Centre for Research Ethics & Bioethics (CRB)

Research regulation

Difficulties in regulation are an interesting study object, not only for researchers, but also for legislators, professional organizations and the society at large. Future developments of regulation should rest on a comprehensive and thoughtful approach to science regulation.

Ethical concerns are increasingly taking on a legal form might create a situation where a procedure of legal interpretations replaces ethical reflection. And the number of professional guidelines, research ethics codes and legal regulations has increased tremendously in the last few years.


The aim of this research is to:

  • investigate to what extent the current regulation of life sciences conform to basic rational demands on a legitimate regulative system and;
  • suggest how a regulative system for the life sciences best can meet those standards of rationality.

This research focuses on rational regulation. In research ethics and bioethics there is a clear trend towards more collaboration between law and ethics. This has been described as a juridification process. Regulation has been seen both as a solution and a problem and it has been questioned whether our regulative system is legitimate.

Legitimacy in a regulative system can be seen both as a function of meeting certain basic requirements on how the various rules and guidelines are created and designed, and as a function of how the system is perceived by those administering or being affected by it.

Previous research in this field

In a previous project, "Are codes and guidelines the right way to go? On ethical competence in medical practice", we investigated the concept of “ethical competence” within the field of medical practice and research and the importance of ethical guidelines (of various forms) in the development of such competence is studied. Stefan Eriksson has also worked with scholars involved in ABIS, Linköping, pondering the feasibility of a right not to know (as suggested by various ethical guidelines), with Gert Helgesson on various issues, with Erik Sundström on norms affecting epidemiological research, and with Anna-Lydia Svalastog on the requirement for anonymity in research. Much of the work on science regulation has been poignantly expressed in a recent article with Linus Johnsson.


Johnsson L, Eriksson S, Helgesson G, Hansson MG: “Making researchers moral: Why trustworthiness requires more than ethics guidelines and review”. Research Ethics 10 (2014):29-46.

Eriksson S, Sundström E: ”Etiska aspekter att tänka på i observationsstudier”, Läkartidningen 110:5 (2013):220-22.

Helgesson G, Eriksson S: “Öka rättssäkerheten vid misstänkt forskningsfusk” [electronic], Curie May 8, 2013. < http://www.tidningencurie.se/22/debatt/debatter/2013-05-08-oka-rattssakerheten-vid-misstankt-forskningsfusk.html>

Svalastog A-L, Eriksson S: “You can use my name; you don’t have to steal my story – A critique of anonymity in indigenous studies”, Developing World Bioethics 10:2 (2010), pp. 104-110.

Eriksson S: “On the need for improved protections of incapacitated and non-benefiting research subjects”, Bioethics 2012:26(1):15-21.

Höglund A, Eriksson S, Helgesson G: “The role of guidelines in ethical competence-building: perceptions among research nurses and physicians”, Clinical Ethics 5 (2010), pp. 95-102.

Höglund A T, Helgesson G, Eriksson S: “Ethical dilemmas and ethical competence in the daily work of research nurses”, Health Care Analysis 18 (2010), pp. 239-51.

Eriksson S, Höglund A T, Helgesson G: “Do ethical guidelines give guidance? A critical examination of eight ethics regulations”, Cambridge Quarterly of Healthcare Ethics 17 (2008), pp. 15-29.

Eriksson S, Helgesson G, Höglund A T: “Being, doing, and knowing: Developing ethical competence in health care”, Journal of Academic Ethics 5 (2007), pp. 207-216.

Helgesson G, Eriksson S: “The moral primacy of the human being: A reply to Parker”, Journal of Medical Ethics 37 (2011), pp. 56-57.

Helgesson G, Eriksson S: “Against the principle that the individual shall have priority over science”, Journal of  Medical Ethics 34 (2008), pp. 54-56.

Eriksson S, Helgesson G: ” Keep people informed or leave them alone? A suggested tool for identifying research participants who rightly want only limited information”, Journal of Medical Ethics 31 (2005), pp. 674-678.

Eriksson S, Helgesson G: “Potential harms, anonymization, and the right to withdraw consent to biobank research”, European Journal of Human Genetics 13 (2005), pp. 1071–1076.

Helgesson G, Eriksson S, Swartling U: “Limited relevance of the right not to know – reflections on a screening study”, Accountability in Research 14 (2007), pp. 197-209.

Swartling U, Eriksson S, Ludvigsson J, Helgesson G: “Concern, pressure and lack of knowledge affect choice of not wanting to know high-risk status”, European Journal of Human Genetics 15 (2007), pp. 556-562.