Common Rule Infographic

by Jim Gearhart

Tiered Consent: A Format for Simplifying Consent Forms

I first heard the term “tiered consent” last July, at Quorum’s annual IRB conference co-presented by Northwest Association for Biomedical Research (NWABR). Tiered consent describes a consent form document that front loads essential elements into a concise first section, and assigns other information to subsequent sections. Crucial stuff up front, other stuff in the back. That was one of many ideas presented at Revolutionizing Informed Consent, but in November the folks at the Clinical Trials Transformation Initiative (CTTI) also endorsed tiered consents. In a set of recommendations, CTTI said that a tiered approach could better serve research participants.

Since 2007, CTTI has sought practical ways to improve clinical trials. Representatives from government, industry, and academia delve into problems and seek practical solutions to improving clinical trials. In this case they looked at the informed consent process.

The group went through a three-step research process. First, it conducted a literature review about informed consent. Then, it conducted a series of interviews. Third, it convened a meeting of over 60 people from the field, with the goal of finding practical solutions for improving consent. One conclusion: informed consent documents are supposed to help readers understand a study and make an informed decision about participating, but they don’t. Informed consent documents fail at their core purpose. The CTTI group concluded that a tiered structure could help an informed consent form do better.

A hierarchical structure for a consent form has an intuitive appeal, but its success might hinge on one question: What can we remove from the core to make it more concise? Choosing content for an annex might not be easy. FDA regulations and the Common Rule set down key elements that must appear in consent documents. Some states add others. Hospitals and universities have their own concerns, as do industry sponsors. And, after all of that, an IRB may have its own ideas about what is most important. Which of these organizations will agree that its material can appear in an annex and not up front, in the core of a consent form?

Consider the recent proposal to change the Common Rule, the NPRM (Notice of Proposed Rule Making). It discusses the necessity of simplifying consent form documents. It also endorses a tiered approach, saying that non-essential content should be divided from the essential:

“Any informed consent form must include only the requirements of informed consent under this section, and appendices that include any other information provided to the subject or representative.” (Federal Register version of NPRM, pages 53969 – 53972 and 54052 – 54055)

But “Requirements of informed consent under this section;” there’s an issue. The current Common Rule cites up to eleven such requirements, and meeting those requirements constitutes a major portion of the consent forms. Now, on top of those eleven requirements, the NPRM — the same NPRM that calls for briefer, simpler consent forms – proposes three new elements. Yes, the new elements address important topics. They deal with collecting, storing, and using biological specimens. They deal with privacy and security. But the new requirements also will add length and complexity to what a research subject has to read, and could make it even harder to create a concise document.

CTTI recommends tiered consent (They even have a sample of how it could look). The NPRM endorses it. And last year’s inaugural ResearchKit studies provided enticing examples of how it might work. Those iPhone-based studies used a tiered approach to convey study information, with graphics, short descriptions, and videos explaining key concepts. Detailed explanations came at the end, or as additional links. But wider adoption of tiered consent, especially for studies that fall under FDA or Common Rule jurisdiction, could depend on the willingness of all players – starting with but not limited to the rule makers – to concede space up front.

Check out CTTI’s webinar, its report, or its toolkit to learn more about recommendations for improving informed consent.

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