ICMR Releases Policy On Research Integrity and Publication Ethics

Mumbai, 5 Aug 2019:

To ensure highest professional and ethical standards for bio-medical and health research at all stages, the Indian Council of Medical Research (ICMR) has released policy on research integrity and publication ethics.

As per the policy document, research must follow applicable guidelines such as ICMR National Ethical Guidelines, Good Clinical Practices/Good Laboratory Practices (GCP/GLP) and other applicable guidelines and regulations.

The policy is intended to also provide procedures to manage allegations of research misconduct to be processed fairly, confidentially and promptly. ICMR Bioethics Unit would provide needful support to ICMR network of institutions in establishing appropriate policies for declaration and management of conflict of interest (COI) at the level of researchers, ethics committee (EC’s) as well as institutions.

The policy has been prepared by the committee headed by Chairperson Prof. Balram Bhargava, secretary, Department Of Health Research (DHR) and Director General (DG), ICMR, New Delhi. Dr. Roli Mathur, Scientist ‘E’ and head, ICMR Bioethics Unit, National Centre for Disease Informatics and Research (NCDIR), Bengaluru is the Member Secretary of the committee.

Dr R Gangakhedkar, Scientist ‘G’ and head, Division of Epidemiology and Communicable Diseases (ECD), ICMR, New Delhi, Dr N C Jain, Scientist ‘G’ and head, Division of Human Resource Planning and Development (HRD), ICMR, New Delhi are members of the committee.

The policy was prepared by the above committee and revised based on inputs received from Divisions of ICMR Headquarters and ICMR Institutes.

As per the policy document, quality and credibility of research is dependent on the integrity of the researchers who have a significant social responsibility to abide by the standards prescribed for their professions and by their institutions and also to be guided by the applicable regulations and guidelines.

Responsible Conduct of Research (RCR) involves components such as planning and conducting research, reviewing and reporting research, responsible authorship and publication of the research work. The research team should maintain highest standards to uphold the fundamental values of research. 

The four basic principles of research (respect persons),  beneficence (to do good), non-maleficence (to do no harm) and justice (concept of fairness irrespective of caste, creed, region or religion etc.). These principles dignity, rights, well-research participants for maintaining the research integrity.

The purpose of the policy is to ensure honesty in conduct of research, obtaining relevant approvals, efficiency, judicious use of resources, ensuring accountability, transparency, declaration and management of Conflict of Interest (COI), justice, reliable data collection, handling, interpretation, integrity in analysis, reporting, publication and translation for the benefit of population.

This policy applies to all ICMR scientific, technical staff and students (regular or contractual) involved in research at ICMR headquarters or at ICMR research institutions, centres or field units across the country (irrespective of source of funding). It provides a road map to overcome or eliminate any sort of misconduct which may happen at any stage of research and improve the quality for better outcomes.

All stakeholders involved in the conduct, review or reporting of research such as researchers, institutions, scientific review committees and ethics committees must ensure research integrity and quality thereby upholding the reputation, trust of research participants and meaningful translation of research findings for public health benefits while ensuring judicious use of resources.

All biomedical and health research must follow ICMR National Ethical Guidelines and maintain research integrity in the conduct of research while ensuring safety of research participants.

Other applicable guidelines and regulations must also be followed and required approvals be obtained before initiating research such as Ethics Committee (EC), Institutional Animal Ethics Committee (IAEC), Institutional Committee for Stem Cell Research (IC-SCR), Genetic Engineering Approval Committee (GEAC), Review Committee on Genetic Manipulation (RCGM), Health Ministry’s Screening Committee (HMSC), Central Drug Standard Control Organisation (CDSCO), Institutional Biosafety Committee (IBSC), Atomic Energy Regulatory Board (AERB) etc.

Researchers should obtain approval of Scientific Advisory Committee (SAC) and EC as per norms and declare COI, if any. Registration with Clinical Trial Registry-India (CTRI) is mandatory for clinical trials but desirable for other types of research to maintain transparency and accountability. Pharmabiz