Rescuing Informed Consent: How the new “Key Information” and “Reasonable Person” Provisions in the Revised U.S. Common Rule open the door to long Overdue Informed Consent Disclosure Improvements and why we need to walk Through that door

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.Rescuing Informed Consent: How the new "Key Information"… or device's promise (Kimmelman and Henderson 2015), the nature of the promise is such that it is proportional to all the potential risks entailed by its pursuit, and the trial is an instance of disinterested science capable of producing unbiased knowledge. As shown below, there is often evidence that calls the accuracy of both this endorsement and the background frame into question, evidence critical to research candidates being able to understand what others are wanting to use them for, and why, which presently falls by the wayside due to the historically parsimonious disclosures in informed consent processes. With these basic considerations about clinical research and informed consent in mind, let us now turn to the previously referenced evidence to understand why it is key information that needs to be disclosed in the informed consent process.

Characterization of key information sections in informed consent forms posted on ClinicalTrials.gov

“…While many of the sampled KI sections in our analysis aligned with the few expectations specified in the preamble to the revised Common Rule, we also identified areas in which KIs could be significantly improved. Although many have called for the issuance of formal regulatory guidance to clarify the regulatory requirements for KI sections [7,16,40], more systematic research is needed to inform development of such guidance. In the short term, the research community should strive toward consensus-based guidelines to support the development of effective and understandable KI sections.…”

“…Further, in 2018, the US Department of Health and Human Services (HHS) Secretary's Advisory Committee on Human Research Protections (SACHRP) offered a list of questions to help determine the content of KI sections [13], although these questions explicitly were not designed to be either comprehensive or to "be used as a checklist" [13]. Others have also considered what topics should be included in KI sections [14][15][16][17].…”

A Modern History of Informed Consent and the Role of Key Information

“… 31 In a different commentary, Mark Yarborough also recognized the key information requirement as a critical opportunity to improve the process of informed consent but more specifically through its potential to create new standards for disclosure. 32 In cataloging the proposed changes to informed consent under the revised rule, Jeremy Sugarman noted that the revised rule retains the focus on a traditional written document. 33 In contrast, Kraft and colleagues called for improving the consent process by offering reasons why some enroll in research and other choose not to enroll.…”

Do we really know how many clinical trials are conducted ethically? Why research ethics committee review practices need to be strengthened and initial steps we could take to strengthen them

“…If so, then they could at least consider another reform that has been recommended, which is for RECs to require informed consent disclosures that would alert research candidates to the fact that there is no guarantee that the clinical trials they are considering joining will be appropriately analysed and reported. 66 Even if there were agreement around either or both of these recommended changes in REC practices in order to combat sponsorship bias, they likely would suffer the same fate as other published recommendations for reforming REC practices. Such recommendations rarely get put to the test to see if they can achieve their intended reforms.…”