How to learn to love your research ethics committee: recommendations for psychologists

Abstract

Ethics review of psychological and sociobehavioural research is increasingly required by leading South African research institutions and universities, following international trends, and national statutory developments. Local and international scholarly journals are also more routinely requesting proof of ethics approval before accepting empirical work for publication. In some instances, psychological researchers may regard ethics review as a process that imposes delays and adds little value to proposed studies, and they may experience the process as frustrating and unrewarding. This article aims to briefly review the issue of ethics review for such research and to focus on pragmatic recommendations for psychological researchers navigating ethical review, including how they could engage their research ethics committee more effectively to strengthen this critical relationship.

Keywords

ethics review research ethics committees psychological research South Africa

Introduction

Debate about the ethics of social science research is not new to many international settings (Wassenaar & Mamotte, 2012a), although it has been relatively late to reach South Africa. This is possibly because s73 of the National Health Act (NHA; South African Government, 2003) governing the ethics review of health research was only implemented in 2005, and the Department of Health only issued national ethical guidelines governing all health research in South Africa in 2004 (South African Department of Health, 2004), now updated (South African Department of Health, 2015). These documents mandate ethics review for health research, including sociobehavioural and psychological research, with some specific exceptions. Therefore, psychological researchers in South Africa have only been obliged to engage seriously with ethics review for the past decade or so as South African universities and research institutions have formed new research ethics committees (RECs) or broadened the scope of existing biomedical RECs to accommodate such psychological studies (Israel & Hay, 2006). However, internationally, ethics review, debate, and scholarship for social scientists, including psychologists, have been active for much longer with early works by MacIntyre (1982), Macklin (2002), and Sieber (1992), introducing various issues that remain current today.

Some have protested that psychological (and social science) research is conceptually, epistemologically, and empirically different from biomedical research (Cribb, 2004; Hoeyer, Dahlager, & Lynöe, 2005; Wynne, 2016) – the latter usually conceptualized as positivistic – and argue that the ethics of biomedical research is not relevant to social science research. However, much of the biomedically triggered debate about ‘what makes research ethical’ remains relevant to social science research (Wassenaar & Mamotte, 2012a; Wassenaar & Rattani, 2016). Arguments by social scientists objecting to ethics review on the grounds that research ethics is biomedically derived are simplistic and overlook the fact that biomedical research and psychological research cannot be judged by different moral standards (Macklin, 2002). Also, some commentators protest that ethics review of social science research seems to constitute a form of tyranny (Cribb, 2004; Schrag, 2009; Wassenaar & Mamotte, 2012a), yet do not object to requirements that their research methodology, whether qualitative or quantitative (see Laher, this issue; Saville Young, 2016), be systematic, defensible, rigorous, and reproducible. Just as poor methodology can compromise the validity and utility of findings, poor ethics can undermine the social value of research. Interestingly, there was also protest from biomedical researchers about the imposition of research ethics when it was systematically introduced during the latter half of the 20th century, resulting in a vast, resource-rich, and vibrant conceptual and empirical literature on research ethics (Wassenaar & Mamotte, 2012a).

Ethics review processes for psychological research should, of course, be sensitively tailored to the nature of social science research, and ethics reviewers should be familiar with, and competent in, psychological research methods (Mamotte & Wassenaar, 2009; Wassenaar & Mamotte, 2012a). Also, RECs should refine and streamline bureaucratic procedures and maximize efficiency to serve their primary purpose to protect the dignity, safety, and welfare of research participants. Work is ongoing to strengthen the training of REC members globally and in Africa (Ndebele, Wassenaar, Benatar, et al., 2014) and in South Africa (Singh & Wassenaar, 2014). Work is also underway internationally to define and examine indicators of REC effectiveness (Abbott & Grady, 2011). RECs are themselves moving away from a ‘behind closed-doors’ approach (Stark, 2012) and are increasingly open to being researched as social phenomena themselves (Candilis et al., 2012; Dixon-Woods et al. (in press); Klitzman, 2015; Silaigwana & Wassenaar, 2015; Stark, 2012; Tsoka-Gwegweni & Wassenaar, 2014). This will hopefully inform REC reform and efficiency of ethics review criteria and review systems (Kasule, Wassenaar, IJsselmuiden, & Mokgatla, 2016). Commentators have also argued that better ethics education of researchers can improve research quality and minimize ethics turnaround times (Ndebele, Wassenaar, Benatar, et al., 2014; Sieber & Tolich, 2013; Wassenaar & Mamotte, 2012a).

