Senest opdateret: 11.02.2009
WE MARGRETHE THE SECOND, by the grace of God Queen of Denmark, hereby make known:
Folketinget has passed and We have by Our Consent confirmed the following Act:
Part 1
The scope of the act – the committee system
1.-(1) The purpose of this Act is to lay down the legal framework for the scientific ethical evaluation of biomedical research projects.
(2) A research ethics committee shall be independent and consist of members who are active within medical research and lay members without medical qualifications and with no current connection with the healthcare professions.
(3) It shall be the responsibility of the research ethics committee system to ensure that from a scientific ethical point of view biomedical research projects are carried out in a responsible manner, and that the rights, safety and wellbeing of trial subjects participating in a biomedical research project are protected, while at the same time creating the possibility of developing new, valuable knowledge.
2.-(1) The county councils shall set up regional research ethics committees. A county council may set up one or more committees within its geographical area. A committee may also be set up jointly by several county councils.
(2) County councils shall also include the local councils of Copenhagen and Frederiksberg and the regional council of Bornholm.
3.-(1) A regional committee shall consist of at least seven members of whom three shall be active within medical research.
(2) The members of the regional committees shall be associated with the region covered by the committee, and the members active within medical research shall be appointed upon the recommendation of relevant professional research forums.
(3) A committee may consist of nine, eleven, thirteen or fifteen members if a county council finds that this is justified by the interests of the activities of a regional committee, the number of projects or other considerations. In case of a membership of nine, eleven, thirteen or fifteen, the members active within medical research shall be four, five, six and seven, respectively.
(4) The regional committee shall elect its own chairperson and one deputy chairperson from amongst its appointed members. The chairmanship shall consist of one person representing medical research and one person representing the lay members.
(5) The regional committee shall prepare draft regulations to be approved by the National Committee.
(6) Committee members shall be appointed for a period of four years, corresponding to the election period of county councils. Members may be re-appointed once. Substitutes may be appointed for the members.
(7) A retiring committee shall continue its activities until new members have been appointed and the new committee has elected its chairmanship.
(8) The Minister for Science, Technology and Development may lay down rules on which forums shall be relevant professional research forums, cf. section 3(2) above.
4.-(1) The Minister for Science, Technology and Development shall set up the Danish National Committee for Biomedical Research Ethics and shall appoint the chairperson and one member. In addition, the Committee shall consist of two members appointed upon the recommendation of each of the regional committees and two members appointed upon the recommendation of the Minister for the Interior and Health.
(2) Of the members appointed on the recommendation of the regional committees one member shall be appointed from among the members who are active within medical research. The other member shall be elected from among the lay members of the committee.
(3) The chairperson shall represent official research interests and public information, general cultural or social interests of significance to the activities of the National Committee. The two members appointed by the Minister for the Interior and Health and the member appointed by the Minister for Science, Technology and Development shall represent public information, general cultural or social interests of significance to the activities of the National Committee. The chairperson and the members appointed by the Minister for the Interior and Health and the Minister for Science, Technology and Development shall not be members of the Folketing or local councils.
(4) The Committee shall elect its own deputy chairperson from among the appointed members.
(5) The Committee shall prepare draft regulations to be approved by the Minister for Science, Technology and Development.
(6) The Committee members shall be appointed for a period of four years, corresponding to the election period of county councils. Members may be re-appointed once. Substitutes may be appointed for the members.
(7) A retiring Committee shall continue its activities until new members have been appointed and the new Committee has elected its chairmanship.
5.-(1) Committees shall continually follow the development within biomedical and clinical research and shall within their fields promote the dissemination of knowledge of the ethical problems that may be involved.
(2) The National Committee shall cooperate with the Danish Council of Ethics, among other things through joint meetings. The Committee and the Council may jointly prepare current reports on fundamental ethical problems that have been discussed between them.
