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In India, ethics review goes digital for good

September 21, 2020 by Varun Sharma

To support India’s growth as a center for clinical research, PATH and partners developed—and recently handed off—an innovative tool for ethics review.


PATH staff performing a demonstration of the CReATE-FERCI software suite for ethics review at a premier research institute in India. Photo: PATH/Varun Sharma.

Biomedical research is strongly regulated to ensure scientists are following ethical and safety requirements. Research proposals must be approved by ethics committees, governmental regulatory bodies, statutory committees, and a host of other committees and platforms. Institutional ethics committees (IECs) play a major role in this process.

In India, where clinical research is growing rapidly, more than 2,000 IECs ensure ethical review of biomedical research. However, only a handful of these IECs have appropriate software tools to facilitate this review and approval process.

PATH’s Clinical Development Training Program in India saw an opportunity to make the ethics approval process more robust, compliant, convenient, and efficient—using a software suite to support IEC processes.

A transformative tool

Over the past four years, with support from the Bill & Melinda Gates foundation, PATH and the Forum for Ethics Review Committees in India (FERCI) co-created a package of five cloud-based software solutions, collectively called the CReATE-FERCI software suite. These software tools provide an online document management system for efficient, paperless functioning of ethics committees as well as tools for researchers to improve the quality of their proposals and research.

We estimate the software can save at least 175 person-hours for small institutions to more than 700 person-hours for large institutions, every year, by automizing time-consuming processes. The software can also help save up to US$3,120 in paper usage costs.

Since its introduction, the software suite has been rolled out for use in more than 40 medical research institutes in India. A survey of users in 2018 showed satisfaction with the software—it saved time, made review processes more convenient, and reduced the overall cost of review.

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Growth and improvement

Buoyed by the initial success, our team set its sights on improving and scaling the software suite. PATH led the introduction of the CReATE-FERCI software to more Indian ethics committees, and we held virtual exchanges to demonstrate the benefits of the tools to research institutions across the country.

We also introduced more features to ensure the software meets the needs of its users. One of the biggest enhancements was the integration of electronic versions of the standardized forms for ethics review developed by the Indian Council of Medical Research. This was done in collaboration with the Clinical Development Services Agency (CDSA, an extramural unit of the Translational Health Science and Technology Institute, Department of Biotechnology, Government of India).

We also created a mechanism to collect feedback from users in order to identify new features or future improvements for the software. We provided technical support to ensure smooth operation of the software. And we leveraged our expertise in market dynamics to create a robust business plan for the long-term development of the software.

An exit, but not an end

In July 2020, PATH handed the software suite to CDSA. CDSA is a pioneering institution that works to create, develop, and nurture world-class clinical product development capacity in India. They have the right kind of technical expertise and resources to help CReATE-FERCI reach national scale. We believe in their vision and know they will steward the software to future success. With this trusted partner in place, PATH exited the project.

Reflecting on the journey of the CReATE-FERCI software suite, we are sure it has the potential to enhance the clinical research environment in India. CReATE-FERCI will increase the confidence of both investigators and research participants in the research process—and lead to faster development of vital health solutions.

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