Waiving Informed Consent Under the Proposed Rule

Meghan Hosely
January 2nd, 2020

When clinical research staff take participants through the informed consent process, they provide sufficient details, allowing the participant to decide whether or not they’d like to continue with the study. Participants need to know and understand the procedures, how the protocol works, risks involved and that their participation in the trial is voluntary. They can withdraw from the study at any time, without needing to provide any reason.

Established as a U.S. law in the 1960s, informed consent is required before enrolling potential participants in a study. While this is key to ensuring participants understand the trial in its entirety, a major drawback to the informed consent process is delayed timelines on study start-up.

In late 2018, the Food and Drug Administration (FDA) proposed a rule to allow sites to waive informed consent, if they meet four criteria:

  • The research involves no more than minimal risk to the subjects;
  • The waiver or alteration will not adversely affect the rights and welfare of the subjects;
  • The research could not practicably be carried out without the waiver or alteration; and
  • Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

The FDA defines minimal risk as “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. 

In July 2017, the FDA issued guidance stating they do not intend to object to an IRB waiving or altering informed consent provided the clinical investigation meets the requirements described in the guidance and the proposed rule. When the rule goes into effect, this guidance will be withdrawn.

The document is designed to guide sponsors, investigators and IRBs when enforcing “FDA regulations governing informed consent requirements for clinical investigations that involve no more than minimal risk to human subjects.” The FDA also will not oppose an initiated, minimal risk clinical investigator for which an IRB waives or alters the informed consent requirements.

While this could ultimately help keep trials on their proposed timeline, there are a few factors to keep in mind when it comes to waived informed consent.

Your Institutional Review Board (IRB) has the Final Say

Just because a trial is labeled as “minimal risk,” it doesn’t gain automatic exemption of informed consent.  As with all research trials, the IRB will ultimately decide to waive informed consent – not the researchers. When deciding whether to waive consent or not, IRBs must consider all the criteria in the proposed rule – not just one part. Additionally, IRBs need to have the participant’s safety in the forefront of their minds, ensuring that waiving informed consent won’t affect the rights and welfare of the participants.

Always Keep Participant’s Privacy at the Forefront

A big part of the informed consent process is making sure participants know and understand their rights as they move through the protocol, including their privacy. According to the U.S. Department of Health & Human Services, a major goal of the Health Insurance Portability and Accountability Act (HIPAA) is “to assure that individuals’ health information is properly protected while allowing the flow of health information needed to provide and promote high quality health care and to protect the public’s health and wellbeing.”

It’s imperative for the IRB to keep in mind the state and federal laws put in place to keep data private, even if participants are on a trial deemed “minimal risk.” For minimal risk trials, IRBs must ensure the subject’s wellbeing and legal rights will not be affected by the waiver set in place.

While waiving an informed consent process can help a trial move according to plan, that’s not to say it will come without challenges. Communication between sites and their IRB is necessary, especially when it comes to ensuring important factors, such as the participant’s safety, will not be altered.