Masters Degrees (Health Research Ethics)

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Is the ethics review process prepared for digital autonomy?
(2024) Odero, Brenda Adhiambo.; Groenewald, Candice Rule.
The ethics review process is of primacy in ensuring research is ethical and the protection and rights of participants are maintained. Internationally, review ethics committees (RECs) are run independently and have different ethics review methods that they use. However, very little is known about what methods are used in the ethics review process, and the challenges and successes around adopting digital platforms for ethics review (DPER). The current study aimed to address this gap by inquiring whether the ethics review process in Kenya is ready for digital autonomy. A qualitative approach was adopted in this study, including six in-depth interviews with REC members and two focus group discussions with researchers. The in-depth interviews and focus group discussions entailed two sub-groups: one group included participants who mainly use traditional methods (paper and email) and the other group included participants who mainly used DPER. These transcripts were analysed using thematic analysis, informed by Braun and Clarke’s (2013) six-step approach. While generalisability is not assumed, the findings suggest that the ethics review process will only be ready for digital autonomy when all the challenges highlighted are dealt with and infrastructure is reinforced to support it. These findings imply that digital autonomy in the ethics review process is best effected when all research stakeholders are involved in the deployment, creation, and implementation stage, where institutions offer support and privacy, and security is upheld in all these technologies. Recommendations are made in practice for all research stakeholders, inclusive of RECs, researchers, and DPER deployers and developers. Recommendations are also made for future research developments on how to make the research ethics review process ready for digital autonomy.
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).
Comparison of instructions to authors and reporting of ethics components in selected African Biomedical Journals: 2008 and 2017.
(2021) Dipeolu, Isaac Oluwafemi.; Wassenaar, Douglas Richard.
Journal editors are expected to provide instructions to prospective authors to describe human participants’ protection measures before, during and after data collection for any original research. However, little is known about authors' adherence to editors’ instructions in African biomedical or health journals. Therefore, the study was designed to review and investigate changes in editors’ instructions to authors and authors’ reporting of research ethics information, based on the recommendations of the International Committee of Medical Journal Editors (2018) and Committee on Publication Ethics (2018) in selected African biomedical journals between the years 2008 and 2017. A review of twelve selected African biomedical journal websites and online articles were reviewed in Eastern, Southern, and Western African [ESWA] countries. Data were collected using a pretested schema and checklist from the selected journal websites, and online articles published in 2008 and 2017 were analysed using descriptive and inferential statistics. Findings showed that more than half of the journals (58.3%) mentioned elements of ICMJE and COPE guidelines in their instruction to authors. Half of the editors requested prospective authors to disclose ethics approval issues in their manuscripts. One-third of the journals (33.3%) requested information from authors on informed consent. Only 16.7% of the journals assessed requested information on protecting research participants from prospective authors. There was a significant increase in the instructions to authors on the request for information on the protection of research participants between 2008 and 2017. Instructions to authors in the selected journals showed requests for information on ethics approval, informed consent, and human participant protection as requirements for publishing in 2008. There was an improvement in these requirements in 2017, and more authors complied with these requirements.
An evaluation of the ethical concerns of a South African Research Ethics Committee using the principles and benchmarks proposed by Emanuel, Wendler, Killen and Grady (2004): Evaluating 2017–2018 minutes.
(2022) Sithole, Khutso.; Mamotte, Nicole.
Historical ethical transgressions in research with human participants led to the development of ethical principles and guidelines to protect research participants. Research Ethics Committees (RECs) then emerged to further protect the rights of research participants and alert the researcher to the need to ensure compliance with legal requirements for research. (Silaigwana & Wassenaar, 2015). This study aimed to identify ethical issues raised during ethics review of research protocols and assess their relative weight using the Emanuel et al. (2004) recommended principles for ethical review of clinical research. The 2017–2018 meeting minutes of a South African Social Science Research Ethics committee were identified, accessed and coded using the eight principles and benchmarks of the Emanuel et al. (2004) framework. This allowed observable patterns in ethical concerns raised during ethics review of research protocols to be recorded. A total of 20 REC meeting minutes entailing 176 submitted protocols in 2017 and 2018 were purposively included in the study sample. Content analysis was used to analyse the data in terms of the Emanuel et al. (2004) framework. The data obtained during content analysis was captured using Microsoft Excel and analysed using frequency counts and simple descriptive analysis. The study found that the most frequently raised ethical issues were around informed consent (n=300; 35%). The remaining principles were ranked as follows: scientific validity (n=159; 18%), fair selection of participants (n=122; 14%), independent reviews (n=76; 9%), ongoing respect of participants (n=71; 8%), risk-benefit ratio (n=41; 5%), collaborative partnership (n=35; 4%) and social value (n=31; 4%). The study further revealed that the Emanuel et al. (2004) framework was useful in identifying and categorising the questions and concerns typically raised by the study REC during protocol review, with only a small number of queries not fitting into the framework. The framework provides a method and logical process to conduct further comparative analyses of RECs’ concerns and can be used as a standard tool for REC members when reviewing protocols (Emanuel et al., 2004).
