Ethics Committees and its role in Dermatology Clinical trials

Ethics committee is an independent entity, functions to ensure transparent ethical review and decision making of a clinical trial. EC involves in pre-trial review, protocol approval, ongoing trial monitoring and approving protocol amendment of the clinical trials involving human participants. It ensures that the clinical trials are comply with ethical standards as per applicable guidelines and regulations (ICH-GCP, Indian-GCP, ICMR, and WHO-GCP). Also safeguarding the rights, safety and well-being of the trial participants are governed. It ensures transparency in ethical review.

The key responsibility of ethics committee:

To evaluate clinical trial protocols for ethical, scientific, and legal compliance.
To protect the rights, safety, and well-being of trial participants.
To ensure informed consent procedures are adequate and meet ethical standards.
To maintain a database of trials under review and their status.
To regularly monitor ongoing clinical trials.

Institutional ethics committee (IEC) is formed under the institution purview. In India, their establishment and operation are governed by the New Drugs and Clinical Trials (NDCT) Rules, 2019 for regulatory studies and the ICMR Guidelines (2017) for health research. Every EC/ IEC must be registered with the Central Drugs Standard Control Organization (CDSCO) through the SUGAM portal. The trials approved by registered EC only proceed to regulatory clearance.

Composition of EC/ IEC: IECs must include 7–15 members, such as:

Chairperson (external to the institution)
Member Secretary (internal)
Medical scientists and clinicians
Legal expert
NGO representative or social scientist
Layperson

Role of EC in dermatology clinical trials:

Ethics Committees in Clinical Trials must address the following ethical considerations in dermatology research:

Use of Photographic Evidence: Frequently used for documenting outcomes, images must be collected, stored, and published with strict confidentiality and informed consent.
Cosmetic vs. Therapeutic Goals: Studies offering aesthetic enhancements require a different ethical lens. Committees must evaluate the necessity, risk-benefit ratio, and potential for exploitation.
Sensitive and Vulnerable Populations: Adolescents with acne or patients with visible skin disorders may be particularly susceptible to psychological or social pressures. Participation must be fully informed and voluntary.
Post-Trial Access: For chronic dermatologic conditions, committees should ensure that effective treatments are accessible to participants even after the trial ends.

Conclusion

EC plays an important role in clinical trials, including those in dermatology, which are conducted with the highest ethical and scientific standards. They safeguard the rights, safety, and well-being of participants while maintaining transparency throughout the research process. By addressing specific ethical concerns such as informed consent, vulnerability, and post-trial care, they uphold the integrity of clinical research.