What is IEC (Independent Ethics Committee) and its Role in Clinical Research in India?
Overview of clinical trials in India
India has emerged as a significant hub for clinical trials due to its diverse population, large pool of patients, and skilled healthcare professionals. Conducting trials in India is often more cost-effective compared to developed countries, making it an attractive option for sponsors and pharmaceutical companies. The regulatory framework in India has evolved to support and streamline the conduct of clinical trials, attracting sponsors and researchers.
India’s population provides a wide range of patient demographics and disease profiles, facilitating faster recruitment and diverse data collection. Lastly, India has a significant burden of diseases such as diabetes, cardiovascular conditions, and infectious diseases, making it an ideal location for conducting studies related to these conditions.
What is IEC? Why is it important?
An Independent Ethics Committee (IEC) is a group of individuals established within an organization, such as a university, research institution, or healthcare facility, to ensure that ethical principles and guidelines are followed in research or other activities involving human participants.
The primary role of an IEC is to review and approve research protocols, ensuring that they comply with ethical standards and regulations. The committee evaluates the potential risks and benefits of the proposed research, assesses the informed consent process, and ensures the protection of participants’ rights, privacy, and confidentiality. The IEC also monitors ongoing research to ensure continued compliance with ethical guidelines.
The committee’s oversight helps maintain public trust in research institutions and promotes the advancement of knowledge while upholding ethical principles.
Composition of IEC
While the exact composition may vary depending on the organization and its specific requirements, here are some key roles commonly found in an IEC:
- Chairperson — Responsible for leading the committee, facilitating meetings, ensuring adherence to ethical guidelines, and overseeing the review process.
- Secretary — facilitates and coordinates administrative tasks, maintains records, and supports the committee’s functioning
- Ethicist — provides expertise in ethical principles and theories, guiding the committee in making informed decisions and addressing complex ethical issues.
- Physicians or healthcare professionals — with relevant expertise often evaluate the medical aspects of research protocols like participant safety and well-being.
- Scientists/Researchers — to provide valuable insights into the scientific aspects of the proposed research.
- Legal Expert — to oversee that the research protocols comply with applicable laws, regulations, and institutional policies.
- Layperson/Community Representative — to help provide a broader perspective and ensure that the interests and concerns of the public are considered.
- Statistician — to evaluate the study design, and data analysis methods, and ensure the validity of the research findings.
- Subject Expert — Some IECs may include an independent member who is not affiliated with the organization conducting the research, thereby bringing an unbiased viewpoint to the committee’s decisions.
Role of IEC in Safeguarding the Rights and Welfare of Trial Participants
The Institutional Ethics Committee (IEC) plays a crucial role in safeguarding the rights and welfare of trial participants involved in research studies. Here are some key aspects of the IEC’s role in this regard:
Protocol Review
The IEC thoroughly reviews research protocols to ensure that they adhere to ethical principles, guidelines, and regulations. The committee assesses the study design, potential risks and benefits, inclusion/exclusion criteria, and the informed consent process.
Informed Consent
The IEC ensures that the informed consent process is clear, comprehensive, and understandable for participants. They review the consent documents to ensure that all necessary information is provided, risks are clearly communicated, and participants have the opportunity to ask questions and make an informed decision to participate.
Participant Protection
The IEC evaluates the measures put in place to protect the rights, safety, and well-being of participants. This includes assessing the adequacy of monitoring procedures, provisions for adverse events reporting, and data confidentiality measures to protect participants’ privacy.
Risk-Benefit Assessment
The IEC critically evaluates the potential risks and benefits of the study. They weigh the potential benefits of the research against the risks to ensure that the study’s benefits justify any potential harm to the participants.
Ongoing Monitoring
The IEC provides ongoing monitoring of the research study to ensure that participants’ rights and welfare are continuously protected. This includes reviewing progress reports, safety data, and any amendments or modifications to the study.
Conflict of Interest
The IEC addresses any potential conflicts of interest among researchers, sponsors, or investigators that could compromise the rights and welfare of participants. They ensure that appropriate measures are in place to manage and mitigate such conflicts.
