What is at stake?
Currently, we estimate that Africa has 10% of the world’s population but only attracts 1% of global clinical trials. So, at stake are the enormous benefits for patients, for health, and for research systems in Africa that would come with being able to attract the other 9% of clinical trials that should come to Africa. The better, more efficient and transparent we can make ethics review in Africa, the more likely we will be able to get our ‘fair share’ of the benefits of global health research. That is the challenge.
The Ethics module of the 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 standardized ethical review of research for global health. It is specifically tailored to cater for the challenges experienced in Africa, including issues of low internet bandwidth, constant power outages and maintenance cost. It is designed and developed in Africa and Latin America with the aim of providing RECs with a highly secure, cloud-based solution to enhance communication, improve quality and efficiency and enhance information management of ethics review. It produces important performance indictors for RECs, sends real-time alerts and reminders to researchers, reviewers and administrators hence increase efficiency. It can be used to report on and monitor Serious Adverse Events (SAEs) thus enhancing the RECs pharmaco-vigilance practices. And it provides user-friendly dashboards and interactive interfaces, making ethics review process less cumbersome, without compromising on its quality. A short web-demo can be found at: www.rhinno.org
The RHInnO Ethics platform is an information management system and an expert-decision support system for individual Research Ethics Committee (RECs). It also has a ‘national’ version, that enables national ethics committees to provide accreditation, and to monitor quality and performance of institutional committees. RHInnO Ethics aims to secure and mitigate risks in ethical review in order to hasten the cycle of drug discovery and delivery and bring about the much-needed relief from the burden of disease. Quality, efficient and timely ethics review can accelerate the discovery of medical innovations, thus save life and invaluable resources.
Developed by COHRED in 2013, RHInnO Ethics has gradually become the de facto Pan-African online ethics review platform. At present, RHInnO Ethics is the platform of choice for 55 RECs operating in 13 countries in African, including Kenya, Malawi, Tanzania, Uganda, Nigeria, Niger, Guinea, Sierra Leone, Zambia, Swaziland, South Africa, Mozambique*, Senegal*. In the year 2017 alone, three leading international organizations that support clinical trials in Africa, including the International Aids Vaccine Initiative (IAVI), European and Developing Countries Clinical Trials Partnership (EDCTP) and the West African Health Organization (WAHO) committed to support a total of 26 national and institutional RECs, bringing the total number of African RECs that have RHInnO Ethics installed to 55. The year 2017 has therefore experienced nearly a 100% increase in the number of RECs installed with RHInnO Ethics. This increase is an important pointer to the importance and increasing trust bestowed on the platform and serves to underscore its potential in changing the ethics review landscape in Africa.
RHInnO Ethics will go a long way in addressing these: all indications are that RHInnO Ethics is set to revolutionize ethics review process in Africa and beyond! Furthermore, linking the ethics review of research to medicine regulation will enhance the potential for accelerating review and regulation process even more.
The stakes are even higher because of this – if regulation and review process can be reduced by 12 or 24 months in complex trials, as was shown after the introduction of RHInnO Ethics, this can save considerable cost, reduce unnecessary ill health and save lives.
This session will look at the potentials and risks of digital platforms for ethics review and medicine regulation to accelerate and improve access to medicines in Africa.
|IJsselmuiden Carel||Chairman, |
Introduction - Using the Web to Enhance Research Ethics Review in Africa
|Kombe Francis||RHInnO Ethics – adding digital power to research ethics review in Africa||COHRED||Kenya|
|Kruger Adriaan||Public Private Partnership in optimising digital power to improve research ethics in Africa - a case study||TCD eClinical Solutions||South Africa|
|Bain Luchuo Engelbert||Public health disaster preparedness and response in low and middle income countries: What have research ethics committees got to offer in a digital age?||Vrije Universiteit||The Netherlands|