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Should Minimal Risk Clinical Trials Require A Different Informed Consent?
(Thursday October 24, 2024) Clinical trials require controls and robust informed consent. However, ethicists argue if the one-size-fits-all approach should be customized to the perceived risk of a given trial. Should the trail risk be determined by the regulators and the information shared with the participants via the informed consent be reduced for lower-risk trials to encourage more investigator participation? The article proposes as adjustment to clinical trial oversight rules. Whether they lead to change or not, these issues need to be understood, particularly in the context of pragmatic clinical trial where clinical care and clinical research intersect. The article presents two recommendations to update research oversight in clinical studies. The first recommendation is for a formal classification of the risk of clinical trials by the FDA. Both the Common Rule and the FDA regulations allow adjustments for minimal-risk studies, but the authors argue there is a need for more specific guidelines to assess the risk level of any clinical trial. The proposed approach suggests that minimal-risk designation should be based on the extent to which research participation increases risks, burdens, or restricts meaningful patient choices compared to standard clinical care. If research only minimally adds to the risks and burdens of usual care, it should qualify for minimal-risk classification. The second recommendation is more aggressive. The authors propose partial informed consent with simplified disclosures or short verbal agreements, providing participants with key information without the full consent processes. The authors contend that such abbreviated consent may be appropriate for low-risk studies such as randomized comparative effectiveness studies, especially those involving post-market products. The authors argue that reduced consent requirements may encourage more clinicians and healthcare systems to participate in studies, particularly those with minimal disruption to clinical routines. Currently, busy clinicians often opt out of participating in research due to the added burden of lengthy consent discussions, even when the research poses little additional risk. The proposed guidance would help address this issue by emphasizing that oversight should focus on the additional risks introduced by the research, rather than the risks inherent in clinical care. The article argues that regulators should promote these alternatives, as they offer a balanced approach—maintaining transparency and participant autonomy while reducing the administrative burden on clinicians and health systems. This would allow more clinical studies to be conducted efficiently without compromising ethical standards. These recommendations could be incorporated within the current regulations. Sponsors of clinical trial and IRBs, that review these studies, already designate the risk-level of clinical trials. IRBs routinely determine if the trials involve significant or non-significant risk and allow flexibility in the informed consent. The authors of the article present the conundrum in front of physicians conducting clinical trials in their clinics where the additional work needed for the clinical trial make seem daunting. While these recommendations are purely theoretical, they raise concerns commonly raised by physicians conducting pragmatic clinical trials where clinical care and clinical research coexist and the physicians find the clinical trial process to be onerus and unnecessary. New rules take much longer than better education and training of investigators about the flexibility available within the current law. Food for thought. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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