the Common Rule requirements through the revision of, as well as the addition of, exemption categories. Research on educational instructional strategies, that only involves interactions between the investigator and the subject, or that which involves only brief interventions between the investigator and the subject are all exempt from the revised version of the Common Rule. There is now a broader definition of secondary research that is allowed under the exemption category and research conducted or supported by a Federal agency, including those funded by a Federal agency, now falling under the exempt category. The storage or maintenance or identifiable private information or biospecimens for secondary research may be exempted if an IRB conducts a review and secondary research involving the use of identifiable private information, or identifiable biospecimens, now require broad consent for storage, maintenance, and use, documentation of an informed consent waiver, and IRB must conduct a limited review and determine the research is within the scope of the consent, and the investigator does not return individual results to subjects as part of the study plan.
The final version of the revised Common Rule also eliminates continuing review for certain types of research studies. Non-clinical research, benign behavioral interventions, and consumer preference surveys and research where there is a minimal risk to human subjects will no longer require continuing review. If an IRB decides to require a study to undergo continuing review, then they must document the reason behind requiring the continued review. Continuing review is not eliminated in every circumstance, for instance with FDA-regulated studies still require annual review.
The new Common Rule also revised the requirements for informed consent for research studies involving human subjects. The most notable requirement is that the informed consent must inform the human subject 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.” The consent document must also be “organized and presented in a way that facilitates comprehension” of the study. Informed consent must now include 1) statement explaining the purpose, procedures, and reasonably foreseeable risks of the research requesting consent; 2) statement informing the subject that their biospecimens may be used for commercial profit and whether the subject will receive part of that profit; 3) statement of whether research results will be returned to the subject, and if so under what conditions; and 4) statement for research involving biospecimens explaining whether the research will or might include whole genome sequencing. Broad consent is allowed in secondary research involving use, storage, and maintenance of identifiable information and biospecimens. For research involving identifiable information, the human subjects should be provided with 1) a statement that identifiers might be removed from identifiable information; 2) the identifiable information could be used for future research studies without additional consent; or 3) that the subject’s information collected as part of the research will not be used or distributed for future research studies.
Finally, cooperative research study requirements were established in the revised version of the Common Rule, however they will not take effect until January 19, 2020. These requirements cover instances of cooperative studies (the same research study is taking place at multiple institutions), in which a single IRB must approve the cooperative study. This doesn’t apply if approval by more than a single IRB is required by law or where the federal department or agency supporting or conducting the research study determines that the use of a single IRB is not appropriate. The federal department or agency supporting or conducting the research or the lead institution subject to the supporting or conducting federal entity will identify the IRB. The institution with the approved IRB oversight has the responsibility of preparing documentation identifying the responsibilities of each entity participating in the research study.
The revised Common Rule has been a work in progress for years and as of last month is now in effect for institutions receiving federal funding for studies involving biomedical and behavioral research on human subjects. The revisions primarily affect institutional IRBs and how research studies interact with the institutional IRBs to maintain compliance with the codified Common Rule.