Regulations on Scientific Research in the Biomedical Field No. 286/2008

No. 286 7 March 2008

REGULATIONS

on scientific research in the biomedical field

Art. 1

Scope

These regulations apply to scientific research in the biomedical field, i.e. research carried out in order to increase knowledge, which inter alia makes it possible to improve health and cure diseases. Pharmaceutical research is subject to the provisions of the Regulations on Clinical Pharmaceutical Research on Human Beings, no. 443/2004, with subsequent amendments.

Art. 2

Objective

The objective of these regulations is to ensure that a research project in the field of biomedicine not be carried out if, in the judgement of the National Bioethics Committee under art. 3 or a bioethics committee under art. 4, on scientific, ethical or human-rights grounds it should not be carried out.

Art. 3

National Bioethics Committee

The Minister of Health appoints the National Bioethics Committee, comprising seven members, for a term of four years, to consider scientific research projects in the biomedical field. One member of the committee shall be appointed on nomination by the Minister of Education; one on nomination by the Minister of Justice, who shall be a law graduate; two on nomination by the Medical Director of Health, of whom one shall be a physician; and one on nomination by the University of Iceland Ethical Research Institute. Two members shall be appointed by the Minister of Health without nomination, one of whom shall be a physician. The Minister appoints the chair of the committee. The committee elects a deputy chair from among the members. Substitutes shall be appointed in the same manner. It shall be ensured that the committee includes individuals with expertise in the fields of biomedical science, ethics of research, human rights and social science.

Art. 4

Ethics Committees

The following ethics committees shall consider research projects at their respective institutions:

The Ethics Committee of Landspítali University Hospital. The executive committee of Landspítali appoints an Ethics Committee of seven members for a term of four years. The hospital’s Medical Council and Nursing Council, the University of Iceland and the Medical Director of Health shall each nominate one member of the committee; the representative of the Medical Director of Health shall be independent of Landspítali University Hospital. In addition one member of the committee shall represent other healthcare professions, nominated by the executive committee, and two shall be appointed by the executive committee without nomination, one of whom shall be a physician and the other a law graduate. Substitutes shall be appointed in the same manner. The committee grants permission for research projects in the biomedical field to be carried out at the hospital, and research projects in the biomedical field to be carried out in collaboration between Landspítali University Hospital and the University of Iceland or the University of Akureyri.
The Ethics Committee of Akureyri Hospital. The executive committee of the hospital appoints an Ethics Committee of seven members for a term of four years. The hospital’s Medical Council and Nursing Council, the University of Akureyri and the Medical Director of Health shall each nominate one member of the committee; the representative of the Medical Director of Health shall be independent of Akureyri Hospital. In addition one member of the committee shall represent other healthcare professions, nominated by the executive committee, and two shall be appointed by the executive committee without nomination, one of whom shall be a physician and the other a law graduate. Substitutes shall be appointed in the same manner. The committee grants permission for research projects in the biomedical field to be carried out at the hospital or the University of Akureyri, or to be carried out in collaboration between Akureyri Hospital and the University of Akureyri or the University of Iceland.

Art. 5

The Role of Ethics Committees

The National Bioethics Committee shall consider collaborative projects, multi-national research projects, clinical pharmaceutical research projects subject to the provisions of the Regulations on Clinical Pharmaceutical Research on Human Beings no. 443/2004, and other planned scientific studies in the biomedical field, which are not within the mandate of ethics committees under art. 4. In addition the National Bioethics Committee shall participate in public and scholarly debate on bioethics, and issue guidance on matters within its mandate.

A request for consideration of a research project shall be accompanied by a detailed research protocol, and other information as further determined by the National Bioethics Committee.

The National Bioethics Committee may call upon experts for consultation when necessary.

Ethics committees under art. 4 shall consider protocols for scientific studies in the biomedical field to be carried out within the mandate of the respective ethics committee.

Ethics committees under art. 4 shall submit their findings to the National Bioethics Committee.

Art. 6

Permission to carry out biomedical research projects

A scientific research project in the field of biomedicine shall not be permitted without prior evaluation of possible risk on the one hand, and benefits on the other. In that evaluation, however, the interest of the individual shall invariably outweigh scientific or societal interests.

