The Health Research Act
The Act on medical and health research (the Health Research Act) was passed on 20 June 2008. The Act entered into force on 1 July 2009. The Regulations on the organisation of medical and health research were passed on the same date. The bill that was submitted in Proposition No. 74 (2006–2007) to the Odelsting was based on Official Norwegian Report 2005:1 Good research – better health, and the objective was to revise and simplify the regulatory framework for medical and health research. The regulations pertaining to this area have now been largely compiled into a single Act, and researchers now have to relate mainly to one authority when applying for approval of research projects. This authority consists of the Regional Committees for Medical and Health Research Ethics (REK).
"Ethically sound medical and health research"
The purpose of the Act is stated in the purpose provision in Section 1 of the Act: "The purpose of the Act is to promote good and ethically sound medical and health research".
The purpose provision serves as a guide for how the other provisions of the Act are to be understood, and how REK's discretionary judgement is to be practised.
Section 5 of the Act, on responsible conduct, stipulates moreover that medical and health research must take account of ethical and privacy factors.
According to the preparatory works for the Act, ethically sound research entails respect for human dignity and human rights.
Research at the expense of human dignity and human rights is neither legal nor ethically sound or good. Ethically sound research respects and at the same time promotes generally accepted research ethics standards. A reminder is brought here of the principle that the interests of the safety and well-being of the participants must always take precedence over the interests of science and society at large (see NOU 2005:1 Section 28.3). A reminder is also brought about the non-discrimination principle, which is fundamental to all medical and health research (see Section 28.12). 'Ethically sound' also implies a requirement that researchers must be ethically aware. (Proposition No. 74 (2006-2007) to the Odelsting, p. 34)
The basis for the Health Research Act is thus that human rights and dignity must be fundamental principles for medical and health research. This means that consideration for "the participants' welfare and integrity shall have priority over scientific and social interests" (Section 5, second paragraph). It does not mean that research subjects must not be subjected to any kind of inconvenience. If it did, there would be very little research in the field of medicine and health. The fact that researchers gain access to some personal and medical data, that the participants give up some of their time to take part in research projects, or that they donate biological material, is not necessarily a violation of "the participants' welfare and integrity".
Ethics and the law
The Health Research Act stipulates minimum general requirements for the organisation and content of research – not least with respect to what is ethically responsible research. International provisions by which Norway is bound are incorporated in the Act. Social and research ethics norms (which may change somewhat over time) will add more specific details as to what is ethically sound research. REK is required to give prior approval to research projects (Section 10), and in this connection to conduct a "standard evaluation of the research ethics of the project". The committees must thus apply ethical standards that supplement the legal standards ensuing from the Health Research Act and other rules of law. If ethical standards are practised over time, they may be regarded as binding legal standards. Ethical standards may be established in writing (for example the ethical rules of professional associations and the Declaration of Helsinki), ensue from individual decisions taken by the ethical bodies of professional associations, supervisory bodies, REK, the National Committee for Medical and Health Research Ethics (NEM) or courts of law, or ensue from principles that are generally recognised by society in general or the professions.
The principal rule applying to participation in medical and health research is "informed, voluntary, express and documented" consent. This requirement is closely linked to ethical considerations regarding the right of self-determination, human dignity and personal integrity. Consent from relevant participants is not sufficient for REK approval, however. First, REK must determine whether the consent is real, by verifying that the participants know what they are consenting to, and that they are not in a dependency situation. REK must of course conduct an independent evaluation of whether the project is ethically sound; for example, whether ethically unacceptable methods are used, or ethically questionable experimental research is employed. For example, payment for taking part in research may be ethically unacceptable in some situations (see also separate article on Consent.)
Exemption from the requirement of consent must have a legal basis. The Health Research Act makes a number of exceptions from the requirement of consent. However, a thorough evaluation is required before the requirement of consent can be waived. The general formulation for these exemption provisions is that exemption from consent "may only be applied if the research in question is of significant interest to society and the participants' welfare and integrity are ensured" (Sections 15, 28, 35). This formulation implies that in given situations, where it is considered difficult to obtain consent, a balancing of interests must take place. The interests of the participants must be weighed up against significant social considerations. This means that the more sensitive the information and the greater the incursions into privacy, the greater the benefits to society at large that must be documented. In some cases, it may also be claimed that it is socially unethical to prevent research that could yield significant health effects, and that a certain incursion into personal privacy must be accepted. However, as stated above, the participants' welfare and integrity must take priority over scientific and social interests. The Act also contains provisions about research on persons who are not capable of giving consent themselves. It might be dubious from an ethical point of view if lack of consent meant that research was not conducted in areas where more knowledge is needed – which in turn would lead to deficient services for certain groups.
Recommendation No.55 (2007–2008) to the Odelsting from the Standing Committee on Health and Care Services
NOU (2005:1): Norges offentlige utredninger: God forskning – bedre helse. Lov om medisinsk og helsefaglig forskning, som involverer mennesker, humant biologisk materiale og helseopplysninger (helseforskningsloven) [Official Norwegian Report (2005:1) Good research – better health - Act on medical and health research (the Health Research Act)
Proposition no. 74 (2006–2007) to the Odelsting: Om lov om medisinsk og helsefaglig forskning (helseforskningsloven) [On the Act relating to medical and health research (the Health Research Act)]