By Stacey Kusterbeck
The revised Common Rule (the U.S. Basic Federal Policy for Protection of Human Research Subjects) was implemented in 2019 to enhance protections for human research subjects. “To reduce the unnecessary burden for researchers, the revised Common Rule expanded the exempt research categories. It also reduced the number of protocols requiring IRB (Institutional Review Board) continuing reviews,” says Min-Fu Tsan, MD, PhD, a senior research scientist at McGuire Research Institute in Richmond, VA.
The revised rule no longer requires annual IRB continuing reviews for studies approved using expedited review procedures, for studies merely analyzing study data after completing all study interventions, or studies involving only observational follow-ups in conjunction with standard clinical care.
Tsan wanted to know how well the revised Rule has achieved its stated goals. Tsan analyzed data on Department of Veterans Affairs facilities conducting research involving human subjects (which ranged from 107 to 109 facilities during the study period of 2016 to 2024). The revised rule did, in fact, reduce the burden of low-risk studies for researchers. The number of studies in the exempt category of research increased by 259%. The number of protocols that required IRB continuing reviews decreased by 44%.
“Once studies are classified as exempt studies, researchers can go ahead with the studies without having them be reviewed by IRBs. That saves researchers and IRBs a lot of time,” says Tsan. Likewise, the revised Common Rule no longer requires IRBs to conduct annual continuing reviews on certain low-risk studies that previously required those reviews. “Studies approved by IRB using expedited review procedures needed to be reviewed annually by IRBs before the revision. Under the revised Common Rule, those studies no longer require IRB continuing reviews,” Tsan explains.
However, the revised rule appeared to impair human research subject protections. “The primary purpose of the Common Rule is to protect the rights and welfare of human subjects participating in research. Despite this, the revised Common Rule included no specific provisions that were designed to enhance human research subject protections,” notes Tsan.
Tsan evaluated five human research subject protection performance metrics. Two of the metrics remained unchanged (research conducted without IRB approval and serious, unanticipated research-related adverse events). The other three metrics deteriorated (continued research activities during a lapse in IRB continuing reviews, failure to obtain required Health Insurance Portability and Accountability Act [HIPAA] authorization, and failure to obtain required informed consent).
“This study reminds researchers that protecting human research subjects remains the highest priority in carrying out their research,” underscores Tsan. Tsan says that researchers should prioritize these practices:
Obtain informed consent and/or HIPAA authorization as required prior to enrolling subjects into the study.“If you audit all patient study records, you will find out that there are patients who were enrolled into research protocols without required informed consent and/or HIPAA authorization. Most people don’t conduct audits and assume that everything is fine!” says Tsan.
Take steps to minimize physical and psychological harms to subjects. “Most unanticipated, serious, and research-related adverse events are due to investigator noncompliance or errors,” says Tsan. In some cases, a study should have been suspended according to the IRB-approved protocols, but the researcher continued to conduct the research anyway.
Institutions and their IRBs should know how well they are doing in protecting human research subjects. “They should track their human research subject protection performance metrics annually and identify areas of vulnerability for quality improvement purposes. IRBs or institutions should conduct audits each year, and if the performance metric data deteriorated, they should find out why and take corrective actions before research participants get hurt,” underscores Tsan.
For example, if the researchers are not getting the required informed consent from every participant, then IRBs should notify the researchers and provide additional training.
Informed consent cannot be obtained from patients or other prospective participants unless they understand the information being presented to them, however. “While some PIs (principal investigators) and their research teams do an excellent job of creating easy-to-comprehend informed consent documents, many do not,” says Susan E. Morgan, PhD, a professor in the Department of Communication Studies and former associate provost for research at the University of Miami.
Morgan’s work and research focuses on clinical trial communication. “I am deeply concerned about informed consent issues,” says Morgan.
Some clinical research coordinators are expected to follow a script closely and are discouraged from “translating” information into lay language. PIs may be concerned that clinical research coordinators (CRCs) will present a study in a way that falls short of 100% technical accuracy. “Directing them to follow a strict script helps prevent this type of problem. But I would argue that CRCs need to be better trained on study details if this is a problem,” says Morgan. Following a script does not ensure that patients will have enough of the right type of information to make an informed decision about participation.
Some informed consent forms use jargon such as “primary endpoint,” “key secondary endpoints,” and “patient-reported outcomes.” “How can an ordinary person make a decision — one way or the other — about whether they should join a clinical trial when they cannot understand the information?” asks Morgan.
Morgan offers this as an example of an explanation, in lay language, of what a study is about: “The goal of this study is to look at how long people who take this drug live compared to people who do not. This study will also look at whether taking this medication helps to delay cancer from coming back. We will also look at whether this medicine helps people have a higher quality of life during their treatment.”
“I believe that academic medical institutions need to be consistently required to use lay language in informed consent forms. I don’t see IRBs following through on this consistently,” says Morgan.
Patients want a balanced picture of the risks and benefits of study participation. “IRBs seem to strongly discourage the presentation of possible benefits. Yet, they require detailed presentation of every conceivable risk associated with study participation. This legal risk-centric approach is not consistent with a patient-centric approach to communicating about study participation,” argues Morgan.
IRB members are concerned about wanting to protect patients from being pressured to participate in studies. “But at what point are we manipulating patients away from fully considering a viable treatment option when we present an imbalanced picture of potential outcomes or use unnecessarily complex language?” asks Morgan.
Complex medical and scientific jargon prevents patients from understanding both the risks and the benefits of study participation. “If [the] benefits of participation aren’t given equal weight to the risks, prospective participants are likely to say no,” says Morgan. “Information about clinical trials takes significant amounts of cognitive effort to process. We need to be good stewards of the energy required by patients to understand what we’re asking of them and offering to them.”
Some patients want the opportunity to contribute to scientific breakthroughs to reduce human suffering. “But this is not acknowledged as a factor that can contribute to informed consent,” adds Morgan. IRBs tend to closely scrutinize any presentation of the benefits of participation to prevent people from being misled or pressured to participate. As a result, researchers may avoid talking about altruism or contributing to scientific discoveries, which are deeply meaningful to some prospective participants.
Researchers are ethically obligated to make sure people are well-informed before they decide to participate — or not to participate. “It’s not just about informed consent,” says Morgan. “Uninformed refusal is just as problematic as uninformed consent because the cost to society — through delays in the advancement of medical science, as well as to individuals who actually do want to pursue cutting-edge medical care — is high.”
Reference
1. Tsan MF. Impact of the revised Common Rule on enhancing human research subject protections and reducing researcher burdens. Qeios. 2025; Mar 3. https://doi.org/10.32388/TU6VRN.2
The revised Common Rule (the U.S. Basic Federal Policy for Protection of Human Research Subjects) was implemented in 2019 to enhance protections for human research subjects. Min-Fu Tsan, MD, PhD, wanted to know how well the revised Rule has achieved its stated goals.
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