No scientific research project in the biomedical field may be carried out without the approval of the National Bioethics Committee or an ethics committee under art. 4.

Studies which require the participation of children, or members of vulnerable social groups, shall be evaluated with especial care, as these groups are entitled to special protection. Such studies may involve, for instance, adults who, due to mental disability, disease or other factors are incapable of granting consent. Such individuals shall be involved in decision-making as far as possible. Child subjects shall be involved in decision-making in so far as their development permits, and without exception if they are aged 12 years or older.

The National Bioethics Committee may issue further rules on participation in research by children and members of vulnerable groups.

Art. 7

Consent

A patient or other participant in a scientific study in the biomedical field shall provide formal consent in advance for participation in a scientific study. Before such consent is granted, the participant shall be provided with detailed information about the research project, the potential risks involved and possible benefits, and what his/her participation entails. This information shall be provided in such a way that the participant can understand it. The participant shall be informed that he/she may refuse to participate, and that he/she may withdraw at any time after the commencement of the study.

If the information and data arising from the study may be used in the future for research purposes, the patient shall be informed of this possibility, and of how further information will be acquired, should such future use be made. The participant’s consent for such use shall be elicited.

The eliciting of informed consent for a scientific study in the biomedical field shall otherwise be in accord with the provisions of Rules no. 170/2001 on How to Obtain Informed Consent for the Processing of Personal Data in Scientific Medical Research.

Art. 8

Data Protection

Access to medical records for the purpose of scientific research is prohibited unless the study has previously been approved by the Data Protection Authority, cp. art. 37 of the Data Protection Act on the Protection of Privacy as regards the Processing of Personal Data no. 77/2000, and by the National Bioethics Committee or an ethics committee under art. 4 of this Act.

The handling of personal information in the context of scientific research is subject to the provisions of the Data Protection Acton the Protection of Privacy as regards the Processing of Personal Data, no. 77/2000.

Art. 9

Monitoring

The National Bioethics Committee and ethics committees under art. 4 shall monitor the progress of research projects which they have approved. The committees may require the researchers to submit progress reports and interim findings. The committees may revoke their approval of a research project if they judge that the implementation of the project is inconsistent with the research protocol and information submitted by the researcher, and that the project no longer meets the criteria of art. 6 or 7 for approval of a scientific study. If approval is revoked, the study shall cease immediately.

The National Bioethics Committee or an ethics committee under art. 4 may also issue a reprimand to the researcher, if they deem the implementation of the study to be faulty, though not warranting revocation of approval.

Art. 10

Rules of procedure

The National Bioethics Committee under art. 3 issues its own rules of procedure, which shall be approved by the Minister. These rules shall also apply to the procedures of ethics committees under art. 4, as applicable.

The procedural rules of the National Bioethics Committee shall be accessible to researchers and others who consult the committees. The rules of procedure shall be in accordance with the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, and additional protocols, and the relevant European Union guidelines on bioethics; the World Medical Association Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects; and other international ethical guidelines on scientific research in the biomedical field. In addition the National Bioethics Committee shall take account of new developments in the field of international guidelines in the field of bioethics, and adapt its rules of procedure to new developments as appropriate.

Art. 11

Procedure

The National Bioethics Committee under art. 3 and the bioethics committees under art. 4 shall comply with the provisions of the Public Administration Act in their decisions. A decision of an ethics committee under art. 4 may be appealed to the National Bioethics Committee. A decision of the National Bioethics Committee may be appealed to the Minister.

Art. 12

Entry into force

These Regulations, which are issued on the basis of the provisions of art. 29, cp. para. 4 art. 2 of the Patients’ Rights Act no. 74/1997, shall take effect immediately. From the same time Regulations no. 552/1999 on Scientific Research in the Biomedical Field are abrogated.

Ministry of Health, 7 March 2008.

Guðlaugur Þór Þórðarson.

Berglind Ásgeirsdóttir.

__________

Published: 25 March 2008

English translation Anna Yates, certified translator

Original version in Icelandic as published by the Icelandic Legal Gazette.(Opens in a new window)