8. oktober 2013

Act on Research Ethics Review of Health Research Projects

Be aware that some regulations in the law has changed. The newest version is available at Retsinformation.dk
WE, MARGRETHE THE SECOND, by the Grace of God Queen of Denmark, hereby Make Known:

The Danish Parliament (Folketinget) has passed and we have granted our Royal Assent to the following Act:

Part 1

Purpose and scope of the act

Section 1

(1) The purpose of the system of research ethics committees is to secure that health research projects are undertaken such as to be justified with regard to research ethics. Consideration for the rights, safety and well-being of trial subjects come before scientific and social interests in the possibilities of gaining new knowledge or investigating existing knowledge that may justify the undertaking of a research project.

(2) The system of research ethics committees consists of regional committees and a national committee, cf. Part 7.

(3) The research ethics committees are independent and consist of members who are active within health research as well as lay persons who have no training within health care and who do not at the time of membership have any affiliation to the health care professions.

(4) The act lays down the legal framework for the research ethics evaluation of health research projects by the committees and lays down the tasks of the committee system on this basis. 

Part 2

Definitions

Section 2

(1) For the purposes of this act the following definitions shall apply:

    1) Health research project: A project that includes trials involving liveborn human individuals, human gametes intended for fertilization, fertilized human eggs, embryonic cells and embryos, tissue, cells and genetic material from humans, embryos etc. or deceased persons. Also included are clinical trials of medicines in humans, cf. no. 2) below, and clinical trials of medical devices, cf. no. 3) below.

    2) Health research project that concerns clinical trial of medicines: Any trial on humans with the aim of uncovering or verifying the clinical, pharmacological or other pharmacodynamic effect of one or several trial medicines or to identify adverse reactions to one or several trial medicines or to investigate absorption, distribution, metabolism or excretion of one or several trial medicines with a view to assessing their effect or safety.

    3) Health research project that concerns clinical trial of medical devices: Any trial on humans with the aim of uncovering or verifying the safety or the performance of medical devices.

    4) Multi-centre trial: A trial that is undertaken on the basis of a single trial protocol but in different sites with a coordinating investigator or with several investigators. Trial sites may all be located in Denmark or in Denmark and in other EU member states or third countries.

    5) Sponsor: A natural or legal person who takes responsibility for the initiation, management or financing of a health research project.

    6) Investigator: An individual who exercises a profession that is approved for the carrying out of research, e.g. though employment as a researcher or Ph.d. student or otherwise through involvement in concrete research, and who is responsible for the practical carrying out of the trial at a given site.

    7) Trial protocol: A document that describes objectives, design, methodology, organisation, statistical considerations, research ethics considerations, financial aspects, publication issues as well as how participants in a health research project are to be informed.

    8) Trial subject: An individual who takes part in a health research project regardless of whether this individual is given trial preparations etc. or is part of a control group.

    9) Incapacitated adult: An individual who is covered by the definition in Section 5 of the Guardianship Act, including when guardianship has been established in a manner that includes powers to give informed consent for participation in health research projects.

    10) Informed consent: A decision to participate in a health research project which has been communicated in writing duly dated and signed or has been communicated electronically with the use of digital signature, and which has been taken freely by an individual able to give consent who has received adequate information on the project’s nature, significance, implications and risks as well as adequate documentation.

    11) Consent by proxy: A decision to participate in a health research project which has been obtained from the legal representative, the holder of custody or the trial guardian or from the nearest relative and the general practitioner or, if the general practitioner is not available, the National Board of Health, and which has been communicated in writing duly signed and dated or communicated electronically with the use of digital signature.

    12) Trial guardian: A unit consisting of two doctors who in acute situations, cf. Section 12, may give proxy consent on behalf of the trial subject for participation in a health research project that concerns clinical trial of medicines. The trial guardian must safeguard the trial subject’s interests and be independent of the investigator’s interests and interests in the research project otherwise.

    13) Research biobank: A structured collection of human biological material that is kept with a view to a concrete health research project, and which may be accessed according to defined criteria and where information bound in the biological material may be traced to individuals.

    14) Adverse event: Any unwanted event in a trial subject who participates in a research project following activity as described in the trial protocol without necessarily a relationship between this activity and the adverse event.

    15) Adverse reaction: Any harmful and unwanted reaction to an activity as a result of participation in the research project.

    16) Unexpected adverse reaction: An adverse reaction whose character or severity does not match the risk incurred by the activity in question as described in the trial protocol.

    17) Serious adverse event or serious adverse reaction: An adverse event or an adverse reaction which regardless of e.g. dose is fatal, is life-threatening, leads to hospital admission or prolongation of ongoing hospital stay, results in lasting or considerable disablement or incapacity for work or leads to congenital anomaly or malformation.

