ICH GCP Section 3- IRB/IEC

And IRB/IEC should...

safeguard the rights, safety and well-being of all trial subjects. Special attention to be paid to trials that may include vulnerable subjects. (3.1.1)

IRB/IEC should obtain the following documents:

-trial protocol/amendments
-ICFs/updates
-recruitment procedures
-written info to be provided to subjects
-IB
-safety information
-payment/compensation available
-investigators CV
(3.1.2)

IRB/IEC considers the qualification of the investigator for trials by

a current CV or other documentation they request(3.1.3)

The IRB/IEC should conduct continuing reviews...

at intervals appropriate to degree of risk, but no less than 1 per year. (3.1.4)

The IRB/IEC can request more information to be given to subjects when...

that information would add meaningfully to the protection of the rights, safety and/or well being of subjects (3.1.5)

When a nontherapeutic trial is to be carried out with LAR consent, the IRB/IEC should...

determine that the protocol and/or other documents adequately address the relevant ethical concerns and regulatory requirements. (3.1.6)

When protocol indicates that the consent of a subject or subjects LAR is not possible, the IRB/IEC should

determine that the protocol and/or other documents adequately address the relevant ethical concerns and regulatory requirements. (3.1.7)

The IRB should review the amount and method of payment to asssure....

Payments should be...

that neither present problems of coercion or undue influence.

prorated and not wholly contingent on completion of the trial by the subject (3.1.8)

The IRB/IEC shoud ensure that information regarding payment to subjects is...

set forth in the ICF and any other written information to be provided to subjects. The way payment is be prorated should be specified. (3.1.9)

The IRB/IEC should include...

At least 5 members

At least one member who is nonscientific

At least one member who is independent of institution

All collectively should have qualifications and experience to review and evaluate the trial.

Only people independent of the investigator can vote on an investigator's trial.

(3.2.1)

The IRB/IEC should perform its functions according to...

written operating procedures (3.2.2)

The IRB/IEC should maintain...

written records of its activities and minutes of the meetings (3.2.2)

The IRB/IEC should comply with...

GCP and other regulatory requirements (3.2.2)

The IRB/IEC should make decisions at...

announced meeting where at least a quorum (as stipulated in written operating procedures) is present (3.2.3)

The only members that can participate in the IRB/IEC vote opinion are...

ones that participate in the review and discussion (3.2.4)

Can the investigator of a trial provide information for IRB/IEC deliberations?

Yes; but they cannot participate in deliberations or vote. (3.2.5)

The IRB/IEC can invite

nonmembers with expertise in special areas for assistance. (3.2.6)

The IRB should establish, document in writing and follow its procedures, which include:

1. Determining composition
2. scheduling, notifying, and conducting meetings
3. conducting intial and continuing review
4. determining frequency of CRs
5. providing expedited review
6. specifying that not subject should be admitted to a trial without approval of IRB
7. specifying that no deviations from, or change of the protocol can be implemented without IRB approval unless necessary to remove immediate hazards
8. specifying that investigator should prompty report to IRB deviations to eliminate hazard, changes increasing risk, ADRs, new information that may adversely impact subjects
9. ensuring that IRB promptly notify investigator/institution in writing about trial related decisions, the reasons for those decisions, and procedures for appeal. (3.3.1-9)

The IRB should retain all relevant records for...

a period of at least 3 years after completion of a trial and make them available upon request to regulatory authorities.