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ABSTRACTS OF THE EIGHTH EDCTP FORUM, 6–9 NOVEMBER 2016
ABSTRACTS OF ORAL PRESENTATIONS
OA-003
IMPROVING THE EFFICIENCY OF AFRICAN RESEARCH ETHICS COMMITTEES AND STANDARDISING ETHICS REVIEW PROCESSES THROUGH AN AUTOMATED REVIEW PLATFORM
  1. Boitumelo Mokgatla1,
  2. Prince Bahati2,
  3. Carel Ijsselmuiden3
  1. 1IAVI, South Africa
  2. 2IAVI, Kenya
  3. 3COHRED, Switzerland

Abstract

Background The sheer amount of research being conducted in Africa, the under-resourced research ethics committees (RECs), and the lack of modern review technologies has resulted in unprecedented review timelines – with an estimated 1.5 years to get ethical clearance in many African countries. The Research for Health Innovation Organiser (RHInnO), a cloud-based ethics review platform, has ushered a new frontier of digital ethics review in Africa. It facilitates and manages the entire ethics review process. RHInnO ethics integration is estimated to reduce the review time by 12 months. In 2015, RHInnO ethics was used by 25 RECs in 8 African countries. We evaluated its impact on efficiency, data security and cost.

Methods Qualitative and quantitative data was collected using an online questionnaire administered to REC administrators/chairpersons in user countries.

Results Responses were received from 60% of RECs using RHInnO ethics. Reported areas of high impact (81%-100% of respondents) included: improved protocol submission and distribution process, improved quality of communication between RECs and researchers, improved standardisation of review process and improved data security. Reported areas of medium impact (60%-80% of respondents) included reduced REC administrator's workload and reduced RECs' administrative costs. Improved reviews of multicentre trials were reported as a low impact area by over 60% of respondents. Respondents (20%) who used RHInnO ethics for more than 2 years reported 57% reduction in review time while those who used RHInnO ethics for less than a year, (80%) reported it is too early to see the impact on reduction of review timelines.

Conclusions RHInnO ethics had high impact on data security, submission process, communication, standardisation and cost reduction. However, a long-term evaluation approach is needed to determine impact on review timelines. Integration of new monitoring and evaluation (M&E) indicators on efficiency into the platform would improve RECs capacity to conduct long-term impact analysis.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjgh-2016-000260.12

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