Functionalities and Benefits

1. Introduction

High disease burden and re-emerging infectious diseases in Africa has led to an increase in western funded transnational research. There are currently about 10,000 active clinical trials that are being conducted in Africa according to the https://clinicaltrials.gov website, which accounts for only 2% of the total registered clinical trials globally. Nonetheless, there has been a noticeable increase in the number and complexity of inter-disciplinary, cross-border health research being conducted in Africa. As such, there is a need to have well trained, competent and experienced multidisciplinary Research Ethics Committees (RECs) that would be able to efficiently review these complex protocols emanating from different emerging new health research disciplines. Doing so would ensure optimum protection of human research subjects, and support timely medicine and vaccine discovery.

Despite efforts to build the capacity of RECs in Africa through training in health research ethics and human research participants protection, traditional paper-based ethics review processes have continued to limit the quality and efficiency of ethics review done in Africa. Experiences and documented evidence, albeit limited, suggest that some Research Ethics Committees (RECs) still take up to three years to review complex multisite trials. Besides the long lag time between submission and review/approval, there are concerns about the level of quality, lack of comparability and inefficiencies in carrying out these reviews. REC members are increasingly required to review and interpret more and more complex international ethics guidelines and protocols, in a rapidly growing complex socioeconomic and cultural environment often without the benefit of appropriate skill-sets and expertise. In addition, RECs do not sufficiently value and develop the role of REC Administrator who, with appropriate support, could help to interpret and enforce adherence to schedules, internationally recognized Standard operational procedures (SOPs) and guidelines.

2. What is at stake?

Currently, we estimate that Africa has 10% of the world’s population but only attracts 2% 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 8% 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.

3. RHInnO Ethics

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 to the challenges experienced in Africa, including issues of low internet bandwidth, constant power outages and high maintenance cost. It was 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 ethics review information management. It produces important performance indicators for RECs, sends real-time alerts and reminders to researchers, reviewers and administrators hence increases 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 the ethics review process less cumbersome, without compromising on its quality. A short web-demo can be found at https://youtu.be/i1MMJSkb6n0.

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 the 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. It should be noted that RHInnO Ethics is also entirely suitable for use by RECs operating in other research contexts, e.g. social science research involving human participants, or medical research that does not involve clinical trials.

RHInnO Ethics was developed by COHRED. From July 2021, EthiXPERT took over the ownership,management and coordination of this platform. We believe that RHInnO Ethics will go a long way toward addressing the challenges experienced by African RECs and revolutionize the ethics review process in Africa and beyond!

4. Benefits of using RHInnO Ethics

4.1 RHinno Ethics offers the following:

• Login/password protection
• SSL encryption – secure authentication
• Designed for Low-bandwidth
• Your data are always backed up – and you control access
• Facilitates communication between the three main users (Administrators, Reviewers and Researchers)
• Real-time notification/alerts
• RHinno Ethics automates the research ethics review process thereby improving overall efficiency, transparency and accountability
• RHinno Ethics avoids loss of submitted materials and delays in communication within and between research ethics committees, administrators and researchers

4.2 For Researchers, RHInnO Ethics enables:

• Electronic submission of new proposals for review including support documentation/attachments
• Applications related to ongoing studies e.g. protocol amendments
• A submission e-certificate of submission is issued upon successful submission
• Secured transmission of proposals (encrypted connection)
• Autofill of information in subsequent submissions for protocols previously submitted through the system
• Monitoring of the review status of submitted protocols through email alerts and online notifications
• Access to REC dashboard announcements
• Access to templates and resources
• Electronically signed certificate of approval
• Ongoing communication with research administrator after approval

4.3 For Ethics Reviewers, RHInnO Ethics can:

• Manage the review process electronically
• Protocols electronically distributed to reviewers
• Provide online review forms to reviewers
• Facilitate monitoring of protocols
• Provide access to REC rules of procedure and
• Supporting documents as well as dashboard
• Announcements
• Accessing to own review
• Access to other reviewers’ comments
• Access to the final decision made
• Auto reminders for reviewers

4.4 For Administrators, RHInnO Ethic scan:

• Customize and configure own institutional interface
• Manage committee and committee membership
• Edit users information, change users’rights, suspend and unsuspend users
• Manage research ethics proposals
• Receive proposals submitted
• Conduct an internal review
• Distribute proposals for review
• Grant ethical approval
• Generate final and progress report
• Generate indicators and chart analysis (Review status, Research type)
• Post and manage dashboard announcement
• Add electronic signatures
• Edit/customize message templates

5. Packages and Pricing

RHInnO Ethics is available in two versions: a single license version for individual RECs and a version for use at the national level – providing accreditation and data aggregation functionalities.

• Updates to RHInnO Ethics will be automatic to all users at no extra cost.
• Change-over to different pricing will be offered to all users when it becomes available. However, this is usually rare and where it happens, users will be given adequate notice to factor these changes in their annual budget
• Table 1 shows the cost items available both for the single license version as well as the national package

Table 1-Cost items for RHInnO Ethics packages

6. Training

Training is usually conducted by EthXPERT once agreements and MOUs have been signed. To conduct training, EthiXPERT will release one or two trainers depending on the number of participants to be trained. The organization procuring RHInnO Ethics on their part will cater for round flight costs, accommodation, meals either booked by EthiXPERT and invoiced to the recipient organization or booked by the organization directly. In addition, person-time per trainer will be payable to EthiXPERT.

7. Conclusion

RHInnO Ethics has shown great potential and proven to be de facto Pan-African online ethics review platform. Accelerated adoption of RHInnO Ethics, is, however, required to enhance efficiency and increase the large-scale adaptability of the platform. RECs and sponsors of RECs need to adopt an effective funding strategy in order to accelerate the adoption of standardized digital platforms in Africa

For further information and support, please contact:

Should you need further information or clarification, contact Francis Kombe at Kombe@ethixpert.org.za; or Corline van Rooyen- corline@ethixpert.org.za