Some of the most significant changes in the revised Common Rule involve the provisions around informed consent, including the new requirement that informed consent begin with a “concise and focused presentation of 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” [46.116(a)(5)(i)]—the “key information requirement,” for short.
I welcome the key information requirement and think it has the potential to greatly improve informed consent, but it is bringing with it several complexities. One is how to operationalize the requirement. Some in the research oversight community are eager to see guidance from the Office for Human Research Protections (OHRP), while others—and I count myself among them—worry that guidance might be constraining and, more importantly, contrary to the spirit of the provision (more on that below). Some institutions are creating templates for the key information portion of consent, but, notably, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) recommends against the creation of standardized approaches, again suggesting that such standardization would undermine the requirement’s intent. In the meantime, institutions are struggling with how to guide their investigators and research teams to meet the requirement.
Part of the issue is that there is an imperfect fit between the key information requirement and the processes and procedures that institutions currently use to implement regulatory informed consent. Under the pre-2018 Common Rule, one could meet at least the “letter” of the informed consent requirements by ensuring that the consent document or process included all eight requirement elements, and any relevant additional elements (presented in understandable language and in conditions free of coercion or undue influence). That approach lent itself to the use of templates or other “check box” approaches.
Under the revised Rule, informed consent must still include required and additional elements, and must also now be organized and presented in a way that facilitates understanding of the reasons for or against participation—itself a not insignificant change. In addition, informed consent must begin with a “concise and focused” presentation of the information that is “most likely” to help a potential subject “understand the reasons why one might or might not want to participate in the research.” The rule presents no checklist for what that information is. Indeed, what information is “key” in this sense will be context-dependent in a number of ways—it will vary by study design, by intervention, by disease or condition, by study population, and possibly even by local setting. Determining what is key information in any particular case will, then, require making judgements about what a reasonable person who is offered enrollment in this study, at this site, would want to know about what the decision to enroll in the study (or not) would mean for them.
The preamble to the revised rule lists five topics that regulators expect, generally, to be addressed in a key information presentation, but that language is not binding, and the final rule “does not strictly specify the types of information that should or should not be included to satisfy [they key information requirement]….” The preamble, in fact, emphasizes the “advantages of allowing institutions to design informed consents…that are tailored to particular research studies….” As I noted above, SACHRP’s recommendations on the topic, too, emphasize the need for flexibility, though they identify nine questions to help IRBs and authors of informed-consent materials identify what the key information might be for any study.
So, the key information requirement doesn’t, by design, lend itself to a check box or standardized approach. How, then, is it to be operationalized? How does one determine what is key information? Who is in the best position to do that? What kind of information, data, or resources are needed to support making that determination? And what guidance can be given to consent authors and reviewers? These are questions that institutions are now struggling with as they seek to implement the new requirements.
The recently constituted Consortium to Advance Effective Research Ethics Oversight (AEREO)—whose goal is to use empirical approaches to evaluate and improve the effectiveness of HRPPs and IRBs—is currently running a project to gather information about and assess how the key information requirement is being implemented across institutions.
To my mind there is also another complexity around the key information requirement, this one more conceptual: what is the function of the key information portion of consent with respect to the function of informed consent as a whole?
Informed consent is the primary (though certainly not the only) way we operationalize the core research ethics principle of respect for persons: respecting potential research subjects as persons demands that they be given the opportunity to provide their informed consent to participate in research. Conceptually, informed consent has three “parts”: (1) disclosure of information; (2) comprehension of (at least some portion of) that information; and (3) a voluntary decision that is in some sense “based on” that information (all assuming that the person has the capacity to make autonomous decisions).
Since they were codified, the regulations have included a requirement that investigators obtain subjects’ informed consent. Notably, the specific requirements have almost exclusively focused on disclosure—what information needs to be provided, and how, to support the giving of informed consent. Those seeking consent are required to provide certain pieces of information, in understandable language, in circumstances free from coercion and undue influence, and with the opportunity to ask questions. Meanwhile, there are no specific requirements having to do with ensuring comprehension or that a subject’s decision is based on that comprehension.
Stakeholders across the research enterprise have long agreed that the way regulatory informed consent is implemented is not meeting the ethical goals of consent. We’re all familiar with the reasons why: consent forms are too long, they are not written at the appropriate reading or health-literacy levels of most potential subjects, and they are written in language that seems more focused on protecting institutions from legal liability than providing useful information to a potential subject. As a result, informed consent, even when it meets the letter of the regulations, does not facilitate obtaining truly informed consent.
The changes in the Common Rule are an attempt to address this problem by placing much more emphasis on how information is presented to potential subjects, and, more specifically, that it be presented in a way that facilitates understanding of the reasons why one might or might not choose to participate in the research. The new rule explicitly acknowledges that it is not sufficient to just disclose a “list of isolated facts,” because disclosing information in this way, no matter how comprehensive or “understandable,” does not facilitate comprehension of the reasons to participate or not, nor, therefore, decision making. Rather, facilitating comprehension and decision making requires identifying the information that would be most useful for making a decision about participating, pulling it out of the rest of informed consent, and communicating it in a focused and clearly demarcated way.
While the emphasis is still almost exclusively on disclosure—that is, what is communicated and how—I think the changes are a positive step toward improving informed consent precisely because they ask consent authors to organize and present information in a way that supports decision making. But to me this has also raised a question about what the rest of the informed consent document or process is now “doing.”
Ivor Pritchard, Senior Advisor to the Director of OHRP, has suggested in recent presentations on the subject that we should think of the key information portion of the consent as a decision aid or guide. But since we’re used to thinking of informed consent, as a whole, as informing and guiding decisions to participate in research (or not), what does this mean for how we think about the function of the rest of the informed consent document or process?
