Ethics committees :
Introduction-
In INDIA the concept of ethics committees was in 1980 by ICMR.
ICMR provided the guidelines for the formation of ethics committee.
Ethics committees formed a group of members including medical or scientific professionals along
with the non medical or non scientific persons.
Ethics committees also known as review board.
Definition-
Ethics committees are formal bodies established within organizations to oversee ethical standards,
especially in sensitive areas such as research, health-care, business practices, and public policy.
Their main purpose is to ensure that actions and decisions are aligned with moral, legal, and
regulatory standards, protecting both individuals and society from harm.
Composition of Ethics Committee-
There should be a heterogeneous group of at least 7 members .
The EC members should be – Qualified, experienced in their professional field and proficient
enough to review and evaluate both scientific & ethical aspects.
• Adequate representation of age, gender etc is maintained.
• Maximum of 15 members are recommended.
Member list must include at least each one of the following––
Chairperson- Outsider (Not from the institution if its Institution Review Board)
Basic medical scientist
Clinicians.
Social worker
Legal person( lawyer)
Lay person (a person who does not have specialized or professional knowledge of a
subject)Experts from different arenas may be also invited for scientific review.
EC member secretary-
To conclude that we say; an ethics committee should have a composition which will function in
a manner that it will justify not only right V/s wrong decision but also will be instead
competent enough in judging various right V/s right situations.
Roles and responsibilities of ethics committees in
research and clinical decision making-
1. Protecting the Rights and Welfare of Participants:
Human Research Participants: Ethics committees primarily ensure that the rights, safety,
and well-being of individuals participating in research or clinical trials are protected.
Informed Consent: They review procedures to ensure that participants provide informed
consent and are fully aware of the risks and benefits of participation.
2. Reviewing Research Protocols:
Ethical Review: Committees assess whether proposed research studies are ethically sound,
evaluating factors such as potential harm to participants, the risk-benefit ratio, and the
scientific validity of the research.
Privacy & Confidentiality: They examine how sensitive information will be handled and
whether data privacy measures are adequate.
3. Monitoring Ongoing Research:
Ongoing Oversight: Ethics committees monitor research as it progresses, ensuring that it
continues to meet ethical standards. This may involve periodic reviews, especially for long-
term studies.
Adverse Events: They review reports of adverse events, ensuring that any harm to
participants is addressed and that corrective actions are taken.
4. Ensuring Compliance with Legal and Regulatory Standards:
Legal Compliance: Committees are responsible for ensuring that research or organizational
practices comply with national and international regulations, such as the Declaration of
Helsinki or other relevant guidelines.
Regulatory Frameworks: They ensure alignment with frameworks like Good Clinical
Practice (GCP) in medical research or relevant corporate or governmental policies in
business settings.
5. Ethical Guidance and Decision-Making:
Resolving Ethical Dilemmas: Ethics committees provide guidance on ethical dilemmas that
arise during research, such as balancing risks to participants with potential societal benefits.
Policy Development: In organizations, they help shape ethics-related policies, ensuring
fairness, transparency, and adherence to moral principles.
6. Conflict of Interest Management:
Managing Bias: They are tasked with identifying and managing any conflicts of interest
among researchers, committee members, or institutions to maintain the integrity of the
research.
Ensuring Impartiality: Committees aim to ensure decisions are made without undue
influence or personal biases.
7. Promoting Ethical Culture:
Training and Education: Ethics committees often participate in educating researchers,
clinicians, or corporate employees on ethical standards and expectations.
Fostering Ethical Practices: In corporate settings, ethics committees may work to promote
a culture of ethics, compliance, and social responsibility throughout the organization.
8. Documentation and Reporting:
Record Keeping: Committees are responsible for maintaining thorough documentation of
their reviews, decisions, and any ethical concerns raised during the research or
organizational activities.
Reporting: They may be required to report their findings or concerns to regulatory
authorities, institutional leaders, or external bodies.
In both research and organizational contexts, ethics committees play a vital role in ensuring that
activities are conducted with integrity and respect for individuals, societal values, and legal
frameworks.
Clinical decision making
Clinical decision making refers to the process healthcare professionals use to assess, diagnose, and
treat patients. It involves integrating clinical expertise, patient values, and the best available
evidence to arrive at decisions regarding patient care. The process is complex and requires a balance
of analytical reasoning, intuition, and collaboration. Below are the key components of clinical
decision-making:
1. Gathering Patient Information
History and Physical Examination: Clinicians begin by collecting information through
patient interviews, medical history, and physical examination to form a foundation for
clinical decisions.
Diagnostic Tests: Laboratory tests, imaging studies, and other diagnostic procedures
provide objective data that help refine or confirm diagnoses.
Patient Values and Preferences: Understanding the patient's values, preferences, and
unique circumstances (e.g., lifestyle, cultural factors) is crucial in aligning medical decisions
with the patient’s goals.
2. Identifying and Defining the Problem
Differential Diagnosis: Clinicians generate a list of potential diagnoses based on the
symptoms, history, and clinical findings. They then prioritize the most likely causes.
Critical Thinking: Clinicians analyze the available data, consider patterns, and identify
inconsistencies to refine the problem's definition.
3. Applying Clinical Evidence
Evidence-Based Practice: Clinical decision-making incorporates research and clinical
guidelines to ensure the most effective and scientifically supported treatments are
considered.
Clinical Expertise: Experienced clinicians draw on their knowledge and prior experience to
interpret data, evaluate risks, and make judgments.
4. Risk-Benefit Analysis
Weighing Risks and Benefits: Every medical intervention carries potential benefits and
risks. Clinicians must balance the likely outcomes, side effects, and potential harm of
treatments or diagnostic tests.
Patient-Centered Care: Decisions should prioritize the patient’s best interests, taking into
account their overall health, preferences, and life goals.
5. Making the Decision
Collaborative Decision-Making: Where possible, decisions are made collaboratively with
the patient, ensuring they are informed about their options, risks, and benefits.
Shared Decision-Making: This approach emphasizes a partnership between the clinician
and the patient. It involves presenting the patient with all available information and
respecting their preferences in determining the treatment plan.
Roles of hospital ethics committee-
Holding regular monthly or quarterly educational sessions on relevant ethical
issues for not only HEC members and hospital staff, but also patients.
Setting annual goals for the ethics committee and regular evaluation of the steps
taken toward their achievement.
Reviewing the policies proposed by the committee.
Encouraging each member of the committee to hold meetings with the members
of their department about ethical issues related to their scope of activity.
Providing patients and their families with brochures containing information about
the process of treatment decision-making, advance directives, and the role and
responsibilities of the HEC.
Holding meetings about ethical issues encountered in different hospital units with
nursing managers or head nurses.
Arranging meetings with other local ethics committees to share experiences and
activities and assess the committee’s performance accordingly.
Reviewing the available literature, selecting and summarizing significant articles
about ethics, and providing the staff and physicians with the produced content.
Designing a protocol to ensure the provision of adequate pain relief for terminally
ill patients.
Assisting other health care institutions in the establishment of their ethics
committees.
Asking nurses, physicians, and social workers to show the committee how they
share information about advance directives, terminal care decisions, or bad news
with patients.
Summarizing hospital policies with significant ethical content and distributing the
produced summary among physicians and other hospital staff.
Designing and implementing a bioethics week with specific daily activities for
both the day and night shift personnel.
Providing courses in mediation or other methods of conflict resolution.
Asking a sociologist to help the committee create its sociogram to clarify the
relationships within the committee that influence its performance.
Identifying health care personnel (including physicians and nurses) who were
admitted to the institution as patients and ask them to share their experiences with
the committee
