NIRRCH Ethics Committee for Human Studies - ICMR-NIRRCH

ICMR-NIRRCH Ethics Committee for Human Studies is an independent body constituted of non-affiliated Chairperson along with varied affiliated as well as non-affiliated members from medical, non-medical, scientific, non-scientific, legal & social-science background whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in the research/ trial, by reviewing, approving and providing continuing review of the research protocols and amendments. It is engaged in ensuring effective implementation of National & International Ethical guidelines for researchers engaged in the Clinical, Biomedical, Operational & Implementation Research which involves Human Study participants.

The Ethics Committee for Clinical Studies involving human participants was established in Institute for Research in Reproduction (formerly known as IRR) in October 1994. Recently, in February 2022 the NIRRH Ethics committee for Clinical studies was renamed as ICMR-NIRRCH Ethics Committee for Human Studies.

The first version of the standard operating procedures (SOP)of the IEC were prepared in 2014 and helped in standardizing procedures and laying a sound foundation for the day to day practices for conduct of ethical research at our Institute. The SOP is revised periodically to ensure compliance with the evolving guidelines.

ICMR-NIRRCH Ethics Committee for Human Studies is recognized by:

1. Office for Human Research Protections (OHRP)- Institutional Review Board (IRB00014568)
2. Strategic Initiate for Developing Capacity in Ethical Review-forum for Ethics Review Committees in Asia and the Western Pacific Region (SIDCER- FERCAP) for its compliance with international an local standards in ethical review (November 2021)
3. Central Drugs Standard Control Organization (CDSCO) Re-Registration No. ECR/221/Inst/MH/2013/RR-24
4. Department of Health Research – National Ethics Committee Registry for Biomedical and Health Research (DHR-NECRBH) Registration No. EC/NEW/INST/2021/MH/0001.

The review process ensures that the documents are submitted to the IEC secretariat at least 3 to 4 weeks prior to IEC meeting. IEC Secretariat checks for the completeness of the project proposal with respect to the information, methodology, informed consent documents and signatures of the Principal as well as Co-Investigator/ Collaborators along with the necessary scientific review/ approval. The member secretary then assigns the project to appropriate reviewers (Expertise as per the subject of the Research Project) & the documents are mailed to the reviewers at least 10 days prior to the meeting date.

These following criteria are considered while reviewing of the study protocol:

• Minimize risks to participants
• Participants are selected equitably
• Risks must be reasonable in relation to anticipated benefits Informed consent is adequate, easy to understand and properly documented
• There are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data, where appropriate;
• Appropriate safeguards are included to protect vulnerable participants.
• Informed consent is appropriate, easy to understand and properly documented
• The research plan makes adequate provision for monitoring the data collected to ensure the safety of participants, where appropriate;
• Ensure that the research project does not induce the participants to be lured into the research/ clinical trials and that the researcher has a recruitment policy to ensure unbiased selection of adequate number of suitable participants according to the protocol.