Composition, Responsibilities, Procedures of Institutional Review Board (IRB) - PHARMD Guru

Introduction

The Institutional Review Board (IRB) is essential in overseeing clinical research to ensure ethical standards.
The IRB's main goals include protecting the rights and welfare of human research subjects.

Diverse Membership: The IRB is composed of members with varying backgrounds to provide a comprehensive review process.
- Includes scientific and non-scientific members.
- Members should represent different genders and cultural backgrounds.
Expertise: Members are chosen based on their experience and expertise in areas related to clinical research and ethics.
Independence: The board functions independently of the institution’s management to avoid conflicts of interest.

Review Protocols: Assess research protocols to ensure they are ethically acceptable and comply with regulations.
Informed Consent: Ensure that informed consent is obtained from all research participants thoroughly and appropriately.
Risk-Benefit Analysis: Evaluate potential risks versus anticipated benefits for research subjects.
Monitoring: Continuously monitor ongoing research for compliance with ethical standards.
Documentation: Maintain detailed records of IRB activities and decisions.

Initial Review: Conduct initial reviews of research proposals before they begin.
Continuing Review: Perform periodic reviews of ongoing research projects.
Amendment Review: Review changes or amendments to approved research protocols.
Communication: Communicate decisions, including approvals, modifications required, or disapprovals, to researchers promptly.

The IRB plays a crucial role in the ethical conduct of clinical research.
It ensures that the dignity and rights of individuals participating in research are respected and protected.
Ongoing monitoring and a structured review process help maintain high ethical standards in clinical research.