In the meantime, psychological researchers will have to make maximal and informed use of the systems currently in place, and this article will recommend strategies to that end, including how psychologists can engage more productively with the RECs that are required to review their research proposals.

Recommendations

‘Know thy framework’: REC review of health research

According to s73 of the NHA (South African Government, 2003) implemented in 2005, every institution where ‘health research’ is conducted must establish or have access to an REC that must review protocols and grant approval to proposals that meet national ethical standards. ‘Health research’ is defined broadly and includes any research which contributes to knowledge of social or psychological processes in humans. Health research should undergo ethical review according to Regulation 719 on health research with human participants (South African Department of Health, 2014) and national ethics guidelines (South African Department of Health, 2015) and professional guidelines (Health Professions Council of South Africa, 2008). South African Department of Health (2015) ethics guidelines acknowledge that discipline-specific research norms or best practices exist. However, they assert that the ethical standards by which the acceptability of studies is judged should not differ across disciplines. In summary, then, research that is sociobehavioural or psychological in nature must be submitted for ethics review, with some exceptions allowed in national guidelines, for example, for studies of publicly accessible information (South African Department of Health, 2015). Psychological researchers need to recognize that ethics review is generally required by law and applicable ethical guidelines, and they should strive to read and internalize the values and norms contained in these national guidelines.

Consider the REC as a research stakeholder to be ‘effectively engaged’

It is increasingly recognized that RECs are a key research role player. Therefore, researchers – including psychological researchers – should aim to build a trusting and transparent relationship with RECs, as they would with other key research stakeholders. Recent international ethical guidelines for participatory research practices (UNAIDS/AVAC, 2011) explicitly identify RECs as a national stakeholder to be effectively engaged by researchers (p. 15). This view complements the more traditional understanding of the REC as the adjudicator of the planned participatory practices of researchers as they engage with other stakeholders such as participating community representatives. Psychological researchers should strive to view the REC as a key stakeholder whose expertise should be harnessed, whose concerns should be canvassed, and with whom discussion should take place (cf. UNAIDS/AVAC, 2011) – especially for studies involving sensitive topics or vulnerable participants – and not merely as a ‘gatekeeper’ or bureaucratic hoop to be jumped through. Researchers, especially if submitting complex or controversial proposals, are advised to communicate with the REC chair in advance of protocol submission to get their early advice and input, where this is possible. REC chairs, in turn, should make it more widely known that they are available to advise applicants in advance on research ethics questions, although most probably do not have the personnel resources required to offer a detailed ethics consultancy service. The REC should be viewed as a partner rather than an adversary. Researchers should bear in mind that if their research attracts post-publication ethics criticism, the REC can help demonstrate that independent peers evaluated and approved their proposal, and, provided that the researcher adhered to the approved protocol, the REC will defend the work (Cleaton-Jones & Wassenaar, 2010). In this way, the REC ‘has the researcher’s back’. Put simply, researchers should strive for high-quality relationships with their REC because this relationship can improve the quality of research protocols (UNAIDS/AVAC, 2011).

‘Read the small print’: understand REC processes and forms

It will also help applicants if they download and check their institution’s research ethics policy and current REC application forms well ahead of the planned submission date to ensure that the information required is thoroughly and appropriately supplied – read the small print regarding word length and type of information required. Using an outdated form (RECs constantly revise their forms as new contingencies arise) will result in frustration and delays. The institutional policy should also advise on what types of research might be exempt from ethics review, and how such exemption is obtained. If requirements are not clear, seek clarity from the REC administrator or chair in advance or engage a research ethics consultant. Identify gatekeeper permissions that might be required if the proposed study is not taking place in public space (Singh & Wassenaar, 2016); obtaining such permissions can involve delays which are often attributed to REC inefficiency but are in fact due to inadequate preparation by researchers.

