Abstract

Background: The IMPROVIing StrokE care in India programme aimed to investigate the feasibility of introducing three packages of care (swallowing and hydration, early neurological deterioration, and patient and unpaid caregiver education post stroke) in three major stroke centres in India, all of which had extensive research experience and
were members of the INDian STRoke Clinical Trial Network. The INDian STRoke Clinical Trial is a strategic initiative, which is overseen by the Indian Council of Medical Research and funded by the Government of India to enable the development of stroke research capability and engagement in India. Within IMPROVIing StrokE care in India, multiple applications for ethical review were made across multiple organisations. This complex process inspired us to map current ethical review processes, identify challenges, enablers and explore the feasibility of establishing a streamlined multicentre ethics approval process for stroke research within the INDian STRoke Clinical Trial Network.

Methods: Semistructured interviews and focus groups were conducted using purposive sampling of IMPROVIing StrokE care in India principal investigators, hospital Ethics Committees’ chairs and secretaries from within the INDian STRoke Clinical Trial Network. Focus groups also involved members representing the Indian Council of Medical Research, Forum for Ethics Review Committees in India and principal investigators from the India and the UK. All interviews were digitally recorded, transcribed verbatim and verified by the interviewers prior to thematic analysis using an inductive approach. Six interviews took place with Ethics Committee representatives (four member secretaries, one chair and one Ethics Committee convenor). A further six interviews were conducted with principal investigators (consultant neurologists), representing the six IMPROVIing StrokE care in India sites. A focus group took place with six principal investigators and a second with 11 participants (2 existing principal investigator participants and in addition 3 principal investigators involved in research in India but based in the UK, 3 members representing Indian Council of Medical Research and Forum for Ethics Review Committees in India, 3 members of the project team and a facilitator).

Results: Analysis of the interviews and focus group data resulted in five main themes (Indian Council of Medical Research regulations, Ethics Committee processes, Ethics Committee member roles and workload, suggested solutions and the impact of the COVID pandemic).

Conclusion: At the time of the study, multiple changes to Ethics Committee processes were already underway and further changes took place due to the COVID-19 pandemic. Suggestions for further improvements include expedited review for observational studies; greater collaboration between Ethics Committees so that questions, clarifications and amendments needed send to researchers are consistent; and use of existing research Ethics Committee infrastructure. Any recent or future changes could be evaluated, and lessons can be learned and examples of good practice can be shared between both high-income and low- and middle-income country organisations.

Limitations: Firstly, the study focused on including participants from research active organisations, primarily from within the INDian STRoke Clinical Trial Network and therefore the findings may not be generalisable to other organisations. The principal investigators were all experienced and more likely to be familiar with the ethics approval processes and procedures for a range of study types. The study took place during the COVID-19 pandemic when major changes within organisations were taking place.

Future work: Future work will explore sharing examples of good practice being between high-income and low- and middle-income country organisations.

Funding: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Global Health Research programme as award number 16/137/16.

A plain language summary of this synopsis is available on the NIHR Journals Library Website https://doi.org/10.3310/GJCW0423.