STRENGTHENING THE ETHICS AND REGULATORY CAPACITY IN GHANA PROJECT
STREC-Ghana consortium is a collaboration between CSIR-Ghana, FDA Ghana, Council on Health Research and Development (COHRED), Pharmalys, and Pharma Ethics sponsored by the European & Developing Countries Clinical Trials Partnership (EDCTP). The aim of STREC-Ghana is to strengthen the regulatory and ethics capacity of Ghana by carrying out a systematic assessment of the regulatory, ethics, and structural capacity of Ghana to identify key gaps and come up with sustainable solutions for the gaps identified.
The project targets an all-inclusive participatory approach, drawing on tested technological approaches. Through this multidisciplinary partnership, the project specifically hopes to: Use a stakeholder participatory approach to review the existing regulatory and ethics capacity situation in Ghana in order to identify key gaps that need to be addressed and use the gaps identified to establish a responsive research and ethics regulatory system in the country with a view to strengthening the general ethics review system in the country, Provide specialised and targeted-high level clinical trial review training to those involved in coordination, regulation, and monitoring of clinical trials and Develop efficiency of the clinical trials portfolio by implementing a tested and proven online ethics review system in the country.
The overall objective of the project:
The overall objective of this project is to strengthen the regulatory and ethics capacities of Ghana.
The specific objectives, the project aims to:
- To ensure effective management of the project
- Review the existing regulatory and ethics capacity situation in Ghana in order to identify key gaps that need to be addressed;
- Establish a responsive research and ethics coordination system in the country with a view to strengthening the regulatory capacity and general ethics review system in the country;
- Provide specialised and targeted-high level clinical trial review training to those involved in coordination, regulation and monitoring of clinical trials and
- Develop an efficient clinical trials portfolio by implementing a tested and proven online ethics review system in the country.
Project Management Board
- Director General CSIR- Chairman
- Mike Yaw Osei-Atweneboana (Director CSIR-WRI)- Member
- Representative (COHRED) – Member
- Representative (Pharmalys) – Member
- Representative (Pharma-Ethic Health Research Ethics Committee)- Member
- Representative (Food and Drugs Authority) – Member
- Pamela Selormey (CSIR-WRI) – Member
- Zaid Haruna (CSIR-WRI-STREC)- Secretary
ROLES OF PARTNERS
Council for Scientific and Industrial Research (CSIR-Ghana)
In this partnership, CSIR will be the lead applicant and the lead coordinator of the project. In coordinating this project, CSIR will undertake all management and coordination roles, including calling for meetings, taking minutes, submitting reports to the funder and networking and communicating with all other partners in the consortium where necessary.
COHRED will provide technical support to implement the RHInnO Ethics online platform for submission and review of research projects.
- Carry out a needs and gap assessment to identify Ghana’s gaps and opportunities on regulatory and ethics capacity
- Install an Institutional RHInnO Ethics package to three high volume IRECs that review clinical trials to enable them to receive and review protocols online as well as make a final review decision
- Train IRECs and CSIR on the use of RHInnO Ethics
- Support Pharmalys to conduct the research regulatory and governance training that will target senior CSIR and FDA personnel
- To support Pharma Ethics to conduct the advanced ethics training that will target IREC personnel
Food and Drug Authority (FDA)
This is a very critical role, as misbranding, substandard and/or counterfeit, as well as unsubstantiated product information, has very grave consequences on public health and serious implications for healthcare delivery. The FDA, since August 1997, has been pursuing various specific objectives to address issues on regulatory control of products as stated in our mandate.
In this partnership, Pharmalys, with support from COHRED, will be responsible for organizing and conducting the research regulatory and governance training that will target senior CSIR and FDA personnel.
Pharma-Ethics will be responsible for organizing and delivering the advanced ethics training for IREC personnel.
ACTIVITIES CARRIED OUT
1.0 MANAGEMENT BOARD MEETING
The project Management Board was established for effective coordination and management of the project. The composition o9f this Board was made up of nominees from the various partner institutions of this project. The first STREC-Ghana project Management Board meeting was held on Thursday, 20th August 2020. This was a one-day virtual meeting via zoom conference due to the COVID-19 pandemic and its associated restrictions to curb the pandemic.
Prof. Victor Agyeman (Board Chairman) admonished members and the coordinating Institution to ensure that subsequent meetings start on time per the schedule. He then expressed his profound happiness about STREC-Ghana project and noted how this will go a long way to help research and ethics regulations in Ghana; by providing guidelines for the responsible conduct of research, educate and monitor scientists conducting research to ensure a high ethical standard.
Prof. Victor Agyeman emphasized the importance of the project and encouraged all members to contribute fully towards the successful completion of the project. His only concern was the lag in the start time of the project due to the COVID-19 pandemic. However, he stressed that members should come up with sustainable solutions to enable smooth implementation of the project amidst the COVID-19 pandemic and officially inform sponsors about current challenges, future anticipated challenges and proposed interventions.
The main function and role assigned to the board were to provide overall ongoing oversight, management, and coordination of the project activities to ensure the quality and effective implementation of all project activities to meet project intended results. The Council for Scientific and Industrial Research (CSIR) lead the formation and establishment of the Management Board and was supported by FDA. The following action points were adopted by the board;
2.0 INCEPTION MEETING
A one-day Inception Meeting of Strengthening the Ethics Capacity and Regulations in Ghana was held on the 24th of November, 2020 at the Salma Auditorium of the Best Western Premier Hotel, Airport Residential Area - Accra. It was a face-to-face meeting attended by about 54 key stakeholders in addition to our partners who joined virtually. This was made possible due to the ease of COVID-19 restrictions by the Ghana government, however, all COVID-19 protocols were observed to ensure the safety of participants. Key stakeholders included representatives from Institutional review boards (specifically administrators and Board chairs), research institutions, and Service providers (Ghana Health Service and Health ministries).
Participants were excited about the project especially the approach adopts and pledge their commitment to the successful completion of this project and also to ensure that Ghana achieves the maximum benefit from the project and its partnership. They believed that in the past, lack of proper consultations has affected the impact of some good projects but were the CSIR is leading this particular one. There was a consensus among participants that there was a need to strengthen current regulations and build needed capacities to ensure optimal compliance by scientific professionals and encourage ethical work in their dealings.
The stakeholders also admonished the CSIR to ensure in their capacity the establishment of the National Ethics and Regulatory Body which they believed has been delayed far too long. They were of the view that considering the increasing number of ethics committees in Ghana currently (eighteen (18) institutionally established), there the need for a national oversight of their activities which is currently producing pockets of issues related to multiple reviews and high administrative fees. These frustrations also resonate with research professionals.