‘Keep it friendly and professional’: responding to REC queries and feedback

Correspondence with the REC should be collegial and not adversarial. A good analogy is correspondence with journal editors, where both parties need each other to publish research successfully and where both are essential partners in knowledge dissemination. Although much could undoubtedly be done to improve the tone of certain RECs’ feedback to applicants; likewise, applicants should show a thoughtful, respectful, and professional response to critique, even if the critique is occasionally annoying, erroneous, or misinformed. In such cases, this should be pointed out in appropriate professional language – for example, ‘Thank you for this comment. However, we wish to point out that research shows that approach XYZ is strongly supported by empirical research . . .’ or ‘Thank you for this comment, but this approach is in line with ethical recommendations on page X of Y guidelines . . .’ or ‘Thank you for this comment – we wish to point out that this information is indeed presented on page X of the proposal’. Applicants should bear in mind that they are dealing with peer reviewers who, in most instances, should be applying normative and procedural guidance, not an enemy. Anecdotally, hostile or arrogant responses to REC review tend to come from new entrants to the research enterprise, while seasoned and senior researchers tend to deal skillfully and diplomatically with unfavourable REC reviews. In response to REC queries, researchers should tabulate reviewer queries and respond to each and attach revised documents with changes tracked. Where queries are not clear, seek advice from the REC administrator or chair. Deal with any inappropriate or erroneous queries politely, reviewers are busy, mainly work without reward and make mistakes. Similarly, when requesting proposal amendments, a clear cover letter explaining what is being requested can simplify the work for the REC and make approval more likely. These strategic interprofessional skills could probably be emphasized more in postgraduate training. When RECs advertise for members and psychologist researchers meet the criteria, psychologists should consider stepping up or volunteering to become a member or offer to help the REC as an expert or ad hoc member, especially because all South African RECs must have members with strengths in qualitative and quantitative methodology (South African Department of Health, 2015, p. 59). It may also help to request to ‘sit-in’ on REC meetings to see how they function (after signing a confidentiality agreement) to demystify the process. Most competent South African RECs welcome observers, be they trainees or seasoned researchers.

Avoid typical pitfalls: know what bothers RECs

Psychologists should become aware of the growing empirical literature, including from South Africa, reporting the ethical issues that RECs typically raise – with or without justification – in protocol reviews, although not necessarily specific to psychosocial research. Nevertheless, applicants might benefit from knowing that at one major South African REC (Tsoka-Gwegweni & Wassenaar, 2014), the issues most frequently raised in non-approval of proposals over several years were, in descending order, as follows:

Problems with the consent form or process (27%);

Problems with the rationale or design or instruments (21%);

Problems with the selection of participants (14%);

Problems with post-research consideration of participants (14%);

Risk/benefit queries (9%);

Administrative queries (7%);

Queries about social value of the study (4%);

Problems with collaborative partnership (3%).

This suggests that applicants need to attend more carefully to these issues when writing their research proposals. Most RECs have information sheets and informed consent form templates available on their websites. These have been carefully designed and are regularly revised to include the components required by the ethical–legal framework – use and adapt these rather than attempt to reinvent the wheel. If the local REC does not provide these, researchers should search the REC websites of major South African universities for examples to adapt.