After all, if the key information portion of informed consent is supposed to communicate the information that is most material to a decision of whether or not to participate—information that would make a difference to a reasonable person trying to make that decision, and therefore that we would want someone in that position to have—it follows that some required elements of regulatory consent may not qualify as key information. Some of those elements may, in fact, rarely be key information. Consider in this context the required element of providing a contact person for answers to subjects’ questions—it is hard to imagine that information being critical to a decision to participate in research or not. Nevertheless, the regulations require that information be provided, as part of the informed consent process. (On the other hand, as SACHRP notes, whether there will be post-trial access to the study drug might in some cases be key information, even though it is not a required or additional element of consent).
The suggestion seems to be that the function of informed consent, as a whole, is to provide information that people should have, or may want to know, about a research study, but not necessarily information they need to have in order to make the decision whether or not to participate in that study.
Inherent in this bifurcation between information that people should have in their possession and information that is relevant to their decision making is an acknowledgment, and maybe codification, of what we have long known, and what empirical research has borne out, about informed consent—namely, that giving people a whole lot of information does not foster understanding. People do not and cannot digest 20, 30, 40 pages of information, and, therefore, information so provided likely isn’t actually doing a very good job of informing their decisions.
So I applaud the introduction of the key information requirement, and I think, if we can get the operational challenges worked out, we may find that it succeeds in better supporting informed decision making—though whether it does so or not will be an empirical question.
I can’t help but think, though, that the revised Common Rule changes what regulatory informed consent is doing. The rule entails that a process would not count as legally binding or valid informed consent if the person being invited to give their consent were not provided with key information, as well as the required and relevant additional elements, all presented in a way that facilitates understanding, and in circumstances free from coercion and undue influence, etc. But the rule also seems to allow that a person might reasonably make a decision to participate based on considering the key information alone, without consulting the rest of the information provided in the consent (leaving aside here questions about whether that information is actually comprehended, and how we would know—important and complex issues beyond my scope here). Dr. Pritchard has suggested that the rest of the information might be seen as a resource that a potential subject could consult later. This may very well be a codification of what is largely happening already with informed consent, but it also seems to me to represent a change in “official” thinking about the function of regulatory informed consent, and I’ve been surprised more hasn’t been made of that.
What do you think? Do you share my puzzlement, or am I over-interpreting this change? I’d love to hear from you.
PRIM&R has an upcoming webinar, Real-World Approaches to Informed Consent under the Revised Common Rule, on Wednesday, October 23, that will explore the informed consent requirements in the revised Common Rule and share real-world experiences/strategies from three institutions. Learn more and register on our website.
We preface our Key information section by saying that the information in this section is a snapshot of what to expect in order to help with the decision process – information we think will be helpful in making a decision. We hit the overall purpose, that participation is completely up to the person being asked, what to expect if they participate (“the study involves blood draws, surveys, how often to come for visit, time requirement, etc. – but this is a BRIEF overview and we instruct them to read the Detailed section for specific information), most common risks, most lethal risks ( and again, see the detailed section for a complete list), what they can expect to be reimbursed and costs they may incur. We include reason(s) why one might or might not want to participate based on the type of research the study will be doing ( For example: You might not want to participate if you want to know what drug you are taking – if the study is blinded). At the conclusion of the Key information section, in which we have opted to use succinct bullet points, we tell them that if they are leaning towards participation they should continue to the Detailed section where other important information and more explanations are provided. We try to limit Key information to the first page, but no longer than 1-1/2 pages. We had pushback at first, but now we seem to have gotten into a groove. And while we try to follow the overall gist of Key information, that information certainly changes with respect to the type of study being done. Our detailed section does not repeat Key information, but it does expand upon concepts and also includes elements that are required that were not addressed in the Key section.
Just wanted to share a couple of complexities our IRB has faced in terms of the key information requirement:
– We are using templates for this section, and are asking for key procedures and key risks to be included. The research team fills out the template and submits them to the IRB. We’ve found that investigators are sometimes leaving out key procedures and risks from key information. For instance a study that involves experimental radiation therapy, may list procedures in the key info as blood draws, vital signs, and questionnaires, without much language on the radiation. Risks of the experimental procedure may include serious risks, but those are omitted in favor of more palatable ones in the key information. We’ve discovered that, with the new key info requirement, we have to be very cautious about not approving a consent form that could reasonably be called a “bait and switch.” Study doesn’t sound too involved or risky in the key information, but if the subject reads the “fine print” of the remainder of the consent, it is much more involved, and much riskier.
– SACHRP recommended in their key info guidance, that if a consent element is sufficiently covered in the key information section, it need not be repeated in the body of the consent. In trying to implement this in practice, as consent forms go back and forth between IRBs and research teams, and elements may be shifted between key info and the main consent, occasionally a required element is missing when the final consent is awaiting approval. So important to do that final checklist review, right before sending out the approval, to ensure that all required elements are present.
I share your puzzlement about this element. What I do NOT think it should be is a short version of the consent elements; that is simply redundant and leads to diminishing the worth of the following information. What I am urging is viewing it as more of an elevator pitch – you have 1 minute to tell the possible subject – in an unbiased fashion – what the study is about and why they might think about considering it in more detail. It should likely be no more than a half page and should be visually distinguishable from the consent form itself.
If we simply want to point to “key” places in the detailed information, why not include a table of contents in the key information section? Interested in risks??? click here.
SACHRP talked about the preamble but it also said that, “the fact that these elements are listed in the preamble makes them attractive as a safe harbor of sorts. SACHRP believes such a use may not be in keeping with the intent of the regulatory change.” Keeping to a recitation of the elements is safe for the institution but is it really useful, does it assist the subject or could it be detrimental?
In these early days, why not explore your options a little.