Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - Consultation

Document information
Reference	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
Validity area	WHO
Scope(s)	HM
Document name	WHO - Guidelines for GCP for trials on pharmaceutical products*
Version / Revision	1995
Status	Current
Document type	International guideline
Language(s)	EN
Description	World Health Organization WHO Technical Report Series, No. 850, 1995, Annex 3 Guidelines for good clinical practice (GCP) for trials on pharmaceutical products*
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 1 — Unit 1.5.4
Scope	HM
Document part	3.2 - Consultation
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Investigator responsibilities, Ethics committee, Protocol, Informed consent

Content

3.2 Ethics committee [...] 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. [...] 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.