WHO Expert Committee on Selection and Use of Essential Medicines - WHO Technical Report Series, No. 850, Annex 3 (Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products) - Sixth Report
(1995; 36 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentINTRODUCTION
View the documentGLOSSARY
Open this folder and view contents1. PROVISIONS AND PREREQUISITES FOR A CLINICAL TRIAL
View the document2. THE PROTOCOL
Close this folder3. PROTECTION OF TRIAL SUBJECTS
View the document3.1 Declaration of Helsinki
View the document3.2 Ethics committee
View the document3.3 Informed consent
View the document3.4 Confidentiality
Open this folder and view contents4. RESPONSIBILITIES OF THE INVESTIGATOR
Open this folder and view contents5. RESPONSIBILITIES OF THE SPONSOR
Open this folder and view contents6. RESPONSIBILITIES OF THE MONITOR
Open this folder and view contents7. MONITORING OF SAFETY
Open this folder and view contents8. RECORD KEEPING AND HANDLING OF DATA
Open this folder and view contents9. STATISTICS AND CALCULATIONS
Open this folder and view contents10. HANDLING OF AND ACCOUNTABILITY FOR PHARMACEUTICAL PRODUCTS
Open this folder and view contents11. ROLE OF THE DRUG REGULATORY AUTHORITY
View the document12. QUALITY ASSURANCE FOR THE CONDUCT OF A CLINICAL TRIAL
View the document13. CONSIDERATIONS FOR MULTICENTRE TRIALS
View the documentREFERENCES
View the documentAPPENDIX 1: World Medical Association’s Declaration of Helsinki1
View the documentAPPENDIX 2: Model list of items to be contained in a clinical trial protocol
 

3.2 Ethics committee

The role of the ethics committee (or other board responsible for reviewing the trial) is to ensure the protection of the rights and welfare of human subjects participating in clinical trials, as defined by the current revision of the Declaration of Helsinki and national and other relevant regulations, and to provide public reassurance, inter alia, by previewing trial protocols, etc. (see Section 2).

The ethics committee should be constituted and operated so that its tasks can be executed free from bias and from any influence of those who are conducting the trial.

The ethics committee should have documented policies and procedures as a basis for its work, which should be available to the public. These should set out the authority under which the committee is established, the number of members elected and their qualifications, a definition of what it will review and its authority to intervene and maintain records of its activities. The documents should also state how frequently the committee will meet and how it interacts with the investigator and/or sponsor.

The investigator, or the investigator and the sponsor, must consult the relevant ethics committee(s) regarding the suitability of a proposed clinical trial protocol (including appendices and amendments) and of the methods and materials to be used in obtaining and documenting the informed consent of the subjects.

The ethics committee has an ongoing responsibility for the ethical conduct of research, and therefore must be informed of all subsequent amendments to the protocol and of any serious adverse events occurring during the trial, or other new information likely to affect the safety of the subjects or the conduct of the trial. The ethics committee should be asked for its opinion if a re-evaluation of the ethical aspects of the trial appears to be required, or if there is any doubt regarding the importance of a protocol change or new information.

Subjects must not be entered into the trial until the relevant ethics committee(s) has issued its favourable opinion on the procedures. The ethics committee should give its opinion and advice in writing within a reasonable time, clearly identifying the trial protocol, itemizing the documents studied and stating the date of review. A list of those present at the committee meeting, including their professional status, should be attached.

When reviewing a clinical trial proposal the ethics committee should consider the following:

(a) The acceptability of the investigator for the proposed trial, on the basis of sufficient information made available to the committee, in terms of his or her qualifications, experience, availability for the duration of the study, supporting staff and available facilities.

(b) The suitability of the protocol including the objectives of the study and the justification of predictable risks and inconveniences weighed against the anticipated benefits for the subjects and/or others, and the efficiency of its design, i.e. the potential for reaching sound conclusions with the smallest possible exposure of subjects.

(c) The means by which trial subjects will be recruited, necessary or appropriate information will be given, and consent will be obtained. This is particularly important in the case of trials involving subjects who are members of a group with a hierarchical structure or another vulnerable group (see Section 3.3 (e)-(f)).

(d) The adequacy and completeness of the information, which should be written in a language and at a level of complexity understandable to everyone involved, to be given to the subjects, their relatives, guardians or, if necessary, legal representatives. All such written information must be submitted in its final form to the ethics committee.

(e) Provision, if any, for compensation or treatment in the case of death or other loss or injury of a subject, if attributable to a clinical trial, and details of any insurance or indemnity (a source of legal and financial support) to cover the liability of the investigator(s) and sponsor. (See Section 5.9).

(f) The appropriateness of the extent and form of payment through which the sponsor will remunerate or compensate the organization(s) and/or investigator(s) conducting the trial, and the trial subjects, as required by local laws and regulations.

(g) The acceptability of proposed amendments to the protocol that are likely to affect the safety of the subjects or the conduct of the trial.

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