1、CAN/CGSB-191.1-2013Research ethics oversight of biomedical clinical trialsICS 03.120.01National Standard of CanadaThe CANADIAN GENERAL STANDARDS BOARD (CGSB), under whose auspices this National Standard of Canada has been developed is a government agency within Public Works and Government Services C
2、anada. CGSB is engaged in the production of voluntary standards in a wide range of subject areas through the media of standards committees and the consensus process. The standards committees are composed of representatives of relevant interests including producers, consumers and other users, retaile
3、rs, governments, educational institutions, technical, professional and trade societies, and research and testing organizations. Any given standard is developed on the consensus of views expressed by such representatives. CGSB has been accredited by the Standards Council of Canada as a national stand
4、ards-development organization. The standards that it develops and offers as National Standards of Canada conform to the criteria and procedures established for this purpose by the Standards Council of Canada. In addition to standards it publishes as national standards, CGSB produces standards to mee
5、t particular needs, in response to requests from a variety of sources in both the public and private sectors. Both CGSB standards and CGSB national standards are developed in conformance with the policies described in the CGSB Policy Manual for the Development and Review of Standards. CGSB standards
6、 are subject to review and revision to ensure that they keep abreast of technological progress. Suggestions for their improvement, which are always welcome, should be brought to the notice of the standards committees concerned. Changes to standards are issued either as separate amendment sheets or i
7、n new editions of standards. An up-to-date listing of CGSB standards, including details on latest issues and amendments, and ordering instructions, is found in the CGSB Catalogue, which is published annually and is available without charge upon request. More information is available about CGSB produ
8、cts and services at our Web site www.tpsgc-pwgsc.gc.ca/ongc-cgsb. Although the intended primary application of this standard is stated in its Scope, it is important to note that it remains the responsibility of the users of the standard to judge its suitability for their particular purpose. The test
9、ing and evaluation of a product against this standard may require the use of materials and/or equipment that could be hazardous. This document does not purport to address all the safety aspects associated with its use. Anyone using this standard has the responsibility to consult the appropriate auth
10、orities and to establish appropriate health and safety practices in conjunction with any applicable regulatory requirements prior to its use. CGSB neither assumes nor accepts any responsibility for any injury or damage that may occur during or as the result of tests, wherever performed. Attention is
11、 drawn to the possibility that some of the elements of this Canadian standard may be the subject of patent rights. CGSB shall not be held responsible for identifying any or all such patent rights. Users of this standard are expressly advised that determination of the validity of any such patent righ
12、ts is entirely their own responsibility. Further information on CGSB and its services and standards may be obtained from: The Manager Standards Division Canadian General Standards Board Gatineau, Canada K1A 1G6 The Standards Council of Canada (SCC) is the coordinating body of the Canadian standardiz
13、ation network, which is composed of people and organizations involved in the development, promotion and implementation of standards. Through the collaborative efforts of Canadian standardization network members, standardization is helping to advance the social and economic well-being of Canada and t
14、o safeguard the health and safety of Canadians. The networks efforts are overseen by SCC. The principal objectives of SCC are to foster and promote voluntary standardization as a means of advancing the national economy, supporting sustainable development, benefiting the health, safety and welfare of
15、 workers and the public, assisting and protecting the consumer, facilitating domestic and international trade, and furthering international cooperation in relation to standardization. An important facet of the Canadian standards development system is the use of the following principles: consensus; e
16、qual access and effective participation by concerned interests; respect for diverse interests and identification of those who should be afforded access to provide the needed balance of interests; mechanism for dispute resolution; openness and transparency; open access by interested parties to the pr
17、ocedures guiding the standards development process; clarity with respect to the processes; and Canadian interest consideration as the initial basis for the development of standards. A National Standard of Canada (NSC) is a standard prepared or reviewed by an SCC-accredited SDO and approved by the SC