6. The regional committees and the National Committee shall each submit annual reports containing an account of the activities and practice of the committees during the past year. The annual reports shall describe significant scientific ethical problems discussed by the committees and state the background for the outcome of important issues. The reports shall include a list of all notified projects.
Part 2
Definitions
7. For the purposes of this act:
1) “Biomedical research projects” shall mean a project that involves trials on liveborn human individuals, human germ cells intended to be used in fertilization, human fertilized eggs, embryos and foetuses, tissue, cells and genetic material from humans, foetuses and the like or deceased individuals. In addition, such projects shall also include any trial intended to discover or verify the clinical, pharmacological or other pharmacodynamic effects, identify any adverse reactions or study pharmacokinetics(absorption, distribution, metabolism and excretion) with the object of ascertaining the safety or efficacy of medicinal products.
2) "Multi-centre clinical trial" shall mean any trial carried out in accordance with one and the same trial protocol, but in different locations, with one investigator as co-ordinator or with different investigators. Trial sites may be located in an individual member state, in several member states or in member states and third countries.
3) “Sponsor” shall mean an individual or a corporate body assuming responsibility for the implementation, management or financing of a biomedical research project.
4) “Investigator” shall mean an individual who is engaged in a profession authorised to perform research, for instance through employment as a researcher or a PhD-student or otherwise through employment within actual research, and who is responsible for the practical implementation of the trial on a specific trial site.
5) “Research protocol” shall mean a document that describes the objective(s), design, methodology, planning, statistical considerations, scientific ethical considerations, financial circumstances, publication matters and the informing of the trial subjects in connection with a biomedical research project and shall include the research protocol, subsequent versions of the protocol, changes to the protocol, a lay-person protocol, written information to participants and material for the recruitment of participants.
6) “Trial subject” shall mean an individual who participates in a biomedical research project, either as a recipient of investigational medicinal products or as a participant in a control group.
7) “Permanently legally incompetent adult” shall mean an individual who is covered by the definition in section 5 of the Act on Guardianship where no guardianship has been established.
8) “Informed consent” shall mean a decision in writing, dated and signed, or in electronic form along with an electronic signature, cf. the Act on Electronic Signatures, to take part in a biomedical research project, such decision being taken freely following satisfactory information about the nature, significance, implications and risk of the project and receipt of suitable documentation by a person capable of giving consent.
9) “Surrogate consent” shall mean a decision in writing, dated and signed, or in electronic form along with an electronic signature, cf. the Act on Electronic Signatures, to take part in a biomedical research project, such decision being made by the closest relatives and the general practitioner, alternatively the medical officer of health or the holder of custody or the guardian following satisfactory information about the nature, significance, implications and risk of the project and receipt of suitable documentation.
10) “Research biobank” shall mean a structured collection of human biological material stored for the purpose of biomedical research, which is accessible under certain criteria and where information bound in the biological material may be traced back to individuals.
Part 3
Notification and authorisation
8.-(1) The investigator shall report any biomedical research projects, cf. section 7, subparagraph 1) to the regional committee for the area in which the investigator is operating. The notification to the regional committee must be in writing or in electronic form with the use of an electronic signature, cf. the Act on Electronic Signatures.
(2) In case of multi-centre trials the investigator co-ordinating the project, or the various investigators, shall report the project to the regional committee for the area in which the investigator is operating. The committee shall notify the other committees of its authorisation. In case of cross-border multi-centre trials, however, notification shall always be made in Denmark.
(3) Questionnaire-based projects and register research projects shall only be notified to a regional committee if the project also involves human biological material.
(4) Trials on cell lines or the like originating from a trial involving collection of cells or tissue for which the necessary authorisation has been obtained shall not be notified.
(5) The Minister for Science, Technology and Development may lay down detailed rules on the issues mentioned in subsection 4 above.
(6) Subsections 4 and 5 shall not apply to trials concerning the use of fertilized eggs, stem cells and stem cell lines from these, the purpose of which is to obtain new knowledge that may improve the treatment of human illnesses, cf. the Act on Artificial Fertilization in connection with medical treatment, diagnostics and research, etc.
