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What is "necessary training" in health-related research ethics?

Associated Professor Kristine Bærøe spent one month as a visiting researcher at the Ethox Centre at Oxford University. She recently published a blog post on Ethoxblog, addressing the question of necessary training in research ethics.


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"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."

Read the full blog post at Ethoxblog.

The Ethox Centre at the University of Oxford is a multidisciplinary bioethics research centre that aims to improve ethical standards in healthcare practice and in medical research through education, research, and the provision of ethics support to health professionals and medical researchers.