For a long time, bioethical research has been primarily concerned with the theoretical reflection of normative questions. This paradigm is based on a sharp separation of normative from descriptive ethics, which are fundamentally different in their epistemological interest as well as their employed methods. In the past decade however, this sharp distinction was revoked and a growing branch of empirical research in bioethics emerged. Multiple authors presented evidence for the increase of empirical studies investigating ethical topics (1–3). The most recent one showed that in a sample of nine bioethical journals, 18% (n = 1007) of the original papers collected and analyzed empirical data (2).
Empirical research can contribute to bioethics in several ways and several categorizations for these ways have been suggested, including studies on beliefs, perspectives, (new) issues, facts relevant to normative arguments, likely consequences, effectiveness and more (4–6).
All these different ways can become relevant for bioethics in at least two ways. First, empirical research aims to inform the development or refinement of ethical recommendations. It can do so by informing about beliefs, perspectives, facts relevant to normative arguments, likely consequences, new ethical concerns and more (4–6). For example, attitudes research such as surveys with different stakeholder groups might reveal important viewpoints on biobanking issues that should be acknowledged in developing practice oriented guidance (7). Another example is the assessment of clinician’s experiences and views about ethical issues encountered in clinical practice to develop a clinical ethics support system (8).
A second complementary set of empirical studies aims to evaluate how effective, efficient, or valid the ethical recommendations are applied in practice (4–6). For example, studies assessing whether and how clinical trials are prospectively registered and how they report their results clarifies the implementation of two ethical recommendations (principles 35 and 36) included in the Declaration of Helsinki (9–11). Likewise, an empirical study assessing the understanding of informed consent materials provides empirical information that helps to understand whether the ethical recommendations of informed consent is implemented in a valid way (12–14).
In most scientific disciplines, it is a matter of course that “scientifically” developed recommendations on how to act in certain situations are consecutively evaluated for how effectively and efficiently they can be and are implemented. In the field of bioethics, however, multiple authors criticized a neglect of the evaluation wing of empirical research and stressed the need for thorough consideration of the consequences of moral advice giving (5, 15, 16). A recent review of practice evaluation of biobank ethics and governance conducted by our working group showed the need for more practice evaluation in the area of normative biobank governance (17).
The field of empirical studies evaluating how ethical recommendations are translated into practice has not been systematically investigated yet. To inform the methodological discourse of this field the aim of this cross-sectional study is a threefold mapping: First, we aim to map the quantitative proportions of evaluative empirical research published in leading bioethics journals (Journal of Medical Ethics, Nursing Ethics, AJOB Empirical Bioethics and the BMC Medical Ethics). Second, we want to map how often the evaluation object of empirical evaluative studies reflects either broad (aspirational) norms, specific norms, or best practices; a typology suggested by Sisk and colleagues (18). Third, we aim to inductively map the specific objects of evaluation (the types of ethical recommendations).