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.
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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

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

  • 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).

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

  • 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.

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


More Definitions of Independent Ethics Committee

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.
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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. 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.
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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.

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