Part 3

Informed consent for participation in health research projects

Section 3

(1) Health research projects that must be notified to the committee system according to Section 14, may include trials on humans if the trial subject has given informed consent for participation prior to the trial, cf., however, (2) below.

(2) Consent must be given as proxy consent according to Section 4 if the trial subject

    1) is a minor,

    2) is under guardianship that includes powers to give informed consent for participation in health research projects, cf. the Guardianship Act Section 5 (1), or

    3) otherwise is an incapacitated adult.

(3) Consent includes access to the communication and processing of required information on the trial subject’s health, other wholly personal matters and other confidential information as part of own control of the research project including quality control and monitoring which a sponsor or a possible monitor is under obligation to undertake.

(4) Consent may be withdrawn at any time without this being detrimental to the trial subject.

(5) In connection with research ethics evaluation of concrete health research projects the committee may deviate from (1) and (2) above according to the criteria laid down in Sections 8 to 12.

Section 4

(1) Proxy consent on behalf of trial subjects that are minors, must be given by the holder of custody.

(2) Proxy consent on behalf of trial subjects under guardianship that includes powers to give informed consent for participation in health research projects, cf. the Guardianship Act Section 5 (1), must be given by the guardian.

(3) Proxy consent on behalf of other incapacitated adult trial subjects must be given by their nearest relative and their general practitioner or, if the general practitioner is not available, the National Board of Health.

(4) Proxy consent must express the trial subject’s interests. The trial subject’s declarations should be taken into consideration to the extent that these declarations are topical and relevant.

(5) Complaint against a general practitioner’s proxy consent cannot be put to the National Agency for Patients' Rights and Complaints or to the health care disciplinary board under the act on complaints and compensation in the healthcare sector.

Section 5

(1) Consent according to Sections 3 and 4 must be given against the background of written and oral information on the content of as well as foreseeable risks and benefits of the research project. It must be clear from the information that consent may be withdrawn at any time.

(2) If the trial subject is a minor, under personal guardianship or otherwise is an incapacitated adult, the information must be adapted to the trial subject's capacity for understanding. Information for minors must be provided by a person with knowledge of the field that the project concerns, and who has the pedagogical competences required for communication of such information to the age group covered by the research project.

(3) The information mentioned in (1) above must also be communicated to persons who are entitled to give proxy consent on behalf of a trial subject.

Section 6

The consent requirements laid down in Sections 3 to 5 also apply to the removal of tissue and other biological material in connection with concrete research projects with a view to storage in a research biobank. 

Section 7

The Minister for the Interior and Health may lay down further rules on consent and information according to Sections 3 to 5. Unless consent requirements follow from other legislation, the Minister for the Interior and Health may lay down further rules for the obtaining of informed consent or proxy consent for use in connection with notifiable health research projects that do not involve trial subjects.

Health research projects that involve deceased persons

Section 8

(1) Health research projects may involve the use of tissue or other biological material from deceased persons that is removed in connection with autopsy according to Part 56 of the Health Care Act, if consent for use of the material for research purposes has been obtained either from the deceased person or from the nearest relative according to Section 187 of the Health Care Act on consent for autopsy for health research purposes. Tissue and other biological material removed in connection with forensic autopsies prior to the coming into force of this act may be used for health research without consent being obtained according to sentence 1 above.

(2) Health research projects may involve the use of tissue and other biological material from deceased persons without the removal being covered by Part 56 of the Health Care Act on autopsy, if the nearest relative has given consent for use of the material for research purposes. Consent by the nearest relative must be given against the background of written and oral information on the content of the research project. 

Exemption from the consent requirement for 15 to 17-year-olds

Section 9

(1) The committee may grant exemption from the requirement of proxy consent from the holder of custody, cf. Section 3 (2) no. 1, and Section 4 (1) in the case of a trial subject that has turned fifteen years of age but has not yet come of age if the minor in question gives informed consent. A decision to grant exemption must be taken with consideration for the nature as well as the risk and the strain of the research project.

(2) When the minor's own informed consent is deemed sufficient, cf. (1) above, the holder of custody must be given the same information as the minor and must be involved in the minor's decision process. 

Database research projects

Section 10

(1) The committee may grant exemption from the requirement of consent or proxy consent according to Sections 3 to 5 if a notifiable database research project does not involve any health risks and if under the given conditions the research project cannot otherwise put a strain on the trial subject.

This also applies if it would be impossible or disproportionately difficult to obtain informed consent or proxy consent respectively.

(2) The Minister for the Interior and Health may lay down further rules on the issues mentioned in (1) above. 