9.-(1) Projects that are notifiable pursuant to section 8 above shall not be initiated until scientific ethical evaluations have been made and authorisations for the initiation have been granted by the regional committee. Furthermore, clinical trials involving medicinal products shall be conditional upon authorisation pursuant to the Act on Medicinal Products.
(2) The committee shall inform the Medicines Agency of its decision.
(3) If a regional committee is unable to reach agreement on the evaluation of a project, the project shall be submitted to the National Committee for decision, cf. section 24 below. In that case the project may not be initiated until the National Committee has approved the project.
(4) The committees shall take advice from experts in cases where they do not themselves have the necessary professional expertise to evaluate projects submitted to them. When processing an application for trials on minors, the committee shall take advice from an expert in paediatrics. When processing an application for trials on individuals comprised by section 5 of the Act on Guardianship regarding personal circumstances and permanently legally incompetent adults, the committee shall take advice from an expert with knowledge on the group of individuals concerned.
Time limits
10.-(1) The committee shall decide on the approval of a project within 60 days of receiving a valid[ibm3] application, however, cf. subsections (2) and (3) below.
(2) The time limit pursuant to subsection (1) above shall be extended by 30 days if the processing concerns an application for the approval of trials involving gene therapy or somatic cell therapy or medicinal products containing genetically modified organisms. The 90-day deadline shall be further extended by 90 days in case of consultation of public boards or commissions. No time limit shall apply to the authorisation period in connection with the processing of an application for the approval of xenogenic cell therapy.
(3) The committee may within the processing period of the application send one request for information supplementary to the information already supplied by the applicant. The time limit pursuant to subsections (1) and (2) above shall be suspended until receipt of such supplementary information.
Part 4
The tasks of the committee system
11.-(1) When processing an application for the approval of a biomedical research project, the committees may not grant authorisation until they have evaluated the circumstances mentioned in this Part and in Part 5. The committees shall not evaluate whether requirements pursuant to other legislation have been met, however, cf. section 14(1), subparagraphs 3), 5) and 6) and section 15(1), subparagraph 1).
(2) The committee shall ensure documentation of the identification of the investigator.
12.(1) The committee may only grant authorisation if
1) any risks in connection with the implementation of the project are neither in themselves nor in relation to the expected benefits of the project of an unjustifiable extent;
2) the project may be justified by the expected therapeutic and public health benefits;
3) the scientific standard of the project meets the requirement that the project must contribute to the development of new, valuable knowledge, cf. section 1(3); and
4) there are sufficient grounds for implementing the project, and the conclusions of the project are justified.
(2) When processing an application for the approval of a biomedical research project, the committee shall weigh the expected risks and inconveniences against the benefits for the individual trial subject and for other present and future patients, especially with regard to pain, discomfort, fear and other foreseeable risks being minimised in relation to the illness and the developmental stage of the trial subject. This weighing shall be carried out with due regard to whether the trial subjects are themselves able to give their informed consent or whether consent must be obtained from the closest relatives and the general practitioner, alternatively the medical officer of health or the holder of custody or a guardian in case of guardianship comprising personal circumstances, including authorisation to consent to participation in a biomedical research project, cf. section 5 of the Danish Act on Guardianship.
(3) The Minister for Science, Technology and Development may lay down detailed rules on the issues mentioned in subsections (1) and (2) above.
13. -(1)When processing an application for the approval of a biomedical research project on trial subjects who are incapable of giving their informed consent, the committee shall in addition to complying with the provisions of section 12 ensure that
1) the project is essential to verify data collected through trials on individuals who are capable of giving their informed consent or through other trial methods;
2) the project concerns directly a clinical condition of that person; and
3) the project may be expected to be beneficial to the group of patients.
