RESEARCH AND ETHICS COMMITTEE

1. Introduction

Research involving human participants must be conducted according to accepted scientific and ethical principles. A Research Ethics Committee reviews proposed research to ensure that the rights, safety, dignity, privacy, and well-being of research participants are protected.

Depending on the institution and jurisdiction, such a committee may be called:

• Institutional Ethics Committee (IEC)
• Institutional Review Board (IRB)
• Ethics Review Board (ERB)
• Research Ethics Committee (REC)

The terminology may differ, but the fundamental purpose is the ethical review and oversight of research involving human participants.

2. Definition of Research

Research is a systematic investigation designed to develop or contribute to generalisable knowledge.

3. Human Subject/Research Participant

A human research participant is a living individual about whom a researcher obtains information or data through:

• Interaction
• Intervention
• Clinical examination
• Collection of biological material, where applicable
• Access to identifiable private information

4. Research Ethics Committee – Definition

A Research Ethics Committee/Institutional Ethics Committee is an independent multidisciplinary body consisting of scientific and non-scientific members that reviews research proposals involving human participants to ensure protection of their rights, safety, dignity, privacy, and well-being.

The committee should conduct its review independently and free from inappropriate bias or influence.

5. Composition of Ethics Committee

An ethics committee should have a multidisciplinary composition.

A typical committee includes:

1. Medical/clinical professional
2. Scientist/researcher
3. Pharmacist, where appropriate
4. Nurse or other healthcare professional
5. Legal expert
6. Social worker/community representative
7. Non-scientific/lay person
8. Member of either sex as appropriate to ensure diversity
9. Independent member/external expert where required

Minimum membership

Your source states at least five members, with representation from different disciplines.

Important characteristics:

• Multidisciplinary
• Scientific and non-scientific representation
• Appropriate gender representation
• Knowledge of ethics
• Knowledge of relevant laws and regulations
• Research experience

6. Main Roles and Responsibilities of IEC/IRB/ERB

1. Protection of participants

Safeguard the:

• Dignity
• Rights
• Safety
• Privacy
• Well-being

of research participants.

2. Ethical and scientific review

Review research proposals to determine whether:

• Scientific requirements are appropriate.
• Ethical principles are followed.
• Risks are reasonable in relation to anticipated benefits.
• Participant selection is appropriate.
• Informed consent is properly addressed.

3. Review of informed consent

Ensure that appropriate information is provided to participants and that informed consent procedures are ethically and scientifically appropriate.

4. Consideration of local values

Ensure that research follows recognised ethical and scientific standards while considering relevant:

• Local community values
• Customs
• Cultural considerations
• Applicable laws and regulations

5. Written decisions

The committee should provide its decision in writing, clearly identifying:

• Research project/trial
• Documents reviewed
• Date of review
• Approval/favourable opinion
• Required modifications, if any
• Disapproval, where applicable

6. Continuing review

The committee should review ongoing research at appropriate intervals according to applicable requirements.

This may include review of:

• Safety reports
• Protocol amendments
• Informed consent amendments
• Important new information
• Serious or unexpected ethical/safety issues

7. Additional information

If additional information is necessary to protect participants, the committee may require researchers to provide appropriate information to participants.

8. Non-therapeutic research

For non-therapeutic research, the committee should ensure that relevant ethical and regulatory requirements are adequately addressed, particularly where consent involves legally authorised representatives.

7. FUNCTIONS OF ETHICS COMMITTEE

The committee works according to written Standard Operating Procedures (SOPs).

Important functions include:

• Review research protocols.
• Review informed consent documents.
• Review participant information sheets.
• Review investigator qualifications where applicable.
• Review risk-benefit considerations.
• Review participant recruitment procedures.
• Review confidentiality and privacy safeguards.
• Review protocol amendments.
• Review safety information.
• Conduct continuing review.
• Maintain appropriate records.
• Provide written decisions.
• Ensure compliance with applicable ethical and regulatory requirements.

8. Documents Required for IEC Review

Important documents include:

1. Research protocol

Detailed study plan describing:

• Objectives
• Study design
• Methodology
• Participants
• Inclusion/exclusion criteria
• Procedures
• Statistical plan
• Risk-benefit considerations

2. Case Report Form (CRF)

Used for systematic collection of study data.

3. Participant Information Sheet (PIS)

Provides study-related information to potential participants.

4. Informed Consent Form (ICF)

Documents voluntary informed consent.

5. Investigator's Brochure (IB)

Contains relevant information about an investigational product, particularly in clinical trials.

6. Participant recruitment materials/procedure

Describes how participants will be approached and recruited.

