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An evaluation of ethical concerns raised by a South African research ethics committee using the principles and benchmarks proposed by Emanuel et al. (2004, 2008).
(2022) Magolela , Melda.; Wassenaar, Douglas Richard.
"Mission creep”, “closed doors”, “bureaucracy”, “time delays”, “incompetence” are terms used in some of the arguments advanced by researchers who are not in favour of or are critical of the system of independent ethics review of research by Research Ethics Committees (RECs). “Human subjects’ projection”, “public accountability”, “good research governance” are some of the terms used by researchers who embrace the system of independent ethics review of research. Also known and referred to as institutional review boards (IRBs), ethics review boards (ERBs), ethical review committees (ERCs), human research ethics committees (HRECs) evaluate all human research to ensure that proposed studies comply with international and national ethics principles and guidelines for conducting human research. These committees may either approve, reject, or require modifications to submitted protocols and their decision is binding. A key feature of such committees and their members is their independence.
Despite being for or against ethics review, there is a growing body of work attempting to describe and understand the functioning and outcomes of RECs in protecting research participants and promoting ethical research. In this area, there is relatively little work describing the actual issues that RECs look for and subsequently raise when reviewing research protocols. The current study therefore assessed minutes of a South African biomedical REC and identified ethical concerns raised during review of protocols submitted between 2015 - 2016. Ten sets of minutes were retrospectively analysed using Emanuel et al.’s (2004, 2008) framework to code, rank and classify the issues raised by the REC. There were 813 queries raised in the two-year period; 86% (697) of the queries were consistent with the framework. Top four most frequently queries were identified with scientific validity (38%) being the most frequently raised concern, followed by informed consent (33%), ongoing respect for participants (11%) and independent ethics review (9%).
Of the 813 queries raised, 14% (116) of queries could not be accommodated by the framework and these pertained to administrative issues. The results of this study support the findings of the primary study by Tsoka-Gwegweni and Wassenaar who were the first to propose and establish that the Emanuel et al. framework is a useful tool to categorize concerns raised by one South African REC. In this study, it was found that 99,7% of 1,043 queries raised for the years 2008 to 2012 were compatible with the Emanuel et al. framework with informed consent emerging as the most frequently raised concern. Equally comparable are the results of a subsequent study by Silaigwana and Wassenaar who also reported that 97,7% of the 1,272 queries raised for the years 2009 to 2014 could be categorised using the Emanuel et al. framework. The Emanuel et al. framework of eight principles and benchmarks proves to be a useful and important tool in evaluating ethical queries raised during EC protocol review meetings. Both the current study and these previous studies support use of this framework.
An exploratory study of vaccinations amongst staff at a South African research institution: personal choice or mandatory?
(2024) Couch , Marilyn Angel.; Toohey, Jacintha Deleane.; Groenewald, Candice Rule.
Controversies related to immunisation have existed since 1840. The focus of much discussion has been on the efficacy of vaccination in protecting public health and safety, as well as the question of vaccine mandates infringing upon individual freedoms. The COVID-19 pandemic, declared by
the World Health Organization on March 11, 2020, reignited these debates.
In South Africa, under Section 27(2) of the Disaster Management Act No 57 of 2002, the Minister of Employment and Labour is authorised to issue directives linked to the country’s state of disaster. As a result, the COVID-19 Occupational Health and Safety Measures in Workplaces directive (C19
OHS) (Department of Employment and Labour, 2020) was issued by the Minister of Employment and Labour in terms of regulation 10(8) issued by the Minister of Cooperative Governance and Traditional Affairs in terms of Section 27(2) of the Disaster Management Act No 57 of 2002
(Republic of South Africa, 2002). The objective of the directive was to implement occupational health and safety measures in the workplace to stop the spread of the COVID-19 virus and to provide guidance to employers on how to deal with COVID-19 in the workplace. Consequently, this brought to light the need to tackle the dilemma of individual versus collective rights in the context of vaccine mandates in the workplace.
The study aimed to explore participants' knowledge and understanding of ethical, human rights, and legal aspects of vaccination. It also sought to understand whether participants believe vaccines should be a personal choice or mandatory, as well as their experiences with COVID-19 vaccination
in the workplace.
