The new article describes in detail the general requirements by FDA for informed consent to be followed by study sponsors and other parties involved in clinical investigations. 

FDA Q&A on eMDR: Overview

The United States Food and Drug Administration (USFDA), the US healthcare products regulatory authority, has released a guidance document on informed consent. It offers an overview of regulatory requirements and additional insights for all involved parties to ensure compliance.

These guidance provisions aren’t legally binding and don’t introduce new rules or obligations. The authority allows alternative approaches, if in line with existing laws and pre-approved by them.

The concept of informed consent is under ongoing review to enhance participant safety.

Regulatory Requirements: Key Points 

To aid stakeholders involved in clinical investigations in comprehending the regulatory mandates within the existing legal framework, the guidance furnishes additional explanations and recommendations.

In general, both the informed consent process and the consent form in clinical investigations should align with 21 CFR 50.20, which outlines requirements for essential components in informed consent.

In certain cases, depending on the nature of the investigation, it may be necessary to include additional elements.

21 CFR 50.20
The aforementioned regulation states the following:

  • “Except as provided in 50.23, and 50.24, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative.”
  • “An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.”
  • “The information that is given to the subject or the representative shall be in language understandable to the subject to the representative.
  • No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.”
medical devices personalised regulations


The applicable legislation contains exceptions for those overseeing clinical investigations. These exceptions, as per the existing legal framework, encompass specific situations:

  • Life-threatening situations
  • Military operations
  • Public health emergencies
  • Emergency research

Additionally, the authority is currently enhancing the informed consent procedure, allowing for potential alterations or waivers of certain elements on a case-by-case basis.

Coercion and Undue Influence
Generally, clinical investigators and sponsor must develop and implement measures to minimize risks of coercion or undue influence.

FDA stated “coercion occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance; undue influence, by contrast, occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance.

Study sponsors must ensure that informed consent is voluntary and free from undue influence.
The FDA underscores that coercion and undue influence can impact any study, especially when there’s a significant connection between an investigator and a potential participant.

Also, it’s strictly forbidden to assert the safety and effectiveness of products under clinical investigation.
This prohibition also applies to statements that overstate the potential benefits of study participation, as they can introduce bias and mislead potential participants into giving consent they might not provide otherwise.

Furthermore, clinical investigators must not advertise studies as FDA-approved or endorsed, creating a misleading impression.


When it comes to remuneration, the authority generally doesn’t consider reimbursement of travel expenses related to investigation participation as something raising concerns about coercion or undue influence.

Simultaneously, the remuneration for clinical investigation participation is rigorously assessed to determine if it’s fair and justified. While such remuneration is generally acceptable, unjustified remuneration may be deemed undue influence.

In summary, the FDA guidance provides an overview of essential regulatory requirements for informed consent in clinical investigations. It highlights key points for clinical trial parties when enrolling new participants and providing necessary trial information.

How Can RegDesk Help?

RegDesk is a holistic Regulatory Information Management System that provides medical device and pharma companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Global expansion has never been this simple.