ICH Harmonised Guideline for Good Clinical Practice E6(R3) - Step 4 Final

ICH E6(R3) Guideline

(a)

Approval/favourable opinion;

(b)

Modifications required prior to its approval/favourable opinion;

(c)

Disapproval/negative opinion;

(d)

Termination/suspension of any prior approval/favourable opinion.

1.2.4

The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to participants.

1.2.5

The IRB/IEC may request more information than is outlined in section 2.8.11 be given to participants when, in the judgement of the IRB/IEC, the additional information would add meaningfully to the protection of the rights, safety and/or well-being of the participants. Where the protocol indicates that prior consent of the trial participant or the participant ’s legally acceptable representative is not possible (see section 2.8.8), the IRB/IEC should determine that the proposed protocol and/or other document(s) adequately address relevant ethical concerns and meet applicable regulatory requirements for such trials (e.g., in emergency situations). If minors are to be included in a trial, the IRB/IEC should review the assent information considering the age, maturity and psychological state of the minor population intended to be enrolled, as well as applicable regulatory requirements. If the trial participants are compensated for their participation in the trial, the IRB/IEC should review both the amount and method of payment to participants to assure that neither presents problems of coercion or undue influence on the trial participants. Payments to a participant should be timely, prorated and not wholly contingent on completion of the trial by the participant. Reasonable reimbursement of expenses incurred by participants, such as for travel and lodging, is not coercive. The IRB/IEC should ensure that information regarding payment to participants, including the methods, amounts and schedule of payment to trial participants, is set forth in the informed consent materials and any other information to be provided to participants.

1.2.6

1.2.7

1.2.8

1.2.9

1.3

Composition, Functions and Operations

1.3.1

The IRB/IEC should consist of a reasonable number of members who collectively have the qualifications and experience to review and evaluate the science, medical aspects and ethics of the proposed trial. It is recommended that the IRB/IEC should include:

(a)

At least five members;

(b) At least one member whose primary area of interest is not in medical sciences;

(c) At least one member who is independent of the institution/investigator site.

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