EthicsGlossary Term
ICH E6(R3) Section 1.27
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.
The Independent Ethics Committee serves the same fundamental purpose as an Institutional Review Board, providing independent ethical oversight of clinical research to protect human participants. The term IEC is more commonly used in Europe and other regions outside the United States, while IRB is the standard terminology in American regulatory frameworks. Despite the different nomenclature, both bodies share the essential mission of reviewing research proposals to ensure ethical conduct and participant protection.
IEC composition and procedures are defined by applicable national and regional regulations, with the European Union Clinical Trials Regulation establishing specific requirements for ethics committees within EU member states. Like IRBs, IECs must include members with diverse backgrounds, including individuals with medical and scientific expertise as well as lay members who can represent community perspectives and non-scientific considerations. This composition ensures that ethical review encompasses both scientific validity and broader societal concerns.
The scope of IEC review parallels that of IRBs, encompassing evaluation of the protocol, investigator qualifications, facilities, informed consent materials, and subject recruitment procedures. The committee must determine that risks are acceptable in relation to potential benefits, that participant selection criteria are appropriate and non-discriminatory, that the informed consent process is adequate, and that privacy and confidentiality protections are sufficient. Approval from the relevant IEC or IRB is a prerequisite for initiating any clinical trial involving human participants.
Multi-country trial
"For the international Phase III trial, the sponsor obtained approval from the IEC in each participating country before sites in that country could begin enrolling participants."
Protocol amendment review
"The IEC reviewed the protocol amendment that increased the maximum dose level and required re-consent of enrolled participants before approving implementation."
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.
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) Section 1.27
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.
The Independent Ethics Committee serves the same fundamental purpose as an Institutional Review Board, providing independent ethical oversight of clinical research to protect human participants. The term IEC is more commonly used in Europe and other regions outside the United States, while IRB is the standard terminology in American regulatory frameworks. Despite the different nomenclature, both bodies share the essential mission of reviewing research proposals to ensure ethical conduct and participant protection.
IEC composition and procedures are defined by applicable national and regional regulations, with the European Union Clinical Trials Regulation establishing specific requirements for ethics committees within EU member states. Like IRBs, IECs must include members with diverse backgrounds, including individuals with medical and scientific expertise as well as lay members who can represent community perspectives and non-scientific considerations. This composition ensures that ethical review encompasses both scientific validity and broader societal concerns.
The scope of IEC review parallels that of IRBs, encompassing evaluation of the protocol, investigator qualifications, facilities, informed consent materials, and subject recruitment procedures. The committee must determine that risks are acceptable in relation to potential benefits, that participant selection criteria are appropriate and non-discriminatory, that the informed consent process is adequate, and that privacy and confidentiality protections are sufficient. Approval from the relevant IEC or IRB is a prerequisite for initiating any clinical trial involving human participants.
Multi-country trial
"For the international Phase III trial, the sponsor obtained approval from the IEC in each participating country before sites in that country could begin enrolling participants."
Protocol amendment review
"The IEC reviewed the protocol amendment that increased the maximum dose level and required re-consent of enrolled participants before approving implementation."
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.
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.