Title: Building Capacity for Research Ethics and Regulation in Zambia

ACRONYM: BUCARERZ

COORDINATOR

Dr Godfrey Biemba, National Health Research Authority (NHRA), Zambia.

PARTICIPANT/CO-APPLICANT

Dr Victor Chalwe, National Health Regulatory Authority (NHRA), Zambia.

Introduction: The capacity of Researchers, Research Institutions, Research Ethics Committees (RECs), and Institutional Review Boards (IRBs), in research ethics in general and in the conduct of clinical trials in particular is still weak in Zambia. The Zambia National Health Research Policy of 2010 identified capacity building in ethical conduct of research as a key priority and even proposed including research ethics in the training curricula of health workers.

The overall health research regulatory body in Zambia is the National Health Research Authority (NHRA); under it is the National Health Research Ethics Board (NHREB) which regulates Research Ethics Committees (RECs) and Institutional Review Boards (IRBs). There are a number of RECs and IRBs in Zambia and some more are being formed. The capacity of the above regulatory bodies in ethical review remains inadequate. The NHRA, though managed by a team of experienced researchers, require most of its technical staff to be trained in research ethics and good clinical practice (GCP) in general. One of the key roles of the NHRA is to build the research capacity (including ethics) of researchers, research institutions, RECs, IRBs. It is therefore necessary that its technical staff be well trained in all aspects of research ethics. The NHREB is composed of members from various disciplines who have just received basic orientation to research ethics; these members need to undergo more intense training in research ethics in order to improve the quality of their ethical review and their oversight and supervision of various RECs and IRBs in the country.

Overall Goal: To support Zambia 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.

Methodology: NHRA proposes to undertake a number of capacity building activities in order to achieve this goal that include training of NHRA/NHREB and ZAMRA staff in regulations and quality assurance systems to serve as trainer of trainers. The capacity building program will include training of trainers locally and at an international site, training of researchers at selected institutions and RECs/IRBs, supportive supervision, mentorship as well as through networking events. NHRA will facilitate local and national networking meetings among RECs/IRBs and Researchers in order to enhance collaboration and strengthening of networking and sharing of good practices. NHRA will also facilitate transnational collaborations involving regional networking activities with partners such as the African Medicines Regulatory Harmonisation Programme (AMRH).

Work Packages:

WP1: Whose main objective is to support National Health Research Ethics Board and UNZABREC’ efficiently review clinical trial applications.

NHREB will take lead under closer collaboration with the Secretariat at NHRA, the installation of the electronic platform for review of proposals and protocols will be done for all participants (NHREB, UNZABREC and NHRA). NHREB through NHRA will move to procure the agreed upon software and dedicated computers. Training of selected NHREB, UNZABREC and NHRA staff will commence and at least 10 participants will take part in the training. Once the training is over, the package will be in use and will only require minimal maintenance and internet to run which for this period of the grant will be 30 months. NHRA will take over and sustain it after that.

WP2: whose main objective is to develop institutional and personnel capacities to enable improved regulatory pathway activities directly related to clinical trials and registration of new medicinal products

Upon submission of the proposal in November 2017, NHRA embarked on getting full details for all the possible short courses in regulation and quality systems from all the 11 accredited institutions in Africa. We assume the course to be less than 10 days. This training will be trainer of trainers’ course for our team and they will be then expected to conduct local trainings and the trainers will be a pool of resource for the NHRA. Training in core regulatory functions from St Luke’s Foundation, School of Pharmacy, Kilimanjaro, Tanzania 6, Registration and Evaluation and Clinical trials oversight, Food and Drugs Authority (FDA), Ghana, Pharmacovigilance training, Medical School, WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance, University of Ghana, Quality Assurance and Quality Control of medicines, North West University, Potchefstroom Campus, South Africa. For the training in regulatory functions, we will have 3 members from NHRA and 2 members from NHREB/UNZABREC trained. For the training in registration and evaluation and clinical trials oversight this will be combined with the Pharmacovigilance training since both will be in Ghana. Four members will undergo registration training and 2 members will do pharmacovigilance. This will be in equal proportions such that three members will come from NHRA and other 3 from NHREB/UNZABREC and ZAMRA. For the quality systems training, 3 NHRA/NHREB members will be trained in South Africa.

WP3: whose main objective is to develop institutional and personnel capacities to enable improved regulatory pathway activities directly related to clinical trials and registration of new medicinal products.