Research in acute situations

Section 11

(1) The committee may allow that a health research project that does not concern clinical trial of medicines is undertaken without prior consent according to Sections 3 to 5 if the nature of the research project is such that it can only be undertaken in acute situations in which the trial subject is not able to give informed consent and when it is not possible to obtain proxy consent, if

    1) participation in the trial may improve the person's health in the long term, or

    2) the trial may improve the condition of other patients with the same disease as the trial subject and participation in the trial involves only minimal strain and risk for the trial subject.

(2) Following such a trial the investigator must seek to obtain informed consent or proxy consent as soon as possible.

Section 12

(1) The committee may allow that a health research project that concerns clinical trial of medicines is undertaken without prior consent according to Sections 3 to 5 if proxy consent is instead obtained from the trial guardian, and if the nature of the research project is such that it can only be undertaken in acute situations in which the trial subject is not able to give informed consent and it is not possible to obtain proxy consent according to Sections 3 and 4.

(2) Following such a trial the investigator must seek to obtain informed consent or proxy consent according to Sections 3 and 4 as soon as possible. 

Part 4

Notification of health research projects

The significance of notification

Section 13

(1) Health research projects that are notifiable according to Section 14 may not be commenced without permission from the competent research ethics committee.

(2) If a research project involves clinical trial of medicines or clinical trial of medical devices that must be approved by the Medicines Agency, the permission of the committee system to undertake the project presupposes the permission required according to the medicines act and the medical devices act respectively.

 

Notification obligation

Section 14

(1) Any health research project must be notified to the system of research ethics committees, cf., however, (2) to (5) below.

(2) Notification of questionnaire surveys and medical database research projects to the system of research ethics committee system is only required if the project involves human biological material.

(3) Health research projects that solely involve anonymous human biological material collected in accordance with legislation at the site of collection need only be notified to the system of research ethics committees if the research project is regulated under Section 25 in the act on artificial insemination in connection with medical treatment, diagnostics and research etc.

(4) Trials involving cell lines etc. which originate from a trial regarding the collection of cells or tissue, and which have obtained the required permission, need only be notified if the trial concerns the use of fertilised eggs, stem cells and stem cell lines from these, cf. Sections 25 and 27 (2) of the act on artificial insemination in connection with medical treatment, diagnostics and research etc.

(5) The Minister for the Interior and Health may lay down further rules on exemption from the notification obligation pursuant to (4) above. Following recommendation from the national committee the Minister for the Interior and Health may, furthermore, lay down rules on notification obligations for further defined new fields of research which would otherwise be exempt from the obligation pursuant to (4) above.

Competence

Section 15

(1) Notification of health research projects must be addressed to the regional committee for the area in which the investigator is active. Health research projects that concern especially complex areas must, however, be notified to the national committee. The notification obligation rests with the investigator as well as with the sponsor, and both must sign the notification.

(2) Cross border multi-centre trials must always be notified in this country. If there are several investigators in Denmark and if the research project is not covered by (1) 2nd sentence above, the multi-centre project must be notified to the regional committee where the coordinating investigator is active.

(3) On the basis of recommendation from the national committee the Minister for the Interior and Health shall lay down further rules concerning what health research projects must be notified to the national committee pursuant to (1) 2nd sentence above.

Notification format

Section 16

(1) Notification must be submitted electronically using a digital signature to the competent research ethics committee along with the trial protocol and other information required for the committee’s assessment of whether the research project may be permitted, cf. Section 17 (1) and Sections 18 to 21, including documentation regarding the identities of the sponsor and the notifying investigator as well as the investigator’s education and training.

(2) The Minister for the Interior and Health shall lay down further rules with regard to the format of trial protocols and on what other information is required for assessment by the committee system, cf. (1) above, and the Minister may lay down further rules on notification procedures. 

Part 5

Research ethics evaluation and administrative procedures of the committees

Research ethics evaluation

Section 17

(1) The committees undertake a research ethics evaluation of notifiable health research projects on the basis of criteria laid down in this act, including Sections 18 to 22, as well as an evaluation of whether the research project is designed in such a way that the required consent for the participation of trial subjects in the project will be sought and given, cf. Part 3. On the basis of the evaluation the competent committee decides whether a given project shall be permitted.

(2) The competent committee may attach conditions to its permission.

(3) In connection with a decision on permission the competent committee decides how the carrying out of a trial shall be monitored, cf. Section 28.

Section 18

(1) It is a condition for the granting of permission that

    1) the extent of the risks that the trial may involve is not unjustifiable, neither as such nor in relation to the foreseeable benefits of the trial,

    2) the expected benefits from a therapeutical perspective as well as from a public health perspective may justify the project,

    3) the project’s scientific standard meets the requirement that the project should lead to new knowledge or investigate existing knowledge, which justifies the implementation of the research project, cf. Section 1 (1) 2nd sentence, and

    4) there is sufficient reason to undertake the project and expectations as to the project’s conclusions are justified.