‘Don’t hide the harms’: demonstrate engagement with ethical issues in psychological research

Psychologists applying for ethics review of their studies may underestimate or understate the potential risks of their research. Some commentators argue that the risks of psychological research are trivial compared to the risks of biomedical research (Schrag, 2009; Wassenaar & Mamotte, 2012a). Yet, historically, the development of institutionalized ethics review was in part a response to several studies where participants experienced harms to dignity, rather than physical harms, including controversial psychosocial studies such Milgram’s obedience study, Humphreys’ Tearoom Trade study, and the Wichita Jury study (Amdur & Bankert, 2011; Wassenaar & Mamotte, 2012a). While emotional distress occasioned by an invasive qualitative interview might seem trivial compared to the risks of being injected with a new molecular compound previously untested in humans, such distress should not be dismissed. In general, applicants should show that they are aware of the emotional, social, legal, or other risks that participants in psychological research might experience and spell out risk mitigation steps (e.g., for emotional distress, state that they will train interviewers to recognize and deal with it, including referral; they should allow opt-out of any awkward questions or procedures). Concealment or trivialization of psychosocial risks (even if risks are unlikely or ‘minimal’) is not a good strategy for engaging the REC. Understating potential risks is not likely to satisfy reviewers, who will examine how carefully risks have been considered and will expect the researcher to describe strategies to minimize such risks. A proposal declaring ‘no risk’ will likely be viewed as a proposal to which ‘no thinking’ has been applied and may be returned for revision. In contrast, an application listing foreseeable risks, even if they are unlikely or minor (plus risk mitigation steps), will be seen as evidence of the applicant’s ethical sensitivity and stands a better chance of being approved because central ethical concerns are addressed. It is a bad strategy to leave the ethics thinking entirely to the REC as this will most likely lead to queries and delayed approval.

Applicants should use a systematic framework to think about ethical issues in their research and application. In our experience, the most applicable and comprehensive framework is that proposed by Emanuel, Wendler, Killen, and Grady (2004; Emanuel, Wendler, & Grady, 2008) which has specifically been adapted to psychological and social science research by Wassenaar and Mamotte (2012a) and will not be outlined again here. Research protocols should include an ‘ethical considerations’ section that sets out how the eight major issues in this framework will be addressed, rather than the more commonplace bald statement ‘This study will be submitted to REC XYZ prior to commencement of data collection’. Such statements suggest no prior ethical reflection by the researcher, and the price paid for this strategy is likely to be several revisions and delays. Some leading South African RECs have developed carefully designed application forms that help applicants carefully anticipate and consider potential ethical issues to reduce prospects of queries and delays. Research ethics sensitivity should be strengthened in basic and postgraduate South African psychology training programmes, and the nature of such training should be evaluated, especially in research psychology. At the very least, psychologists engaged in research should complete the free, South Africa–specific online research ethics training available through TRREE¹ (Singh & Wassenaar, 2014) or seek more advanced training through programmes like SARETI² or ARESA³ (Ndebele, Wassenaar, Benatar, et al., 2014).

Make use of the rich scholarship on research ethics

Research ethics is a fast-growing area of both conceptual and empirical research, informed by several historical and emerging philosophical perspectives. There are several journals committed to publishing such research (e.g., Journal of Empirical Research on Human Research Ethics or Ethics & Behavior) (incidentally, both of these journals were started by psychologists) and journals striving to improve the efficiency and effectiveness of RECs (e.g., IRB: Ethics & Human Research). Applicants should be aware of these rich resources to inform the ethical quality of their research proposals (Emanuel, 2002a, 2002b). This literature is too vast to be summarized here, yet topics include how to promote voluntary consent to research (Appelbaum, Lidz, & Klitzman, 2009; Mamotte & Wassenaar, 2015, 2016), how to ensure authentic engagement of various ‘communities’ in research (MacQueen et al., 2015), how to promote and assess participants’ understanding in research (Flory & Emanuel, 2004; Lindegger et al., 2006; Ndebele, Wassenaar, Masiye, & Munalula, 2014; Wendler & Grady, 2008), how to pay participants appropriately (Grady, 2005; Koen, Slack, Barsdorf, & Essack, 2008), how to involve students ethically in research (Wassenaar & Mamotte, 2012b), and how to negotiate the complexities of adolescent participation in research (Strode & Slack, 2009) to mention a few.

