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.
Sample 1Sample 2Sample 3
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 (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

Examples of Independent Ethics Committee in a sentence

  • The parties acknowledge that Protocol Amendments are also subject to approval by the responsible Independent Ethics Committee (“IEC”).

  • If applicable, the Parties acknowledge that Protocol Amendments are also subject to approval by the responsible Independent Ethics Committee (“IEC”) and/or Regulatory Authority (“RA”).

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

  • It is the duty of the National Coordinating Investigator to obtain all approvals for the Study required pursuant to Norwegian law or regulatory requirements from the relevant Independent Ethics Committee (“IEC”) before commencing the Study.

  • 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).

  • The Parties acknowledge that Protocol Amendments are also subject to approval by the responsible Independent Ethics Committee (“IEC”).

  • Principal Investigator will conduct the Study and Principal Investigator and Institution will perform all Study-related activities in accordance with the Protocol, including, but not limited to, the requirements relating to Institutional Review Board or Independent Ethics Committee (“IRB/IEC”) approval and adverse event reporting.

  • The legal status, composition, function, operations and regulatory requirements pertaining to Independent Ethics Committees may differ among countries, but should allow the Independent Ethics Committee to act in agreement with GCP as described in this guideline.

  • 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.

  • For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC.


More Definitions of Independent Ethics Committee

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;
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 an oversight committee elected at a general meeting;

  • 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;

  • 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 a Regional Committee constituted under these articles;

  • 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 this Administrative Agreement as outlined in section 7 (Oversight Committee) of this Administrative 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 means the committee assigned to review a contract for professional architectural, engineering and land surveying services, which shall include at least three persons designated by the Director and approved by the Executive Director.

  • 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.

  • Credentials Committee means the committee established by the Medical Advisory Committee to review applications for appointment and reappointment to the Professional Staff and to make recommendations to the Medical Advisory Committee and if no such committee is established it shall mean the Medical Advisory Committee;