On September 8, the Department of Health and Human Services (DHHS) issued a Notice of Proposed Rulemaking (NPRM) for revisions to the Federal Policy for the Protection of Human Subjects , or “Common Rule.” If adopted, the proposals in the NPRM will result in the most substantive revisions to the core regulation governing federally funded human subjects research in the United States since 1981.
In earlier posts, we explored a new category of activities that would be excluded from oversight under the Common Rule and proposed changes to the category of exempt research. We also reviewed the NPRM’s broad consent provisions for biospecimens research.
In this week’s post, we examine the NPRM proposals related to informed consent, including the waiver provisions.
Overview of Informed Consent in the NPRM
The NPRM outlines several new requirements about how information must be organized and presented to potential subjects to facilitate their understanding of the reasons to enroll in a research study or not. It emphasizes that potential subjects must be “provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate [in research]” [§__.116]. It also addresses the structure of an informed consent document.
Specifically, the NPRM proposes to reorient informed consent language to highlight the “essential information that a reasonable person would want to know” (DHHS 2015, 53970). An investigator who is obtaining informed consent would have to present the required information before any additional information is provided. This additional information must be placed in an appendix [§__.116]. The NPRM cites concern that, too often, subjects receive lengthy informed consent documents where important information is “buried” (DHHS 2015, 53970). The Secretary of DHHS will publish guidance on how consent forms should be written in order to comply with the new regulatory requirements.
The NPRM also proposes changes to the Common Rule’s provisions on waivers of informed consent [§§____.116 (e), (f) and ____.117]. DHHS cites concern that the current Common Rule criteria for waivers is not “flexible enough for dealing with a variety of circumstances, such as when federally sponsored research is conducted in an international setting where for cultural or historical reasons signing documents may be viewed as offensive and problematic” (DHHS 2015, 53975). Thus, under the proposed rules, the requirement for signed informed consent may be waived if the human subjects belong to “a distinct cultural group…for whom signing documents is not the norm” as long as the research is of minimal risk and that there is a mechanism to document that informed consent was given (DHHS 2015, 53977). It is important to note that the documentation requirement for informed consent may not be waived if the research is regulated by the FDA, “unless otherwise authorized by 21 CFR 56.109(c)(1)” (DHHS 2015, 54055). HHS received few comments on this area when the ANPRM was released in 2011.
Finally, the NPRM is requiring that a copy of the informed consent form for each federally supported trial be posted on a public federal web site. The form must be posted within 60 days after the trial closes recruitment by either the awardee or the federal department conducting the trial [§__.116(h)(1)(2)].
Analysis of Proposed Changes
Informed consent is an essential component of research with human subjects, as it operationalizes the principle of respect for persons and, when done successfully, provides potential subjects with an opportunity to make an informed decision about research participation, based on an understanding of the nature of the research, its risks, and its benefits. The NPRM, which, as discussed above, includes new requirements aimed at ensuring potential subjects are able to make thoughtful research participation decisions, clearly recognizes this fact. For those who have been lamenting the trend of longer and longer consent forms that seem more focused on protecting institutions from liability than providing potential research subjects with adequate information to support their autonomous decisionmaking, the informed consent proposals will be seen as a move in the right direction.
However, the NPRM does not create requirements or incentives to utilize techniques that have been demonstrated to enhance the consent process, such as tools aimed at assessing understanding. Furthermore, some of the NPRM proposals do not seem adequately informed by the wealth of empirical research on best practices in consent and the facilitation of subject understanding that has been generated since the regulations were first promulgated.
One notable example is the requirement to post consent forms on a public website. This requirement may reinforce the perception that a consent form is, if not the only acceptable way to obtain informed consent, the most important part of the consent process. However, when done properly, informed consent involves a robust and purposeful discussion that allows time for questions and that utilizes tools, such as visual aids, aimed at fostering subject comprehension.
The posting requirement also perpetuates the use of standard, written consent forms at a time when such a model is rapidly becoming outdated. Indeed, with the emergence of new technologies, many innovative ways of obtaining consent are being proposed and tested with the ultimate goal of enhancing subject understanding. A regulation that requires posting a standard form may in the end stifle such innovation, a result that contradicts DHHS’ stated goal of modernizing the regulations governing human subjects research.
In the absence of evidence to suggest otherwise, the requirement to post consent forms may well result in additional administrative burdens without corresponding gains for subject protections. However, DHHS may wish to consider the advantages of incentivizing sponsors and institutions to voluntarily share consent forms and investing in empirical evaluation of whether the availability of consent materials on a public website benefits the research enterprise or research subjects.
Members of the research ethics and oversight community are encouraged to share their thoughts on these topics, as well as other issues raised by the NPRM, by submitting formal comments to DHHS. Comments are being accepted on the proposed rule through January 6, 2016 at 5:00 PM ET.
References
Department of Health and Human Services (DHHS). 2015. Notice of Proposed Rulemaking: Federal Policy for the Protection of Human Subjects. Federal Register 80 (173): 53969-54055.
