FDA Says it's OK With Modernizing the Clinical Trial Informed Consent Process

New guidance issued by the US Food and Drug Administration (FDA) could make it easier for companies to conduct clinical trials by explaining how federal regulators will permit companies to use electronic media like interactive websites to help facilitate the informed consent process.

Background

In the US, clinical trials are regulated by FDA and the Federal Food, Drug and Cosmetic Act (FD&C Act).

Under Chapter 21, Section 50.25 of the Code of Federal Regulations (21 CFR 50.25), Elements of Informed Consent, companies must obtain written consent from a clinical study participant that they understand the potential benefits and risks of participation in a trial. The regulation is meant to ensure that a study participant is not deluded or deceived into participating in a trial from which they are not likely to benefit.

There are eight basic elements to informed consent, according to FDA:

1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
2. A description of any reasonably foreseeable risks or discomforts to the subject.
3. A description of any benefits to the subject or to others which may reasonably be expected from the research.
4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records.
6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.
8. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Other informed consent elements can include that a trial may pose a risk to a fetus, that a trial may be terminated prior to its conclusion and the number of study subjects participating in a trial.

How to Collect Informed Consent?

That's the what—the information sponsors need to collect and convey. The how—the method sponsors should employ to present information or collect informed consent from patients—is another matter.

As FDA explains in its new draft guidance document, Use of Electronic Informed Consent in Clinical Investigations, "the term informed consent is mistakenly viewed as synonymous with obtaining a handwritten signature… on a written consent form."

In fact, sponsors aren't limited to just written documents any more, which are required under 21 CFR 50.27(a):

"Except as provided in 56.109(c), informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject's legally authorized representative at the time of consent."

Instead, those sponsors can use graphics, audio and visual aids, podcasts, interactive websites, card readers and even "biological recognition devices" to convey and capture information related to the informed consent process.

FDA explains: "When written informed consent is required, the use of electronic (including digital) signatures is permitted, provided the electronic signature is in compliance with applicable FDA regulations. In such cases, the electronic signature is considered by FDA to be trustworthy, reliable, and generally equivalent to handwritten signatures executed on paper (see 21 CFR part 11, subpart A (11.1)(a))."

As long as the information provided is "adequate" and "understandable,” FDA says it is OK with a variety of methods used to convey informed consent. Similar provisions are permitted under 21 CFR 50.27(b)(2), which permits oral presentations about clinical trial information.

Potential Benefits

For FDA, the benefits to using electronic media to facilitate the informed consent process may have potential benefits.

For example, it might enhance a patient's understanding of the trial risks and their ability "to retain and comprehend the information," FDA explained. Further, it could help to update trial participants about new risks of participating in the trial, speed up the trial enrollment process, and allow for subjects to consent from "remote locations," such as a patient's home.

These innovations come with several new requirements, however. For example, if a subject enrolls in a trial remotely, the sponsor will need to allow that subject to "ask questions and receive answers prior to signing the electronic informed consent document to participate in the study," FDA noted. In addition, sponsors will need to ensure that data captured in the electronic informed consent process cannot be altered, and that a patient's privacy is adequately protected.

"The electronic systems should ensure the security of the data as well as the subject’s privacy when such electronic communication tools are used as part of the informed consent interview process," FDA writes.

FDA is accepting comments on its draft guidance for the next 60 days.

Use of Electronic Informed Consent in Clinical Investigations (FR)