One of the important mechanisms for the protection of participants who deviate from the guidelines is the creation of research ethics committees (RECs), also known in the USA as institutional review boards (IRBs), which must review protocols before the implementation of research (Joffe , 2012). These ethical issues will be discussed in detail in the relevant sections of the literature review.
Emanuel et al. framework
In general, the study should be beneficial for each participant and for the community targeted by the research (Emanuel et al., 2004). Finally, the protocol must clearly explain how the research results will be disseminated to participants and the host community (Emanuel et al., 2004).
Ethical considerations in research
- Community engagement and collaboration
- Social value
- Scientific validity
- Fair participant selection and research with vulnerable populations
- Favourable risk-benefit ratio
- Independent review
- Informed consent
- Disclosure
- Understanding/comprehension
- Decision-making capacity
- Voluntariness
- Compensation and incentives
- Respect for participants
- Confidentiality
- The sharing of results
- Standard of care
- Post-research commitment
Furthermore, the knowledge generated from the research must be relevant to the population of research participants (Horn, Sleem, & Ndebele, 2014). The risks associated with the research must be acceptable in the context of the expected benefits (Che Chi et al., 2014).
Criticism of research ethics committees
Furthermore, the post-research commitment must form part of the investment in developing local capacity and expertise through all externally sponsored research (Nuffield Council on Bioethics, 2014). The existence of many guidelines makes it difficult for RECs to determine which of the guidelines to apply (Kruger & Mogkatla-Moipolai, 2014). They argue that this tendency influences REC members' perceptions of the researcher's credibility and his/her work (Clapp et al., 2017).
Some of the concerns relate to multi-site reviews of a single study, conflicts of interest among REC members, and lack of relevant expertise in REC matters (Abbott & Grady, 2011). There has also been concern that many of these guidelines have been developed in Western contexts with limited evidence of their applicability to developing countries (Emanuel et al., 2004; Mkhize, 2006). These inequalities cannot be solved by guidelines alone; they require greater involvement of other stakeholders and commitment to the development of local capacity in ethical review of research, as well as the adoption and use of the ethical principles in developing countries (Bhutta, 2002).
They found that reviewers' stories set the tone of the discussions and influenced the REC's decisions (Fitzgerald et al., 2006).
Research ethics in Africa
South African experience
InstX was chosen for its record review in part because related studies to date have reported on review outcomes of biomedical RECs (eg, Silaigwana & Wassenaar, 2019; Tsoka-Gwegweni & Wassenaar, 2014) rather than on review results of a REC that had a social science focus. InstX REC is one of several recognized social science focused RECs in South Africa.
The relevance of the framework to social science research
As InstX REC reviews mostly social science research, Wassenaar and Mamotte's (2012) model provides important guidelines for analyzing InstX REC minutes. Research should be based on the needs of the community and the community should be involved in all phases of the research. Fieldworkers should be considered as key collaborative partners because of their important role in research, participant liaison and data collection.
A quantitative design should have a scientifically acceptable sample size, and qualitative studies should have a comprehensive methodology to ensure the authenticity of the findings. The risk-benefit ratio of social science research must be carefully weighed, as the benefits of such research are not easily determined. In some types of qualitative research, it is recommended that informed consent be negotiated at each stage of the research.
The model was used in this study to complement and improve the understanding of Emanuel et al.
Criticisms of ethics principles/ frameworks
Research with children should include consent from parent/guardian with consent from children. Permission from an institution such as a school does not replace consent from a guardian or parent. This may not be comfortable for some participants as they may have to identify themselves due to the small sample size of qualitative research.
It identified some ethical issues that the framework does not consider, such as the use of storage and transport of biological samples (Silaigwana, 2017; Tsoka-Gwegweni & Wassenaar, 2014). Other issues identified that are not addressed by the Framework and that could affect the principles of societal value and scientific validity are research funding and researcher expertise (Silaigwana, 2017; Silaigwana & Wassenaar, 2019; Tsoka-Gwegweni & Wassenaar, 2014). .
Summary
RATIONALE
- Introduction
- Rationale of the study
- Research questions
- Aims and objectives
Are there other concerns raised by InstX REC that are inconsistent with the framework discussed by Emanuel et al. The purpose of the study was to identify the main ethical issues that arose during the ethical review of social science research proposals by the REC and to assess their relative weight using the recommendations of Emanuel et al. (2004) on principles of ethical review of clinical research. This study is a replication of Tsonga-Gwegweni and Wassenaar's (2014) study, using a social science oriented REC instead of a biomedical REC.
To study the minutes of the InstX REC's review meetings to identify and describe the ethical concerns and issues raised in their review of research proposals. To analyze the identified ethical issues and concerns using Emanuel et al. (2004) framework, by ranking and assessing how they fit the framework or not.
