Clinical Research Coordinator|worked as CRC in oncology studies | Duchenne muscular dystrophy|RAVE iMedidata, Oracle software B. Pharm Graduate at KL University
Roles and responsibilities of an Ethics Committee in ensuring ethical conduct in clinical research? An Ethics Committee (also known as an Institutional Review Board or IRB in some countries) plays a critical role in ensuring that clinical research is conducted ethically, responsibly, and in compliance with legal and regulatory requirements. The primary responsibility of the Ethics Committee is to safeguard the rights, safety, and well-being of research participants. It ensures that participants provide informed consent after understanding the purpose, risks, and benefits of the study. Vulnerable populations (e.g., children, pregnant women, or individuals with cognitive impairments) receive additional protections. The Ethics Committee evaluates the study's design to ensure it is scientifically sound and ethically acceptable. They assess whether the potential benefits outweigh the risks involved. The committee ensures that the study follows ethical principles outlined in key guidelines like the Declaration of Helsinki, Belmont Report, and Good Clinical Practice (GCP). The committee ensures that all foreseeable risks to participants are minimized through appropriate study protocols. They assess whether there are measures in place to address potential adverse events and ensure proper monitoring. Ethics Committees help prevent the exploitation of vulnerable individuals or groups. They ensure that participation in research is voluntary, free from coercion or undue influence, and without any unfair inducement. By reviewing and approving study protocols, the Ethics Committee promotes transparency in the research process. They require investigators to submit progress reports, adverse event reports, and any protocol amendments for review. Ethics Committees ensure that the research complies with local and international laws, ethical guidelines, and regulatory requirements. This reduces the risk of legal or regulatory issues that could arise from unethical research practices. They ensure that participant selection is fair and not biased toward or against any particular demographic or social group. Special attention is given to studies that might disproportionately burden specific populations. The committee ensures that the study design includes adequate measures to protect participants’ personal data and maintain confidentiality. The committee ensures that researchers address post-trial responsibilities, such as providing access to interventions proven effective during the study or disseminating findings transparently. Example of Ethical Failures Highlighting the Need for Ethics Committees Tuskegee Syphilis Study (1932-1972): Participants were misled and denied treatment, leading to unnecessary suffering. Nuremberg Trials: Revealed unethical human experiments during World War II, which spurred the development of modern ethical guidelines. Thalidomide Tragedy: Demonstrated the need for rigorous ethical review in drug trials.