ABSTRACT
OBJECTIVES: Institutions conducting research involving human subjects establish institutional review boards (IRBs) and/or human research protection programs to protect human research subjects. Our objectives were to develop performance metrics to measure human research subject protections and to assess how well IRBs and human research protection programs are protecting human research subjects. METHODS: A set of five performance metrics for measuring human research subject protections was developed and data were collected through annual audits of informed consent documents and human research protocols at 107 Department of Veterans Affairs research facilities from 2010 through 2021. RESULTS: The proposed performance metrics were: local adverse events that were serious, unanticipated, and related or probably related to research, including those that resulted in hospitalization or death; where required informed consent was not obtained; required Heath Insurance Portability and Accountability Act authorization was not obtained; non-exempt research was conducted without IRB approval; and research activities were continued during a lapse in IRB continuing reviews. Analysis of these performance metric data from 2010 through 2021 revealed that incident rates of all five performance metrics were very low; three showed a statistically significant trend of improvement ranging from 70% to 100%; and none of these five performance metrics deteriorated. CONCLUSIONS: Department of Veterans Affairs human research protection programs appeared to be effective in protecting human research subjects and showed improvement from 2010 through 2021. These proposed performance metrics will be useful in monitoring the effectiveness of human research protection programs in protecting human research subjects.
ABSTRACT
The Federal Policy for the Protection of Human Subjects, generally referred to as the "Common Rule," is the basis for the human research protection policies of 16 signatory federal agencies and governs virtually all federally funded research involving humans. The Common Rule was originally published in 1991. It has been recognized that changes to the Common Rule are needed to accommodate changes in the research environment and advances in information technology. The Department of Health & Human Services (HHS) issued an Advance Notice of Proposed Rulemaking in the Federal Register in 2011 and a Notice of Proposed Rulemaking in 2015. The final rule was published on January 19, 2017, just prior to the change in presidential administrations. The long gestation of the new Common Rule reflects the difficulty of obtaining consensus on a number of controversial issues. HHS received more than 2100 public comments on the proposed rule. The revised rule introduces important changes that may be particularly relevant to clinical pharmacology research and drug development. These include: (1) revised informed consent requirements, (2) procedures for "broad consent" to facilitate secondary research use of identifiable private information and/or biological specimens, (3) a mandate to promote review by a single institutional review board (IRB) for oversight of federally funded domestic cooperative research involving multiple institutions, (4) expansion of the categories of exempt research, and (5) removal of the requirement for annual continuing IRB review of research in which the remaining activities are limited to data analysis or accessing clinical follow-up data. Also noteworthy are proposed revisions not included in the final rule, including one to extend the Common Rule to multicenter studies that are not federally funded and one to require informed consent for research use of de-identified biological specimens. Major changes could also be coming for approval of new drugs by the Food and Drug Administration (FDA), although it is not a signatory to the Common Rule. The 21st Century Cures Act, which became law in December 2016, enables faster drug approvals by expanding the kinds of evidence, beyond traditional clinical trials, that the FDA can consider when reviewing new drug applications. For example, the law allows greater use of surrogate markers and data from "real-world experience" to evaluate a drug's efficacy. The Cures Act requires HHS and the FDA to harmonize differences between the Common Rule and FDA regulations for protection of human subjects in research.
