Joint ethics review of multicentre research has multiple benefits

Collaborations in research provide a unique opportunity to present meaningful outcomes. The ability to quickly recruit a large number of people, document population and subpopulation variety, statistical power, generalizability, improved relevance and increased likelihood of practice and or policy translations are all primary benefits of multicentre research. The collaborations can be inter-departmental, inter-institutional or international and involvement of public and or private research centres and agencies

In a significant move that will do away with the delays and barriers in research activities for want of multiple ethical approvals for multicentre research in the country, the Indian Council of Medical Research (ICMR) recently issued guidelines for ICMR network of institutions for joint ethics review of multi-centre research. These guidelines are significant as there are reported delays and barriers due to the need for multiple ethical approvals, inability to use technology, managing Conflict of Interest (COI), ambiguity in ownership of materials and data, intellectual property rights (IPRs) and joint publications.

This guidance aims to illustrate the roles and responsibilities of all stakeholders involved in the joint ethics review of multicentre research for ICMR institutions. It also elaborates on the steps to be adopted to streamline the ethics review process of multicentre research being undertaken by ICMR so that research can proceed expeditiously, however, without compromising any ethical values or principles in order to protect the research participants. It applies to Ethics Committees (ECs), investigators and other stakeholders involved in multicentre biomedical and health research involving human participants, which is spearheaded ICMR or its network of institutions.

However, the guidance does not extend to clinical trials, which require approval from Central Drugs Standard Control Organization (CDSCO) under the Drugs and Cosmetics Act (D&C Act) and Rules as amended from time to time. The guidelines are complementary to the main ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017.

In fact, the significance of national and international cooperation and collaboration was demonstrated during the Covid-19 pandemic. The need for quick and informed ethics review as the situation demands becomes the need of the hour, especially in pandemics, emergencies and disasters.

In this regard, a step-by-step ethics review and governance framework for multicentre research is an important research tool that can facilitate fast-tracking decision-making while ensuring the protection of human research participants. Currently in India, for multicentre research, all centres seek approval from their respective ECs, which would consider the local needs and requirements of the population and safeguard the dignity, rights, safety and well-being of the participants. Collaborations in research provide a unique opportunity to present meaningful outcomes. The ability to quickly recruit a large number of people, document population and subpopulation variety, statistical power, generalizability, improved relevance and increased likelihood of practice and or policy translations are all primary benefits of multicentre research. The collaborations can be inter-departmental, inter-institutional or international and involvement of public and or private research centres and agencies.

The ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017, has discussed the process for common ethics review for multicentre research, which is conducted at more than one centre by different researchers usually following a common protocol.

A large number of clinical trials, clinical studies and public health research including surveys are conducted at several research centres within the country or at international sites. Multicentre research studies are carried out with the primary aim of providing a sound basis for the subsequent generalization of its results. All sites are required to obtain approval from their respective ECs, which would consider the local needs and requirements of the populations being researched and safeguard their dignity, rights, safety and well-being.

However, there are concerns related to duplication of effort in a parallel review by the involved ECs, wastage of time and also those related to communication between the committees. According to ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017, the ECs/Secretariats of all participating sites should establish communication with one another. If any EC does not grant approval for a study at a site the reasons must be shared with other ECs and deliberated upon. The EC can suggest site-specific protocols and informed consent modifications suiting the local needs. A separate review may be sought for studies with a higher degree of risk, clinical trials or intervention studies where conduct may vary depending on the site or any other reason which requires closer review and attention.

Taken under any yardstick, ICMR’s latest guidelines are a welcome step as they will save time, prevent duplications and streamline the review process.

(The author is freelance journalist with varied experience in different fields)