13
Jun2017

It has been close to five months since the release of the revised Common Rule, and many in our community are continuing to digest the content of the rule and beginning to determine what sorts of changes to make to policies, procedures, and systems, should the rule go into effect on January 19, 2018 as scheduled. (As a reminder the compliance date for the single IRB provisions is two years later, January 20, 2020).

The fate of the rule is still uncertain. On May 25, the director of the Office for Human Research Protections (OHRP), Jerry Menikoff, told a meeting of the Secretary’s Advisory Committee on Human Research Protections (SACHRP) that the Trump Administration is only now conducting a routine administrative review of the rule. However, Dr. Menikoff was quick to say there is no reason to think the rule raises any particular concerns for the Administration, or that it is targeted for any particular kinds of changes. And, in another sign that the rule may be here to stay, SACHRP has been charged with, and is working on, drafting proposed guidance for OHRP’s consideration on some key areas, including broad consent, the transition provisions, “benign behavioral interventions,” and the expedited review categories—all areas on which guidance will be welcomed by the regulated community. Interestingly, Dr. Menikoff also indicated that one possible outcome of the current administrative review could be a delay in the effective date of the rule. It is not clear when we might know about such an extension; PRIM&R will of course keep you posted on our Common Rule resource page.

In the meantime, over the coming months, I’m going to look more closely at a few areas of the revised rule. I won’t be giving tips on implementation, just pointing out some of what I find interesting in a few specific areas. In this post, I’m going to take a deeper dive into the changes around informed consent, an area that, as I mentioned in my preliminary reflections on the rule, I am pretty excited about.

The first change to note is the organization of §__.116 on the general requirements for informed consent. In the pre-2018 rule, the section starts with a short and very general, unnumbered paragraph about the fundamental requirement to seek informed consent, before getting to the list of basic elements of consent. The revised rule has a much longer introductory section that is broken up into numbered paragraphs. This might not seem like a particularly substantive change in itself, but as the preamble makes clear, the change was made “to emphasize the fact that this paragraph includes multiple independent and important regulatory requirements and to enable stakeholders and Common Rule departments and agencies to more easily reference particular requirements” (82 FR p.7212). In other words, the reworking of the introductory paragraph is designed to ensure that even the most general requirements regarding informed consent are taken as seriously as the enumerated basic and additional elements that come later.

What are these general regulatory requirements? In addition to language from the pre-2018 rule about providing information in a language understandable to the subject, ensuring that the circumstances in which consent is sought minimize the possibility of coercion or undue influence, providing sufficient opportunity for discussion, and refraining from using exculpatory language (all now presented in numbered paragraphs), the new rule adds provisions regarding the presentation of information in a manner that facilitates a prospective subject’s understanding of what is involved in the research and, more importantly, the reasons why one might choose to or choose not to participate. To that end, the new rule includes new provisions stating that informed consent:

  1. Must provide information any “reasonable person” would want to know (§__.116(a)(4));
  2. Must begin with “a concise and focused presentation” of “key information… organized and presented in a way that facilitates comprehension” (§__.116(a)(5)(i)); and
  3. Must present information in “sufficient detail,” but not “merely provide lists of isolated facts” (§__.116(a)(5)(ii)).

In other words, there is a lot more detail than in the pre-2018 rule about what kinds of considerations should be in play when designing a meaningful informed consent form or process, and more guidance for how to think about the presentation of information from the perspective of a potential subject. The preamble is explicit that the decision to make this section more organized and robust in these ways is a response to concerns that consent forms are too long and complex, and too often function as “sales documents or means to protect against institutional liability” (82 FR p.7211).  While this kind of focus on the presentation of the information is, to my mind, a step in the right direction for improving informed consent, further guidance is needed to help researchers and institutions operationalize these requirements, including, specifically, guidance about what counts as “key information.”

In addition to some reorganization and expansion of the overall requirements, there are new basic and additional elements of informed consent worth looking at as well. For instance, there is a new basic element requiring a statement about what will happen to any identifiable private information or identifiable biospecimens collected during the course of research—that is, whether or not the information or biospecimens might be stripped of identifiers and distributed or used for future research without consent (§__.116(b)(9)). As everyone by now knows, the proposal in the notice of proposed rulemaking to bring research with de-identified biospecimens within the scope of the definition of human subjects research was—thanks to widespread objections—jettisoned in the final version of the rule, leaving in place the status quo whereby researchers can strip identifiers from biospecimens or data collected for clinical or primary research purposes and subsequently store, share, or use them for secondary research without consent. This new basic element of consent requires that researchers tell people that this might happen to their biospecimens.

The three new additional elements of informed consent—that is, pieces of information that must be included when they are appropriate for the study in question—are as follows:

  • A statement that biospecimens may be used for commercial profit, and whether or not the subject will share in that profit (§__.116(c)(7));
  • A statement regarding whether clinically relevant research results will be returned to subjects, and under what conditions (§__.116(c)(8)); and
  • A statement specifically for research involving biospecimens about whether the research will or might include whole genome sequencing (§__.116(c)(9)).

The preamble explains that each of these elements has been added because it provides information that may be especially important to prospective subjects’ decisions about whether or not to participate in research.

With respect to all of these additional elements, we can clearly see the influence of two high-profile cases that have in recent years prompted widespread discussion and debate about consent, commercial profit, and privacy in the context of biospecimen research: namely, the cases of Henrietta Lacks and that of the Havasupai Indian Tribe. Each of these cases helped to reveal a continued distrust in the research enterprise, especially among minority communities. One way to address such distrust is to increase transparency about how research works, what its benefits are, and, specifically, what research participation involves. Adding these four new elements to consent clearly serves this goal of increased transparency, and should be applauded and embraced on those grounds. But if we truly want to promote transparency and the public trust it serves, as I’ve argued elsewhere, we also need better and broader public education and engagement about research; we can’t expect informed consent to do all of that work. In my ideal world, these important additions to the information provided during the informed consent process would be reinforced, supported, and enhanced by the understanding of research that prospective subjects bring to the consent process.

There is of course much more to say about consent in the new rule. I haven’t touched on the new requirement to post consent forms, the changes to requirements about waiver of consent, or the addition to the rule of a detailed broad consent process that may be used for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens. For a closer look at those elements, I invite you to view PRIM&R’s webinar on informed consent, part of our Focus on the Revised Common Rule webinar series.

The current consensus is that our approach to seeking research informed consent is deeply flawed. The question, then, is whether the changes to consent in the rule will improve informed consent, and to what extent. We’ll have a panel, titled Making Consent Meaningful in the Context of the Revised Common Rule, addressing this question at the 2017 Advancing Ethical Research Conference taking place November 5-8 in San Antonio. I hope you’ll join us. And in the meantime, tell us: what do you think of the changes to informed consent in the revised Common Rule? 

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