INTRODUCTION
Biomedical and health research as defined in Chapter I of the New Drug and Clinical Trials Rules-2019 means research including studies on basic, applied, and operational research or clinical research, designed primarily to increase scientific knowledge about diseases and conditions (physical or social-behavioural); their detection and cause; and evolving strategies for health promotion, prevention, or amelioration of disease and rehabilitation but does not include clinical trials 1.
Regulating authorities under the Ministry of Health and Family Welfare requires an Institutional Review Board (IRB) overviewing Biomedical research to have written policies and procedures to be carried out systematically as described in the written policies and documents.
The written SOP’s are a guide for both ethical committee members as well as the researchers to adhere to the underlying universal principle of protecting human research participants.
In advancing knowledge whether in areas of prevention or amelioration of diseases or conditions, the ethically sound researchers are expected to have knowledge about the institute’s IRB and to get approval for conducting any biomedical and health research.
The ethical committee members share the responsibility of reviewing research protocol, making sound judgement and providing solutions or recommendations for conducting research.
1. TERM OF REFERENCE
PURPOSE
The main aim of the Institutional Ethics Committee (IEC) at CIHSR is to protect the rights, dignity, safety, and well-being of the human subjects who are part of biomedical and health research. The IEC guarantees that all studies carried out under its auspices will be in conformity with such ethical standards as those established by the ICMR and all other relevant laws of the land. The committee recognizes the need for scientific research while respecting the rights of the people involved; it ensures that ethical principles such as
Beneficence, Autonomy, and Justice, for instance, are guaranteed in all research undertakings.
SCOPE
The scope of the work of the IEC-CIHSR also includes the ethical review and approval of research works belonging to different categories of research with human subjects. It covers the following areas: Biomedical and Health Research: Studies that seek to enhance understanding and to develop cures in the field of medicine and healthcare. Academic Studies: These are the studies which are carried out by university lecturers, students or other educational staff with a view of providing education or conducting training. Investigator-Initiated Studies: This includes research propositions that have been made by individual investigators and are consistent with the objectives of the institution. Proposals from Outside the Institution: The IEC shall also review research proposals which external researchers would wish to undertake as long as these would not be in conflict with any institutional and ethical criteria.
CONDITIONS FOR ACCEPTING PROPOSALS FROM OUTSIDE THE INSTITUTION
External proposals submitted to the IEC-CIHSR for ethical review will be considered under the following conditions:
- The research proposal must adhere to the ethical standards outlined by the ICMR and relevant national and international guidelines.
- The researchers must demonstrate collaboration or partnership with CIHSR or its affiliated bodies.
- External projects should have the potential for benefiting the communities served by CIHSR or contribute to the broader goals of improving health outcomes.
- The review process for external proposals will follow the same rigorous standards applied to internal projects.
FEE STRUCTURE FOR REVIEW
A review fee of Rs. 5000 plus 18% GST will be charged on a case-to-case basis for external research proposals submitted to the IEC for ethical approval. The fee is intended to cover administrative costs and the resources needed to carry out a comprehensive ethical review. This structure ensures that all research proposals, whether internal or external, are evaluated with a focus on safeguarding participants while enabling the advancement of biomedical and health research.
The IEC will provide ethical approval in line with the principles of the ICMR guidelines and assess whether projects are considered ethical. Are ethical requirements met for research involving human participants? It considers aspects such as informed consent. Risk-to-benefit ratio Confidentiality and welfare of participants before approving research.
TYPES OF PROJECTS REVIEWED UNDER THE PURVIEW OF BIOMEDICAL AND HEALTH RESEARCH
The IEC will review:
- Clinical research study: A study that tests a new drug, treatment, device, or intervention. for efficiency, safety, and potential public health impacts after meeting regulatory registration needs.
- Epidemiological research: Studies examining the patterns, causes, and effects of disease in various populations to improve public health policy.
- Public Health Research: Studies that evaluate the effectiveness of health programs, policies, and practices to inform and improve health care delivery.
- Behavioral and Social Science Research: The study of human behavior, social factors, and health effects
- Genetic research: Studies that examine the genetic basis of disease.including the impact of new genetic technology
- Survey Research: A study that involves interviews, questionnaires, or other forms of data collection involving volunteers.
Failure to Submit a research proposal for IRB Review
Any activity which qualifies as research that warrants CIHSR-IRB approval shall be met with serious consequences unless IRB approval had been obtained prior to collecting the data. Results from such activities may not be published, to do so is in violation of Institutional policy. It is also against Institutional policy to use such data to satisfy thesis or dissertation requirements.