Reporting of Research Ethics Committee approval and participant consent in South African biomedical journal articles (2007-2018).
(2022) Nzuza, Arthur Khonzani.; Wassenaar, Douglas Richard.
The commencement of a study involving human participants may only happen when the study has been approved by a registered research ethics committee and when consent of participants has been obtained. Most biomedical journals require confirmation of this requirement by authors in their publication of research results, not just as a mere formality, but as a culmination of a long process and careful attention to every step and detail in the process. This is an ethical requirement that guides researchers throughout the world. For example, the Declaration of Helsinki (2013), despite its numerous revisions and adjustments, is clear on this point, as are current South African ethics guidelines (Department of Health, 2015). The issue of obtaining informed consent from prospective participants does not just lead to the signing of the document but should also reflect that all processes that are meant to safeguard rights of prospective participants are not compromised in any way. Publishing authors are expected to report those details in their articles but the frequency of such reporting in South African health research articles remains unclear. Reporting and publication of studies in peer-reviewed journal articles, does not only communicate findings of the study but it is also a source of information for judging the ethical quality of the study. Publications are assessed by various audiences such as peer researchers, sponsors, policy makers and industry practitioners. All these audiences apply different criteria in assessing the information, as some material might be considered less significant than others, depending on the needs of the audience. This factor should be taken into consideration during article reviews. The study is aimed at exploring whether authors of South African biomedical journal articles mention research ethics approval and informed consent in their research publications and explores whether there were any temporal changes in such reporting between 2007 and 2018.
Systematic review of an African bioethics framework: conception of person-hood and its influence in improving the process of informed consent in health research.
(2020) Ndimuangu, Nchotou Hilton.; Mkhize, Nhlanhla Jerome.
Cultural pluralism is vital to the understanding of bioethics in different societies. The principles that guide research ethics decision-making have a cultural basis derived from the west. These principles are drawn from just one worldview out of the many existing worldviews and they are often presented as universal. When these principles are implemented internationally, they are not sufficient to address rising concerns around informed consent. The challenges of implementing these principles in Africa are not an exception. It has been very challenging to obtain genuine informed consent for research, as the procedures of decision-making, in addition to the implementation of community engagement, are always accompanied by the importation of a western ethical philosophy, some of which differs from that of the African people. The western conception of the process of informed consent is premised on the idea of individuality and an abstract self that is not encumbered by culture and society. Culturally embedded semiotic aspects of ethical decision-making are often neglected. A systematic review was conducted on how the African understandings of personhood and community have influenced decision-making in the process of informed consent and community engagement, using keywords to recruit research papers published in English via the HINARI and Google Scholar electronic databases. Among the 322 papers identified, 46 were eligible to be recruited for the study. The results from this study indicate the community plays a critical role in the successful implementation of a truly informed consent. The findings indicate the process of informed consent and decision-making varies with the level of risk and complexity associated with the research, as well as the category of the participants who will be involved in the study. The study recommends that research ethics committees should take into consideration the level of community engagement and the process of informed consent when making a decision on a particular protocol.
A forensic review and evaluation of the regulatory and ethical framework governing health-related research in post-ebola Liberia.
(2021) Franklin, Kokulo.; Mkhize, Nhlanhla Jerome.
