Informed Consent: Questions on New FDA Requirement

FDA Requirements Informed Consent Questions

FDA Has New Requirements for Informed Consent

FDA has implemented a new informed consent requirement by updating their informed consent regulations (21 CFR Part 50). The principle of informed consent has been a central ethical factor for efforts to protect participants in clinical trials since the aftermath of World War II. This Guest Commentary by Steven Steinbrueck discusses the new FDA requirement and asks some basic questions about informed consent. I think they are questions well worth asking. What works and what doesn’t work in the informed consent process? Are informed consent forms understandable? Do research participants understand the concepts of the research? Are the right questions being asked? The new FDA regulation is copied at the bottom of Steven’s commentary.

Guest Commentary by Steven Steinbrueck

I was prompted to write by two things—a nice invitation from Carl and the soon to be implemented change to the informed consent regulations. As most of us are aware, there will be a new element required for those clinical studies subject to 21 CFR 50.25; notification that results of the trial will be published in

Although I have very little against this requirement, I do find it interesting that the first substantial change in informed consent regulations in quite some time, while logical and required by FDAAA 2007, adds little to help potential research subjects make an informed risk assessment regarding the advisability of participating in a clinical trial.

I think we should stop and think about what we believe, and what we know, about informed consent.

Fundamentally, we believe that human research requires voluntary consent by the participant and that this consent may only be legitimately sought following the provision of required information. Without such consent, human research is thought to be unethical. We can all point to multiple publicized instances where this widely accepted tenet has been ignored.

informed consent questions

The Nuremberg Code was Adopted After the World War II Nuremberg Trials

More than 60 years ago, the Nuremburg Code began with the exhortation that “…voluntary consent is absolutely essential;” the guilt of the physicians on trial began with consent issues. We find similar and more detailed guidance in Belmont, Helsinki and ICH. Most countries have codified their requirements in multiple laws and regulation. In the US, these requirements are primarily found in 21 CFR 50.25 and 45 CFR 46, the so-called Common Rule.

I doubt that we have much argument about the fundamental requirement for truly informed consent, or even its major topics. So, what am I even talking about?

But, what do we know? Essentially, that a large portion of research participants do not understand one or more important concepts about the research they are involved in. Many researchers have documented what has been called therapeutic misconception, therapeutic optimism, and even therapeutic nihilism on the part of both participants and researchers. Although percentages vary between 40 and 70+%, we are aware that we have not fulfilled the obligation to ensure that the information provided is not only complete, that it contains all elements required by regulation or guidance, but also that the volunteer comprehends the information provided—prior to their participation.

Although compliance is necessary, it is insufficient. We must do something about the incomprehensibility of many consent forms. They must be shorter and the time between presentation of the information and consent must be longer. Additional information, including HIPAA authorizations and lengthy explanations of alternative treatments and non-experimental procedures must be provided in separate documents. And finally, we must routinely assess understanding before and during the trial. For, to enroll someone who does not understand, is to enroll someone who has not truly been given the opportunity “to decide what shall o r shall not happen to them.” And that is simply against our collective beliefs.

Steven Steinbrueck, MPH
Stonebridge Consulting


“Sec. 50.25 Elements of informed consent.

* * * * *
(c) When seeking informed consent for applicable clinical trials,
as defined in 42 U.S.C. 282(j)(1)(A), the following statement shall be
provided to each clinical trial subject in informed consent documents
and processes. This will notify the clinical trial subject that
clinical trial information has been or will be submitted for inclusion
in the clinical trial registry databank under paragraph (j) of section
402 of the Public Health Service Act. The statement is: “A description
of this clinical trial will be available on, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”


MHRA and Clinical Trials– Read about the Academy of Medical Research Report by Nick Taylor in Outsourcing-Pharma

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One Response to Informed Consent: Questions on New FDA Requirement

  1. […] Need?” The speakers are Christine Pierre, RN and Steven Steinbreuck, MPH and the author of a Guest Commentary on GxP Perspectives on Informed Consent Requirements. Remember, I am always looking for a good Guest Commentary. Send me a note and ask me […]

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