Objects of research

Ethical assessment in medicine and healthcare is applied to a constantly expanding field. Originally, such assessment was restricted to studies that directly involved human beings, such as experiments and pharmaceutical trials. Today we include research on human biological samples which are required to be collected in a research biobank prior to use in research. Of course, samples may be collected in connection with a research project, but they may often have been obtained and collected for diagnostic or treatment purposes. Research on health data is also included. All health data is considered sensitive, except anonymous information, which may be used without prior approval.. Research on embryos, stem cells and fetuses and on the recently deceased (cadavers) is included as well.

The basis

Assessments are based on the provisions of the Norwegian Health Research Act and other Norwegian legislation such as the Health Registry Act and the Act on Medical Use of Biotechnology, in addition to the ethical principles for medical research drawn up by the World Medical Association in the Declaration of Helsinki, and the Council of Europe's Additional Protocol on Biomedical Research, often referred to as the Oviedo Convention. Certain specific regulations apply within particular areas, such as pharmaceutical trials (Norwegian Regulation relating to Clinical Trials on Medicinal Products for Human Use, which implements the EU Directive on Clinical Trials), including ethical recommendations with respect to the choice of method and the selection of control groups, or research on people in developing countries (North/South). The National Committee for Medical and Health Research Ethics (NEM) has also drawn up reports and guidelines intended for specific areas, such as research on people with impaired capacity, epidemiological research, guidelines for the assessment of post-marketing studies of pharmaceuticals and commissioned research (in liaison with the other committees).

The most important standards

The standards for research ethics which are the most important within this field include the Project Manager's responsibility for individuals, scrupulous risk-benefit assessments, satisfactory informed consent and an assessment of the suitability of informants/subjects pursuant to the principle of descending order of permissibility (as established by the philosopher Hans Jonas). This principle suggests that the healthiest subjects are the most appropriate for inclusion in research while others should be included only if warranted for scientific and ethical reasons.

This has meant that people considered to be vulnerable have traditionally been excluded from research for reasons of (exaggerated) precaution. The groups which are most often referred to as vulnerable in medicine and healthcare are children, dementia sufferers, detainees, people with limited life expectancy or who suffer from mental disorder or learning disabilities, substance abusers and ethnic minorities. The current guidelines suggest that people in vulnerable situations should be included in research provided there are no strong scientific or ethical grounds to the contrary. All guidelines emphasise that vulnerable people are entitled to particular care and protection. The Oviedo Convention and the Helsinki Declaration provide almost identical criteria for appropriate protection of these people's interests without excluding them from research, e.g. that research should be conducted on questions that are of relevance and potential benefit for the group.

Influence and voluntary participation

Due to a long pre-history of coerced inclusion in research, great importance is attached to ensuring that all participation is voluntary. This was a particularly important principle laid down in the so-called Nuremberg Code, which was drawn up in the aftermath of World War II in connection with the trial of German doctors for crimes against humanity. It is therefore a premise that informed consent is based on voluntary participation.

It is important, however, that voluntary participation is not seen as an absolute requirement, irrespective of circumstances or objective. It is legitimate to seek to encourage people to take part in research as long as no undue influence is exerted, whether in terms of incentives or rewards offered. Any such reward may be directly linked to the research if this is combined with treatment (as set out in the Helsinki Declaration) or the participants may benefit from treatment they would otherwise not have access to. Incentives and rewards may also be associated with the payment of informants/subjects. The Council for International Organizations of Medical Sciences (CIOMS) and the Oviedo Convention consider encouragement to be legitimate as long as it is reasonable.

Choice of method and selection of control groups

It has been maintained that neither the choice of method nor the selection of control groups is an issue that involves ethical considerations as these are choices made purely on an academic or scientific basis. However, within the research ethics community it is a commonly held view that these choices are indeed of an ethical nature. It is therefore significant that according to guidelines issued by the International Council of Harmonization, ethical considerations may justify a choice of methods or control groups other than those which are considered preferable from a purely scientific point of view. They stress the fact that methods can be modified in order to safeguard the interests of individuals in research. With respect to pharmaceutical trials this refers in particular to justifying the use of placebo controls rather than comparative drug testing in randomised clinical studies (which is the Helsinki Declaration's first choice). It is also important to look at how placebo-controlled trials can provide better ethical safeguards for certain patient groups by changing or adjusting the research method and the selection criteria for control groups.

Special considerations for qualitative research

Traditionally, qualitative methods have not had a particularly high-profile status in medical and healthcare research. However, with the expansion of research ethical evaluations to include all healthcare disciplines, there has been a significant increase in the use of qualitative methods, particularly interviews and observation. From the point of view of research ethics it is important that these methods be assessed differently from quantitative methods. To a certain extent this also means that the standards of research ethics must be considered in a different way. For instance, it is impossible to have the entire course of a study laid out in advance, because research is often conducted as a process which needs to allow for new choices to be made along the way. It can be difficult to fulfil the requirements for informed consent if the task is to observe interactions or the workings of a department – particularly if the intention is to disclose misconduct (deception research). It is also necessary to take account of the difficulties involved with meeting normal confidentiality requirements because researchers work with small samples. There is therefore a risk that informants may be recognised by others who read later reports. In qualitative research, researchers often take on a different role by personally participating in the study or by being motivated by a desire to understand and improve current practice. In this respect, the normative objectives of action research are particularly explicit.

Preventing misconduct

Research ethics is also a matter of research values. This aspect has largely been dealt with by the research communities themselves, because any infringement of these standards – through deception or plagiarism – will undermine the credibility of research. In particular, much research fails to be published and researchers may be bound by agreements that restrict publication. This has led to the introduction of a requirement that all clinical trials that are initiated must be registered in a database and that the results must be published or otherwise made available in the public domain. The publication of studies has also raised important questions with regard to co-authorship within the disciplines of medicine and healthcare. The journals themselves have issued uniform standards in the Vancouver Recommendations. Under the Norwegian Act on Ethics and Integrity in Research the national committees on research ethics are responsible for the prevention of academic misconduct within their field of work. The most important action taken towards this end is the formation of a dedicated library for research ethics, FBIB, in co-operation with the Norwegian universities. Any suspicion of misconduct in a research project may be investigated by the National Commission for the Investigation of Research Misconduct.

This article has been translated from Norwegian by Hege Hernæs, Akasie språktjenester AS.