Once the computer software has been installed and the training has been conducted and the trainer of trainers has taken place, which will provide a pool of national trainers, NHRA in collaboration with ZAMRA will embark on the country-wide training of the researchers and research institutions and the IRBs in regulatory functions, pharmacovigilance and quality systems. This training will be done by zoning the country by combining the provinces. The first ones to go will be the Northern zone which will combine Luapula, Northern and Muchinga provinces, and the Southern zone which will combine Lusaka, Eastern and Southern provinces. Then other trainings will take place in Copperbelt zone combining North-western and Copperbelt provinces and also Western zone which will combine Central and Western provinces. NHRA being newly established will integrate and also use these orientations to sensitize and bring awareness to the individuals and institutions about the functions of the Authority, which we hope will bring injection of new energy and promote research activities, but also improve quality in the proposal as the researchers will be more enlightened on procedures, and have deeper appreciation of regulations governing clinical trials. The process will be such that only the trainers will be paid from the project and also stationery and transportation will be supported by the project. The individual participants and institutions will be invited and they will meet their own costs. The training will be done in the first year of the project. By the following year, we envision to try the same but with country ownership, such that the trainings will be conducted with a fee attached that should support trainers. Closer to the same estimates will be the cost of training by year two, mostly it’s the fuel that will vary.

WP4: whose main objective is to effectively review clinical trials applications

Once the computer software has been installed and the training thereof conducted, NHREB under the coordination of NHRA will pilot monthly meetings from three months into the project up to 12 months into the project and then NHREB and NHRA will sustain this activity. During this pilot, NHREB will co-opt some members of UNZABREC to have a working experience. The main cost to the project is to host the NHREB members for the two days on a monthly basis. This will improve efficiency in the review process and ensure the Ethics Board copes with the anticipated increased volume of proposals that will come with the awareness by individuals about the function of the NHRA and NHREB.

WP5: whose main objective is to develop institutional and personnel capacities to enable improved regulatory pathway activities directly related to clinical trials and registration of new medicinal products and also strengthening pharmacovigilance system

 From the time the electronic system will be installed and then once the monthly reviews are underway, after 6 months in, a sample of approved and cleared proposals will be selected for monitoring. NHRA being full time and part of their responsibility, will be in the field to conduct this exercise. This will be done jointly with ZAMRA so components of pharmacovigilance can also be enhanced. The joint team will monitor how the selected projects are being implemented and ensure no protocol deviations or violations are happening and corrective measures are done. Further during monitoring exercises, the officers will gather data on adverse events and this will be reviewed by the central team and presented to NHREB in readiness for their interactive meetings with the IRBs. During the life span of this project we hope to conduct 4 monitoring field visits. Each visit will comprise 3 groups dispatched at the same time to cover all selected sites at once.

The two monitoring visits will be done with the support of the project funds. The third and fourth one will be a trial of ownership and sustainability with funds charged on studies being monitored.

WP6: whose main objective is to provide ethical oversight for clinical trials and health research in general and also review and make recommendations in relation to submitted reports for AE data

IRBs are obligated to submit reports regularly to NHREB on their activities, yet there is little interactions that provide a platform for NHREB to further interrogate activities that IRBs are conducting. As such this activity, which will be strategically scheduled to follow monitoring visits of selected studies, will give NHREB and NHRA being newly established, a unique opportunity to interact and network with the IRBs and give general oversight. NHREB can further provide updates and guidance over old and emerging issues The interactive meetings will start from seven months after the monthly NHREB ethical reviews and just after the first monitoring visit. Invitation will be sent to all IRBs, public and private, and the meeting will compel all the IRBs to present on their activities and this can take up to 2 days of deliberations The IRB members will support themselves and NHREB will be supported by the project. NHREB members can rotate to make 5 members plus 2 secretariat members at least attend. All invited IRBs will send two members to represent each IRB. In total, 2 such interactive meetings will take place supported by the project then the third and 4th ones will be the trigger of ownership and shall have the support from studies.

WP7: whose main objective is to facilitate international meetings for exposure and sharing lessons learnt with other regulators

This transnational collaborations involving regional networking activities between NECs or NRAs and other partners such as the African Medicines Regulatory Harmonisation Programme (AMRH). This activity will start after the initiation of all the activities of the project, i.e. monthly reviews, monitoring of studies, trainings in regulatory functions and interactive meetings with IRBs have taken place. Then the NHRA can start packaging lessons learnt and utilize available fora to share. At the minimum especially for local fora, two presenters from NHRA and NHREB will present at different fora. There will be four minimum data sharing fora which will be two international and two local.