What You Need to Know About the FDA and OHRP’s Joint Draft Guidance on Informed Consent in Clinical Trials 

All FDA-regulated clinical investigations of drugs, medical devices, and biologics require participants to give informed consent. Knowing a therapeutic’s potential risks and benefits protects patient safety and supports research success.

The Health and Human Services’ Office of Human Research Protection (OHRP) and the FDA both have rules regarding informed consent, but in 2018, OHRP revised its common rule, requiring consent information to “begin with a concise and focused presentation of the 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”.

Now, the FDA plans to include this exact language in CFR Title 42, but before these changes are made, the FDA and OHRP have issued draft guidance called Key Information and Facilitating Understanding in Informed Consent. The document explains how sponsors, investigators, and institutional review boards should structure and present their informed consent documents. Here, we highlight some of those recommendations.

Tips for providing key information

The FDA outlines several strategies for providing key information at the beginning of the informed consent process. Rather than sticking to a strict, “one-size-fits-all” format, the authors encourage flexibility. 

Notably, the key information doesn’t have to be presented in document form. Trial designers are welcome to use multimedia, including illustrations, videos, or electronic devices. The only real requirement is ensuring that after viewing the key information, participants understand the following:

• The purpose of the research, including procedures to be followed. In other words, why the study is being conducted, and why prospective subjects are being asked to participate. This section should also inform patients whether a placebo will be used and if they will have to follow a specific treatment regimen.
• The expected duration of participation. This section explains how long the study will take as well as the frequency of either in-person or telehealth appointments. 
• The potential risks and discomforts. This section spells out potential risks and/or side effects that may occur when participating in the study. If possible, it should also include information about how these discomforts will be managed and what steps will be taken to reduce or prevent them.
• Reasonably expected benefits. Industry experts say this section is the most important because it explains why someone would want to participate in the clinical trial. Explain the potential therapy’s benefits as clearly and truthfully as possible. 
• Appropriate alternative procedures. This section explains the appropriate, non-research-related treatment options available to the trial participants. Since there aren’t always alternative treatments available, this section may not be necessary depending on the research being conducted. 
• Compensation and medical treatments for research-related injuries. If a clinical trial presents a risk of injury, the FDA recommends including this section in the informed-consent document. It spells out whether or not you will compensate participants for any research-related injuries. 
• Costs related to subject participation. This section outlines any potential costs that participants might accrue during the study. For example, charges for tests, procedures, products or interventions. It should also explain whether or not you plan on reimbursing patients for travel, lodging, and other personal expenses. If you’re paying trial participants, spell that out, too. 

Similarly, the FDA’s draft guidance emphasizes the need for key information that is simple and concise. Despite the complexity of many research topics, trial participants must be able to understand what they’re getting into. Therefore, the FDA suggests using a presentation format that breaks up large blocks of text into smaller sections. This can be done through thought bubbles, bullet points, or numbered lists. 

Why following the FDA’s informed consent draft guidance is essential

Drafting informative, easy-to-understand  informed consent materials might seem like a minor thing to worry about, considering all of the moving parts required to bring a clinical trial together, but even minor mistakes can result in major headaches later on. 

For instance, in 2023, the FDA’s Bioresearch Monitoring Program (BIMO) issued 11 warning letters to clinical investigators or sponsors following investigations. Of those warning letters, two featured findings of failure to conduct a study in compliance with informed consent requirements. That means approximately 18% of clinical trials that undergo a BIMO inspection fail to meet the government’s informed consent requirements. Though surprising, these findings are an important reminder to keep informed consent at the forefront of all trial-related preparations.

This focus on informed consent becomes even more important in clinical trials with dozens or hundreds of participants. If your organization’s informed consent process fails in any way, it could mean the end of the study altogether. By following the FDA’s new draft guidance on properly conveying key information, you can meet all government-related regulations regarding informed consent and better ensure participant safety.

This article was inspired by a recent guest column in Clinical Leader – Informed Consent In Clinical Trials: Understanding The FDA’s And OHRP’s Joint Draft Guidance By Liz Oestreich, JD, and Thomas R. Berry, PharmD.