Informed consent – is a procedure intended to ensure that participants make autonomous and informed decisions about their involvement in research studies, respecting their rights and well-being. Informed consent is a critical aspect of ethical research conduct and is required for all clinical trials involving human participants.
Autonomous decisions
These are decisions made by clinical trial participants without external coercion or undue influence. It signifies that participants have the capacity to understand the information provided about the trial and can make their own choices based on their personal values, beliefs, and preferences.
Autonomy in decision-making is a fundamental principle of ethical research conduct and ensures that participants have the freedom to consent or decline participation in a clinical trial based on their own judgment.
Definitions
ICH E6(R2)
- 1.28 Informed Consent: [1]
- A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.
Elements of Informed consent as procedure
Informed consent is a fundamental ethical principle in clinical research that ensures participants have a full understanding of the research study before agreeing to participate.
Disclosure of information
Researchers provide participants with detailed information about the study, including its purpose, procedures, potential risks and benefits, alternatives to participation, and the voluntary nature of participation.
Voluntary participation
Participants must freely choose whether to participate in the study without coercion or undue influence. They have the right to withdraw from the study at any time without penalty.
Comprehension
Participants are given adequate time to review the information provided and ask questions to ensure they understand the study’s details, including any potential risks or discomforts.
Ongoing communication
Throughout the study, researchers maintain open communication with participants, providing updates on any changes to the study protocol or new information that may affect their participation.
Documentation
Participants who agree to participate provide their informed consent by signing a written Informed Consent Form (ICF). This document serves as evidence that the participant understands the study and voluntarily agrees to participate.
See also
Another relevant pages
Links to this page
- Clinical research (← links)
- Phase II clinical trials (← links)
- Protocol Amendment (← links)
- Approval (in relation to Institutional Review Boards) (← links)
- Impartial witness (← links)
- Regulatory inspection (← links)
- Institutional review board (← links)
- Opinion (in relation to Independent Ethics Committee) (← links)
- Source data (← links)
- Standard operating procedures (← links)
- Sub-investigator (← links)
- Vulnerable subjects (← links)
- Well-being (← links)
References
- ↑ ICH, 2016, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf Accessed Sep 2023
External links
- FDA, 2024, Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/key-information-and-facilitating-understanding-informed-consent-guidance-sponsors-investigators-and Accessed Nov 2024