Ethics Committee
1|Page
TABLE OF CONTENTS
1.Definition and Purpose ................................................................ 2
2. Composition................................................................................ 3
3. Scope of Review .......................................................................... 3
4. Key Responsibilities .................................................................... 4
5. Regulations and Guidelines ......................................................... 5
6. Types of Studies Reviewed .......................................................... 5
7. Challenges and Limitations.......................................................... 6
8. Collaboration and Networking .................................................... 7
9. Training and Capacity Building .................................................... 7
10. Future Directions ...................................................................... 8
Brindha Chandrasekaran
Ethics Committee
2|Page
1. Definition and Purpose
• An Ethics Committee (EC) is a multidisciplinary body responsible for
ensuring ethical practices in research and healthcare.
• It protects the rights, safety, and well-being of participants in medical and
scientific studies.
• The EC evaluates the ethical implications of proposed and ongoing
research.
• It ensures compliance with international ethical standards, such as the
Declaration of Helsinki.
• ECs promote transparency and accountability in research and medical
practices.
• They safeguard against exploitation of vulnerable populations.
• The committee mediates conflicts between researchers and participants.
• It ensures informed consent is obtained in a culturally appropriate
manner.
• ECs contribute to the advancement of ethical guidelines in their regions.
• They often provide guidance on the ethical use of innovative medical
technologies.
Brindha Chandrasekaran
Ethics Committee
3|Page
2. Composition
• ECs include members from diverse professional backgrounds, such as
medical, legal, and social sciences.
• A typical EC includes healthcare professionals like physicians and nurses.
• Laypersons are included to represent community perspectives.
• Legal experts ensure compliance with national and international laws.
• Ethicists provide philosophical and ethical insights.
• Religious or cultural leaders may be part of ECs in some regions.
• Members must be unbiased and free from conflicts of interest.
• Gender balance is often encouraged to ensure diverse viewpoints.
• Regular training is mandatory to keep members updated on ethical
standards.
• Membership terms and rotations are established to maintain objectivity.
3. Scope of Review
• ECs review research protocols to assess ethical compliance.
• They examine the risks and benefits of proposed studies.
• ECs evaluate the adequacy of informed consent processes.
• Data privacy and participant confidentiality are scrutinized.
• The committee assesses the inclusion and exclusion criteria for fairness.
Brindha Chandrasekaran
Ethics Committee
4|Page
• ECs review compensation plans for participants to avoid undue influence.
• Community-based and public health studies fall under their purview.
• They oversee the ethical implications of healthcare policies.
• The committee ensures ethical compliance in emergency research
settings.
• Post-approval monitoring of studies is also part of their role.
4. Key Responsibilities
• Reviewing and approving research protocols.
• Monitoring ongoing studies for compliance with ethical guidelines.
• Providing guidance on ethical dilemmas in research and healthcare.
• Ensuring that vulnerable populations are adequately protected.
• Investigating allegations of research misconduct.
• Reviewing adverse event reports to ensure participant safety.
• Educating researchers about ethical standards and practices.
• Facilitating open communication between researchers and participants.
• Maintaining transparency in decision-making processes.
• Collaborating with international bodies to harmonize ethical standards.
Brindha Chandrasekaran
Ethics Committee
5|Page
5. Regulations and Guidelines
• ECs follow international guidelines like the Declaration of Helsinki and
ICH-GCP.
• National regulations often dictate specific requirements for ECs.
• Compliance with local laws is a critical part of their operations.
• Ethical principles like beneficence, respect for persons, and justice guide
EC decisions.
• ECs ensure alignment with the Belmont Report's principles in research
ethics.
• Regular audits ensure compliance with legal and ethical standards.
• ECs must adapt to evolving guidelines in response to new challenges.
• They provide feedback on gaps in current regulations.
• International collaborations enhance standardization of ethical practices.
• Transparency in applying guidelines ensures public trust.
6. Types of Studies Reviewed
• Clinical trials involving drugs and medical devices.
• Behavioral and psychological studies.
• Public health interventions and epidemiological studies.
• Genetic research and studies involving biobanks.
Brindha Chandrasekaran
Ethics Committee
6|Page
• Research involving vulnerable populations, like children and the elderly.
• Innovative surgical procedures and experimental therapies.
• Cross-cultural studies requiring ethical sensitivity.
• Community-based participatory research.
• Studies on controversial topics, such as euthanasia or cloning.
• Emergency research conducted during disasters or pandemics.
7. Challenges and Limitations
• Limited resources in low- and middle-income countries.
• Balancing cultural norms with global ethical standards.
• Managing conflicts of interest among committee members.
• Ensuring informed consent in illiterate populations.
• Navigating ethical dilemmas in rapidly evolving research fields.
• Addressing biases in decision-making processes.
• Ensuring compliance in multicenter and multinational studies.
• Keeping up with advancements in medical and scientific technologies.
• Handling public scrutiny and criticism in controversial cases.
• Developing effective mechanisms for post-approval monitoring.
Brindha Chandrasekaran
Ethics Committee
7|Page
8. Collaboration and Networking
• ECs collaborate with other committees for knowledge sharing.
• They participate in international forums on ethical research practices.
• Joint reviews with other ECs in multinational studies enhance efficiency.
• Networking helps in harmonizing ethical standards globally.
• ECs work with regulatory bodies to ensure comprehensive oversight.
• Partnerships with academic institutions facilitate training.
• Collaboration with community organizations fosters inclusivity.
• Sharing case studies helps in addressing complex ethical dilemmas.
• Networking aids in developing best practices and guidelines.
• Collaborative research enhances global ethical standards.
9. Training and Capacity Building
• EC members undergo regular training on ethical guidelines.
• Workshops focus on emerging ethical issues in research.
• Case studies are used to train members on real-world scenarios.
• Online courses provide flexibility in learning.
• Collaborations with academic institutions enhance training quality.
• Mock reviews help members practice decision-making.
• Training ensures uniformity in understanding ethical principles.
Brindha Chandrasekaran
Ethics Committee
8|Page
• Capacity-building programs address resource limitations in developing
countries.
• Continuous education ensures adaptation to evolving research trends.
• Specialized training modules are developed for specific research types.
10. Future Directions
• Integrating AI tools for efficient protocol review processes.
• Enhancing global collaboration to standardize ethical practices.
• Increasing focus on ethical implications of digital health technologies.
• Addressing ethical challenges in precision medicine and genomics.
• Developing frameworks for ethical oversight of AI and machine learning
in healthcare.
• Promoting community engagement in ethical decision-making.
• Strengthening transparency to build public trust in research.
• Expanding EC coverage to address emerging research fields.
• Investing in training and capacity building in underserved regions.
• Adapting ethical guidelines to meet the challenges of a rapidly evolving
world.
Brindha Chandrasekaran
Ethics Committee
9|Page
-----------------------------------------------------------------------------------------------
Disclaimer:
This content is intended solely for educational and informational
purposes. It does not constitute medical advice, diagnosis, or
treatment. Always consult a qualified healthcare provider or medical
professional with any questions regarding a medical condition or
treatment. The information presented here should not be used as a
substitute for professional medical guidance. Use of this content is at
your own risk.
Brindha Chandrasekaran
Ethics Committee
10 | P a g e
Brindha Chandrasekaran
