COMPOSITION, RESPONSIBILITIES & FUNCTIONS OF IRB/IEC

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COMPOSITION, RESPONSIBILITIES & FUNCTIONS OF IRB/IEC

IRB/IEC Responsibilities:

1. An IRB/IEC should safeguard the rights, safety and well being of all trail subjects. Special attention should be paid to trails that may include vulnerable subjects.

2. The IRB/IEC should obtain the following documents:

• Trail protocols/ amendments

• Informed consent forms and consent form updates that the investigator proposes for use in the trail.

• Subject recruitment procedures eg: advertisements

• Investigators brochure

• Information about payments and compensation provided to the subjects

• Investigators CV and other qualification evidencing documents

The IRB/IEC should review a proposed clinical trial within a reasonable time and document its views in writing, clearly identifying trail, the documents reviewed and the dates for the following:

• Approval or favourable opinion

• Modifications required prior to its approval

• Disapproval or negative opinion

• Termination or suspension of trail

3. The IRB/IEC should review the trail once per year

4. The IRB/IEC may request more information other than the submitted one for the protection, safety  and well being of the subjects

5. When a non-therapeutic clinical trial is going in without consent of the subject is legally acceptable representative then the IRB/IEC should determine that the proposed protocol and other documents adequately addresses relevant ethical concerns and meets applicable regulatory requirements for such trials.

6. When protocol indicates the prior consent of the trial subject or subject legally accepted representative is not possible the IRB/IEC should determine the proposed protocol and other documents adequately addressed relevant ethical concerns and meeting regulatory requirements for such trials (i.e emergency situations).

7. The IRB/IEC should review payments and compensation given to the subjects. The payments should be prorated but not wholly contingent on completion of the trial by the subject.

COMPOSITION, FUNCTIONS & OPERATIONS:

1. The IRB/IEC should have a reasonable number of members who collectively have the qualifications and experience in order to evaluate medical scientific aspects and ethics of the proposed trial.

2. A list of 5 members- One member from non-scientific area, one member who is independent of the trial site.

3. A list of IRB/IEC members and their qualifications should be maintained.

4. Only members of IRB/IEC should vote/provide opinion for a decision

5. The IRB/IEC should function according to its written procedures, should maintain records and minutes of its meeting, and should comply with GCP and other applicable regulations.

6. The investigator should provide opinion on any aspect of the trial but should not participate in
deliberations of the IRB/IEC.

FUNCTIONS:

The IRB/IEC should establish document in writing and follow its procedures which includes:

 Determining its composition (name and qualifications of the members) and the authority under which it is established.

 Scheduling, notifying its members, and conducting its meetings

 Conducting initial and continuing review of trials.

 Providing approval or favourable changes for the ongoing trial

 Specifying that no subject be admitted into a trial before the IRB/IEC issues its approval.

 Specifying that no deviations from the protocol.

 Specifying that the investigator should promptly report to the IRB/IEC:

a. Deviations from the protocol to eliminate hazards to the trial subjects.

b. All ADRs those are both serious and unexpected.

 Ensuring that the IRB/IEC promptly notify in writing the investigator concerning:

a. Its trial related decisions/opinions

b. The reasons for its decisions/opinions

c. Procedures for appeal of decisions/opinions

RECORDS:

 The IRB/IEC should maintain all records which include written procedures, membership lists, and list of qualifications of members, submitted documents, and minutes of meetings for at least 3 years.

 The IRB/IEC may be asked by investigators, sponsors or regulatory authorities to provide its written procedures.

By Mehnaaz Alam

PharmD V/VI

Clinosol Research Pvt. Ltd...