This study used a qualitative methodology approach, conducting 20 semi-structured, in-depth, open-ended individual interviews that took place either face-to-face or virtually. The study sample comprised of staff members from a South African research institution, across three provinces. The
interview data were transcribed and then loaded onto Atlas. ti software for coding, using the thematic analysis approach.
This social science study employs an interdisciplinary approach that considers the human rights, ethics, and legal aspects in the workplace setting concerning mandatory vaccination policies. The research aimed to provide valuable insights from participants in this study concerning the multifaceted interactions between human rights law, bioethics, and the social dynamics of mandatory vaccination policies. The research also utilises the social constructionist framework as a conceptual model to examine and understand how individuals have shaped their perceptions regarding personal freedoms, the mandatory nature of vaccination, trust in vaccine role players, experiences with COVID-19 in the workplace, and the factors influencing their beliefs. This conceptual approach is used to analyse and interpret participants' viewpoints but does not dictate the entire study.
The study indicates that most participants are in favour of personal choice. These findings imply that, for these participants, individual choice in medical freedoms is paramount in healthcare decision-making, including vaccination. Recommendations are made for the South African government, vaccination policymakers, employers, and for future research.
Evaluating ethics approval and informed consent in selected online Nigerian medical journals.
(2021) Alimasunya, Joseph Ethagbe.; Wassenaar, Douglas Richard.
Overview to this study.
This was a quantitative, retrospective study which sought to determine the frequency of research ethics approval and informed consent reporting in
selected online Nigerian medical journals.
The need to regulate research activities involving human subject participation led to the establishment of Institutional Review Boards (IRBs), also known as Research Ethics Committees (RECs) in most research institutions globally. It is a universal requirement that all biomedical research studies involving human subjects be reviewed by an independent REC/IRB (World Medical Association, 2013).
One of the fundamentals of research activities involving human participants, including identifiable human materials, data or information, is the provision for ethical protections. The Declaration of Helsinki (WMA, 2013) clearly states the need for researchers to obtain informed consent from
study participants as one of the prerequisites that should be met in the study protocol before approval can be granted by an REC or IRB. Similarly, the Council for International Organizations of Medical Sciences (CIOMS, 2016) in its international guidelines has made provision for the ethical
protection of participants involved in biomedical research activities.
In recent years there has been an increase in social and biomedical research activities throughout the world, with particular emphasis in developing countries where the disease burden is at its highest (Nyika, Kilama, Tangwa et al., 2009). With the increase in biomedical research activities involving human participants in developing countries, Nigeria is no different; there is an increasing need to publish and disseminate research findings in accessible regional and local journals.
Studies have been conducted among some western biomedical and health-related journals to examine compliance with adherence to the Declaration of Helsinki (2013). The International Committee of Medical Journal Editors working in conjunction with numerous biomedical journals have developed guidelines which require that “…when reporting experiments on human participants, authors should indicate whether the procedures followed were in accordance with ethical standards of the responsible committee on human experimentation (institutional and national) and with Helsinki Declaration of 1975, as revised in 2000” (Schroter et al., 2006, p. 718–723). Most countries have developed and adhere to their own national framework for human subject research based on these guidelines (Tangwa, 2004).
There are no known empirical studies of Nigerian journals which assess the extent to which regional or national biomedical health related journals report adherence to existing research ethics guidelines; in particular regarding whether REC review and informed consent are expressly mentioned in publications reporting research which involves human participants. A study to evaluate the reporting of research ethics approval and informed consent in articles from samples of biomedical Journals in Nigeria may shed light on their reported compliance with national and international ethics guidance. Using a quantitative approach, a consecutive series of articles from five Nigerian online medical and biomedical journals publications were reviewed for reporting of research ethics approval and informed consent. This study attempts to replicate a study by Schroter et al. (2006).
Strategies to reduce the emigration of engineering professionals in the South African petroleum refining industry.
(2023) Ngonyoza, Ntsikelelo Sipho.; Pelser, Theuns.; Chummun, Bibi Zaheenah.
