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Rescuing Informed Consent: How the new "Key Information" and "Reasonable Person" Provisions in the Revised U.S.
1Bioethics Program, University of California Davis Health, 4150 V Street, Suite G100, Sacramento, CA, 95817, USA. mayarborough@ucdavis.edu.
Abstract:
There is substantial published evidence showing that countless people enroll each year in ethically deficient clinical trials. Many of the trials are problematic because the quality of the science used to justify their launch may not be sufficiently vetted while many other trials may lack requisite social value. This poses the question: why do people volunteer for them? The answer resides in large part in the fact that informed consent practices have historically masked, rather than disclosed, the information that would alert research candidates to the ethically problematic nature of the trials. The "reasonable person" and "key information" provisions in the revised US Common Rule create the opportunity to correct this historical shortcoming. Two sources are employed to shed light on what the "key information" is that should be disclosed to a "reasonable person": the original disclosure aims of the Nuremberg Code, as well as an extensive body of meta-research evidence. Those sources jointly support a range of new disclosures in the informed consent process that would unmask the heretofore undisclosed information. The resulting proposed new disclosures pertain to the overall success prospects of clinical trials, the quality of the prior research that both forms the basis of clinical trials and informs assessment of their risks and benefits, the potential social value of clinical trials, and the commercial purposes of clinical trials.
Insights
Many people enroll in ethically flawed clinical trials because informed consent often hides crucial details. New rules and research suggest disclosing trial success rates, scientific quality, social value, and commercial aims to protect volunteers.
Area of Science:
- Bioethics
- Clinical Trial Ethics
- Informed Consent Research
Background:
- Numerous individuals participate in ethically compromised clinical trials annually.
- Ethical deficiencies stem from inadequate scientific vetting and lack of social value.
- Informed consent processes historically obscure, rather than reveal, trial ethical issues.
Purpose of the Study:
- To investigate why individuals volunteer for ethically deficient clinical trials.
- To leverage revised US Common Rule provisions ('reasonable person,' 'key information') to improve informed consent.
- To propose enhanced disclosures for clinical trial informed consent.
Main Methods:
- Analysis of the disclosure aims of the Nuremberg Code.
- Review of extensive meta-research evidence on clinical trial quality and outcomes.
- Synthesis of these sources to identify necessary 'key information' for 'reasonable person' disclosure.
Main Results:
- Identified specific areas for improved disclosure in the informed consent process.
- Proposed disclosures include trial success prospects, quality of foundational research, social value, and commercial interests.
- These enhanced disclosures aim to reveal previously hidden ethical concerns to potential participants.
Conclusions:
- Revised informed consent practices can address historical shortcomings in participant protection.
- Disclosing trial success rates, scientific rigor, social impact, and commercialization is crucial.
- Implementing these changes can empower research candidates to make more informed decisions.
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