18、C according to NSC approval requirements. Approval does not refer to the technical content of the standard, as this remains the responsibility of the SDO. An NSC reflects a consensus of a number of capable individuals whose collective interests provide, to the greatest practicable extent, a balance
19、of representation of general interests, producers, regulators, users (including consumers) and others with relevant interests, as may be appropriate to the subject at hand. NSCs are intended to make a significant and timely contribution to the Canadian interest. Those who have a need to apply standa
20、rds are encouraged to use NSCs. These standards are subject to periodic review. Users of NSCs are cautioned to obtain the latest edition from the SDO that publishes the standard. The responsibility for approving standards as NSCs rests with: Standards Council of Canada 270 Albert Street, Suite 200 O
21、ttawa, Ontario K1P 6N7, CANADA How to order Publications: by telephone 819-956-0425 or 1-800-665-2472 by fax 819-956-5740 by mail CGSB Sales Centre Gatineau, Canada K1A 1G6 in person Place du Portage Phase III, 6B1 11 Laurier Street Gatineau, Quebec by email ncr.cgsb-ongctpsgc-pwgsc.gc.ca on the Web
22、 www.tpsgc-pwgsc.gc.ca/ongc-cgsb NATIONAL STANDARD OF CANADA CAN/CGSB-191.1-2013Research ethics oversight of biomedical clinical trialsNATIONAL STANDARD OF CANADA CAN/CGSB-3.14-2006Prepared by the Approved by the Canadian General Standards BoardPublished May 2013 by the Canadian General Standards Bo
23、ard Gatineau, Canada K1A 1G6 HER MAJESTY THE QUEEN IN RIGHT OF CANADA, as represented by the Minister of Public Works and Government Services, the Minister responsible for the Canadian General Standards Board (2013). No part of this publication may be reproduced in any form without the prior permiss
24、ion of the publisher.CETTE NORME NATIONALE DU CANADA EST DISPONIBLE EN VERSIONSFRANAISE ET ANGLAISE.CAN/CGSB-191.1-2013CANADIAN GENERAL STANDARDS BOARDCommittee on Research Ethics Boards Reviewing Biomedical Clinical Trials(Voting membership at date of approval)Chair (non-voting)Griener, G.1National
25、 Council on Ethics in Human ResearchGeneral Interest CategoryKelly, J.M.H. Centre for Indigenous Research, Culture, Language and Education (CIRCLE)Kovacs Burns, K. Best Medicines CoalitionLeonard, P. Canadian Patient Safety InstituteSczelecki, L. Canadian Cancer SocietyThomas, K. Canadian AIDS Socie
26、tyProducer CategoryClark, E. McGill University Health CentreCollins-Mrakas, A. York University, Office of Research EthicsCorman, J. Institutional Review Board ServicesGodlovitch, G. Conjoint Health Research Ethics Board/University of CalgaryLaviolette, M.A. Ottawa Hospital Research InstituteManzo, J
27、. Ontario Institute for Cancer ResearchNeuman, R. Canadian Association of Research Ethics BoardsOwen, M. Canadian Association of University Research AdministratorsPaige, C. University Health NetworkRolleston, F. Canadian Blood ServicesSaryeddine, T. Association of Canadian Academic Healthcare Organi
28、zationsShort, D. Research Ethics Board Legal SocietySugarman, R. Hospital for Sick ChildrenVan Nie, A. McMaster University Faculty of Health SciencesRegulator CategoryKasina, A. Health Canada, InspectionsMonette, P. Health Canada, Science Policy DirectorateViner, N. Health Canada, Biologics the purp
29、ose of a note accompanying a clause is to separate from the text explanatory or informative material.CAN/CGSB-191.1-20131CGSB 2013 All rights reservedResearch ethics oversight of biomedical clinical trials1 Scope This National Standard of Canada applies to Research Ethics Boards (REBs) that evaluate
30、 applications for ethical acceptability. If an REB grants ethics approval to conduct biomedical clinical trials, it will provide research ethics oversight of biomedical clinical trials that are subject to the Food and Drugs Act and applicable Regulations (see 2.1). This Standard does not preclude or
31、 override any applicable regulatory or legal requirement.Intended users This Standard is intended for use primarily by REB chairs, members and administrative staff, qualified investigators and study teams conducting biomedical clinical trials, sponsors and funders of biomedical clinical trials, thos
32、e with responsibility for establishing and ensuring effective REB operations, those with responsibility for research ethics oversight of biomedical clinical trials in organizations where they are conducted, and regulatory authorities that evaluate REBs with research ethics oversight of biomedical cl
33、inical trials.An organization with an REB intending to use this Standard will take responsible measures to ensure that the roles and responsibilities of the REB are defined, resources are made available, and processes are in place for research ethics oversight of biomedical clinical trials conducted
34、 under its auspices, to ensure that the REB meets the requirements of this Standard and applicable statutory and regulatory requirements.2 Normative references The following documents contain provisions that, through reference in this text, constitute provisions of this National Standard of Canada.