ABSTRACT BACKGROUND The end of the deadly 2014 Ebola outbreak in Liberia has seen a noticeable influx of western researchers into the country. Given the vulnerable nature of the majority of Liberians (impoverished and poorly educated), this raises a lot of ethical concerns. This study sought to gauge the local research governance frameworks to discover what protective structures and documented stipulations exist, since there has never been any such assessment. METHODOLOGY The study made use of a triangulated qualitative design, involving a desk review of fifteen (15) national guidelines, policies, procedures, and regulations, coupled with eleven (11) in-depth key informant interviews with purposively-identified oversight institutions and some researchers. RESULTS Key documents (Public Health Law, National Research for Health Policy, and the Clinical Trial Guidelines, National Research Ethics Board Guidelines, and the University of Liberia – Pacific Institute for Research and Evaluation IRB Handbook), along with key institutions (Ministry of Health, the National Public Health Institute of Liberia, the Liberia Medicines and Health Products Regulatory Authority, the National Research Ethics Board, and the University of Liberia – Pacific Institute for Research and Evaluation (UL-PIRE) IRB) were found to be critical to the overall governance, review, approval, and monitoring of health research in Liberia. The frameworks governing health research were found to contain most of the traditional protective stipulations, though significant gaps were also identified from the desk review and in-depth interview with the major stakeholders. Stipulations on emerging issues (stored samples, bio-banks, genetic/genomic research, and data ownership and sharing) and contextually relevant issues (post-trial access, ancillary care, and consent in local languages) are evidently absent or only fleetingly mentioned. CONCLUSION Overall, Liberia appears to have in place the relevant foundational frameworks for acceptable governance of health research. However, the documents are in need of substantial overhaul and contextualisation, especially given the rapidity with which legal and ethical governance of health research has advanced over the past few decades. The local institutional governance is also in need of reorganisation, something that will enhance adequate coordination and management of health research.
Understanding constraints and enablers of turnaround time for ethics review
(2019) Mrisho, Mwifadhi.; Essack, Zaynab.
Background Independent ethics review is one of the fundamental principles of research ethics. The body of literature has documented increasing bureaucratic delays associated with ethics review, which has impacted the start of research activities. This study aimed to determine the extent of variability in turnaround times for protocol review among different institutional review boards (IRBs) within Tanzania. It also assessed the challenges and experiences of submitting and reviewing protocols after introducing the tablet PC, from the perspectives of Ifakara Health Institute IRB (IHI-IRB) members and investigators. Methods This cross-sectional study employed a mixed-methods approach which consisted of qualitative and quantitative approaches. The quantitative data were obtained retrospectively from databases of seven selected IRBs in Tanzania. Purposive sampling was used to select seven IRBs for inclusion in the study. Seven IRB secretaries and their assistants from five institutions were interviewed to respond to the research questions. In addition, 19 in-depth interviews were conducted with IRB members and investigators to explore their experiences of using tablet PCs in reviewing protocols and in submitting electronic proposals, respectively. This study was conducted in mainland Tanzania and Zanzibar. Quantitative secondary data were analysed using Stata software (quantitative data analysis software, version 10). Qualitative data were categorised in an Excel spreadsheet and analysed using thematic analysis. Results The median time for ethics review across the visited sites was 32 days and ranged from 1 to 396 days. Qualitative results found that eleven thematic issues emerged from in-depth interviews with IRB members and the secretariat in the visited study areas. Generally, looking into the procedures for submission of protocols to the secretariat of the IRB, these were more or less the same across IRB institutions in Tanzania. However, investigators sometimes failed to adhere to the submission checklist and guidelines which resulted in delays in the timeous review of protocols. Most of the IRB members and investigators preferred electronic submission for its ease of use and reduced burdens associated with paper-based submissions, such as printing, distribution and misplacing of protocols. Conclusion Data from this study suggest that there is an urgent need to address the issues raised in order to improve the turnaround time of protocol review in Tanzania. Investigators should adhere to the submission checklist and guidelines to avoid delays in the ethics approval process. Ethics review boards need to invest in technology and system strengthening to facilitate timeous processing of ethics applications.
An evaluation of ethical concerns raised by a Ugandan Research Ethics Committee using the principles and benchmarks proposed by Emanuel et al. (2008).
(2020) Kirimuhuzya, Claude.; Wassenaar, Douglas Richard.
