COHRED, the Council on Health Research for Development, is a global, non-profit organisation whose singular goal is to maximise the potential of research and innovation to deliver sustainable solutions to the health and development problems of people living in low and middle-income countries. COHRED will provide technical support to implement the RHInnO Ethics online platform for submission and review of research projects. COHRED’s Research for Health and Innovation Organiser (RHInnO Ethics) is an innovative cloud-based platform or ‘Software as a Service’ (SaaS) enabling Research Ethics Committees (RECs) / Institutional Review Boards (IRBs) in low- and middle-income countries (LMICs) to deliver better quality, more efficient, accelerated and standardised ethical review of research for global health. Implementation of RHInnO Ethics drastically reduces the review time by as much as 12 months for study protocols, particularly in complex, multi-centre studies that are increasingly becoming the norm to test new medicines, vaccines, technologies, diagnostics and services. In this project, COHRED will:

• Carry out a consultative forum with a view to developing a deeper understanding of the weaknesses regarding the ethics and regulatory capacities of Rwanda.
• Install an Institutional RHInnO Ethics package at all the IRECs that review clinical trials to enable them to receive and review protocols online as well as make a final review decision.
• Install the national RHInnO Ethics package at the RNEC to enable real-time transmission of information and data from the IRECs to the RNEC.
• Train IRECs and RNEC on the use of RHInnO Ethics.
• Support Pharmalys to conduct the one-week intensive workshop for RNEC and FDA personnel.
• To support Pharma Ethics to conduct the advanced ethics training that will target IREC personnel.

The national RHInnO Ethics package at the RNEC will enable accreditation of new institutional RECs, real-time transmission of data from the institutional IRECs to the RNEC and enable RNEC to monitor the performance of the institutional RECs and enhance timely reporting on SAEs. RHInnO Ethics will also enhance communication through real-time sharing of information between NREC and FDA, including, but not limited to, annual and audit reports.

In the proposed amendment of this consortium, COHRED will hand over all the outstanding tasks and budget related to the coordination and implementation of RHInnO Ethics from 1st July 2021 onwards as agreed by COHRED, EthiXPERT and other BRECOR consortium (Refer Appendix 1). However, COHRED will remain responsible for all tasks related to linking of RECs that will be installed with the RHInnO Ethics platform, with Health Research Web (HR WEB).

The RHInnO Ethics platform is integrated with HRweb. Health Research Web (HRWeb) is a web-based information and management platform that provides online users interested in building a high-quality information and management system in a spirit of mutual respect and in pursuit of 'health for all', a resource to promote health, equity and development through research, by enabling them to search, find, use and share health research information, that is essential in achieving these goals. Developed by COHRED in the year 2006, it is a public online portal that provides information on the structure, organisation, financing and prioritisation of research for health in and for low- and middle-income countries hence able to organise global information on research for health from the point of view of low- and middle-income countries; captures research system information – enabling countries and institutions to govern and manage health research as an essential aspect of increasing health, equity and development; makes this domain interactive, open to the public – to everyone – not just to research institutions, donors or industry; and provides a platform that can be used for internal institutional management or for sharing institutional, national or regional data with the world. HRWeb is organised to provide integrated information on research for health at country and regional levels. Its organising principle is national health research systems. It is directed at everyone who has an interest in increasing the impact of research on health, equity and development in low- and middle-income countries. It aims to strengthen national health research capability to produce research that is excellent and relevant. It is not only a 'self-updating' information base, but also a web-based software platform that can be used in private or be shared with the world, and a community of people interested in helping to develop the full potential of research as a way to health, equity and development everywhere.

In the partnership agreement between COHRED and EthiXPERT, COHRED retained the ownership, coordination and management of HRWeb, but handed over the ownership, coordination and management of RHInnO Ethics to EthiXPERT. The partnership agreement further stipulates the need for COHRED and EthiXPERT to ensure they maintain the linkage between RHInnO Ethics and HRWeb. Maintaining this linkage is critical for the mutual benefit of both RHInnO Ethics and HRWeb users, and most importantly, for the invaluable benefit of the wider public.

BRECOR