Introduction

Why does research on human biological material raise ethical questions? This is material that is no longer a part of the human body, so one might think that research on such material presents no problems. It is not that simple, however. First, the fact that the material stems from a human body implies a connection with a particular individual. Some will claim ownership of "their" material and the right to decide over it, for example with respect to what it is used for. Others are not concerned with ownership or other forms of right of disposal, but will nonetheless have interests associated with the material that require safeguarding. The principal issue relates to the possibility of identifying individuals.

With the aid of modern biotechnological methods, human biological material can be traced back to individuals, provided that individualising characteristics are not removed from the material. This may create problems for the individual, for example if blood tests show a genetic disposition to a particular disease, and if such sensitive information is not handled properly and in accordance with the rules on duty of confidentiality. Section 27 of the Health Research Act therefore stipulates that human biological material from research biobanks may not be released for insurance-related purposes to an employer, a prosecuting authority or a court. This applies even if the person from whom the material stems gives consent to its release, the intention being to prevent persons in vulnerable positions from feeling pressurised into disclosing sensitive information on their own health.

Ethics and legislation

The purpose of today's regulations is to promote good medical and healthcare research, whilst also making proper provision for the protection of the individual's self-determination, integrity and privacy. These considerations apply to varying degrees and in different ways to different types of medical and healthcare research. The consideration of respect for the individual's self-determination and integrity is prominent in research that directly involves humans (for example clinical research), and the requirement of voluntary informed consent therefore weighs heavily.

With regard to research on human biological material, which does not involve individuals in the same way, the considerations of self-determination and integrity apply in a somewhat different manner, most particularly in the form of a need for protection and right of control of sensitive information (privacy). It has therefore been a challenge to develop legislation that allows to a greater extent than in the past for the fact that different types of research entail different challenges and issues. The new Health Research Act (Act on medical and health research of 20 June 2008 no. 44; see also Proposition no. 74 (2006–2007) to the Odelting relating to an Act on medical and health research (the Health Research Act)) reflects the need for more nuanced requirements for consent, depending on whether the research concerns individuals, human biological material or personal data derived from such material. The general rule is that "broad-based consent" is allowed on certain conditions for research on human biological material and personal health data (section 14) but not on research involving humans. Consent is not required for the use of anonymised human biological material and anonymous data. Consent is, however, required for collecting material and data for subsequent anonymisation (section 20).

Terminological nuances

One question that arises is whether absolutely all human biological material raises research ethics questions and is covered by the provisions of the Health Research Act. What about material that is excreted from the human body, such as sweat, urine and faeces? Is this also human biological material to which research ethical considerations apply as a matter of principle? All material that has been a part of the human body is covered by the definition in the Health Research Act. In the preliminary works it is stressed that plasma, sweat and urine are to be regarded as human biological material that is covered by the provisions of the Act, while exhaled air is mentioned as an example of "material" that is not covered. The reason is that all human biological material that can be traced back to a particular individual is covered by the provisions of the Act, while material that does not have any such connection with a particular individual is not covered. In other words, the intentions underlying the Act are crucial for determining what material is covered.

Treatment biobanks

The definition of a research biobank (section 4 (c) of the Health Research Act) is "a collection of human biological material that is used in a research project or that is going to be used for research". A collection of human biological material that has been provided for medical tests, diagnostics and treatment, but not research, is regarded as a treatment biobank, however. Treatment biobanks are regulated by the Act relating to treatment biobanks of 2003 (the Treatment Biobank Act). The purpose of the Treatment Biobank Act is to "ensure that the collection, storage, processing and destruction of material in a biobank is carried out in an ethically responsible manner, and that biobanks are used for the good of the individual and for society. This shall be carried out in accordance with fundamental privacy considerations, principles regarding respect for human dignity, human rights and personal integrity, and without discrimination of persons from whom the biological material originates.

The Act shall pave the way for use of the material in the biobank for health-related purposes, including diagnostics, treatment and teaching in an ethically responsible manner" (section 1). The Health Research Act, which regulates the use of human biological material in research, and the Treatment Biobank Act, which regulates the use of human biological material in diagnostics, are otherwise largely harmonised. For example, the definition of human biological material is the same in both. However, the rules for consent are different, in that the Treatment Biobank Act refers to the somewhat less stringent rules for consent in the Patient Rights Act.

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