Adverse Event Reporting
The IEC oversees the reporting and management of adverse events occurring during the study. They review adverse event reports, assess their severity, and ensure that appropriate measures are taken to protect participants and prevent further harm.
Compliance and Audit
The IEC ensures that the research study complies with relevant ethical guidelines, laws, and regulations. They may conduct audits or inspections to verify the study’s adherence to ethical standards and ensure the rights and welfare of participants.
Challenges and Ethical Issues
In India, Institutional Ethics Committees (IECs) face various challenges and ethical issues in fulfilling their role of safeguarding the rights and welfare of trial participants. Here are some key challenges and ethical issues commonly encountered:
Limited Expertise
Many IECs in India may struggle with the limited availability of experts from diverse fields, such as ethics, law, medicine, and research. This can make it challenging to comprehensively evaluate the ethical aspects of research protocols and adequately address complex ethical issues. Quinary Clinical Research strives to combat these issues by providing more than 6 years of expertise and a pool of industry experts with over 15 years of experience spanning from different backgrounds.
Resource Constraints
IECs in India often face resource constraints in terms of funding, infrastructure, and human resources.
Capacity Building
Ensuring that IEC members are well-informed about the latest ethical guidelines, regulatory requirements, and advancements in research ethics can be a challenge. Continuous capacity building and training programs are essential to enhance the expertise and knowledge of IEC members.
Informed Consent Challenges
Obtaining informed consent from trial participants can be challenging in diverse cultural and literary contexts. Language barriers, low health literacy, and the influence of power dynamics between researchers and participants can impact the quality and understanding of informed consent.
Conflicts of Interest
Identifying and managing conflicts of interest among researchers, investigators, and sponsors is crucial. IECs need to ensure that potential conflicts of interest do not compromise participant rights, safety, or the integrity of the research.
Manual Paper-based Process
The manual, paper-based process of an Independent Ethics Committee poses a challenge in terms of inefficient record-keeping and potential data loss or misplacement. It also slows down the review process, hinders collaboration, and makes it difficult to track and analyze information effectively.
Changes in the regulatory landscape for clinical trials in India
New Drugs and Clinical Trials Rules, 2019
In March 2019, India introduced the New Drugs and Clinical Trials Rules, replacing the earlier Drugs and Cosmetics Rules, 1945. The new rules aimed to simplify the regulatory process and expedite the approval of clinical trials while ensuring participant safety.
Introduction of a new category of ethics committee for review of biomedical research. Registration of the biomedical research ethics committee is mandatory with the Department of health research. The biomedical research ethics committee can review only biomedical research and academic research and the ethics committee registered with CDSCO can review only clinical trials and BA/BE studies.
Online Application Process
The introduction of an online application process for clinical trials simplified the submission and review process. This digital platform enables faster document processing, reduces paperwork, and enhances transparency. SUGAM online platform for the CDSCO ethics committee and NAITIK platform for the DHR ethics committee.
Regulatory Authority
The New Drugs and Clinical Trials Rules established the Central Drugs Standard Control Organization (CDSCO) and the Department of health research ( DHR) which are the two authorities for ethics committee registration in India.
Harmonization with International Standards
India has been taking steps to align its regulatory framework with international standards, such as the Good Clinical Practice (GCP) guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). This alignment helps promote global collaboration and facilitates the acceptance of Indian clinical trial data by regulatory authorities worldwide.
Conclusion
By upholding ethical principles, promoting participant welfare, and ensuring compliance with regulatory requirements, IECs contribute significantly to the advancement of medical knowledge, the development of safe and effective treatments, and the protection of participants’ rights in clinical trials conducted in India.
Quinary Clinical Research is pioneering the concept of ethics committee management with a digitalisation approach. QCR is the first to release a comprehensive web application to digitize the research submission processes. Each clinical research stakeholder is a beneficiary of this initiative. We are the one-stop solution for all ethics committee and research submission-related needs. We boast a wealth of experience in managing IEC activities including a highly experienced panel of members to cater to all needs.
