Impact of Provisions of Revised Rules of FDA-Regulated Clinical Investigations

Rae Hintlian

Associate Editor

Loyola University Chicago School of Law, J.D. 2019

The FDA regulationson human subject protection and Institutional Review Boards(IRBs) provide guidance to protect the rights, safety, and welfare of subjects who participate in FDA-regulated clinical investigations. The regulations conform with the requirements set forth by the Department of Health and Human Services (HHS) Federal Policy of Human Research Subjects(45 CFR 46, part A).  In order to reduce confusion and burdens associated with complying with both the FDA regulations and the HHS policies regarding human subject protections, the FDA is revising the current “common rule”.


The Department of Health and Human Services, in its application of the Common Rule, regulates human subject research conducted or supported by HHS.  The purpose of the Common Rule is to promote uniformity, understanding, and compliance with human subject protections by creating a uniform body of regulations throughout the federal departments and agencies. After the Century Cures Actwas signed in 2016, it was determined that, to the extent practical, the differences of the HHS human subject regulation and FDA Human subject regulations would be harmonized.

What Will Change

The new requirements contain several changes to informed consent, expedited review procedures, and IRB continuing review procedures. The 2018 requirements for informed consent seek to change the content, organization, and presentation of information included in both the consent form and the process of obtaining a prospective subject’s consent. The 2018 requirements contain a new basic element, and three additional elements for informed consent. To be compliant, the informed consent form must include one of two statements involving the collection of identifiable private information or identifiable biospecimens. The first statement informs the potential subject of identifiers removed from private information or identified biospecimens, allowing the biospecimen to be used in future research studies or distributed to another investigator for further study without the informed consent of the subject. The second option informs the potential subject that the information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future studies. In addition to the above statements, the new rules require that the consent inform the potential subject of the potential for commercial profit, clinically relevant results, and if the study will include genome sequencing for any biospecimens.

The new regulations also set forth new expedited IRB review proceduresfor certain kinds of research where there is minimal risk, based on a list provided in the Federal Register. Under the expedited review procedure, the review must keep all members advised of the research proposals which have been approved. Further, the FDA may restrict, suspend, or terminate the IRB’s use of the expedited review when it is determined to be in the best interest of the welfare of subjects. In the instance of an IRB to conducting a continuing review, under the new regulations, the research must have progressed to the point that the only remaining activities are data analysis, and/or accessing follow-up clinical data from procedures that would generally be considered as a part of clinical care.  Thus, the new rules remove the requirement for continuing review of ongoing research for studies which have undergone expedited review or have completed study interventions.  Even if the continuing review is not required, the study team must still submit amendments for project changes, report adverse events, and terminate the project once it ends, or when all personal identifiers are removed and the biospecimens are destroyed.


In its decision to harmonize the use of informed consent with both the HHSand FDA Human Subjects regulations, trials should be better able to comply with the regulations.  Further, the changesto informed consent and expedited review procedures will better inform patients of the potential uses of the data or biospecimens collected while also allowing more studies which pose minimal risk to the patient. In allowing the FDA to restrict, suspend, or terminate IRB use of expedited review, the FDA is now granted more control of IRB procedures. Finally, the changes allow for studies which have progressed to the point where follow-up and data analysis are the only remaining procedures to be considered part of general clinical care, removing the need for continuing review of these studi