This section hopes to dispel the impression that RECs are narrowly rule-bound and replace it with the view that research ethics is a dynamic area driven by ongoing conceptual and empirical work. This work in turn influences the development of ethics guidelines and ethics review systems, although these may lag behind new developments in research ethics. Also, amendments to ethics guidelines may be driven by new scientific developments such as genomic research (de Vries & Pepper, 2012) or data sharing (Bull et al., 2015; Denny, Silaigwana, Wassenaar, Bull, & Parker, 2015). Psychological researchers should access this literature and cite it in their proposals or engage a research ethics advisor when grappling with novel or complex research ethics issues. Researchers should also cite the current ethics guidelines in the reference list of their applications to show that they are familiar with the most up-to-date document insofar as guidelines are living documents that evolve in response to the developments in the field.

Prepare for potential problems

Lack of timely review is an oft-cited concern about RECs (Abbott & Grady, 2011; Mamotte & Wassenaar, 2009). There have been many recommendations made about what institutions and RECs can do try to improve REC efficiency (Abbott & Grady, 2011; Kasule et al., 2016). For example, electronic review systems, similar to those used by major academic journals, will accelerate efficiency and are slowly being implemented in South Africa, massively reducing the chances that applications will be mislaid at any step of the process and ensuring that reviewers are routinely reminded of deadlines on each submission. Such systems notwithstanding, this section focuses on what researchers themselves can do in anticipation of some inefficiencies. Researchers should be aware that their protocol is one of many protocols in the REC’s system (even one of hundreds, if the REC is high-volume) at any one time (Cleaton-Jones & Vorster, 2008; Silaigwana & Wassenaar, 2015; Tsoka-Gwegweni & Wassenaar, 2014). Therefore, researchers need to play some role in tracking their application through the review process, but without annoying the REC administrators. In the absence of an electronic review and tracking system, researchers should follow-up regularly with the REC or should delegate this task to a dedicated member of the research team. Researchers should inquire about the expected time-in-review, so they can plan accordingly. Psychological researchers and ethics applicants generally, typically overlook delays in their own response times to ethics queries when narrating delays occasioned by the ethics review process. A study by Dixon-Woods et al. (in press) describes these periods as stopped clock periods in studies determining average ethics review times. RECs cannot be held accountable for delays caused by researchers themselves while responding to legitimate REC queries and requirements.

Another oft-cited concern is inconsistent application of ethical requirements, that is, the REC’s assessment of what is ethically permissible varies in a way that is hard to understand or justify (Abbott & Grady, 2011). This is a concern in multicentre studies where different RECs come to different conclusions about what is ethically permissible in the same proposal, but may also occur in single-centre studies where the REC might apply different norms to similar protocols over time. In the face of unclear or inconsistent feedback from RECs, researchers should request clarity about the ethical–legal norm being applied.

Conclusion

In this article, we essentially argue that psychological researchers should strive to be as rigorous about the ethical aspects of their work as they are about the rigour of their research methodology (see Laher, 2016; Saville Young, 2016). We also argue that undergraduate and postgraduate research training programmes in psychology should devote more time to research ethics training, using a systematic framework (Wassenaar & Mamotte, 2012a). Such training should include coverage of the applicable legal, professional, regulatory, and ethics frameworks and should teach researchers the diplomatic and strategic skills required to negotiate effectively and collegially with important research stakeholders, such as RECs. Researchers should familiarize themselves with the requirements and processes of their RECs and know the typical pitfalls that RECs commonly raise. There is rich and resourceful conceptual and empirical literature on specific issues in research ethics that, on the whole, is intended to enable the ethical conduct of complex and socially valuable research.

Footnotes

Acknowledgements

The authors would like to thank Dr Ann Strode of UKZN for helpful comments on the legal framework, and the Editorial team of the South African Journal of Psychology for inviting them to write this article and for helpful editorial comments.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

Disclaimer

The views expressed in this article are those of the authors and not of any councils, committees or grants on which they serve.

Notes

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