A Poorer Practice: The Consequences of Unethical Research

By Ethan Sim

Ethics are ubiquitous normative statements which delimit societally acceptable behaviour, and thereby advise individual and collective action (Vanclay, Baines & Taylor, 2013). As scientific research primarily aims to benefit society (Rull, 2014), ethical standards, which permit discrimination between beneficial (“right”) and detrimental (“wrong”) research practices are necessary. Although, unethical research which flouts these standards, can arise by various means. Such research fails to accurately enhance human knowledge in a societally acceptable manner, and thereby erodes public trust in science. Because of this, many measures seek to discourage unethical research, although their effectiveness remains controversial. For such efforts to truly succeed, scientists must view them as aids to their research rather than obstacles to be circumvented. 

At a basic level, ethical standards regulate both the conduct and publication of scientific research (Sivasubramaniam et al., 2021). By ensuring researchers adhere to principles such as empiricism and objectivity throughout the research process, ethical standards allow science to accurately enhance human knowledge (Resnik, 2020). The scientific method, which encapsulates the conduct of scientific research (Hanne & Hepburn, 2020), is predicated on empiricism: faithfulness to evidence (Reiss & Sprenger, 2020). To abide by this standard, researchers must report their observations truthfully and completely (Steneck, 2007); however, a research climate which overwhelmingly favours significant results incentivises researchers to engage in unethical practices (Mlinarić, Horvat & Smolčić, 2017), with data fabrication an extreme example (Resnik, 2014). Although traditionally thought to be rare due to its incontrovertibly unethical nature (Koshland, 1987), a meta-analysis by Fanelli (2009) found that almost 2% of scientists across various disciplines admitted to fabricating data, challenging this perception. Apart from outright fabrication, unethical research may involve questionable research practices (QRPs), which exploit ethical ambiguities in research methodology (Artino, Driessen & Maggio, 2019); researchers remain faithful to evidence, but only when the latter is desirable in some way. Such QRPs include p-hacking, the repetition of analyses with the intent of obtaining a significant result for publication (Head et al., 2015), and sample manipulation, where sample sizes are arbitrarily altered to facilitate the attainment of a significant result (Suter, 2020). Because QRPs are ethically “greyer” than outright fabrication, and therefore more defensible, their incidence is more frequent (John, Loewenstein & Prelec, 2012); 42% of ecology researchers admitted to p-hacking, while 4.5% admitted to fabricating data (Fraser et al., 2018). Following the completion of the study, papers are subject to the peer-review process, which is predicated on objectivity: freedom from bias (Reiss & Sprenger, 2020). To abide by this standard, peer-reviewers must assess a paper purely on its scientific merit, without knowledge of the author’s personal or professional identity (Horbach & Halffman, 2018). However, the nexus between career advancement and research productivity incentivises unethical researchers to subvert this process (Maggio et al., 2019); they may deliberately identify themselves within their manuscripts (Sivasubramaniam et al., 2021), or suggest reviewers more likely to recommend publication (Liang, 2018). Although quantitative evidence on the incidence of peer-review subversion is lacking, the greater tendency for author-suggested reviewers to recommend publication has been documented by numerous studies (Fox et al., 2017). Thus, while ethical standards preserve scientific accuracy in theory, the environment in which research is conducted may mitigate their effect in practice. 

Beyond ensuring simple adherence to truth, ethical standards also regulate the relationship between researchers and their research subjects (Ferdowsian et al., 2019). By ensuring that researchers respect research subject autonomy and wellbeing, ethics allow science to enhance human knowledge in a manner congruent with societal values (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (NCPHS), 1978). Respect for autonomy arises from a fundamental moral principle: that all individuals have a right to personal liberty (United Nations, 1948). This is demonstrated by the process of obtaining informed consent: the full disclosure of all relevant aspects of the study to prospective participants, who have the freedom to refuse (Nijhawan et al., 2013). However, to increase participant recruitment, and therefore data for analysis (Kapp, 2006), unethical researchers exploit the information asymmetry between researcher and subject to mislead the latter. For instance, a novel therapeutic regimen may be disguised as standard clinical practice (Sade, 2003), or information pertaining to possible side-effects may be withheld (Cyranoski, 2005). 

Unfortunately, while case studies of informed consent violations are well-known, such violations only come to light following extensive public scrutiny, frustrating attempts to quantify the problem (Weyzig & Schipper, 2008). Respect for wellbeing likewise arises from another fundamental moral principle: the universal right to life (United Nations, 1948). In line with this principle, researchers are expected to “maximise possible benefits and minimise possible harms” (NCPHS, 1978: p.6) to participants. Yet, in practice, conflicts of interest – the intrusion of secondary influences which diverge from the primary aim of knowledge enhancement – may cause researchers to breach this ethical standard (Weinbaum et al., 2019). For example, corporate financial interests may influence study design to the detriment of research participants (Chopra, 2003), with a striking example being the propensity of industry-funded clinical trials – which constitute the “vast majority” of trials (Blazynski & Runkel, 2019: p.8) – to compare novel therapy with placebos, rather than available (and potentially more effective) treatment, potentially causing avoidable harm to the control group (Djulbegovic et al., 2000). Unfortunately, while qualitative evidence is plentiful, the subjectivity of risk assessment (Bernabe et al., 2012) hinders efforts to quantify these unethical practices. Thus, although ethical standards ensure research remains societally acceptable, this role may be frustrated by personal and corporate interests. 

