EthicsGlossary Term
ICH E6(R3) 1.28
A process by which a subject voluntarily confirms willingness to participate in a clinical trial after being informed of all aspects relevant to the decision.
Informed consent stands as one of the most fundamental ethical requirements in clinical research, representing far more than a signature on a document. The process encompasses the entire communication between the research team and the potential participant, ensuring that individuals have sufficient understanding of the trial's purpose, procedures, potential risks, possible benefits, and alternatives before making their decision about participation. This communication must occur in language that is understandable to the participant and must allow adequate time for questions, reflection, and consideration without any pressure or coercion.
The informed consent process begins before enrollment and continues throughout the participant's involvement in the trial. Any new information that emerges during the study that might affect a participant's willingness to continue must be communicated promptly, and participants must understand from the outset that they retain the right to withdraw from the trial at any time without penalty or loss of benefits to which they would otherwise be entitled. For participants who lack decision-making capacity, such as children or individuals with cognitive impairment, consent must be obtained from a legally authorized representative in accordance with applicable laws, while the participant's assent should also be obtained when possible.
Documentation of informed consent is a critical regulatory requirement, typically involving a written, signed, and dated informed consent form that has been approved by the IRB or IEC. The form must include all elements required by regulations, including a statement that the study involves research, explanations of purposes, procedures, risks, and benefits, disclosure of alternative treatments, descriptions of confidentiality protections, and information about compensation and medical treatment for injuries. However, the documentation must never be confused with the process itself. A signed form obtained without genuine comprehension does not constitute valid informed consent.
The investigator bears ultimate responsibility for ensuring that the consent process is properly conducted and that each participant's decision is truly voluntary and informed. This responsibility cannot be delegated entirely, though qualified staff may assist in the consent discussion. Ongoing assessment of participant understanding is essential, as consent obtained at enrollment may become outdated as the study progresses or as the participant's circumstances change. The ethical principle underlying informed consent recognizes that human dignity requires that individuals be able to make autonomous decisions about their own participation in research.
Initial enrollment
"The investigator spent forty-five minutes with the prospective participant, explaining the study procedures in lay terms, answering all questions about risks and alternatives, and ensuring the individual understood the voluntary nature of participation before the informed consent form was signed."
Protocol amendment
"When a protocol amendment added a new invasive procedure, all enrolled participants were re-consented using an updated informed consent form that explained the additional requirement and allowed them to decide whether to continue participation."
Vulnerable population
"For the pediatric study, the research team obtained written permission from parents while also obtaining assent from children using an age-appropriate assent form that explained the study in terms they could understand."
An independent body constituted of medical/scientific professionals and non-medical/non-scientific members whose responsibility is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial.
An independent body constituted of medical, scientific, and non-scientific members whose responsibility is to ensure protection of the rights, safety, and well-being of human subjects involved in research.
An individual whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation of benefits or fear of negative consequences, or who may have diminished capacity to provide informed consent.
ICH E6(R3) 1.28
A process by which a subject voluntarily confirms willingness to participate in a clinical trial after being informed of all aspects relevant to the decision.
Informed consent stands as one of the most fundamental ethical requirements in clinical research, representing far more than a signature on a document. The process encompasses the entire communication between the research team and the potential participant, ensuring that individuals have sufficient understanding of the trial's purpose, procedures, potential risks, possible benefits, and alternatives before making their decision about participation. This communication must occur in language that is understandable to the participant and must allow adequate time for questions, reflection, and consideration without any pressure or coercion.
The informed consent process begins before enrollment and continues throughout the participant's involvement in the trial. Any new information that emerges during the study that might affect a participant's willingness to continue must be communicated promptly, and participants must understand from the outset that they retain the right to withdraw from the trial at any time without penalty or loss of benefits to which they would otherwise be entitled. For participants who lack decision-making capacity, such as children or individuals with cognitive impairment, consent must be obtained from a legally authorized representative in accordance with applicable laws, while the participant's assent should also be obtained when possible.
Documentation of informed consent is a critical regulatory requirement, typically involving a written, signed, and dated informed consent form that has been approved by the IRB or IEC. The form must include all elements required by regulations, including a statement that the study involves research, explanations of purposes, procedures, risks, and benefits, disclosure of alternative treatments, descriptions of confidentiality protections, and information about compensation and medical treatment for injuries. However, the documentation must never be confused with the process itself. A signed form obtained without genuine comprehension does not constitute valid informed consent.
The investigator bears ultimate responsibility for ensuring that the consent process is properly conducted and that each participant's decision is truly voluntary and informed. This responsibility cannot be delegated entirely, though qualified staff may assist in the consent discussion. Ongoing assessment of participant understanding is essential, as consent obtained at enrollment may become outdated as the study progresses or as the participant's circumstances change. The ethical principle underlying informed consent recognizes that human dignity requires that individuals be able to make autonomous decisions about their own participation in research.
Initial enrollment
"The investigator spent forty-five minutes with the prospective participant, explaining the study procedures in lay terms, answering all questions about risks and alternatives, and ensuring the individual understood the voluntary nature of participation before the informed consent form was signed."
Protocol amendment
"When a protocol amendment added a new invasive procedure, all enrolled participants were re-consented using an updated informed consent form that explained the additional requirement and allowed them to decide whether to continue participation."
Vulnerable population
"For the pediatric study, the research team obtained written permission from parents while also obtaining assent from children using an age-appropriate assent form that explained the study in terms they could understand."
An independent body constituted of medical/scientific professionals and non-medical/non-scientific members whose responsibility is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial.
An independent body constituted of medical, scientific, and non-scientific members whose responsibility is to ensure protection of the rights, safety, and well-being of human subjects involved in research.
An individual whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation of benefits or fear of negative consequences, or who may have diminished capacity to provide informed consent.