Other documents may include

• Questionnaires
• Data collection forms
• Patient diaries
• Advertisements/recruitment materials
• Safety reports
• Previous ethics approval documents
• Protocol amendments
• Relevant regulatory documents

9. Records Maintained by Ethics Committee

According to your provided material, documents maintained according to the committee's SOP may include:

• Ethics Committee SOPs
• Correspondence with investigators
• Meeting agendas and minutes
• Dates and times of meetings
• Research proposals
• Participant information sheets
• Informed consent forms
• Committee decisions
• Amendments
• Continuing-review records

Record-retention periods should follow the applicable institutional and regulatory requirements rather than relying on one universal period.

10. Education and Training of Ethics Committee Members

Continuous education of ethics committee members is important.

Training should cover:

Ethics

• Principles of research ethics
• Informed consent
• Confidentiality
• Vulnerable populations
• Risk-benefit assessment

Law and regulations

Members should understand relevant:

• National regulations
• Institutional policies
• Research guidelines
• Legal requirements

Science

Members should understand basic:

• Research methodology
• Study designs
• Statistics
• Clinical research concepts

Communication and conflict management

Training should also include:

• Communication skills
• Conflict resolution
• Ethical deliberation
• Case discussion

Continuing education

Members may participate in:

• Workshops
• Conferences
• Training programmes
• Expert lectures
• Case discussions
• Relevant scientific literature review

11. Operations and Methods of Ethics Committee

The committee should establish:

1. Purpose and scope of the committee.
2. Roles and responsibilities of members.
3. Membership and selection procedures.
4. Responsibilities of the Chairperson.
5. Meeting procedures.
6. Submission and review procedures.
7. Decision-making procedures.
8. Conflict-of-interest management.
9. Confidentiality of committee documents.
10. Continuing education and training.
11. Record-keeping procedures.
12. Continuing review of approved research.

Meetings

The committee should meet according to its SOP and institutional requirements.

Applications for ethical review are commonly submitted by investigators/researchers, with the required supporting documents.

12. Types/Models of Hospital Ethics Committees

Your source describes three broad perspectives.

Model	Main feature	Important consideration
Professional model	Mainly healthcare professionals/physicians	Provides professional ethical expertise but may give less attention to wider community perspectives
Organisational model	Established/supported by hospital administration	Integrates ethical considerations into institutional policies but requires appropriate independence
Social/community model	Includes broader community representation	Promotes wider and more participatory ethical discussion

These are conceptual models, and actual committees may combine features of more than one model.

13. Functions of Clinical/Hospital Ethics Committee

A Clinical/Hospital Ethics Committee may assist the institution with:

1. Bioethics education.
2. Ethical evaluation of difficult clinical cases.
3. Providing ethics consultation.
4. Developing institutional ethical guidelines and policies.
5. Addressing fair and equitable allocation of resources.
6. Supporting community-oriented ethical initiatives.
7. Promoting patient participation in healthcare decision-making.
8. Addressing conflicts involving patients, relatives, healthcare professionals, and institutional interests.
9. Supporting ethically appropriate institutional policies.
10. Conducting or supporting bioethics-related educational or research activities.
11. Promoting bioethics awareness among healthcare institutions.
12. Facilitating discussion of ethical issues related to healthcare financing.
13. Contributing ethical perspectives to public-health issues.
14. Providing ethical input into organ transplantation policies.

Important distinction

Clinical Ethics Committee ≠ Research Ethics Committee

• Clinical Ethics Committee: primarily deals with ethical problems arising in patient care and clinical decision-making.
• Research Ethics Committee/IEC: primarily reviews research involving human participants and protects research participants.

This distinction is very important for examinations.

14. Ethics Consultation

Ethics consultation may be provided through:

• An individual ethics consultant
• An advisory/ombudsman team
• A subcommittee of the ethics committee

The purpose is to assist healthcare professionals and patients in resolving ethical issues without unnecessarily interfering with the patient–physician relationship.

15. Financial Resources of Ethics Committee

Ethics committee members may serve as part of their institutional responsibilities, depending on institutional policy.

Resources may be required for:

• Meeting facilities
• Administrative/secretarial support
• Documentation and record keeping
• Training and education
• Access to scientific and ethical literature
• Conferences and workshops

Adequate administrative and educational support helps the committee function effectively.

RESEARCH ETHICS COMMITTEE

Research proposal

↓

IEC/IRB/ERB review

↓

Scientific + Ethical review

↓

Risk–benefit + Consent + Participant protection

↓

Approval / Modifications / Disapproval

↓

Continuing review

↓

Protection of research participants

Remember the core responsibility:

“Rights + Safety + Dignity + Privacy + Well-being of participants”