(2) The competent committee must balance the foreseeable risks and drawbacks in relation to the benefit for the individual trial subject and for other present and future patients, including whether pain, discomfort, fear and other foreseeable risks are minimised in relation to the trial subject’s disease and stage of development, cf. Section 1 (1) 2nd sentence. This balancing must take into account whether the trial subject is able to give informed consent or whether informed consent must be obtained in the form of proxy consent.

(3) The Minister for the Interior and Health may lay down further rules on the issues mentioned in (1) and (2) above.

Section 19

(1) In order for permission to be given to health research projects which include trial subjects that are unable to give informed consent, it is a condition furthermore that

    1) the project is decisive in order to verify data obtained from trials involving persons who are able to give informed consent or through other trial methods,

    2) the project is directly linked to the intended trial subject’s clinical condition, and

    3) the project may be expected to benefit the patient group.

(2) If the conditions in (1) above are not met, and if the notified health research project does not involve clinical trial of medicines, it is, however, a condition, cf. (3) below, that

    1) the project cannot be carried out with similar benefits using trial subjects who are able to give informed consent, and

    2) the project is likely to benefit the trial subject directly.

(3) If neither the conditions in (1) or (2) above are met, and if the notified health research project does not involve clinical trial of medicines, it is a condition that

    1) the project can only be implemented by involving persons of a given age group or persons who have a given disease or condition,

    2) the project is likely to directly lead to great benefits for the patient group that falls within the same age group or who suffer from the same disease or condition as the trial subject, and

    3) the project involves minimal risks and discomfort for the trial subject.

(4) The Minister for the Interior and Health may lay down further rules on the issues mentioned in (1) to (3) above.

Section 20

(1) In order for permission to be given for health research projects, it is furthermore a condition that

    1) the investigator is qualified to take treatment decisions and has proper training and clinical experience,

    2) it is clear from written or electronic information what financial support the investigator receives from private companies, foundations etc. for the undertaking of the research project in question and whether the investigator otherwise has any financial affiliation to private companies, foundations etc. who have an interest in the research project under consideration.

    3) any payment or other compensation for trial subjects in return for participation in a health research project is not such as to affect the giving of consent,

    4) the trial subject’s right to physical and mental integrity and the right to privacy are respected and information concerning the trial subject is protected according to the act on data protection,

    5) the principal investigator has secured that the trial subject has access to further information on the project,

    6) projects that involve export of biological material and information to third countries must be undertaken in accordance with the rules laid down in the act on the processing of personal data,

    7) there is a compensation or indemnification arrangement if the trial subject suffers any harm or dies as a consequence of the project, and an insurance has been taken out or other compensation arrangement is in place to cover the liability of the investigator and the sponsor vis-à-vis the participating trial subjects, and

    8) publication is undertaken in accordance with the act on the processing of personal data both with regard to negative, inconclusive and positive trial results as soon as this is possible and justifiable from a professional point of view.

(2) The Minister for the Interior and Health may lay down further rules on the issues mentioned in (1) above.

Section 21

(1) In order to get permission for a health research project that involves clinical trial of medicines covered by the medicines act or clinical trial of medical devices covered by the act on medical devices, it is a condition that

    1) the Medicines Agency is involved in the approval of the project, cf. Section 13 (2), and

    2) the investigator is qualified to take treatment decisions and has appropriate medical training as a doctor or, when this is relevant, a dentist, and has clinical experience.

(2) Furthermore the competent committee must ensure the extent of and the detailed rules for the payment of any fee or any compensation to the investigator and the trial subjects as well as the content of the relevant provisions of any considered contract between the sponsor and the site of the trial.

(3) The Minister for the Interior and Health may lay down further rules on the issues mentioned in (1) above.

Assistance by consultants

Section 22

(1) The competent committee must use assistance from consultants in cases when the committee itself does not have the professional expertise required to evaluate notified projects.

(2) In connection with the processing of notified research projects that involve incapacitated adults, the trial protocol must be assessed by an expert who has knowledge of the group of individuals in question. In connection with the processing of notified research projects that involve minors, the trial protocol must be evaluated by an expert in paediatrics if the minor is involved an intervention trial. 

Time-limits for processing etc.

Section 23

(1) The committee must decide on approval of a project within 60 days of having received an appropriately presented notification, cf. Section 16, cf., however, (2) to (4) below.

(2) The time-limit pursuant to (1) above is prolonged by 30 days if a notification concerns trials involving genetic therapy, somatic cell therapy or medicines that contain genetically modified organisms. The time-limit of 90 days is prolonged by another 90 days if public boards and committees are to be heard. If a notification concerns trial involving xenogeneic cell therapy, there is no time-limit for the processing of the notification.

(3) Within the period during which the notification is being processed, the committee may on a single occasion request information in addition to what has already been provided by the applicant with the effect that the time-limit in (1) and (2) above is suspended until the supplementing information has been received.