Because ethical standards undergird accurate and societally acceptable science, their violation necessarily generates incorrect or improper research, which lowers public trust in science. Although public trust may seem intangible, it begets the continued provision of public, private, and personal resources for scientific research, and thereby drives scientific progress (Resnik, 2011). An “implicit contract” (Shrader-Frechette, 1994: p.24) between society and scientists therefore exists: society supports scientific research to the extent that it can trust scientists to use its resources in an appropriate manner for human benefit. By breaching this contract, unethical research taints public perception of science in general, and harms the broader scientific enterprise (Shrader-Frechette, 1994). For instance, QRPs are thought to be a leading cause of the replicability crisis – the failure to replicate key studies in numerous scientific fields – simply because QRPs generate incorrect conclusions (Romero, 2019). The effect of these ethical violations on public trust was detrimental: individuals informed about QRPs and the replicability crisis reported lower levels of trust in science (Anvari & Lakens, 2018). Similarly, the failure of investigators to obtain adequate informed consent from members of the Havasupai Indian tribe prior to blood sample collection (Mello & Wolf, 2010) led to a broader distrust of medical research among the tribe (Van Assche, Gutwirth & Sterckx, 2013), and a refusal to participate in further studies (Sterling, 2011). Yet, while the erosive impact of unethical research on public trust in science is indubitable, its importance should not be overstated: although 85% of Americans are sceptical that medical researchers disclose conflicts of interest most of the time, 86% are confident that scientists act in the public interest (Funk et al., 2019). This seeming contradiction may arise from public perception of unethical researchers as “a few bad apples” (LaFollette, 2000); this deflects distrust onto these individuals and shields the wider scientific architecture (Chen, 2014). Thus, although unethical research undermines public trust in science, its effect may be ameliorated by public opinion. 

Due to the harmful effect of unethical research on public opinion, a variety of measures aim to prevent its occurrence. Foremost among them is the enshrinement of ethical standards in international agreements, such as the Helsinki Declaration (World Medical Association, 2013), and in national policy documents, such as the Belmont Report (NCPHS, 1978). By translating ethics into expectations for researcher conduct, these documents reduce ethical ambiguity (Vollmer & Howard, 2010) and inform laws which govern ethical conduct in research, such as the United States’ Common Rule, which predicates public funding on approval by an institutional review board (IRB), a body empowered to evaluate the ethicality of research involving human subjects (Meyer, 2020). IRBs themselves constitute the second tier of ethical regulation – they ensure that measures to obtain informed consent are sufficient and that the benefits of such research outweigh the harms, thereby preventing potentially unethical research from being performed (Shaul, 2002). Following study completion, publicatory processes impose a final barrier to unethical research; the detection of incorrect or improper research practice by peer reviewers often results in editors refusing to publish such work, preventing unethical researchers from furthering their careers (Angelski et al., 2012). Although seemingly comprehensive, the effectiveness of these measures remains controversial: because some forms of unethical research are still factually correct, and therefore beneficial to human understanding, some editors argue that publication, albeit with an editorial critiquing its unethical aspects, will invite public scrutiny and prevent similar studies from being conducted (Sade, 2003); however, critics assert that such editorials are rarely read, and are therefore a poor deterrent (Hunter, 2012). Furthermore, the extent to which researchers internalise the ethical standards these measures codify – and thus, whether these measures truly discourage, rather than prohibit, unethical research – is also debateable (Carlson, Boyd & Webb, 2004); some researchers view IRBs and their ethical frameworks as “intrusive, invasive [and] frustrating”, especially when paperwork is burdensome and judgements are opaque (Brown, Spiro & Quinton, 2020), although other studies suggest that these views are uncommon (Labude et al., 2020), and that IRB criticism mainly stems from procedural, rather than conceptual, grounds (Page & Nyeboer, 2017). A potential solution may therefore be to improve IRB efficiency and credibility; this could include greater administrative resource allocation to IRBs (Page & Nyeboer, 2017), or standardised IRB auditing and accreditation programs (Coleman & Bouësseau, 2008). Thus, while a hierarchy of measures exists to prohibit unethical research, they will only be truly effective when researchers identify with their underlying ethics, and perceive them as supporting, rather than obstructing, their endeavours. 

While unethical research may take numerous forms, such research ultimately erodes public trust in science. To preserve this trust, an array of measures seeks to deter unethical research, although their effectiveness, and how they can be improved, remain subjects of debate. Although the necessity of a rigorous ethical framework for scientific research is generally accepted (Brown, Spiro & Quinton, 2020), increasingly innovative efforts to circumvent these measures will persist if an unfavourable research climate discourages researchers from adhering to their underlying moral compasses. Any permanent solution to unethical research must therefore restore the incentive to be ethical, whether via procedure or policy. Only then will the integrity of scientific practice be preserved.

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