Regulatory Requirements for Informed Consent in Clinical Trials

by | Mar 20, 2024 | Clinical Trials, Compliance, FDA, Global Leader, Medical Devices, Medicine, MedTech, Pharma, Pharmaceuticals, Regulatory

In the realm of clinical research, ensuring ethical conduct and protecting the rights and welfare of research participants are paramount concerns. Central to this endeavor is the process of informed consent, whereby individuals are provided with comprehensive information about a study before voluntarily agreeing to participate. While informed consent is a universal ethical principle, regulatory agencies such as the FDA play a pivotal role in establishing and enforcing specific requirements to safeguard participants’ rights and ensure the integrity of clinical trials.

The FDA is responsible for regulating the conduct of clinical trials in the United States to ensure the safety and efficacy of investigational drugs, biologics, and medical devices. Informed consent requirements are outlined in Title 21 of the Code of Federal Regulations (CFR), specifically in Part 50 (Protection of Human Subjects). These regulations establish the framework for obtaining and documenting informed consent in clinical research conducted under FDA jurisdiction.

FDA regulations mandate that researchers provide prospective participants with a clear and understandable explanation of the study’s purpose, procedures, risks, benefits, and alternatives. This information must be presented in a manner that facilitates comprehension and informed decision-making.

Investigators are required to document the consent process using a written consent form approved by the IRB or Ethics Committee. The consent form must contain specific elements outlined in 21 CFR 50.25, including a statement of voluntary participation, a description of foreseeable risks and discomforts, and details regarding confidentiality and compensation.

Prior to initiating a clinical trial, researchers must obtain approval from an Institutional Review Board (IRB) or Ethics Committee. The IRB is responsible for reviewing and approving the consent documents to ensure compliance with regulatory requirements and ethical standards.

When enrolling minors in clinical trials, researchers must obtain informed consent from the parent or legal guardian. Additionally, depending on the child’s age and maturity level, assent may also be required from the child to affirm their willingness to participate. The consent process is ongoing and extends throughout the duration of the trial. Researchers are obligated to provide participants with updated information about the study’s progress, any new findings that may impact their decision to continue participation, and the right to withdraw consent at any time without penalty.

Ensuring compliance with FDA requirements for consent involves rigorous oversight and monitoring at multiple levels:

  • FDA Inspections: The FDA conducts routine inspections of clinical trial sites to assess compliance with regulatory requirements, including the adequacy of the consent process.
  • IRB Review: IRBs play a critical role in evaluating the ethical conduct of research and ensuring that consent documents adhere to regulatory standards.
  • Informed Consent Audits: Sponsors and Contract Research Organizations (CROs) may perform audits to verify the adequacy and documentation of the informed consent process at investigator sites.

Informed consent serves as a cornerstone of ethical clinical research, and adherence to FDA regulations is essential to safeguarding the rights and welfare of research participants. As you navigate the complex landscape of clinical trials, compliance with FDA requirements for informed consent remains a non-negotiable imperative. EMMA International’s clinical experts can help set up your clinical trial and prepare all of the informed consent documentation, including continuous monitoring. Call us at 248-987-4497 or email to learn more.

FDA (Aug 2023) Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors retrieved from:

EMMA International

EMMA International

EMMA International Consulting Group, Inc. is a global leader in FDA compliance consulting. We focus on quality, regulatory, and compliance services for the Medical Device, Combination Products, and Diagnostics industries.

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