(2) A biomedical research project not involving trials with medicinal products may be approved even if the provisions of subsection (1) above have not been met if
1) the project cannot with similar benefit be conducted by including legally competent trial subjects of legal capacity and
2) the project is expected to be of direct benefit to the trial subject.
(3) Furthermore, a biomedical research project not involving trials with medical products may be approved even if the provisions of subsections (1) and (2) above have not been met if
1) the project can only be carried out by the inclusion of individuals comprised by the age group, illness or condition concerned;
2) the project is expected to be of considerable benefit to the group of patients comprised by the same age group, illness or condition as the trial subject ; and
3) the project entails minimal risk and discomfort for the trial subject.
(4) The Minister for Science, Technology and Development may lay down detailed rules on the issues mentioned in subsections (1) – (3) above.
14.-(1)The committee may only grant authorisation if
1) the written or electronic information clearly states the financial support that the investigator receives from private companies, funds etc. for the implementation of the research project concerned, and whether the investigator has any financial connection with private companies, funds etc. with an interest in the research project concerned;
2) any remuneration or other payment for participation in a biomedical research project will not influence the giving of consent;
3) the right of the trial subject to physical and mental integrity and the right to privacy are respected, and if information regarding the trial subject is protected pursuant to the Act on the Handling of Personal Information;
4) the investigator has ensured that the trial subject has access to further information about the project;
5) projects involving the export of biological material and information to third countries are carried out in accordance with the provisions of the Act on the Handling of Personal Information; and
6) both negative and positive trial results are published as soon as possible and as soon as it is professionally justifiable. Publication shall be carried out in accordance with the Act on the Handling of Personal Information.
(2) The Minister for Science, Technology and Development may lay down detailed rules on the issues mentioned in subsection (1) above.
15.-(1)When processing an application for the approval of a biomedical research project concerning clinical trials with medicinal products comprised by the Danish Act on Medicinal Products, the committee shall, in addition to the matters mentioned in sections 12 – 14, verify
1) that the Danish Medicines Agency is involved in the approval of the project, cf. section 9(1);
2) that a compensation or indemnification scheme is in place in case the trial subject is injured or dies due to the project and that insurance policies have been taken out or that there is an indemnification scheme to cover the investigator’s and the sponsor’s responsibility;
3) the size of and the detailed rules on the payment of any remuneration or compensation to the investigator and trial subjects, and the contents of the relevant clauses in any contemplated contract between the sponsor and the site of the trial; and
4) that the investigator is qualified to make decisions as regards treatment and is an appropriately qualified doctor or, where appropriate, a qualified dentist and has clinical experience.
(2) The Minister for Science, Technology and Development may lay down detailed rules on the issues mentioned in subsection (1) above.
Part 5
Informed consent
Biomedical research projects involving legally competent individuals
16.-(1)The committee may only grant authorisation to initiate and continue a biomedical research project if the legally competent trial subject has given his or her informed consent.
(2) The committee may only grant authorisation to initiate and continue a biomedical research project if the trial subjects involved in the project will receive written and verbal information about the content, foreseeable risks and benefits of the project, and if informed consents will be obtained and given.
(3) If a register research project that is notifiable pursuant to section 8(3) does not involve any health risks for the individual trial subject and will not in any other way according to circumstances cause harm to that person, the committee may decide that the project is not comprised by subsections (1) and (2) or section 17, subsections (1) and (2). Furthermore the committee may decide that a notifiable register research project is not comprised by subsections (1) and (2) or section 17, subsections (1) and (2) if it is impossible or disproportionately difficult to obtain informed consent.
(4) The committee may only grant authorisation if the information clearly states that trial subjects may at any time withdraw their consent pursuant to subsection (1) above.
(5) The committee may only grant authorisation if the trial subject gives his or her informed consent when, in connection with a specific research project, the subject’s tissue is removed with the intention of storing it in a research biobank.
(6) The Minister for Science, Technology and Development may lay down detailed rules on the issues mentioned in subsections (1) – (5) above.