The South African refining companies have been losing experienced engineers, due to emigration, which has negatively impacted the refinery Operations. This study aimed to explore the factors that affect the emigration of engineers working in the South African petroleum refining industry. The study used a mixed method approach combining qualitative and quantitative research techniques using structured, in-depth interviews and an electronic survey questionnaire. The study participants were refinery engineers with a formal engineering diploma or degree from a recognized
University or University of Technology. The findings revealed that more than half of the engineers had a positive emigration potential and were actively applying for jobs overseas (56% for interviews and 52% for the surveys). The preferred emigration destinations were the Middle East and Europe for a duration of 5 years. The engineers were Millennials, aged between 31-36 years with 5-15 years’ work experience. The emigration drivers were a rapidly deteriorating macroeconomic climate resulting in a higher cost of living and unhappiness at work due to poor career advancement, poor work-life balance, and a perceived inaccurate and unreliable performance appraisal system where promotions and recognition awards were affected by manager bias. Some recommendations were to have clear career progression paths incorporating job redesign strategies, reduce appraiser bias in the performance appraisal process, incorporate appraisee feedback, and review company benefits to ensure they meet the work-life balance needs of a changing workforce. The study has contributed to the body knowledge by developing a method to measure the emigration potential of petrochemical refining engineers and plot it on an emigration potential matrix. As well as to better understand the critical factors that lead to a positive emigration potential and propose strategies to reduce it by implementing the developed emigration potential reduction framework.
Public financial management framework for the Department of Public Works in Durban Metro, South Africa.
(2018) Ngcobo, Malusi David.; Nzimakwe, Thokozani Ian.
During Apartheid era the Public Service of the RSA did not adhere to principles of good governance like (PFM), transparency and accountability. They were actual lip or spoken conceptual frameworks, but not executed to the latter. As a consequence (PFM) operational systems and processes experienced insurmountable challenges ranging from embezzlement and squandering of public funds. Unprecedented failures by government institutions and employees to comply with financial legislation led to fraud and corruption skyrocketing. Mammoth task facing democratic government was to overhaul and transform Apartheid regime PFM systems. The amalgamation and integration of SA’s Public Service into single unit was indispensable yet it caused gigantic challenges. One of the pressing challenges faced democratic government was to gain citizenry confidence, therefore public financial management reforms, transparency and accountability was at the epicenter to gain legitimacy. The SA’S Constitution affirms that execution of (PFM) regulatory reforms, systems and strategies must aligned with PFMA. Despite democratic government innovations of improving government financial operations and performances, some provincial and local governments had not complied with public performance-measurement. That led to some being placed under national or provincial administration under section 100 and 139 (1 and 4) or 137 of the MFMA under the SA’s Constitution. Theoretical frameworks and systems of performance measurement were designed to assist the employees to achieve efficiency, effectiveness and decision making. Successful changes envisaged by the democratic regime required financial,
technical and human resources to bolster the process. Literature emphasized that resources are fundamental elements needed in improving public sector and subsequently bring the envisaged change. Literature consistent findings highlights that organizational change does not come cheap and it requires incentives and trade-offs to be successful. SA’s government changes were needed to redirect the scarce resources of the state towards a new host of avenues, developing new strategies, processes, practices, plans to implement proposed change, and redeployment of employees with expertise. Strategic interventions became an indispensable phenomenon why the change was envisage at that point. There was an urgency of reorganizing and restructuring governmental operational systems to test the recent innovations. Failure to provide necessary resources to beef up envisage change would have led to feeble execution efforts coupled with high levels organizational failures. PFM is the case study taking into cognizance PFMA’s impact in handling public revenue in government institutions like Department of Public Works. PFMA is an Act crafted to strengthen the objectives of sound public financial management. PFM and PFMA had to ensure that financial modernization and improvements were implemented. PFMA, of 1999 must safeguard that management manages operations with distinction, be held accountable by eradicating fraud, corruption, and wasteful expenditure in government. Twenty four years after 1994 democratic dispensation SA’s public service transformation continues, but government struggle to produce clean financial audits. SA is constitutional democracy mandated to implement PFMA in all government institutions. The study assesses success rate at which financial management reforms like PFMA, PFM, Integrated Financial Management System (IFMS) and New Public Financial Management (NPFM) mechanisms has achieved in handling public finances. PFM must ensure proper
utilization of public funds by meeting defined standards of probity, regularity, efficiency and effectiveness.