(4) The Minister for the Interior and Health may lay down rules requiring the research ethics committees to decide on the approval of projects within shorter time-limits than laid down in (1) to (3) above against charging a special fee for speedy processing.

(5) Following recommendation from the national committee the Minister for the Interior and Health may in special cases lay down rules to the effect that research projects within further defined new fields of research that do not involve clinical trial of medicines in special cases may be suspended for a determined period until general ethical or scientific clarification has been obtained.

Decision procedures

Section 24

(1) If in the competent committee it is not possible to reach agreement on the evaluation of a health research project, the committee shall take a vote to decide whether the project is to be approved and its implementation should be permitted, cf., however, (3) and (4) below. The project is approved if a qualified majority, cf. (2) below, of the members of the competent committee based on a research ethics evaluation according to Section 17 find that the research project may be approved, possibly on certain conditions. In the case of parity the vote of the committee’s chair shall be decisive, and if the chair is unavailable, the vote of the deputy chair shall be decisive.

(2) The chair or if the chair is not available the deputy chair, must be part of the majority. In a regional committee there must, furthermore, be a majority for the decision both among lay members and among medical members.

(3) If in connection with a regional committee’s processing of a notified project both lay members and medically appointed members and altogether at least one third of the members of the committee express a wish to this effect, the research project shall be put before the national committee which will take a final decision.

(4) The chair of a regional committee may decide on behalf of the committee in cases that are deemed not to provide any reason for doubt. 

Communication of permission and orientation

Section 25

(1) The competent committee shall communicate its decision whether a health research project may be permitted, or its decision according to Section 24 (3), to the investigator and the sponsor.

(2) If a decision has been taken by the chair, the remaining members of the committee must be informed of this decision at a time reasonably ahead of the time when the decision is communicated to the investigator and the sponsor.

(3) The competent committee shall inform the Medicines Agency about decisions that concern clinical trial of medicines or clinical trial of medical devices.

(4) The competent committee shall inform other affected regional committees and the national committee about decisions on multi-centre trials.

Complaints procedures

Section 26

(1) Within a time period of 30 days after having been informed of a decision on approval of a notified research project by a regional committee, the investigator and the sponsor may together put this decision before the national committee with a view to renewed processing and decision. Within a delay of 30 days after a decision any person who otherwise is party to the case, may put a decision taken by a regional committee before the national committee with a view to renewed processing and decision. The complaint must be submitted electronically with the use of digital signature.

(2) Complaints concerning legal aspects of decisions on research projects that concern especially complex areas taken by the national committee, cf. Section 15, shall be put before the Ministry of the Interior and Health. The provisions of (1) above also apply to these complaints. 

Part 6

The carrying out of health research projects, follow up, control and other tasks of the committee system

 

Amendment of approved health research projects

Section 27

(1) Significant amendments of the trial protocol for an approved health research project may only be introduced following permission from the committee system. If a research project involves clinical trial of medicines or clinical trial of medical devices that must be approved by the Medicines Agency, the permission of the committee system to introduce amendments of the protocol presupposes the permission required according to the medicines act and the medical devices act respectively. The sponsor or the investigator must secure the required emergency procedures in order to protect the involved trial subjects.

(2) Amendments covered by (1) above must be notified to the committee that has approved the research project in question. This notification must be submitted electronically using digital signature along with the amended protocol and other information required for the committee’s assessment of whether the amendment may be approved.

(3) The competent committee shall decide according to Sections 17 to 25 whether the amendment under consideration can be approved. There is a time-limit for processing, however, of 35 days from the reception of an adequately presented notification.

(4) Section 26 also applies to decisions regarding amendment of an approved health research project.

(5) The Minister for the Interior and Health shall lay down further rules with regard to the format of amended protocols and with regard to what other information is required for the assessment by the committee system of whether an amendment is to be approved, cf.(2) 2nd sentence above.

Supervision

Section 28

(1) The regional committee that has approved the carrying out of a research project shall supervise that an approved health research project which does not involve clinical trial of medicines, is carried out in accordance with this act. If the approval has been given by the national committee, supervision is taken care of by the regional committee in the area where the investigator is active unless because of the complexity of the project the regional committee in question requests the national committee to supervise a given project. Supervision of approved health research projects that involve clinical trial of medicines is taken care of by the Medicines Agency according the medicines act.

(2) The supervising committee may follow the course of a research project and demand that the final research report or publication is sent to the committee.

(3) As part of its supervision of a project that does not involve clinical trial of medicines covered by the medicines act, the supervising committee may require that the project is amended or is temporarily suspended, and in special cases the committee may prohibit a project. These powers also cover notifiable research projects that have been commenced without due permission.

(4) The Minister for the Interior and Health may lay down further rules on the supervision by and the powers of the committees according to (1) to (3) above. 

