Independent Ethics Committee (IEC) definition

Independent Ethics Committee (IEC) means an independent body (a review board or a committee, institutional, regional, national or supranational), consisting 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 clinical trial and to provide public assurance of that protection, by, among other things, reviewing and approving/providing favorable opinion on the Protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting the informed consent of Study Patients.
Sample 1Sample 2

Examples of Independent Ethics Committee (IEC) in a sentence

  • The judgement and/or the advice provided by an Independent Ethics Committee (IEC).

  • If required by applicable regulations, the PI must inform the Institutional Review Board (IRB)/ Independent Ethics Committee (IEC) promptly and provide the reason for the suspension or termination.

  • This study will not be initiated until the protocol and informed consent document(s) have been reviewed and approved by a properly constituted Institutional Review Board (IRB) or Independent Ethics Committee (IEC).

  • To assist organizations in responding to the EOI, an interactive website will established where questions can be posed and answers posted for discussion. June – July 2010 (closing date July 30).

  • Authorized representatives of the sponsor, a regulatory authority, an Independent Ethics Committee (IEC) or an Institutional Review Board (IRB) may visit the site to perform audits or inspections, including source data verification.

  • Where required by applicable regulations, the investigator or head of the medical institution must inform the Independent Ethics Committee (IEC) promptly and provide the reason(s) for the suspension/termination.

  • Authorized representatives of the sponsor, a regulatory authority, an Independent Ethics Committee (IEC) or an Institutional Review Board (IRB) may visit the Center to perform audits or inspections, including source data verification.

  • The protocol, informed consent form (ICF), and appropriate related documents must be reviewed and approved by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) constituted and functioning in accordance with International Conference on Harmonisation (ICH) E6 (Good Clinical Practice [GCP]), Section 3, and any local regulations.

  • Project funds may not be used to enroll human subjects in any research project subject to Institution Review Board (IRB) or Independent Ethics Committee (IEC) approval until such approval has been obtained for each site.

  • This study will be conducted in compliance with the protocol, Good Clinical Practice (GCP), the ethical principles of the Declaration of Helsinki, and applicable regulatory and Institutional Review Board (IRB) or Independent Ethics Committee (IEC) requirements.

Related to Independent Ethics Committee (IEC)

  • Ethics Committee means an independent body established in a Member State in accordance with the law of that Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of laypersons, in particular patients or patients' organisations;

  • independent review committee means the independent review committee of the investment fund established under National Instrument 81-107 Independent Review Committee for Investment Funds;

  • OPSI Advisory Committee means the committee established under Tariff, Attachment M, section III.G.

  • standards committee (“pwyllgor safonau”) means the standards committee of the county or county borough council which has functions in relation to the community council for which it is responsible under section 56(1) and (2) of the Local Government Act 2000.

  • Transition Committee shall have the meaning set forth in Section 2.14.

  • Compliance Committee means the committee referenced under the Federated Code of Business Conduct and Ethics, consisting of, among others, the Chief Compliance Officer, the General Counsel, the Chief Audit Executive and the Chief Risk Officer.

  • Independent Board Committee means the independent board committee of the Company

  • Audit Committee means the audit committee of the board of directors of the Company established pursuant to the Articles, or any successor committee.

  • District Evaluation Advisory Committee means a group created to oversee and guide the planning and implementation of the Board of Education's evaluation policies and procedures as set forth in N.J.A.C. 6A:10-2.3.

  • Architectural Review Committee or “ARC” shall mean the architectural review committee established by the Organization to review plans submitted to the Organization for architectural review.

  • Technical Committee means the body established in accordance with article VII;

  • Evaluation Committee means a body appointed to perform the evaluation of Offerors’ proposals.

  • Peer review committee means one or more persons acting in a peer review capacity who also serve as an officer, director, trustee, agent, or member of any of the following:

  • Evaluation Committee Report means a report prepared by the Procurement Manager and the Evaluation Committee for contract award. It will contain written determinations resulting from the procurement.

  • Appeal Committee means the appeal committee established by the Council in terms of section 12(3)(a);

  • Audit Committee Financial Expert means a person who has the following attributes:

  • Board of Review or “board” means the state building code board of review created by Iowa Code section 103A.15. The three members of the board of review are appointed by the building code commissioner from among the membership of the building code advisory council.

  • Nominating Committee means the nominating committee of the board of directors of the Company established pursuant to the Articles, or any successor committee.

  • Supervisory Committee means the Comisión Fiscalizadora of the Company.

  • Regional Committee means the regional committee on school

  • Review Committee or “Committee” means a committee established pursuant to rule Chapter 67-60, F.A.C.

  • Advisory Committee means the Employer's Advisory Committee as from time to time constituted.

  • Nomination Committee means the nomination committee of the Board established in accordance with Article 114;

  • Benefits Committee means the Employee Benefits Committee of Textron.

  • Independent Board Member means a trustee of the Fund who is neither an “interested person” of the Fund as defined in Section 2(a)(19) of the Investment Company Act of 1940, as amended, nor a party to the Proceeding with respect to which indemnification or advances are sought.

  • Investigation Committee means the Investigation Committee appointed by the Board under Regulation 5 of these Regulations;