Research Ethics Committees (RECs) serve several important public functions, including ensuring that research participants are protected in addition to provision of a public forum for the accountability of researchers. As such they are required to follow established national and international standards when they are carrying out protocol reviews. However, there is no standardised model on which to base their reviews. In order to help RECs in their work, Emanuel and colleagues analysed existing ethics codes and produced a framework of eight principles and benchmarks, to give eight principles to guide RECs in the process of reviewing research proposals for ethical issues. However, prior to this study, there was little empirical research into the actual issues that RECs in Uganda raise when reviewing research proposals, leave alone determining whether the issues raised during the review process were in line with those envisaged by the Emanuel and colleagues or not. This study was therefore undertaken to establish the concerns raised during the review of study protocols, using archived minutes of one REC in Uganda. The study analysed the minutes for initial full reviews of protocols for the years 2102 to 2013 using the eight principles and benchmarks proposed by Emanuel and colleagues. Expedited and ongoing reviews were excluded. The results indicated that of 2008 issues raised in the 28 meetings that reviewed the 110 protocols, 90.5% could be accommodated under the eight principles in Emanuel et al. (2008) framework. The most commonly raised issues were scientific validity (54.1%) and informed consent (11.4%). Other additional issues included administrative and feasibility issues at 9.5% and 6.0% respectively. The Emanuel et al. framework provides a useful tool that can be used to categorise the issues and concerns raised during research protocol review meetings of RECs in Uganda. The results further demonstrate that it is possible to use this model to carry out comparative studies to evaluate the review outcomes of RECs in the country and other countries in Africa and the world at large.
Research ethics committee member insights into the structures, processes, responsibilities and needs of health research ethics committees in Malawi: a mixed methods.
(2019) Phiri, Nicholas.; Barsdorf, Nicola Wendy.; Masiye, Francis Damiano.
Background: The dearth of studies on the composition and functioning of Malawi’s research ethics committees (RECs)prompted this study. The aim of the study was to describe Malawi’s two health RECs. Towards better understanding REC members’ insights into the structures, processes, responsibilities and needs of Health Research Ethics in Malawi, the following variables and components were considered: REC demographics, composition, training, guideline use, processes and procedures, financial and material resources, and affiliation. Methods: This study used a mixed method approach where quantitative descriptive cross-sectional survey and a retrospective record review/document analysis design were used. The study focused on RECs which review health research protocols only. We targeted a sample size of 30 participants. Sample selection was through a convenience sampling method. Results: The response rate for our study was 80% (24/30) of the total REC members from Malawi’s two RECs. Medical doctors dominate in membership. Most members (87%) had official training in research ethics after joining the RECs. The types of research most commonly reviewed by these RECs included: Public health research, laboratory research and health systems research. REC meetings were held either monthly or bi-monthly. On average, 33.5 protocols were reviewed per month, inclusive of all minimal risk and continuing research. REC members report the Declaration of Helsinki (83.3%), ICH GCP guidelines (75%)and the CIOMS guidelines (45.8%)as the most commonly used international guidelines, in conjunction with Malawi’s own ethical guidelines, law and policy. Application fees and research levies allow the RECs to generate their own income. This covers some of their basic expenses, the RECs lack the funding for a dedicated office space, transportation, and information and communication technologies. Eighty-three percent of members indicated the need for training in research ethics, especially in placebo-controlled clinical trials and scientific design issues in health research. Both RECs are accredited by a regulatory body in Malawi. Conclusion: REC members highlighted many strengths and some challenges and weaknesses in their RECs which require some consideration for the RECs to function more effectively. Some of the strengths include record keeping, use of international and local law, policy and research ethics guidelines, creative means of income generation and training of REC members. The RECs expressed a need for national audit and monitor ring mechanisms, and for specific research ethics training for their members.
How do Kenyan research fieldworkers conceptualize the consenting process? implication for training in health research ethics.
(2017) Kombe, Francis Kazungu.; Mamotte, Nicole.