Access to information etc. in connection with supervision

Section 29

(1) The supervising committee or a representative of this committee may require surrender of all information on the research project that is required for the purposes of supervision. Communication of and processing of required information on the health condition of trial subjects, other purely private matters and confidential information otherwise may take place as part of supervisory activity without the consent of the trial subject.

(2) Against proof of identity and without any court order the supervising committee or a representative of this committee shall have access to companies, hospitals, medical practices and other sites that are affected by the implementation of the research project in order to gather information that is required for the carrying out of the committee’s supervision.

(3) Buildings or parts of buildings that are used solely for private residence are not covered by (2) above. 

Obligation to notify adverse reactions and adverse events

Section 30

(1) The sponsor or the investigator shall immediately inform the supervising committee if during the implementation of a health research project there is any assumption of serious unexpected adverse reactions as a consequence of the project. Unless the research project concerns clinical trial of medicines covered by the supervision of the Medicines Agency according to the medicines act, the notification obligation furthermore covers serious adverse events. When serious adverse events are reported, the supervising committee may require any information from the investigator that the committee finds is relevant for its supervision.

(2) Once a year throughout the trial period the sponsor or the investigator shall send to the supervising committee a list of all presumed serious unexpected adverse reactions that have occurred during the trial period and provide information on the safety of the trial subjects. Unless the research project concerns clinical trial of medicines covered by the supervision of the Medicines Agency according to the Medicines Act, the notification obligation furthermore covers serious adverse events.

 

Notification on the termination of health research projects

Section 31

(1) No later than 90 days after the termination of a notifiable health research project the investigator and the sponsor shall jointly inform the supervising committee that the project has been terminated.

(2) If a research project is discontinued before its planned termination, the investigator and the sponsor shall jointly inform the supervising committee about the project’s discontinuation no later than 15 days following the decision to discontinue the project. The reasons for discontinuation of the project must be stated. If necessary the supervising committee may require that the investigator and the sponsor submit an explanatory report.  

Other tasks

Section 32

(1) The national committee shall coordinate activity in the regional committees, shall lay down recommended guidelines and shall express its opinion on fundamental issues that are not related to the approval of any concrete research project.

(2) The national committee may suggest to the Minister for the Interior and Health that further rules are laid down as provided for in the present act.

Section 33

(1) The committees shall follow development within health care research and try to promote understanding of the ethical issues that this development may lead to in relation to the health care services and health research environments.

(2) The committee system shall actively cooperate with and coordinate tasks with relevant national and international authorities and organisations etc.

(3) The committee system shall secure quality development, quality assurance and learning processes within the committee system. The Minister for the Interior and Health may lay down further rules in this regard.

Section 34

(1) The regional committees and the national committee shall submit a joint annual report with details on the activity and practice of the committees during the previous year.

(2) The annual report, which is to be published, shall include a list of all notified projects and shall describe

    1) general tendencies in the development of the activity of the committee system including cooperation according to Section 33 (2) and activity according to Section 33 (3) in relation to quality development, quality assurance and learning processes within the committee system,

    2) general development trends within health research,

    3) significant issues of research ethics discussed in the committees, and

    4) the reasoning underlying decisions in significant cases.

Part 7

Establishing of research ethics committees 

The regional research ethics committees

Section 35

(1) The regional councils shall set up regional research ethics committees. A regional council may set up one or several committees within its geographical area. A committee may also be set up by several regional councils.

(2) The regional councils may agree on a division of received notifications among themselves.

Section 36

(1) A regional committee shall consist of at least 7 members of which 3 are active within health research. If the regional council finds that considerations for the activity of a regional committee, the number of projects or other reasons indicate this, a committee may consist of 9 or 11 members. If there are 9 or 11 members, 4 or 5 members respectively must be active within health research.

(2) Members of the regional committees must be affiliated to the region or regions that the committee in question covers. The members active within research shall be appointed following recommendation from relevant research fora, cf (7) below. Recommendations shall, if possible, include an equal number of women and men. On appointment it shall be secured to the extent possible that in the committee one gender outnumbers the other by only one member.

(3) The regional committee shall select its chair among the appointed members active within research and a deputy chair among the appointed lay members.

(4) The regional committee shall propose rules of procedure that must be approved by the national research ethics committee.

(5) Committee members are appointed for 4 years corresponding to the electoral period of the regional councils. Members may be reappointed twice. Alternates may be appointed.

(6) The previous committee shall continue its activity until new members have been appointed and the new committee has elected its officers.

(7) The Minister for the Interior and Health may lay down further rules on what fora are considered relevant research fora, cf. (2) above. 

The national research ethics committee

Section 37

The Minister for the Interior and Health shall set up the national research ethics committee.

