When is re-consent required?

Re-consent is necessary when there are significant new findings or changes to the study protocol that may affect the participant's willingness to continue, as advised by the IRB and outlined in 21 CFR 50.25(b)(5).

Who is responsible for obtaining informed consent?

The investigator, or a person delegated by the investigator and trained to do so, is responsible for obtaining informed consent after ensuring the participant has sufficient opportunity to consider participation and ask questions.

Can informed consent be waived?

In limited circumstances, an Institutional Review Board (IRB) may waive or alter informed consent requirements. The criteria for waiver are outlined in 21 CFR 50.25(d) and involve situations such as minimal risk, public benefit, or emergency research.

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Clinical & TrialsQuality System Clinical Evidence

Informed Consent

Voluntary, informed agreement to participate in research after disclosure of risks and benefits.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

Definition

Per 21 CFR Part 50, informed consent is the legally effective agreement of a subject to participate in a clinical investigation, obtained under circumstances that minimize coercion and ensure understanding of risks, benefits, and alternatives.

What the regulation says

Under 21 CFR Part 50, informed consent is a fundamental ethical and regulatory requirement for clinical investigations involving human subjects. The EU Medical Device Regulation (MDR) 2017/745, in Annex I, Section 1, also mandates that subjects provide informed consent for clinical investigations, emphasizing documentation and the right of withdrawal. ICH E6(R2) Good Clinical Practice guidelines further elaborate on the responsibilities of investigators and institutional review boards (IRBs) regarding the informed consent process and documentation.

What this means in practice

Informed consent documents are reviewed by IRBs. Pediatric, vulnerable population, and digital trial contexts have additional considerations.

Examples

A medical device company conducting a clinical trial for a new implantable cardiac device must obtain informed consent from each participant using a document that outlines the device’s purpose, potential risks, and the participant’s rights, such as withdrawing at any time.
Before enrolling a patient in a study evaluating a novel diagnostic software, a researcher provides an informed consent form explaining the data collection process, privacy safeguards, and how the results will be used.
For a study involving a drug to treat a rare disease, the research team meets with potential participants and their legal representatives to thoroughly discuss the experimental nature of the treatment, possible side effects, and available standard therapies, ensuring all questions are answered before signature.

Common pitfalls

•Failing to clearly explain all reasonably foreseeable risks and discomforts to the participant is a common pitfall.
•Overlooking the need for re-consent when significant new information arises during a clinical investigation can lead to non-compliance.
•Using overly technical or complex language in informed consent forms can hinder a participant's understanding, invalidating the consent.
•Not ensuring that the informed consent process is free from coercion or undue influence, especially with vulnerable populations, is a serious violation.
•Failure to document the informed consent discussion and signed form appropriately can result in regulatory deficiencies.

Frequently asked questions

Essential elements, as described in 21 CFR 50.25, include a statement that the study involves research, an explanation of procedures, risks, benefits, alternative treatments, and a statement regarding confidentiality and compensation for injury.

Cross-references

Used by

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Institutional Review Board(IRB)

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Institutional Review Board(IRB)

Board that reviews and approves human-subjects research at an institution.

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Investigational Device Exemption(IDE)

FDA authorization to use an investigational device in a clinical study.

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Adaptive Trial Design

Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data.

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Adverse Event(AE)

Any untoward medical occurrence in a subject, whether or not related to the device.

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Clinical Evaluation Report(CER)

Documented assessment of clinical data demonstrating EU MDR conformity for a device.

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Feasibility Study

Small clinical study evaluating initial safety, usability, and design parameters of an investigational device.

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Primary references

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Link health: 3 verified· last checked 2026-06-20

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On this term

Category: Clinical & Trials
Sources: 3
Updated: 5/5/2026

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Learn in 60 seconds

Voluntary, informed agreement to participate in research after disclosure of risks and benefits.

·Informed consent documents are reviewed by IRBs.
·Pediatric, vulnerable population, and digital trial contexts have additional considerations.

Remember this

Watch out: Failing to clearly explain all reasonably foreseeable risks and discomforts to the participant is a common pitfall.

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