Biomedical research projects involving minors, individuals under personal guardianship and permanently legally incompetent adults
17.-(1)The committee may only grant authorisation to initiate and continue a biomedical research project involving minors if surrogate consent [ibm4]has been obtained from the holder of custody. The surrogate consent shall express the interest of the minor. The committee may only grant authorisation if the minor will receive information from a person with knowledge of the project area and also with educational qualifications to communicate the contents to the age group comprised by the project.
(2) The committee may only grant authorisation to initiate and continue a biomedical research project involving individuals under guardianship and comprising personal circumstances including authorisation to consent to participation in biomedical research projects, cf. section 5 of the Act on Guardianship, if surrogate consent has been obtained from the guardian. The committee may only grant authorisation to initiate and continue a biomedical research project involving permanently legally incompetent adults if surrogate consent has been obtained from the closest relative and the general practitioner, alternatively the medical officer of health. The surrogate consent shall express the interest of the trial subject. The committee may only grant authorisation if the trial subject will receive information adjusted to his/her capacity of understanding.
(3) The committee may only grant authorisation if the information clearly states that the surrogate consent pursuant to subsection (1) above, respectively subsection (2) above, may at any time be withdrawn without this being detrimental to the trial subject. Importance shall be attached to the indications of the trial subject in so far as these are relevant.
(4) The committee may only grant authorisation if the research protocol for projects involving individuals comprised by subsections (1) or (2) is evaluated by an expert with paediatric expertise or expertise in the condition of the group concerned.
(5) The committee may only grant authorisation if surrogate consent is obtained if, in connection with a specific research project, the tissue of the minor, the trial subject under guardianship or the permanently legally incompetent adult is removed with the intention of storing it in a research biobank.
(6) The Minister for Science, Technology and Development may lay down detailed rules on the issues mentioned in subsection 1-5.
Biomedical research projects involving deceased individuals
18.-(1)The rules on consent laid down in this Act shall not apply to the processing of applications for the approval of a biomedical research project involving deceased individuals comprised by the Act on Coroner’s Inquests, Post-Mortem Examinations, Transplantation Etc.
(2) Surrogate consent shall be obtained from the closest relative in connection with the processing of applications for the approval of a biomedical research project involving deceased individuals who are not comprised by the Act on Coroner’s Inquests, Post-Mortem Examinations, Transplantation Etc.
Exemptions from the requirement for surrogate consent regarding 15 – 17 year olds
19.-(1) The committee may grant exemptions from the requirement for consent from the holder of custody, cf. section 17(1), if the trial subject has attained the age of 15 and is not legally competent and if the subject in question gives his/her informed consent. The exemption shall be given with due regard to the nature, risk and harmfulness of the project.
(2) If the 15 – 17 year old minor gives his/her informed consent pursuant to subsection (1), the holder of custody shall receive the same information and shall be involved in the decision of the 15 – 17 year old.
Research in emergency situations
20.-(1) If the nature of the project means that it can only be implemented in emergency situations where the trial subject is unable to give his/her informed consent and it is impossible to obtain surrogate consent, the project may be implemented if it may in the long term improve the health of the subject.
(2) The investigator shall as soon as possible thereafter attempt to obtain informed consent or surrogate consent.
(3) However, subsections (1) and (2) above shall not apply to clinical research with medicinal products.
Consent in other situations
21. As regards the processing of an application for the approval of a biomedical research project that is notifiable pursuant to section 8 above but not comprised by sections 16 – 20 above, the Minister for Science, Technology and Development shall lay down detailed rules on the obtaining of informed consent or surrogate consent if the requirement for consent is not prescribed by other legislation.
Part 6
Implementation and control of biomedical research projects
22.-(1) The regional committee shall monitor that the biomedical research project is carried out in accordance with the authorisation given, cf. section 9.
