Institutional Review Board (IRB) / Institutional Ethics Committee (IEC)

An IRB/IEC is an ethical committee with the primary motive to review the researches or experiments that are conducted by considering ethical measures or not which is constituted under FBA regulations to safeguard the rights and welfare of research involving human volunteers.

Common Terms:

• Research: To foster information or add, to sum up, knowledge, a systematic investigation is intended to develop.
• Human subject: Living being, an individual with life about whom an investigator conducts research by acquiring distinguishable information, or by collecting data through close interaction.
• Private information: Valuable information about any behavioral changes that happen in a setup wherein the individual will be completely unaware of the fact that no observation or recording is taking place.
• Any secretive information that has been provided for explicit purposes, is not expected from the individual to be made communal.

Why is it needed?

• To protect the study subjects’

1. Welfare
2. Rights
3. Confidentiality

• To meet the ordinance of Proclamation of Helsinki (June 1964 in Helsinki, Finland)
• A number of principles of ethical importance are required to conduct experimentation on humans developed for the medical world by the World Medical Association (WMA).
• It is widely regarded as the foundation document of human research ethics.
• To make clinical research ethically worthy, and acceptable to regulatory authorities and journal editors

What should be its composition?

• At least 5 members
• Members from either gender
• Members that come from varied professions
• One non-scientist background member
• One member whose essential concerns are in the scientific domain or scientific logic
• One member independent of the institution
• Experienced researchers with expertise in all of the areas of research being reviewed
• Members of diverse background
• Sensitivity to social problems
• A great sense of knowledge of institutional and country rules and regulations
• Experience with rich and denser populations

How should an IEC function?

• According to written standard operating procedures (SOP)
• The following reports should always be constantly available for audit or review:

1. The SOP, all correspondence with the investigators
2. Records of all gatherings, meetings and their timeframe

• The documents related to a study should be a safeguard for at least 3 years after the study is closed (completed or terminated).

Should the IEC review the scientific aspects of a protocol?

• Scientific audit and ethical audit cannot be isolated.
• Scientifically irrational research is viewed as deceptive, which may expose human subjects to risk or any kind of inconvenience for no reason.
• With considering no danger of injury, even wasting of participants and loss of time of valuable resources or assets.

What documents does the IEC ask for?

• The detailed study plan, with case report form (CRF)
• Information for Subjects, with informed consent form (ICF)
• Investigator’s Brochure (IB)
• Subject recruitment procedure, and documents related to it
• Payment and compensation available to the subjects
• Investigator’s CV, and facilities available to him
• Any changes to these for review before implementation
• Periodic progress reports, AE reports, and final report

Criteria for EC Approval of a research proposal are as follow:

• Suitability of Investigator

1. Qualifications, Experience
2. Supporting Staff, Available Facilities
3. Time available

• Suitability of Protocol

1. Objectives of the study
2. Justification: risks/ inconveniences vs. benefits
3. Scientific efficiency
4. Equitable Selection of Subjects

• Confidentiality of Subjects and Data
• Informed consent process
• Regulatory aspects

Types of IRB reviews are as follow:

• Full committee review
• Expedited review

(Chairman + 1 or more experienced members)
For minimal risk studies:

Minimal risk = Data analysis from records, prospective collection of biological specimens, protocol amendments of a minor nature

Who should deal with the IEC?

• The chief investigator, not the sponsor
• However, the sponsor should help the investigator

1. Respond to the issues raised by the IEC
2. Supply additional information required
3. Amend the study plan if necessary
4. Comply with the IEC’s other requirements

Challenges faced by the Ethics Committee are as follow:

1. Requirement for regulatory authority clearance
2. DCGI permission for Phase 1-3 studies
3. Definition of a “new drug” – new indication/new route of administration/new dosage form
4. Sending samples abroad

Must every institute have its own IEC or IRB?

• It is desirable but not necessary or mandatory, although this is most desirable.
• By following certain terms and conditions an institute without an IEC may submit the proposal to an existing IEC in another institute if:

1. The SOP of that Committee allow such review
2. Institute and investigator acknowledge Committee’s authority to review the lead and progress of the study, and its final decision about approval, continuation, or termination of the study.

What are the common shortcomings of IECs in India?

• Improper membership
• Poorly written or no SOP
• Infrequent or irregular meetings
• Review by correspondence rather than at convened meetings
• Poor record-keeping and follow-up
• A mix of members
• At least 5 members for the quorum
• Basic medical scientist, clinician, legal expert, layperson, social scientist/philosopher
• SAE to be reported within 14 calendar days

What do research ethics actually do?

• They provide a framework for analysis and decision making
• Remind researchers that subject safety is paramount
• Provide definitions of benefit and risk and guidelines for evaluating the risk-benefit ratio

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