FDA recommends participants receive key trial information early, concisely

The US Food and Drug Administration (FDA) wants sponsors and clinical trial researchers to present information to trial participants or their representatives early and concisely, making it easier to understand why they should or should not participate, according to a new draft guidance. The guidance also proposes communication strategies that can be used to ensure the information is more accessible.

When Congress passed the 21^st Century Cures Act (Cures Act) in 2016, lawmakers included language that updated the Federal Policy for the Protection of Human Subjects, also known as the Common Rule, to ensure clinical trial participants were better informed about their trials. Similarly, FDA proposed a rule with identical requirements.

On 29 February, FDA and the Office for Human Research Protections (OHRP) at the Department of Health and Human Services (HHS) published a draft guidance on how sponsors and researchers can conform to the rules.

The guidance proposes that sponsors and researchers present informed consent information to trial participants in layperson language, ensuring they better understand what the trial aims to do and their role in it. More specifically, it lays out how key information should be presented, and recommends what the information should cover, how it should be organized, and how it should be presented in clinical trials for drugs, devices, and biologics.

The revised Common Rule requires that clinical trial participants or their legally authorized representatives receive concise and easy-to-understand language to help them decide why they should or should not participate in the trial. With that in mind, the guidance recommends how sponsors and researchers can present key information to meet the requirements set in the rule and the strategies they can use to present such information. It also includes a sample approach to how key information may be presented.

“The presentation of key information at the beginning of the consent process can help facilitate discussions between a prospective subject and an investigator about whether the prospective subject should participate in the trial,” said FDA. “This information also may be useful to enrolled subjects as a resource and to facilitate any further discussions with investigators.”

The communication strategy proposed in the guidance is based on prescription drug labeling research which aims to make such information more accessible to patients.

“By using simple phrases and plain language principles, as well as formatting and organizational tools, researchers found that presenting information in a discrete bubble format with topics organized or grouped together can facilitate consumer understanding,” said FDA. “In the appendix of the draft guidance, we provide an example of a key information section using the bubble format.”

“We encourage interested parties, with input from [institutional review boards (IRB)], to develop innovative ways to provide key information that will help prospective subjects better understand the reasons why one might or might not want to participate in research,” the agency added.

While the aim is to present key information concisely not to overwhelm trial participants, the guidance notes that supplemental information may be included in the key information section when it may be important to the trial participant’s decision-making. It adds that the HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP) has recommendations on how to present such information that is consistent with the provisions of the Common Rule.

Stakeholders can comment on the draft guidance on www.regualtions.gov under docket no. FDA-2022-D-2997 until 30 April.

Informed consent draft guidance

FDA recommends participants receive key trial information early, concisely

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