(2) A committee may follow the course of a project and request that the final research report or publication be sent to the committee. The committee may request a reasoned statement from the investigator or the sponsor in cases where the project is not completed.
(3) The investigator shall immediately inform the scientific ethical committee if serious adverse reactions or serious events are encountered during the project. When reporting serious events caused by the project such as deaths, the investigator shall submit the information requested by the committee.
(4) Once every year during the entire research period the sponsor or the investigator shall to the committee submit a list of all serious adverse reactions and all serious events encountered during the period and shall provide information about the safety of the trial subjects.
(5) Subsections (1) and (3) above shall not apply to clinical research with medicinal products.
Amendments to an approved biomedical research project
23. During the implementation of an approved biomedical research project, cf. section 9, amendments may only be made according to the following rules:
1) Substantial amendments to the research protocol may only be made following approval by the committee system. The sponsor or the investigator shall, according to the circumstances, take the appropriate urgent safety measures to protect the subjects.
2) The committee shall make a statement within a time limit of 35 days after receipt of the valid application for amendment. Amendments to the research protocol may only be initiated when the committee’s approval is available. The committee’s decision may be brought before the National Committee.
3) 90 days after the completion of a biomedical research project the investigator shall inform the committee that the project has been completed. If a project is terminated earlier than planned, the time limit for informing the committee shall be 15 days from the time when the decision to terminate the project is made. The grounds for the premature termination shall be given.
Part 7
The Danish National Committee for Biomedical Research Ethics
24. It shall be the responsibility of the National Committee
1) to coordinate the work of the regional committees, lay down guidelines and make statements regarding issues of a principle nature if these are not included in the approval of a specific research project;
2) to monitor the development of research within the health care sector and further the understanding of the ethical problems resulting from the development in relation to the public, the authorities etc.; and
3) to process research projects presented to the Committee pursuant to section 9(3) and act as an appeals body for the decisions of the regional committees.
25.(1) An investigator whose application for the approval of a biomedical research project has been refused may bring the decision before the National Committee no later than 30 days after receipt of the decision of the regional committee. Individuals who are parties to the case in the meaning of the Danish Public Administration Act may also bring a project before the National Committee no later than 30 days after the decision of the regional committee. The National Committee shall make a decision within the time limit stated in section 10 and section 23(1), subparagraph 2). Complaints to the National Committee shall be in writing or in electronic form with the use of an electronic signature, cf. the Act on Electronic Signatures.
(2) If the National Committee is unable to reach agreement on the evaluation of a project, the Committee may make its decision by simple majority, provided that the majority comprises a majority among both the members active within medical research and the lay members appointed to the Danish National Committee for Biomedical Research Ethics, cf. section 4(2). In connection with a vote, the chairperson of the National Committee shall be regarded as a member who is active within medical research. The other three members appointed by the Minister shall in connection with a vote be regarded as lay members.
(3) Decisions by the National Committee may not be brought before another administrative authority.
26. The Minister for Science, Technology and Development may upon the recommendation of the Danish National Committee for Biomedical Research Ethics lay down rules to the effect that the processing of projects within specific, new research areas not involving clinical research with medicinal products may be suspended for a specified period until general ethical or scientific ethical clarification has taken place.
27. The Minister for Science, Technology and Development may upon recommendation from the Danish National Committee for Biomedical Research Ethics lay down rules for the regional committees on the scientific ethical evaluation of research projects within specific, new research areas. The Minister may in this connection decide that section 8(4) and (5) shall not apply to such a specific, new research area.
Part 8
Funding
28.-(1) The costs of the regional committees shall be paid by the county councils. The Copenhagen Hospital Corporation shall pay a proportional part of the costs of the regional committee serving the institutions of the Corporation. Research institutions etc. and private companies and hospitals shall as part payment of the costs pay a fee per project to the relevant county council. The county councils shall decide the size of the fee, which shall not exceed an amount corresponding to the project’s expected share of the relevant committee’s total annual expenditure.
