An overview of Institutional Review Board or Independent Ethics Committee

An Institutional Review Board (IRB) or Independent Ethics Committee (IEC) is a critical component of the ethical oversight process in clinical research involving human participants. Its primary purpose is to protect the rights, welfare, and well-being of study participants by ensuring that research studies are conducted ethically, following established ethical principles and regulatory guidelines. IRBs/IECs play a crucial role in reviewing, approving, and monitoring research protocols to ensure they meet ethical and regulatory standards.

1. Welcome An overview on Institutional Review Board (IRB)/ Independent Ethics committee (IEC) Mohammed Junaid Pasha Pharm.D CSRPL_STD_IND_HYD_ONL/CLS_164/082023 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 1

2. Definition It is a regulatory body that regulates all researches which are carried out on human subjects. The main objective of Institutional Review Board (IRB)/ Independent Ethics committee (IEC ) is to ensure that the research should be conducted in accordance with the ethical principals Ensuring the safety, rights and well being of the human subjects 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 2

3. Institutional Review Board (IRB ) 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 3 Safeguard Obtaining Documents Review Evaluates Approves Decision

4. Roles and Responsibilities It helps in safeguarding the rights, safety and well being of all the subjects in the trial. IRB/IEC Should obtain the following documents: - Trial Protocol - Informed Consent Form - Written information is being provided to the subjects - Investigator’s brochures (IB) - Information about the compensation or any reward being given to the subjects - Safety information for the subjects and the Curriculum vitae of the investigator IRB/IEC should timely review the clinical trial and propose a written document which should consist of: - Approval/favorable opinion - If any modification is required - Any negative opinion - Termination of the opinion 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 4

5. Roles and Responsibilities 4. The IRB or IEC should consider the investigators qualification and should be documented by a curriculum vitae. 5. They should conduct a continuing review of the ongoing trial at least once a year. 6. The IRB or IEC can request more information about the trial, and should be furnished to the subject when ever required. It should be meaningful and protect the rights, safety and well being of the subjects. 7. The IRB or IEC should ensure that there is no undue influence on the subjects by anyone in the trial and the amount and method of payment to the them are carried out accordingly and should be mentioned in the written informed consent form. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 5

6. Members of the IRB/IEC Chair Person 1-2 Medical Scientist 1-2 Clinicians One Legal Expert One Philosopher Lay Person Member Secretary 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 6

7. Composition, Function and Operations: It is recommended that the IRB/IC should include : ( a) At least five members . ( b) At least one member whose primary area of interest is in a non scientific area . ( c) At least one member who is independent of the institution/trial site: 1 . Only those IRB/IC members who are independent of the investigator & the sponsor of the trial should vote/provide opinion on a trial related matter . 2 . A list of IRB/IEC members and their qualifications should be maintained . • The IRB/IEC should perform its functions accordingly to written operating procedures, should maintain written records of its activities and minutes of its meeting, and should comply with GCP. and with the applicable regulatory requirements . An IRB/IC should make its decisions at announced meetings at which, at least a quorum, as stipulated in its overwritten operating procedures, is present . 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 7

8. Procedure The IRB/IEC should follow its procedures, which should include: 1 . Determining its composition (names and qualifications of the members) 2. Plan and notify its members and conducting its meeting . 3 . Conducting a continuing review of trials . 4 . Maintaining a frequency of continuing review. 5 . Providing approval/favorable opinion of minor changes in ongoing trials 6 . Specifying that no subjects should be admitted to a trial before the IRB/IEC approval/favorable opinion. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 8

9. 7. Mentioning that no deviations from the protocol should be initiated without consulting IRB/IC approval/favorable opinion 8. The investigators should report to the IRB/IC : If there is any deviation or changes of the protocol, to eliminate immediate hazards to the trial subjects . Any changes that put the subject at risk Serious and unexpected adverse drug reactions(ADR's). 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 9

10. Records The IRB/IEC should maintain relevant records even after 3 years of completion of the trial of the following documents: SOP's Membership files Submitted documents of meetings Correspondence 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 10

11. Thank You! www.clinosol.com (India | Canada) 9121151622/623/624 [email protected] 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 11