Section 38

(1) The national research ethics committee consists of 13 members to be appointed as follows:

    1) The Minister for the Interior and Health shall appoint the chair of the national research ethics committee.

    2) 2 members shall be appointed by the Minister for the Interior and Health following joint recommendation from governing boards of the Danish Council for Strategic Research and the Danish Council for Independent Research.

    3) 5 members shall be appointed by the Minister for the Interior and Health in consultation with the minister for science, technology and development following open advertisement.

    4) 5 members shall be appointed by the Minister for the Interior and Health on the basis of recommendations from the individual regions.

(2) To the extent possible an equal number of men and women shall be recommended pursuant to (1) no. 2 above, respectively (1) no. 4 above. Recommendations pursuant to (1) no. 4 shall include as many lay persons as persons who are active within health research.

(3) In connection with appointment it shall be secured that the committee is constituted such as to cover a broad range of members who are active within health research and lay members. On appointment it shall be secured to the extent possible that in the committee one gender outnumbers the other by only one member.

(4) The chair shall represent state research interests as well as interests pertaining to general education, research ethics, general culture or social considerations that are significant to the activity of the national committee.

(5) Members appointed according to (1) nos. 2 and 3 above shall represent research interests as well as interests pertaining to general education, research ethics, general culture or social considerations that are significant to the activity of the national committee.

(6) The chair and the members appointed according to (1) nos. 2 and 3 above may not be members of the Folketing or of regional or municipal councils.

(7) The committee selects its deputy chair among the members appointed.

(8) The committee shall draw up a proposal for rules of procedure to be approved by the Minister for the Interior and Health.

(9) Committee members are appointed for 4 years corresponding to the electoral period of the regional councils. Members may be reappointed twice. Alternates may be appointed.

(10) The previous committee shall continue its activity until new members have been appointed and the new committee has elected its officers.

Part 8

Financing

Section 39

(1)The costs of the regional committees shall be borne by the relevant regional council.

(2) Research institutions etc. and private companies and hospitals shall pay a fee per project or amendment of a project that is notified to the region in question in order to cover part of the cost. The Minister for the Interior and Health shall lay down rules on the amount of such fees and their collection.

(3) Members of the regional committees and any alternates shall receive reimbursement of expenditure according to the provision of Section 11 of the act on the regions.

(4) The Minister for the Interior and Health shall lay down further rules on access for the regions to provide supplementing reimbursement for members of the regional committees and any alternates.

Section 40

(1) The costs of the national research ethics committee shall be borne by the Ministry for the Interior and Health. The Minister for the Interior and Health provides the required administrative assistance for the national committee.

(2) In order to partially cover the cost of processing notifications concerning especially complex areas, cf. Section 15 (1), research institutions etc. and private companies and hospitals shall pay a fee per project or amendment that is notified to the national research ethics committee. The Minister for the Interior and Health shall lay down rules on the amount of such fees and their collection.

(3) The chair and the deputy chair of the national research ethics committee and the 7 members appointed according to Section 38 (1) nos. 2 and 3 and any alternates are paid according to agreement with the Minister for the Interior and Health who shall also bear the cost.

(4) Members of the national research ethics committee appointed according to Section 38 (1) no. 4 and any alternates shall be paid subsistence allowances, compensation for lost earnings and reimbursement of expenditure according to Section 16a in the act on municipal governance. The costs shall be borne by the regional council that has recommended the member in question as member of the committee.  

Part 9

Penalties and compensation

Section 41

(1) Unless a more severe punishment is deserved according to other legislation, a fine or up to 4 months of imprisonment is incurred by anyone who

    1) commences a project in contravention of Sections 13, 14 or 27 or commences a project in contravention of the conditions provided for in the permission given, cf. Section 17 (2),

    2) fails to comply with the notification obligation according to Section 30,

    3) fails to comply with an injunction or disclosure obligation provided for in Section 28 (3) or Section 29 (1),

    4) acts in contravention of injunctions issued according to Section 28 (3), or

    5) denies access of the supervisory authority according to Section 29 (2).

(2) Rules laid down pursuant to this act may include provisions on punishment in the form of penalties for contravention of provisions contained in these rules.

(3) Companies etc. (legal persons) may incur criminal liability according to Part 5 of the penal code.  

Section 42

(1) The sponsor or, if the sponsor does not belong under Danish jurisdiction, the investigator, shall pay a compensation of DKK 1350 to persons who have participated in a project commenced in contravention of Sections 13, 14 or 27 or who have not given informed consent or when proxy consent has not been obtained, cf. Sections 3 to 5 and Section 12 unless the investigator or the sponsor are able to substantiate that this contravention is not caused by any error on the part of the investigator or the sponsor.

