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Maricel-van-Rooyen
Maricél van Rooyen, Project Manager for Research Information Management System (RIMS) and Research Ethics Adviser in the Directorate Research Development (DRD) at the University of the Free State (UFS), is the Programme Coordinator for a first-of-its-kind Southern African Research and Innovation Management Association (SARIMA)/ COP webinar on Environment and Biosafety Research Ethics.

The University of the Free State (UFS) is playing host to a first-of-its-kind webinar on Environment and Biosafety Research Ethics later this month with Maricél van Rooyen, Project Manager for Research Information Management System (RIMS) and Research Ethics Adviser in the Directorate Research Development (DRD), playing a pivotal role.

The webinar, which is part of the Eastern Region Community of Practice (COP), is taking place on 20 August. The target market for this virtual workshop is Biosafety and Environmental Research Ethics Committee (REC) chairpersons and members, professionals including research management professionals, administrators, research compliance managers and advisers, and research directors in Southern Africa and beyond.

Van Rooyen will be the Programme Coordinator for this Southern African Research and Innovation Management Association (SARIMA)/ COP Research Ethics Webinar, while Prof Robert Bragg, chairperson of the UFS Environmental and Biological Research Ethics Committee (EBREC), will give a presentation on the establishment of an EBREC.

The UFS, Stellenbosch University and the University of the Witwatersrand, form part of the COP which is a SARIMA (Southern African Research and Innovation Management Association) initiative to assist and share research ethics questions between institutions to empower research management and ethics compliance. SARIMA assisted with the online hosting and advertising of the webinar.

Purpose of the webinar

“Environment and Biosafety Committees in South Africa are a new idea, and only a few institutions in the country have such a committee. The UFS and the other institutions that will present at the workshop, take a leading role because they have already registered committees in place. We want to share and assist with establishing and operating such committees,” says Van Rooyen.

According to her, the need for the webinar arises from the upsurge of research and innovation in biotechnology and related fields over the past two decades that has led to exciting new discoveries in areas such as the engineering of biological processes, gene editing, stem cell research, CRISPR-Cas9 technology, Synthetic Biology, recombinant DNA, LMOs and GMOs, to mention only a few.

These advances, however, have generated concerns about biosafety, biosecurity and adverse impacts on biodiversity and the environment, leading to the establishment of Research Ethics Committees (RECs) at Higher Education and Research Institutions dedicated to reviewing research with implications for biosafety and the environment.

These EBRECs are in the early stages of their establishment and formalisation in South Africa, and there is much uncertainty about their composition, scope, procedures of decision-making and the principles that should guide their deliberations and assessments.

Leading the charge

The UFS took the lead in South Africa in ensuring international ethical compliance in this extended area of research, by establishing its own Environmental and Biological Research Ethics Committee (EBREC) six years ago. The UFS EBREC is one of only two such ethics committees at a South African university that combines the biosafety committee with environmental and biological research ethics to ensure ethics compliance in these fields.  The initiative started with Van Rooyen and her RIMS EthicsTeam, (Willem Kilian and Amanda Smith). The university is again taking charge with this webinar, which is a first of its kind.  

News Archive

UFS to monitor the use of ARV-drugs on pregnant women and children
2004-12-08

The University of the Free State (UFS) is to establish a Pharmacovigilance Centre that will monitor the effects of Anti-Retroviral (ARV) drugs on HIV positive pregnant women and children starting early in the new year.

The UFS is one of only two institutions chosen by the Minister of Health, Dr Manto Tshabalala-Msimang, to establish such an ARV monitoring centre.

The other centre will be based at Medical University of South Africa (MEDUNSA) and will concentrate mainly on monitoring the effects of the drugs on adults.

“The establishment of the UFS’s Pharmaconvigilance Centre forms part of government’s Comprehensive Plan on HIV and AIDS, often termed the roll-out plan for ARV drugs. The centre’s primary responsibility will be to specifically monitor the use of these drugs in pregnant women, and children under the age of 13,” said Prof Andrew Walubo of the UFS’s Department of Pharmacology.

“Although most of the side effects of ARV drugs have been identified in other countries, it has now become critical to identify the side effects amongst the South African population. This is important because many people will be exposed to the drugs within a short time. Our aim is so identify the most common side effects and make recommendations for the prevention thereof. The centre will help in detecting the risk of using anti-retroviral drugs in pregnancy and children, and prevention of adverse drug reactions,” said Prof Walubo.

According to Prof Walubo 12 drugs will be monitored – these drugs will be selected according to the patient’s profile.

The centre will comprise of two components: A pregnancy registry, which will focus on a new-born child up until two months and a pediatric registry, which will focus on children who are born of mothers who used ARV drugs and children using ARV drugs.

According to Prof Walubo, the Pharmaconvigilance Centre will also be responsible for offering relevant technical advice, training and selected research on ARV drugs in these patients.

The centre will be fully sponsored by the national Department of Health. It will be based in the UFS’s Faculty of Health Sciences, Department of Pharmacology, and will be run in collaboration with experts from different departments in the faculty.

Media release
Issued by: Lacea Loader
Media Representative
Tel: (051) 401-2584
Cell: 083 645 2454
E-mail: loaderl.stg@mail.uovs.ac.za
8 December 2004

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