35、The referenced documents may be obtained from the sources noted below.An undated reference is to the latest edition or revision of the reference or document in question, unless otherwise specified by the authority applying this standard. A dated reference is to the specified revision or edition of t
36、he reference or document in question. However, parties to agreements based on this National Standard of Canada are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below.2.1 Health CanadaFood and Drugs ActFood and Drug Regulations: P
37、art C, Division 5, Drugs for Clinical Trials Involving Human SubjectsMedical Devices RegulationsNatural Health Products Regulations.2CAN/CGSB-191.1-2013CGSB 2013 All rights reserved2.1.1 SourceThe above may be obtained from the Department of Justice Canada, Communications Branch, Public Affairs Divi
38、sion, 284 Wellington Street, Ottawa, ON K1A 0H8, Telephone 613-957-4222, Facsimile 613-954-0811, http:/canada.justice.gc.ca.2.2 International Conference on Harmonisation (ICH)ICH GCP International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
39、 ICH Harmonised Tripartite Guideline Guideline for Good Clinical Practice E6(R1), http:/www.ich.org/LOB/media/MEDIA482.pdf.2.2.1 SourceThe above may be obtained from ICH Secretariat, c/o IFPMA, 15 ch. Louis-Dunant, P.O. Box 195, 1211 Geneva 20, Switzerland, Telephone +41 (22) 338 32 06, Facsimile: +
40、41 (22) 338 32 30, http:/www.ich.org.2.3 World Medical AssociationWorld Medical Association, Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects, http:/ SourceThe above may be obtained from the World Medical Association (WMA), 13, ch. du Levant, CIB - Btiment A
41、, 01210 Ferney-Voltaire, France, Telephone +33 4 50 40 75 75, Facsimile: +33 4 50 40 59 37, http:/.3 Terms and definitions For the purposes of this National Standard of Canada, the following terms and definitions, and those set out in the Food and Drugs Act and applicable Regulations, apply:3.1appli
42、cantindividual, sponsor, institution or organization which applies to an REB for an ethics review of a biomedical clinical trial.3.2applicationrequest by an applicant for the initial review by an REB of a biomedical clinical trial or requests for review of protocol amendments, changes to consent doc
43、uments, advertising, or any other materials or changes related to a clinical trial reviewed by the REB of Record as part of its research ethics oversight of the biomedical clinical trial.3.3assentaffirmative agreement to participate in a biomedical clinical trial given by a child or other person inc
44、apable of giving informed consent.3.4biomedical clinical trialinvestigation in which a health product (drug, medical device, or natural health product) is administered to or used by humans and that is intended to discover or verify the clinical, pharmacodynamic or pharmacokinetic effects of the prod
45、uct, or ascertain the safety or efficacy of the product.CAN/CGSB-191.1-20133CGSB 2013 All rights reserved3.5community membermember of the general public with no formal affiliation with the sponsor of the biomedical clinical trial, with the organization under whose auspices the biomedical clinical tr
46、ial is being conducted, or with any site where the biomedical clinical trial is being conducted.NOTE An example of a community member is a patient or a former research subject.3.6conflict of interestcircumstance of a person or organization in a real, perceived or potential conflict between their dut
47、ies or responsibilities related to research and their personal, institutional or other interests. EXAMPLE Conflicts of interest may occur when individuals judgments and actions or organizations actions in relation to research are, or could be, affected by personal, organizational or other interests,
48、 including, but not limited to, business, commercial or financial interests, whether of individuals, their family members, their friends, or their former, current or prospective professional associations or of the organization itself.3.7continuing reviewprocess of research ethics review for continui
49、ng ethical acceptability of an ongoing biomedical clinical trial conducted by the REB at an interval no greater than every twelve months and prior to the expiration of the preceding ethics approval.3.8delegated reviewexpedited reviewreview carried out on behalf of the REB by the Chair and/or members of the REB according to eligibility criteria and processes authorized by the REB. 3.9ethical conduct of researchobligation to comply with applicable ethical pri