Fieldworkers are an important cadre of research staff due to the critical roles they play in health research not just in Africa but globally. In Africa, most international research centres employ fieldworkers to provide support in seeking informed consent; collecting basic samples and maintaining good relationships with communities involved in research. Seeking informed consent is an especially important role. It does not only ensure the promotion of autonomy for those involved in the research but has an important implication on the quality and reliability of data collected from research participants. According to most international ethical guidelines, ensuring potential research subjects voluntarily participate in research after fully understanding all key elements of the research they are involved in is essential. Although research in most international research centres is overseen by highly qualified and renowned researchers and scientists, the influence of fieldworkers, who are the cadre of health research staff involved in the day to day operationalization and ground application of this important ethical principle, has received little focus and continues to be understudied. Understanding how fieldworkers conceptualize the informed consent process can provide important insight on fieldworkers’ ethical practices and how ethical guidelines are operationalized on the ground. We conducted four Focus Group Discussions (FGDs) with health research fieldworkers and eight In-depth Individual Interviews with field managers/supervisors at the Kenya Medical Research Institute (KEMRI-Wellcome Trust Programme (KWTRP) to develop an in-depth understanding of how this cadre of staff conceptualize the process of informed consent. Data were captured using digital recorders and transcribed before being analyzed thematically. The results indicate a good understanding of health research for both fieldworkers and field managers. The relationship between KWTRP and the community was described to be of mutual benefit sharing, with the community benefiting from new interventions and improved health care while KWTRP got research subjects from the community. Informed consent was described as an important part of getting people to participate in research voluntarily. There was, however, some mixed attitude and perceptions regarding the value and key elements of the informed consent process. Several factors were said to influence informed consent process, including the environment where consenting was done, recruitment targets, support and supervision and the training that was given to fieldworkers. Fieldworkers perceived their work as critical in health research. However, lack of recognition, capacity building and clear approaches for professional development affected their motivation and attitude about their roles. The findings support the need for further research to identify specific mechanisms for supporting fieldworkers to undertake their roles more effectively.
Knowledge and perception of health research ethics among health care professionals at Greys hospital Pietermaritzburg – South Africa.
(2016) El-Koha, Omran Ali.; Lindegger, Graham Charles.
To explore familiarity and awareness of codes and regulations related to the conduct and practice of research ethics among health care professionals. Furthermore, to establish the level of knowledge of research ethics and relate that to research experience and level of training in research ethics A survey based study of 20 self-administered questionnaires about reported and actual knowledge of research ethics was distributed to various categories of staff at Greys hospital using convenience sample. In total 152 questionnaires were distributed. The study was approved by the biomedical and research ethics committee (BREC) of UKZN. Data were collected and entered into SPSS (version 20). Data were analysed using frequencies, cross tabulations, Pearson’s coefficient and one way analysis of variance (ANOVA). The completed questionnaires were returned by 103 participants with a total response rate of 67.7%. Doctors comprised 55% of all responses. Consultants, medical officers, and registrars formed 28.16%, 21.36%, 5.83% of the sample respectively. Nurses contributed 12.6% of all responses. 65.05% of the respondents were females, whereas 32.04% were males. Only 18% had full knowledge of informed consent. 68 % knew about research ethics committees, but the majority were not aware of its structure and function. Results clearly indicated an inadequate knowledge of ethics guidelines, and the majority of respondents had either little or very little knowledge on all the ethical codes and guidelines. Council for international organisations for medical sciences (CIOMS) appeared to be the least known and World Health Organisation (WHO) the most known of all guidelines. Twenty percent of respondents reported to have no research experience. Results also showed positive correlation between knowledge of ethics in general and training and research experience. The study concluded that the level of knowledge and awareness of research ethics among health care professionals at Greys hospital was generally poor. Therefore, improvements in research ethics education is recommended for health care professionals at all levels. Furthermore, larger studies are needed to confirm these findings.
Exploring communication strategies that promote sound informed consent for HIV vaccine trials.
(2017) Matandika, Limbanazo.; Slack, Catherine May.
