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 Ministry of Health and Family welfare requires 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
The CISHR IRB shall follow the general principles and guidelines as detailed in National Ethical Guidelines for Biomedical and Health Research Involving Human participants 2. The following are the universal ethical principles guiding research involving human subjects.
Beneficence – The sum of the benefits to the subject and the importance of the knowledge to be gained so outweighs the risks to the subjects as to warrant a decision to allow the subject to accept these risks.
Autonomy – Legally effective informed consent is obtained, unless the requirements for waiver of informed consent are met by adequate and appropriate methods in accordance with the provisions of applicable regulations.
Justice – The selection of subjects is equitable and is representative of the group that will benefit from the research.
All biomedical and health research and its activities conducted in CIHSR shall be overviewed by the institutes IRB regardless of the sponsorship. The following policies shall be observed:
1.1 The researcher shall not initiate the process of recruitment of participation or any form of interaction with potential human research subjects for the purpose of data collection before the research has been reviewed and approved by the IRB.
1.2 The purpose of the IRB is to ensure quality research backed with the rationality and justification as well as protection of the rights and safety of the human research participants.
1.3 All research activity should be presented to the CIHSR IRB if one or more of the following apply:
- The research is sponsored by institutional authorities and/or;
- The research is conducted by or under the direction of any employee, faculty, residents, fellows, staff, student or agent of the Institution in connection with his or her institutional responsibilities; and/or
- The research is conducted by or under the direction of any employee, faculty, staff, student or agent of the Institution using any property or facility of the Institution; and/or
- The research involves the use of the Institution’s non-public information to identify or contact human research subjects.
- The research is conducted in the Institute’s premises involving either human subjects (employees or non-employees) or other objects or equipment(s) which may or may not be the property of the Institute.
Any external research of scientific nature conducted outside the Institute but affiliated to the Institute.
1.4 The CIHSR-IRB shall ensure scientific validity of all proposal by ensuring that every proposal will be reviewed and revised according to the recommendations of the Scientific committee (SC) constituted specifically for the purpose of the scientific review of the proposal.
1.5 Disapproval by the IRB (before or after approval by any other committee) means that the research cannot be carried out at any facility under this IRB’s jurisdiction.
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.