RESEARCH METHODOLOGY
- Research design
- Sampling strategy
- Unit of analysis
- Developing content categories
- Data collection
- Data analysis
- Ethical considerations in conducting the research
- Validity, reliability and rigour
- RESULTS
- Profile of minutes assessed
- Ethical concerns raised by InstX REC in reviewing protocols
The categories used for the analysis of the ten REC minutes were based on the eight principles and associated benchmarks for ethical research developed by Emanuel et al. The eight ethical principles in Emanuel et al. 2004) were further divided into three or more categories within each principle. Prasad (2008) shows that the quality of the content analysis is dependent on the categories; these must be clearly formulated and exhaustive.
The minutes were accessible in electronic form after signing a confidentiality agreement with InstX. Transcripts were coded using the eight principles and performance criteria of Emanuel et al. 2004) framework for recording a discernible pattern in ethical concerns that arise during the ethical assessment of research proposals. The coding framework was validated to ensure completeness and shared understanding of the principles of Emanuel et al. The issue of study validity is related to the ability to generalize based on the results.
Thus, the coding rules developed for this study addressed concerns about the generalizability of the results.
Types of protocols
- Social value
- Scientific validity
- Fair participant selection
- Favourable risk-benefit ratio
- Independent ethics review
- Informed consent
- Respect for participants
- Systematic prioritisation of some ethical issues over others
- Informed consent concerns
- Scientific validity concerns
The concerns raised by the InstX REC in meetings during the review of protocols were categorized as follows by the Emanuel et al. Many concerns raised by the InstX REC in this category relate to the quality of the data collection tools and data analysis plan. Numerous comments were made by the InstX REC in various protocols about sampling method, sample size and lack of justification for the choice of a method.
Other concerns from InstX REC in this category were related to researchers not indicating how they would handle information that constitutes a reportable violation. Many of the InstX REC's comments on informed consent related to appropriate disclosure, with a focus on the information provided to potential participants. All the concerns that were raised by the InstX REC on the subject of recruitment and incentives were related to incentives.
The ethical principle that received the second highest attention from InstX REC was scientific validity.
Informed Consent
Respect for participants’ concerns
Scientific Validity
Fair participant selection concerns
The fourth most frequently discussed ethical concern of the InstX REC was the fair selection of participants.
Respect for Participants
Consistency of InstX REC concerns with Emanuel et al. framework
The concerns raised by the InstX REC at its meetings were consistent with Emanuel et al. However, ethical issues of informed consent and scientific validity dominated the concerns of the InstX REC. Of the 998 concerns identified, 309 were related to informed consent and 210 to scientific validity.
Fair Participant Selection
Other concerns raised by the InstX REC
They relate to the following comments from InstX REC: abbreviations/acronyms, spelling errors, clarity correction, timelines, and budget concerns.
Summary
DISCUSSION
- Ethical concerns raised by the InstX REC .1 Introduction
- Community engagement and collaboration
- Social value
- Scientific validity
- Fair participant selection
- Favourable risk-benefit ratio
- Independent review
- Informed consent
- Respect for participants
- Systematic prioritisation of some ethical issues over others
- Consistency of InstX REC concerns with Emanuel et al. framework
- Features of Emanuel et al. framework that dominate the concerns
- Other concerns raised by InstX REC
- Study limitations
- Summary
InstX REC placed particular emphasis on informed consent when reviewing studies with children. Many studies reviewed by InstX REC during this period had qualitative designs. The ethical concerns raised by the InstX REC at its meetings were consistent with Emanuel et al.
In the ethical review of protocols, InstX REC took scientific validity very seriously. Most of the InstX REC comments concerned the use of appropriate design and methods. InstX REC also paid a lot of attention to the quality of research design, which is reflected in the principle of scientific validity.
The results show that the concerns raised by InstX REC were aligned with the eight principles of Emanuel et al.
CONCLUSION AND RECOMMENDATIONS
Conclusion
These efforts include, among other things, ensuring that the selection of research participants in planned research is scientifically motivated. It was observed from the survey results that InstX REC raised ethical concerns for community engagement mainly during the review of multinational surveys. The ethical issue of community engagement is obviously crucial for multinational studies in terms of understanding the community's social context and its priorities.
Consultation with the host community on research will ensure that the research is beneficial to the community. The research results will need to be tested with a larger sample of RECs than was the case in this study.
Recommendations for future research
Define and negotiate the social value of. research in public health facilities: Perceptions of stakeholders in a research-active province of South Africa. Retrieved from www.beltz.ze. 2008) Research ethics committees: The role of ethics in a regulatory authority. Journal of Empirical Research on Human Research Ethics Content Analysis: A Method of Social Science Research.
Ethics committees for biomedical research in some African emerging countries: which establishment for which independence. Empirical investigation of ethical issues raised by two research ethics committees reviewing biomedical research in South Africa. The oversight of research ethics committees over biomedical research in South Africa: athematic analysis of ethical issues raised during the ethical review of non-accelerated protocols.
Using the Emanuel framework to examine ethical issues raised by a biomedical research ethics committee in South Africa.
