Independent Ethics Committee definition

Independent Ethics Committee or “IEC” means an independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving / providing favorable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. The legal status, *** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment. An unredacted version of this exhibit has been filed separately with the Commission. composition, function, operations and regulatory requirements pertaining to IEC may differ among countries, but should allow the Independent Ethics Committee to act in agreement with GCP as described in this guideline.
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Independent Ethics Committee or “IEC” means an independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving / providing favorable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects, all to the extent required by the Applicable Laws and Regulations or by the applicable Regulatory Authority. The legal status, composition, function, operations and regulatory requirements pertaining to IEC may differ among countries, but should allow the Independent Ethics Committee to act in agreement with GCP as described in this guideline.
Sample 1
Independent Ethics Committee or “IEC” means an independent body constituted of medical professionals and non-medical members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection by among other things, reviewing and approving or providing favourable opinion on the trial protocol, the suitability of the investigators, facilities, methods and material to be used in obtaining and documenting informed consent of the trial subjects;
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Examples of Independent Ethics Committee in a sentence

  • H.2.1 Safety and Monitoring Issues Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval Before award and then with Annual Progress Reports, the Contractor shall submit to the Government a copy of the current IRB or IEC approved informed consent document, documentation of continuing review and approval and the Office of Human Research Protections (OHRP) FWA number for the institution or site.

  • Receptos will further ensure that an Institutional Review Board, an Independent Ethics Committee, or both, as applicable, established and constituted in accordance with Applicable Law, approves and oversees the conduct of any human clinical study included in the Development Plan and Budget.

  • Receptos will comply with the directives of the Institutional Review Board, the Independent Ethics Committee, or both, as applicable, respecting the conduct of any such clinical study, and will promptly notify AbbVie of any action or threatened action by the local Regulatory Authority or other agency that may affect continuation of such clinical study.

  • Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval Before award and then with Annual Progress Reports, the Contractor shall submit to the Government a copy of the current IRB or IEC approved informed consent document, documentation of continuing review and approval and the Office of Human Research Protections (OHRP) FWA number for the institution or site.

  • The investigator will obtain a signed Letter of Approval for the study and for the Informed Consent Form from the appropriate Independent Ethics Committee prior (IEC) to the study start and provide POI with a copy of the approval documentation.

  • Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval Before award and then with the annual progress report, the Contractor must submit to the Government a copy of the current IRB or IEC approved informed consent document, documentation of continuing review and approval and the Office of Human Research Protections (OHRP) FWA number for the institution or site.

  • BioNTech as the sponsor and Regulatory Approval holder of the Clinical Trials shall ensure that the Clinical Trial is approved by and subject to continuing oversight by an appropriate Institutional Review Board (IRB) or Independent Ethics Committee (IEC), except that BioNTech shall delegate this responsibility to Pfizer for any Clinical Trial for which Pfizer is the Lead Development Party.

  • Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval Before initiation of research and then with Annual Progress Reports, the Contractor shall submit to the Government a copy of the current IRB or IEC approved informed consent document, documentation of continuing review and approval and the Office of Human Research Protections (OHRP) FWA number for the institution or site.

  • Institutional Review Board or Independent Ethics Committee Approval Before initiating enrollment of subjects then with the annual progress report, the Contractor must submit to the CO and COR a copy of the current IRB-or IEC-approved informed consent document, documentation of continuing review and approval and the OHRP federal wide assurance number for the institution or site.

  • The protocol and the proposed informed consent form have to been reviewed and approved by a properly constituted Independent Ethics Committee (IEC/IRB) before study start at a particular study site.


More Definitions of Independent Ethics Committee

Independent Ethics Committee or “IEC” means an independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving / providing favorable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. The legal status, composition, function, operations and regulatory requirements pertaining to IEC may differ among countries, but should allow the Independent Ethics Committee to act in agreement with GCP as described in this guideline.
Sample 1
Independent Ethics Committee or “IEC” means an independent body, institutional, regional, national or supranational committee or review board, whose responsibility it is to ensure the protection of rights, safety and well-being of human subjects in a clinical study and who is responsible for, among other things, reviewing and approving or providing opinions on, the Collaboration Study Protocol, the suitability of the investigator(s), facilities, subject recruitment materials, methods and the information to be provided to potential Subjects in a Collaboration Study to secure their informed consent.
Sample 1

Related to Independent Ethics Committee

  • 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 Board Committee means the independent board committee of the Company

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

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

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

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

  • 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.

  • 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.

  • 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 116;

  • Operating Committee means the Operating Committee of Epoch which meets frequently and is responsible for implementing the Company’s strategy, making operational decisions and overseeing the day-to-day running of the Company.

  • Regional Committee means the regional committee on school

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

  • Independent Committee means a committee of the board of directors of the General Partner made up of directors that are “independent” of Brookfield and its Affiliates, as contemplated by applicable securities Laws;

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

  • 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.

  • Governance Committee means the Governance Committee of the Board.

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

  • Oversight Committee means the committee established to monitor the overall implementation of the Canada-Ontario-AMO-Toronto Agreement.

  • 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:

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

  • 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.

  • 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.