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This section has briefly described the South African research ethics system, highlighting its history, legislative context and the applicable national ethical guidelines used by RECs and researchers in ensuring that research with human participants conducted in the country is of high ethical and scientific standards. While many countries, including South Africa, have
implemented laws and guidelines mandating ethics review of research with human participants (Department of Health and Human Services, 2016), there have been numerous complaints and criticisms of mandatory ethics review (Mamotte & Wassenaar, 2009). The following section will review some of the literature on this debate.
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not adequately dealing with the main ethical issues that such committees were actually put in place to address (Emanuel et al., 2004; Iltis, 2009a) and idiosyncratic decision-making (Stark, 2012; Tolich, 2014).
Similarly, mandatory ethics review of social science has also been heavily criticized (de Vries, de Bruin & Goodgame, 2004; Schrag, 2011; Wassenaar & Mamotte, 2012). One of the criticisms levelled against RECs is the power that they have to reshape proposed research, in particular, although not at all exclusively, for qualitative research designs (Librett & Perrone, 2010; Tolich
& Fitzgerald, 2006). Several reports describe how research proposals have been disapproved because of inappropriate interpretations of ethical norms that were applied incorrectly to the proposed research (Dingwall, 2008; Librett & Perrone, 2010). For instance, Librett and Perrone (2010) decry how their proposals were disapproved by an REC and how the review process fundamentally reshaped the original methodology and direction of the research. Furthermore, some have complained about how the medical model has extended into such areas as social science, a consequence of so-called “ethics creep” (Haggerty, 2004).
Some social scientists have also criticized ethics review in disciplines such as journalism. For example, Dash (2007) in his paper titled, “Journalism and institutional review boards”, opposes any IRB oversight for academic work on journalism done by professors and journalism students in any academic institution, arguing that the tendency for IRBs to require anonymity for persons interviewed immediately reduces the credibility of any journalistic story. The main concern here is the perception by social scientists academics that they are being subjected to stringent rules
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over how and what they can investigate, and hence infringing on their academic freedom (Dingwall, 2008; Hamburger, 2005; Hammersley, 2009; Hedgecoe, 2015; Katz, 2007; Scott &
Fonseca, 2010; Tierney & Corwin, 2007).
Another concern expressed by opponents of ethics review of social science research is the perception that social science research has relatively low risk or no risk and that these risks are different from the risks posed by biomedical research (Dingwall, 2008; Haggerty, 2004;
Hammersley, 2009). Furthermore, RECs are sometimes viewed as a barrier which blocks responsive research as a result of the cumbersome administrative burden created by ethics application, considering the already limited time that academics have to conduct research within timeframes and funding periods. Opponents argue that this restrictive administrative burden placed on them drastically limits the capability of social science researchers to respond to and investigate rapid social changes, particularly during social crisis (Hemmings, 2006; Hammersley, 2009).
Another criticism raised by opponents of ethics review of qualitative research is that RECs lack an understanding of and sensitivity towards the unique research designs and methodological underpinnings of qualitative research studies (Librett & Perrone, 2010; Tolich & Fitzgerald, 2006; Van Den Hoonaard, 2003; Wynn, 2011). The key concern here is that some ethical principles are difficult to implement, for example, in ethnographic study designs, which makes such qualitative methods less likely to be approved using a one-size-fits-all model of ethics review. For example, Van Den Hoonaard (2003) maintains that while anonymity is a widely
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recognized ethical requirement highlighted in several research ethics guidance, it is a practically unattainable in ethnographic and qualitative research designs. In addition, some commentators argue that the informed consent requirements render ethnography generally impossible as it
‘denaturalises’ the research settings and environment being researched, converting it into a formal research encounter instead of its intended goal, which is to explore people and culture as it occurs naturally (Murphy & Dingwall, 2007). Consequently, there have been suggestions that, owing to the substantial methodological differences between qualitative research and the
positivistic paradigm, ethnographic studies be assessed for ethical suitability using a different review process to the quantitative positivistic approach (Librett & Perrone, 2010).
An additional argument raised by opponents of ethics review of social science research is that there is substantial lack of consensus in research communities regarding ‘appropriate ethical practice’, criticizing the idea that RECs – a gathering of members constituted to review and approve research - are well suited to make determinations on ethical decisions (Hammersley, 2009). He further argues that the interpretation of general ethical principles must be context- dependent, i.e., consideration should be given to the specifics of a local research setting and methodological expertise. In his view it is not RECs who possesses this knowledge, rather it is the researchers themselves. For these reasons, Hammersley argues that RECs are unsuited to conduct ethics review. In his view, the regulatory framework on which RECs are grounded is counterproductive when, or because, it prevents researchers from the need and the practical process of reflecting on the ethical considerations raised by, and during, their own research (Hammersley, 2009). More recently, Dyck and Allen (2012) argued that mandatory ethics review
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is in itself unethical because “review boards do not respect researchers or each other, lack merit and integrity, are not just and are not beneficent” (p. 1).
While it is beyond the scope of this study to rebut arguments against mandatory ethics review of social science – or any research for that matter, the present researcher is of the view that some arguments by social scientists against ethics review may be misguided. For example, arguments by social scientists resisting ethics review of psychology research on the view that research ethics is meant only for biomedical research are “simplistic and overlook the fact that biomedical research and psychological research cannot be judged by different moral standards” (Wassenaar
& Slack, 2016, p. 307). In addition, closer analysis of cases raised by critics suggest that
complaints arise out of single cases, rather than out of consistent attempts to evaluate criticisms of REC processes across a representative sample of cases.
Several proposals have been made to deal with some of the criticisms levelled against RECs (Emanuel et al., 2004; Klitzman, 2015). For instance, centralized ethics review (Abbott & Grady, 2011) has been proposed to address the allegedly unnecessary delays and costs, and variations experienced by investigators submitting similar protocols in multi-site studies. Proponents of a centralized system of ethics review argue that this will result in more efficient reviews in multisite studies (Fitzgerald & Phillips, 2006). Under the new proposed changes to the US regulations for human research, certain types of research will no longer require REC review (Emanuel, 2015).
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The current section has reviewed some of the literature critiquing mandatory ethics review. This section highlighted that while the importance of ethics review and protecting human participants is acknowledged, there are several complaints regarding mandatory ethics review of research, particularly by social scientists whom continue to debate the suitability and relevance of research ethics/and or ethics review to social science research (Mamotte & Wassenaar, 2009). The next section reviews literature on the ethical issues of international biomedical research (Emanuel et al. 2004, 2008; Lavery et al., 2007). For the purposes of this present study, that is, to facilitate clear discussion of the findings (see Chapter 7), these topics will be set out below as follows:
collaborative partnership, social value, informed consent, vulnerability, scientific validity, favourable risk/benefit ratio, payment of research participants, standards of care, ancillary care, post-trial access, compensation for research-related injury, post-approval monitoring of studies and dissemination of results.