Project Title: The Zambia Health Research Systems Strengthening Project: Working Towards a Harmonized Regulatory Framework
Background: The knowledge and skills of research regulatory institutions, research ethics committees and researchers in research regulation in general and in regulation of the conduct of clinical trials in particular is improving, but remains fragmented.
The aim of this project is to support the research regulatory institutions, the National Health Research Authority (NHRA), National Health Research Ethics Board (NHREB), Zambia Medicines Regulatory Authority (ZAMRA), and National Biosafety Authority (NBA) to closely collaborate and network to strengthen the national health research regulatory systems and capacities for ethical review of clinical research and use of medicinal products and technologies for use in humans as well as strengthen clinical trials coordination and the conduct of clinical trials in general.
Project Objectives: In line with the objectives of the Call, this project has two main objectives, which are to support the:
1. NHREB to develop institutional and personnel capacities to enable it to perform its national ethical oversight function over Research Ethics Committees (RECs); efficiently review clinical trial applications; and provide ethical oversight for clinical trials and health research in general.
2. NHRA and its related regulatory bodies (NHREB, ZAMRA and NBA) by developing their institutional and personnel capacities to enable improved regulatory pathway activities directly related to clinical trials and registration of new medicinal products, including strengthening pharmacovigilance systems.
Implementation: Our proposal is to implement activities in order to build the regulatory capacities of the national health research and ethical regulating bodies (NHRA, NHREB, ZAMRA and NBA) as well as REC. This is in line with EDCTP2’s aim to “support sub-Saharan African countries to establish and develop robust national medicines regulatory systems and capacities for ethical review of clinical research and use of medicinal products and technologies for use in humans.” NHRA plans to achieve the above objectives through the following activities:
1. Build NHRA/NHREB capacity through:
a) Continued in-country training in research regulation, and
b) Accreditation of regulatory staff.
2. Harmonise the ethics review system (NHRA and ZAMRA) through:
a) An integrated digital review system and o Harmonisation of clinical trial guidelines.
3. Build NHRA research development, regulatory, and operational capacity through:
a) Study tours of other regulatory regional bodies to learn and share skills
b) An electronic registration and accreditation system
c) An e-learning system for the researchers' training programme as a pilot to deliver this teaching facility to 40 participant
d) Regulations drafting and advocacy
e) Grant management training
4. Build NBA regulatory capacity through
a) Training of the members of its Technical Committee in Research Ethics and Protocol Review system for clinical trial
At the end of the project we expect the following results:
1). The National Health Research Regulatory System, at a higher level represented by the NHRA, NHREB, ZAMRA, and NBA, will have strengthened capacity to regulate the ethical conduct of researchers and be able to provide ongoing supportive supervision and mentorship to researchers.
2). NHRA and other regulators in Zambia will have increased efficiency in terms of time and cost in clearing research protocols and other requests from researchers and research institutions as a result of its expanded digitalisation.
3). NHREB's capacity to approve clinical trials will be strengthened and its efficiency in terms of both time and cost will be increased due to the digitalisation of its protocol clearance process (riding on the BUCARERZ project) and additional support from the external review members who will be co-opted to review complex studies.
4). Overall the clinical trials research environment will be strengthened and clinical trials in the country will be well coordinated through the harmonisation of clinical trials guidelines by all the regulators.
5). Researchers benefitting from the project's training programme will have the capacity to conduct clinical trials and to apply for grants (riding again from the BUCARERZ project), with the ultimate results that Zambia will continue to see an increase in the number of clinical trials and other studies conducted and an improvement in the quality of clinical trials conducted (in this current project, as a result of the pilot for researcher curriculum, which will be online and also indirectly from the accreditation of the trainers).
6). All RECs/IRBs and research institutions benefitting, will have strengthened their functionality, recognition, and performance in terms of ethical conduct of research.
7). All RECs/IRBs and research institutions benefitting will have developed sustainable capacity building strategies based on our model capacity building programme.
8). All RECs/IRBs and research institutions benefitting will be providing more effective and efficient services.
9). More of the health research conducted in Zambia will adhere to internationally recognised ethical standards.
10). Overall, a more enabling health research regulatory environment that strikes a fair balance between public health interest, the interests of the pharmaceutical industry, and ethical values will be realised in Zambia.
11). Both the NHRA and NHREB will be recognised and their performance enhanced within the region through interactive and networking meetings at the Research Ethics Association of Southern Africa, and also the indirect benefit of being accredited by VSCR.
12). As a result of this project, both the NHRA and NHREB will have a pool of national trainers in regulation and ethics who will act as a resource for future research regulations capacity building support to both local (Zambia) and international researchers requiring such training. NHRA aspires to become one of the Centres of Regulatory Research Excellence and a training centre within Africa.
13). Together with the current research and ethics regulation capacity building project, this project will act as a stepping stone towards sustaining the activities and functionality of the NHRA. The project will help NHRA further establish functional systems for regulating clinical trials, which over the three year period will result in the organisation having developed sustainable strategies for both NHREB and NHRA to continue with their functions by aiding in development of regulations/SIs.
14). We expect that the systems of tracking (the current project will set up a data system that will provide expanded data storage with servers) and monitoring clinical trial implementation will be built (riding on from the BUCARERZ project).
15). The Zambia Medicines Regulatory Authority will have its pharmacovigilance capacity enhanced and data sharing with the NHRA will be seamless.