Promoting Disclosure and Understanding in Informed Consent: Optimizing the Impact of the Common Rule “Key Information” Requirement

Introduction

Millum and Bromwich (2021) provide a thorough and thoughtful analysis of what is required for sufficient informed consent, offering distinct conceptualizations of the ethical requirements of disclosure and understanding. They conclude by applauding the “key information” requirement in the 2018 revision of the federal Common Rule, which provides guidelines for protecting human research participants and now requires informed consent forms to begin with a presentation of key information about the research (Department of Health and Human Services (DHHS) 2018). The authors state that key information should be interpreted as the information that potential participants need to understand and would consider relevant to their decisions (Millum and Bromwich 2021). Here, we build on their analyses and examine the key information requirement’s potential to address the goals of both disclosure and understanding, identifying opportunities for investigators and IRBs to use this requirement to better support potential participants during the informed consent process.

Informed consent and the “key information” requirement

Criticism of informed consent forms is widespread among IRBs, investigators, and participants alike, generally describing informed consent forms as too long, complicated, and boring. And yet they are primary mechanisms through which potential participants receive information about a research study. The consent process for research involving human participants is regulated by a federal policy known as the “Common Rule,” in reference to its widespread adoption across federal agencies. In 2018, a major revision to the Common Rule went into effect, including a new requirement that states:

“Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.” (DHHS 2018)

This requirement notably does not specify precisely what counts as key information, although the Common Rule’s preamble identifies five elements that would constitute key information in most cases: the voluntary nature of participation; the research study’s purpose, duration, and procedures; its risks; its benefits; and alternatives to participation. The preamble also notes that the key information requirement aims to strike “an appropriate balance between facilitating the comprehension of subjects of key issues and allowing study-specific flexibilities” (Federal Register 2018).

Disclosure and understanding via key information

The Target Article’s reference to the key information requirement’s ability to promote both disclosure and understanding warrants consideration of how it supports these goals. We suggest that the key information requirement contains three distinct elements that support disclosure and understanding as envisioned by Millum and Bromwich: (1) emphasis on participant comprehension; (2) exploration of reasons why one might or might not want to participate; and (3) promotion of study-specific flexibilities. First, by prioritizing comprehension, the key information requirement encourages investigators to clearly communicate information about the study and what participation would entail, thus supporting potential participants’ understanding of what they are being asked to consent to and how to exercise their rights. Second, the key information requirement involves presenting the enrollment decision in a way that allows a potential participant to understand reasons for and against participation. Such presentation emphasizes that research participation is voluntary and that people make different choices for different reasons. It further ensures that investigators identify the information that would be relevant to a potential participant’s decision and that they would expect to be told in order to make that decision. Third, the key information requirement is designed to allow for flexibility based on each research team’s judgment of what information is known to them and relevant to, and reasonably expected by, potential participants and thus must be disclosed. It also supports understanding by enabling investigators to develop approaches that are best suited to their participants and study. If these flexibilities exist to support the goals of disclosure and understanding, we must next examine whether research teams have successfully supported these goals in implementing the key information requirement and where improvements could be made.

Key information in practice

The Secretary’s Advisory Committee on Human Research Protections (SACHRP), a group that advises the Secretary of the Department of Health and Human Services on protection of human research participants, wrote that the key information requirement “provid[es] an opportunity to fundamentally change and improve the consent process,” further commenting that “[t]he process of writing consent forms and obtaining consent had become stagnant and overburdened with competing purposes” (SACHRP 2018). However, it is not evident that such fundamental change has occurred since the 2018 revision to the Common Rule. Fundamentally changing informed consent is by no means an easy task. Research may involve complicated medical and scientific concepts that warrant a nuanced risk/benefit analysis. Regulatory requirements from local IRBs and hospitals may be slow to change. Issues with inherent regulatory and legal complexities such as privacy and data sharing can be difficult to convey simply. These issues are made ever more challenging in the reality of needing to communicate with potential participants in a variety of preferred languages, at varying levels of health literacy, and in often stressful clinical contexts.

In order for the key information section to live up to the goal of increasing accessibility and understandability of informed consent, we propose three primary areas of focus for improvement: (1) user-centered formatting; (2) articulation of study-specific reasons for and against participating; and (3) increased stakeholder involvement. First, investigators and IRBs must work to create user-centered formats so that the information presented is clear and understandable to a wide range of potential participants. Collaborating with experts in user-centered design and implementing strategies that incorporate more accessible formatting and multi-media tools could greatly increase the understandability of key information. Empirical bioethicists should also study the effects of different approaches to presenting information about research on people’s experience and decision-making (e.g. Speight et al. 2021).

Second, investigators must utilize the existing and growing literature on potential participants’ reasons for and against participating in research (e.g. Kim et al. 2012; Genetti et al. 2019), in addition to drawing on their own content-specific knowledge and soliciting input through community engagement. Our recommendation builds on the requirement to disclose information that might be relevant for a participant to understand “the reasons why one might or might not want to participate in the research.” We suggest that investigators explicitly state in the key information section actual study-specific reasons why some people might choose to participate and why some may not. When investigators present true reasons for and against participation, they support a choice that better fits the values of potential participants (Kraft et al. 2017) and promote respect for participants by emphasizing the voluntariness of the decision (Kraft et al. 2020).

Third, for informed consent form change to be actualized, buy-in from key stakeholders, including IRBs, patients and participants, and investigators, is essential. Collaborating with IRBs to identify institutionally acceptable ways to incorporate flexibility and comprehensibility into template language will greatly increase the likelihood of adoption of a less traditional consent form. Furthermore, IRBs are tasked with regulatory oversight of informed consent documents and therefore it is important to understand their views on what formatting and content is acceptable under the regulations. Collaboration with patient and participant stakeholders is also important in order to learn what a comprehensible consent form looks like for various types of research and what approaches best support understanding and decision-making (Dickert et al. 2020). Finally, investigators who are tasked with developing consent forms for their own studies must be supported in thinking through these nuances of disclosure and understanding. The “study-specific flexibilities” that the key information requirement allows will only result in consent form improvements if investigators have resources to help them identify the information that needs to be disclosed and present it in a way that facilitates comprehension and understanding.

Conclusions

The Common Rule’s key information requirement can promote both the disclosure and understanding requirements as described by Millum and Bromwich. The revised regulations not only permit, but also encourage, a more thoughtful approach to informed consent, but their successful implementation will require careful consideration and collaboration between investigators and IRBs. If the key information requirement is implemented with attention to user-centeredness, reasons for and against participation, and stakeholder perspectives, it has the potential to fundamentally improve the informed consent process’s ability to fulfill its ethical goals.