What is ‘necessary training’ in health-related research ethics?

Kristine Bærøe, Associate Professor at the Department of Global Public Health and Primary Care, University of Bergen

A couple of months ago a new Research Ethics Act was implemented in Norway. The rationale for replacing the preceding regulation was to strengthen legal responsibilities of researchers and institutions for promoting acceptable research [1]. According to the new regulation, researchers are held legally responsible for ensuring that they ‘act with caution to ensure that all research is conducted according to recognised research ethical norms’ [2]. At the same time ‘institutions are responsible for: a) necessary training of candidates and employees in recognised research ethical norms and b) that everyone who conducts or participates in the research is familiar with recognised research ethical norms’ [2]. The lawmakers have explicitly left it to the researcher community to define what is covered by ‘recognised norms’ [1], but implicitly the community will also have to define what should go into ‘necessary training’.

Today this interpretation is dependent on the opinions of local study program committees, course coordinators and the available teachers. There is no common standard, either for the education, or for the expected competence required by the researchers. This could threaten the legal security of the researchers; they may end up being held responsible according to a standard that their particular, institutional training has not properly prepared for. Therefore, clarification of ‘necessary training’ is not only crucial for safe practice of human research; it secures the legal protection of researchers as well.

This new regulation prompts an issue of crucial importance within all research disciplines in general, and within health-related research in particular: What is required for a ‘necessary training’ in health-related research ethics? A justified approach would need to address a variety of challenges. Let me mention some of them here.

What is meant by ‘necessary’ may vary depending on whose perspective is being considered. Whose perspective should determine the required training in research ethics? A preliminary response could be sketched out according to the following reasoning. The research community enjoys extended discretionary power to define the substantive content of the ethical norms that will shape their research activities. The justification for researchers’ autonomy is similar to the justification for the discretionary power of those in other professions. Society grants those in certain professions (here, researchers) freedom to organise their work with the expectation that they will serve the interests of society [3]. In the case of research, institutions and individuals need to be able to trust researchers and their work; if not, there are no good reasons to apply the results, fund research activities or subject oneself to trials. Thus, as a first guideline for ethical standards, the perspectives and expectations of the individuals and institutions constituting the parts of society that depend on – but do not carry out the research – should inform what is considered ‘necessary’ with respect to training in research ethics. If this is a sensible perspective, how should this required information be gathered? And exactly how should it inform the conditions of the training?

The phrase ‘recognised norms’ implies that these norms are evident. This is probably true for some norms, such as the restriction on committing fraud through fabrication, falsification and plagiarism or the duty to obtain consent from research subjects. However, other institutionalised norms (norms found in codes of ethics, declarations and reports) are contested within the researcher community (see e.g., [4]). In addition to researchers’ individual opinions on research ethics, their own experiences with research might skew their opinions on what is important regarding research ethics. Thus, on a large scale, the substantive concept of ‘recognised norms’ considered relevant to be taught may vary greatly between teachers and health research institutions. In what way should one then proceed in order to obtain consensus across distinct research communities and researchers on what norms to include in the training?

What kinds of educational activities should be included in the ‘training’? The answer to this question depends on the aim of the training, which this legal regulation leave undefined. For example, the aim can be to convey information about relevant norms and requirements or to foster competence in conducting research in an acceptable manner. The training required to achieve the first aim will be different from that required to achieve the second, which involves developing the ability to transform knowledge about normative restrictions into actions in concrete settings (i.e. showing practical competence).

A related challenge is that there are various strategies and opinions regarding how to teach research ethics, and the teaching methods for training vary. For instance, it is often not obvious whether the training should be conducted implicitly or explicitly, or reactively or proactively [5]. There is evidence suggesting that mentors play an important role in the success of postgraduate students [6]. However, to what extent should learning be left implicit in terms of conveyance through role models like supervisors and colleagues, and to what extent should it be explicit in terms of explanations, demonstrations and exercises? Should punishment for not acting in accordance with norms be used as a reactive method of teaching, or should proactive interference at an early stage in researchers’ careers be implemented to prevent unacceptable behaviour from occurring in the first place? International findings indicate that those involved in teaching research ethics are confused with respect to what their role as teachers or role models should be [7]. A recent study performed in Finland demonstrates that academics have various opinions regarding how to promote research ethics and integrity [5], and there is no obvious reason to believe the situation in Norway – or any other country for that sake – is any different. Again, how should we proceed to gain consensus on the methodological approach to teach research ethics?

So, how can we proceed to establish a common interpretation of ‘necessary’ training in health-related research ethics? As a first step, there is a need to debate and establish a well-justified, comprehensive set of relevant ‘meta-research-ethical’ assumptions to base a collective approach on (a research proposal on this has recently been submitted). Next, it should be left to the researcher community to debate the substantive content of – and ways of conveying- the required ‘necessary training’ in health-related research ethics. This debate should be informed by research on the perspectives and expectations of society at large towards ethical research conduct.

Finding an answer to what ‘necessary training’ in research ethics implies, is not only of relevance for research ethics committees, research participants, the public at large and health researchers in Norway. The researcher community transcend national borders, researchers move between countries, and safe practice of human research is a global concern.   

The author would like to acknowledge the support of the Caroline Miles Scholarship that funded a stay at the Ethox Centre, University of Oxford, in May 2017.

The text is based on a research proposal submitted by Kristine Bærøe and Hallvard Fossheim.

  1. Kunnskapsdepartementet. Prop. 158 L Lov om organisering av forskningsetisk arbeid (forskningsetikkloven) Oslo, Norway, 2015–2016.
  2. Lovdata. Lov om organisering av forskingetisk arbeid (Forskningsetikkloven), 2017.
  3. Molander A. Discretion in the Welfare State: Social Rights and Professional Judgment: Routledge, 2016.
  4. Millum J, Wendler D, Emanuel EJ. The 50th anniversary of the declaration of helsinki: Progress but many remaining challenges. JAMA 2013;310(20):2143-44 doi: 10.1001/jama.2013.281632.
  5. Hyytinen H, Löfström E. Reactively, Proactively, Implicitly, Explicitly? Academics’ Pedagogical Conceptions of how to Promote Research Ethics and Integrity. Journal of Academic Ethics 2017;15(1):23-41 doi: 10.1007/s10805-016-9271-9.
  6. Gray PW, Jordan SR. Supervisors and Academic Integrity: Supervisors as Exemplars and Mentors. Journal of Academic Ethics 2012;10(4):299-311 doi: 10.1007/s10805-012-9155-6
  7. Löfström E, Trotman T, Furnari M, et al. Who teaches academic integrity and how do they teach it? Higher Education 2015;69(3):435-48 doi: 10.1007/s10734-014-9784-3.
What is ‘necessary training’ in health-related research ethics?

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