(2) The expenditure of the National Committee shall be paid by the Minister for Science, Technology and Development. The Minister shall provide the Committee with the necessary secretarial assistance.
(3) Members of the regional committees and their substitutes, if any, shall be reimbursed for their expenses according to the rules in section 16(10) of the Danish Local Government Act. The county council may decide that the members and their substitutes, if any, shall also be paid attendance fees and compensation for documented loss of earnings pursuant to the provisions of section 16 a of the Local Government Act. Furthermore, county councils may decide that membership of a regional committee shall be remunerated at DKK 10,000 per year, that the job as chairperson of a regional committee shall be remunerated at DKK 35,000 per year and that the job of deputy chairperson shall be remunerated at DKK 30,000 per year. A chairperson or deputy chairperson receiving remuneration shall not at the same time receive attendance fees or compensation for documented loss of earnings.
(4) Members of the National Committee and their substitutes, if any, shall, apart from the chairperson and the deputy chairperson and the three members appointed by the Minister, receive attendance fees, compensation for documented loss of earnings and reimbursement of expenses pursuant to the provisions of section 16 a of the Local Government Act.
(5) The relevant county council shall pay the costs involved in remunerating members of the regional committees and the members of the National Committee who are also members of a regional committee. The same shall apply to costs in relation to any substitutes. The cost of fixed remuneration to the chairperson, the deputy chairperson and the three members of the National Committee appointed by the Minister shall be paid by the Minister for Science, Technology and Development.
(6) The Minister for Science, Technology and Development may lay down detailed rules on the issues mentioned in subsection (1) above.
Part 9
Penal provisions
29.-(1) Any person who initiates a project contrary to sections 8, 9 and 23 or initiates a project contrary to the terms of the authorisation, cf. Parts 4 – 6 may be punishable by fine or imprisonment up to four months.
(2) Regulations issued pursuant to the Act may determine penalties in the form of fines for violation of the provisions of the regulations.
(3) Companies etc. (corporate bodies) may be held criminally liable pursuant to the provisions of Part 5 of the Danish Criminal Code.
Compensation
30.-(1) The sponsor or, if Danish courts do not have jurisdiction over the sponsor , the investigator shall pay compensation of DKK 1,000 to any person who participates in a project initiated contrary to sections 8, 9 and 23 or who has not given their informed consent, cf. sections 16 and 19, or where surrogate consent has not been obtained, cf. section 17, unless the investigator or the sponsor is able to document that this is not due to an error on the part of the investigator or the sponsor.
(2) The provisions of subsection (1) do not affect a person’s right to compensation pursuant to the general rules of Danish law.
Part 10
Commencement etc.
31.-(1) This Act shall come into force on 1 June 2003.
(2) The Act shall apply to the processing of applications for the approval of biomedical research projects notified after 1 May 2004.
(3) Act on a Biomedical Research Ethics Committee System and the Processing of Biomedical Research Projects, cf. Consolidated Act No. 69 of 8 January 1999, shall be repealed on 1 May 2004, cf. subsection (2).
(4) Regulations issued pursuant to the Act, cf. subsection (3), shall remain in force until they are repealed or replaced by new regulations.
(5) Members of present committees shall continue their activities until the end of their appointment period with the possibility of re-appointment if they could have been re-appointed pursuant to the previous act.
(6) The Minister for Science, Technology and Development shall lay down detailed rules on the transitional provisions regarding the processing of applications for the approval of biomedical research projects notified before 1 May 2004.
32. This Act shall not extend to the Faroe Islands or Greenland, but may by Royal decree be extended to these parts of the realm with the variations dictated by the special conditions in the Faeroe Islands or Greenland.
Given at Christiansborg Castle, 28th May 2003
Under Our Royal Hand and Seal
MARGRETHE R.
/Helge Sander
1) The Act contains provisions implementing part of the European Parliament and Council Directive 2001/20/EC of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ 2001 no. L 121, p. 0034-0044)