There exists, I believe, an assumption, never spoken, that every piece of information in the Informed Consent Form needs to be treated in the same way. Actually, I’m not sure how many people on this side of the process (investigators, coordinators, IRB members) feel that way. But we certainly give that impression to those folks who are expected to become informed. In the typical ICF, the statement: “This study will last 18 months” is treated in exactly the same way as this one: “Make sure you keep your pills in a dry place.” along with a raft of similar bits of knowledge. And, because they appear to be equally significant, a person who is being “informed” or educated can be expected to try to learn each one in the same way. (Which, as often as not, involves blowing the whole thing off – a very realistic response.)
The result is what usually happens when we fail to examine our assumptions that is that we miss a lot of opportunities to make things better.
So I offer this is a starting point for improving the Informed Consent Process:. We need to make sure that, in developing and evaluating the informed consent process, we acknowledge that not all consent information requires the same level of learning. We need to work within a framework that begins by identifying the kind of learning a prospective research subject is expected to achieve for each set of facts. We need to communicate that expectation to those who are being informed. And the expectation needs to shape the way the information is conveyed.
In educational jargon, a kind of learning can be called a “learning level response.” What an educator tries to do is create a change in the learner. The “learning level response ” just identifies the nature of that change. You might, for example, want to make sure that a person you are teaching can then turn around and teach others. That’s pretty close to the top of learning level responses. On the other hand, maybe all you want is for this learner to be able to recognize that “ball” and “bawl” sound the same. That one comes pretty close to the bottom, but it is still a learning level response.
In between are a lot of different responses, including those that apply in different ways to the Informed Consent Process.
For example, in some – but definitely not all – cases, the learner is expected to be able to accurately respond to any question about what has been presented: What is the purpose of this study ? How long will it take ? Do I have to Join ? If I change my mind, can I withdraw ?
This information, which reflects the heart of the Common Rule, is so important that the goal ought be that 100% of the subjects (the learners) know 100% of the information. We’re not grading on a curve here. This is basic crucial stuff. Fortunately, most of it is not all that complicated and, if its properly identified, the desired learning level is likely to be be happily achieved. (One exception might be the difference between clinical and research medicine, an issue that is cursorily addressed at the end of this communication.)
So far so good. But what we also find, often interwoven with this kind of information, is content that the ordinary prospective research subject cannot, should not and need not be expected to memorize and then answer questions about. For example, there is the frequently-lengthy overly-detailed description of what is going to happen during the course of a research study. Much of the data here is important and the research subject needs to see it and “learn”. it. But learn it at a different level. In this case, all that is required is that the person determine if or how each piece of information influences her or his decision to take part in the research: look at the first item and evaluate its impact, then move on to the next one and the next one. We could call this a “check the box” kind of learning. It is important and useful. But its presentation just needs to be designed to achieve “check the box” kind of learning – no more than that. My guess is that if a consent form developer were required to acknowledge the level of expectations for this kind of learning, the “What is Going to Happen” portion of an ICF would not require a special study for it to take up less than a thousand words. That length – or even less – would be the norm.
A similar situation exists with respect to the portion of the ICF that lists possible side effects, although there may be a difference in the way the document itself is handled. The important requirement is that the list be a clear identification of what could happen, organized according to how likely it is and how serious it could be. The learner needs to “check the box:” read each one, think about it in terms of her or his participation in this study and, depending on the response, go to the next one or decline to participate and go home.
As with the “what is going to happen” description, there can be no requirement that all or any particular part of the information be remembered. In this case, though, it may make sense to suggest that the document be kept handy in case there is a need to refer to it. We could call this a “check the box and save the paper” level of response.
There might be two other learning levels appropriate to an informed consent process.
One, if we choose to treat it separately, would be the information involved in distinguishing between clinical and research medicine. This has a heavier emotional content than the other Common Rule items and can run afoul of people’s expectations. For those reasons, it might be more difficult to define expectations and maybe it would be helpful to try to hammer out a desired learning level response that decision-makers could agree on and then develop a way to achieve that response.
Another issue that might lead to the need for a different kind of response would address consent to the future use of genomic and similar kinds of information. This is and is likely to remain a thorny issue for a long time. Identification of the desired learning level of the prospective learners would be the best starting point.
That’s it. Nothing earth-shaking here; but sometimes the simplest ideas are the most useful. In this case, it is the belief that we should start from the perspective of the learner, clearly define realistic learning expectations and then build the whole process within that perspective. If we could actually manage to do that, it might make an enormous difference in the reformation of the informed consent process.
Excellent writing , Coincidentally , people are wanting a VA 3288 , my colleagues used a blank form here
https://goo.gl/27UZxhIt’s true that sometimes subjects receive lengthy informed consent documents where important information is “buried” and that’s a really bad thing which should be changed for the better. I wanted to learn more about how to apply the regulations reviewed in the Informed Consent Form so I applied for an online course and got an international GCP certificate, provided by Astra Nova Ltd – https://shop.crotraining.co.uk/main/courses/view/Good-Clinical-Practice – It was really useful.