(2) The amount of this compensation shall be regulated annually as of January 1 by 2 per cent to which shall be added the adjustment percentage for the fiscal year in question, cf. act on rate adjustment. The resulting amounts shall be rounded up to a figure divisible by an amount of DKK 50. Adjustment shall be undertaken on the basis of the amounts applicable at the time of adjustment prior to rounding up.

(3) Compensation shall be fixed on the basis of the amounts applicable at the time when the trial subject took part in the project.

(4) The provision of (1) above shall be without prejudice to an individual’s access to or the amount of any indemnity according to general Danish legislation.

Part 10

Coming into force, transition arrangements etc.

Section 43

(1) This act shall come into force on January 1 2012 and shall be applicable to health research projects that are notified after its coming into force.

(2) At the same time act no. 402 of May 28 2003 on a research ethics committees system and review of biomedical research projects shall be repealed.

(3) Rules laid down pursuant to act on a research ethics committee system and review of biomedical research projects shall remain in force until they are repealed through provisions laid down pursuant to the present act.

(4) Rules in force till now continue to be applicable to health research projects that have been notified prior to the coming into force of this act.

(5) Members of the existing regional committees shall continue their activity in the regional committees in accordance with the present act until expiry of the period for which they have been appointed. Appointment as member of a regional committee pursuant to the act on a research ethics committee system and review of biomedical research projects shall be taken into account when it is assessed whether a given individual may be appointed as member of a regional committee pursuant to Section 36 (5) of the present act.

(6) The Central Research Ethics Committee shall be abolished as from the coming into force of the present act and shall be replaced by the National Committee on Health Research Ethics.

(7) Appointment of members of the National Committee on Health Research Ethics shall take place prior to the coming into force of the act. The first appointment period shall be shortened so as to expire concurrently with the end of the present regional electoral period. The first appointment period shall not be taken into account when it is assessed whether an individual may be reappointed as a member of the National Committee on Health Research Ethics. Appointment as member of the Central Research Ethics Committee according to act on a research ethics committee system and review of biomedical research projects shall be taken into account when it is assessed whether a given individual may be reappointed as a member of the National Committee on Health Research Ethics according to the present act.

Section 44

In the health care act, cf. Consolidation Act no. 913 of July 13 2010 as amended by Section 2 of Act no. 1546 of December 21 2010 and Act no.327 of April 18 2011 the following amendments shall be made:

  1. In Section 32 “biomedical” shall be changed into “health” and “act on a research ethics committee system and review of biomedical research projects” shall be changed into “act on research ethics review of health research projects”.
  2. In Section 46 (1) “biomedical” shall be changed into “health”.
  3. In Section 46 (2) “act on a research ethics committee system and review of biomedical research projects” shall be changed into “act on research ethics review of health research projects”.

Section 45

In Act no. 440 of June 9 2004 on the Ethics Council as amended by Section 16 of Act no. 545 of June 24 2005 the following amendment shall be made:

  1. In Section 9 (1) “the Central Research Ethics Committee” shall be changed into: “the National Committee on Health Research Ethics”.

Section 46

In Act no. 1180 of December 12 2005 on medicines as amended through Section 81 of Act no. 538 of June 8 2006, Section 1 in Act no. 1557 of December 20 2006, Section 1 in Act no. 534 of June 17 2008 and Section 1 in Act no. 464 of May 18 2011, the following amendment shall be made:

  1. In Section 88 (1) and (6) “act on a research ethics committee system and review of biomedical research projects” shall be changed into “act on research ethics review of health research projects”. 

Section 47

In the act on artificial insemination in connection with medical treatment, diagnostics and research etc., cf. Consolidation Act no. 923 of September 4 2006 as amended by Section 1 of Act no. 1546 of December 21 2010, the following amendments shall be made:

  1. In Section 25 (1) “biomedical” shall be changed into “health”.
  2. In Section 27 (1) “biomedical” shall be changed into “health”.

Section 48

In the act on complaints and access to compensation in the health care services, cf. Consolidation act no. 24 of January 21 2009 as amended by Section 1 of Act no. 706 of June 25 2010 the following amendment shall be made:

  1. In Section 19 (2), Section 38 (2), Section 40 (4) and Section 50 (3) “biomedical” shall be changed into “health”.

Section 49

This act does not apply to the Faroe Islands and Greenland, but Sections 1 to 45 as well as Sections 47 and 48 may through Royal Decree be put into force for the Faroe Islands wholly or in part with the adjustments suggested by Faroese conditions.

Done at Christiansborg Palace, June 14 2011

Margrethe R

/ Bertel Haarder

 

This act contains provisions that implement parts of Directive 2001/20/EC of the European Parliament and the European Council of April 4 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, Official Journal 2001 no. L 121 pages 34-44 as well as parts of directive 2005/28/EC of the European Parliament and the European Council of April 8 2005, Official Journal no. L 91 pages 13-19.