Role and Function of an IRB/IEC

In the realm of clinical research, the safety, dignity, and well-being of human participants are paramount. This protection is primarily guaranteed by an independent body known as the Institutional Review Board (IRB) or Independent Ethics Committee (IEC).

Constituted under regulatory frameworks like the $\text{FDA}$ regulations and guided by international declarations, the IRB/IEC's central mission is to ethically and scientifically review research involving human volunteers.

1. ❓ Why Do We Need an IRB/IEC?

The existence and function of an Ethics Committee are driven by fundamental ethical and legal necessities:

Subject Protection: To safeguard the welfare, rights, and confidentiality of every study participant.
Compliance with Global Standards: To meet the standards set by the Declaration of Helsinki (1964), widely regarded as the foundational document of human research ethics developed by the World Medical Association ( $\text{WMA}$ ).
Ethical Validity: To ensure that clinical research is ethically worthy and acceptable to regulatory authorities and journal editors.

Key Definitions in Research Ethics:

Research: A systematic investigation intended to develop or contribute to generalizable knowledge.
Human Subject: A living individual about whom an investigator obtains data through intervention, interaction, or identifiable private information.
Private Information: Information about an individual's behavior that occurs in a context where they have a reasonable expectation that no observation or recording is taking place.

2. 👥 Composition and Functioning of the IEC

The effectiveness of an Ethics Committee depends on its independence, diverse composition, and adherence to rigorous procedures.

A. Composition Requirements

An IRB/IEC must be composed to ensure comprehensive, unbiased review:

Minimum Members: At least 5 members.
Diversity: Members must be from varied professions and include both genders.
Key Roles:

One member from a non-scientist background (e.g., layperson).
One member whose primary concern is in the scientific domain (scientist/clinician).
One member independent of the institution.

Expertise: Experienced researchers, knowledge of institutional rules, sensitivity to social issues, and experience with dense populations.

B. Functioning Guidelines

The IEC must operate strictly according to written Standard Operating Procedures ( $\text{SOPs}$ ).

Record Keeping: All $\text{SOPs}$ , correspondence, records of meetings, and their timelines must be constantly available for audit.
Document Retention: All study-related documents must be safeguarded for at least 3 years after the study is closed (completed or terminated).

3. ✅ Criteria for Ethical Approval

The IEC's main function is to review protocols to ensure two things: scientific rigor and ethical acceptability. Scientifically flawed research is unethical because it exposes subjects to risk for no potential benefit.

A. Documents Required for Review

The IEC reviews comprehensive documentation before granting approval:

Detailed Study Plan/Protocol with the Case Report Form ( $\text{CRF}$ ).
Information for Subjects and the Informed Consent Form ( $\text{ICF}$ ).
Investigator’s Brochure ( $\text{IB}$ ) (detailing the drug/intervention).
Subject Recruitment Procedure and materials.
Investigator’s $\text{CV}$ and available facilities.

B. Key Criteria for Approval

Approval is granted based on the suitability of the protocol and the investigator:

Suitability of Protocol:

Clear study objectives and scientific efficiency.
Justification of Risk: The potential benefits must outweigh the risks/inconveniences ( $\text{Risk-Benefit Ratio}$ ).
Equitable Selection of Subjects.
Robust Confidentiality measures for subjects and data.
Appropriateness of the Informed Consent Process.

Suitability of Investigator: Qualifications, experience, supporting staff, available facilities, and time.

4. 📝 Types of Reviews and Reporting

The level of risk associated with a study determines the type of review required:

Full Committee Review: Required for studies involving significant or more than minimal risk.
Expedited Review: Handled quickly by the Chairman plus one or more experienced members. This is typically used for minimal risk studies such as:

Data analysis from records.
Prospective collection of biological specimens.
Minor protocol amendments.

Who Communicates with the IEC?

The Chief Investigator is primarily responsible for dealing with the IEC, not the sponsor. However, the sponsor must assist the investigator by providing information, amending the protocol, and complying with the IEC's requirements.

Reporting Adverse Events

A key responsibility is reporting safety data. Serious Adverse Events ( $\text{SAE}$ ) must typically be reported to the $\text{IEC}$ within 14 calendar days of their occurrence.

5. 🇮🇳 Challenges and Requirements in India

While it is desirable for every institution to have its own $\text{IEC}/\text{IRB}$ , it is not always mandatory. An institution without an $\text{IEC}$ can submit its proposal to an existing, external $\text{IEC}$ provided both parties adhere to the external committee's $\text{SOPs}$ and the institution acknowledges the external $\text{IEC}$ 's authority.

Common Shortcomings of IECs (General/India-Specific):

Improper or insufficient membership diversity (lack of legal expert, layperson, etc.).
Poorly written or non-existent $\text{SOPs}$ .
Infrequent or irregular meetings, or reviews conducted via correspondence instead of convened meetings.
Poor record-keeping and follow-up on approved studies.

Research ethics ultimately provides a robust framework for analysis and decision-making, ensuring that subject safety is paramount and that the balance between benefit and risk is continually evaluated.