The development of an HIV vaccine is a foremost universal health priority, necessitating research with human volunteers. It has been internationally accepted that informed consent is a fundamental ethical requirement for all clinical trials, including HIV vaccine trials (HVTs). However prospective trial participants often demonstrate a lack of understanding of information conveyed to them during the informed consent process. Ways of communicating complex concepts may need to be identified and developed to promote understanding. This study had the following aims: (a) To explore communication strategies reportedly implemented by key HIV vaccine trial stakeholders to communicate key concepts (Community Advisory Board or CAB members, Educators, Consent Counsellors) b) To explore correspondence between reported strategies and recommendations from the conceptual and empirical literature, and c) To explore the implications for strengthening informed consent for research in resource- constrained settings. The study comprised an analysis of four Focus Group Discussions with key stakeholders at an HIV vaccine trial site in South Africa, that had been previously conducted by members of the HIV AIDS Vaccines Ethics Group from the University of KwaZulu-Natal (UKZN). These stakeholders included CAB members who interacted with participating-community members; Educators who interacted with interested community members at the site, and Consent Counsellors who interacted with persons interested in enrolment in actual HIV vaccine trials. These transcripts were analysed using Thematic Analysis, informed by aspects of a popular framework for the informing process (the Meerwein model). This study adopted a qualitative approach which was broadly set in an interpretive perspective – focusing on practices, subjective meanings that stakeholders attached to their practices, and the context. Study findings are presented under three main themes. The informational theme describes how site staff reportedly employed numerous strategies to ensure that information presented to potential participants was understandable, such as simplifying, using preferred language, using analogies, using culturally appropriate terms and promoting discussion. The emotional theme describes how site staff implemented several strategies to try respond to emotions of anxiety and to try address feelings of suspicion, such inquiring about and collating suspicions, using trustworthy sources (ex-participants or influential community members) and referring to safe, licensed vaccines. The relational theme describes how site-staff reportedly employed various practices to develop respectful relationships (by creating a friendly environment) that are responsive to cultural norms, such as requesting permission to break cultural norms, and using culturally acceptable terms. The study concludes that strategies employed appear consistent with several key principles of adult learning, and communication, as well as with ethical guideline recommendations for HIV vaccine trials. These findings imply that the individual consent process is best understood as embedded in a larger process of engagement and that consent staff at sites need to have core communicative competencies, need to be sensitive to the emotional aspects of their engagements, and need to be culturally competent. Recommendations are made for key stakeholders such as Research Ethics Committees, CAB members, and ethical guideline developers. Recommendations are made to strengthen the informed consent process for research in resource-limited settings.
Stakeholder perspectives on informed consent and ethics review of research involving human specimen resource repositories (biobanks) in South Africa: a quantitative study.
(2017) Mwaka, Erisa Sabakaki.; Horn, Lynette Margaret.
On-going research has made the use of human biological materials and genetic material/data for biomedical research an area of high interest to researchers, bioethicists, philosophers, lawyers and various regulatory bodies. In this era of globalization, there are profound ethical, legal and social implications for the evolving nature of biobank research; these have to be considered during the ethics review process. The main objective of this study was to explore stakeholders’ perspectives of informed consent and ethics review of biobank research in South Africa, with the aim of obtaining information that could contribute to the harmonization of ethical guidelines of the consent process and biobank governance. This was a descriptive cross-sectional study that employed a positivist approach involving qualitative data collection methods. The study was conducted at Stellenbosch University, the University of KwaZulu-Natal, and seven research ethics committees in the KwaZulu-Natal and Western Cape provinces in South Africa. A purposive sampling technique was used to recruit significant stakeholders in biobank research in South Africa. Data was collected using self-administered online survey instruments. Completion of the survey implied consent. Quantitative data were summarized using descriptive summary statistics. Conventional content analysis was used for data collected from open ended questions. The response rate was low; 19 research ethics committee members and 62 researchers and other stakeholders participated in the study. All stakeholders agreed that there is need for functional regulatory frameworks to govern biobank research, particularly the strengthening of research ethics committees, to ensure comprehensive ethics review of biobank-based research. There were several areas of agreement and divergence in respondents’ perspectives on the collection, storage and future use of human biological materials. There was no consensus on the issue of re-consent and the likelihood of donor identification and harm during the use of human biological materials for secondary research. Stakeholders also identified a number of challenges in the ethics review process and the sharing of human biological materials. Generally, the attitude of research ethics committee members, researchers and other stakeholders on informed consent, ethics review of biobank research, and the export and sharing of de-identified HBM is positive and ethically informed. Stakeholders believe that there is need for robust regulatory frameworks to govern the collection, storage, sharing and future use of HBM both within South Africa and across borders. Several recommendations are proposed that could contribute to the harmonization of ethical guidelines on the relevant consent process and biobank governance.

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