Pursuant to Section 4, subsection 7, of Act No. 1853 of December 9, 2020, on the ethical treatment of clinical trials of medical equipment, etc. ("Equipment Committee Act"), Executive Order No. 966 of May 21, 2021, on the ethical treatment of health science research projects ("Equipment Committee Order"), Executive Order No. 964 of May 21, 2021, on the nomination of research-active members to the medical research ethics committees, and Executive Order No. 965 of May 21, 2021, on feedback on significant health findings from mandatory health science and health data science research projects, clinical trials of medical equipment, etc., and certain registry research projects, the following is determined:
Composition and Constitution
§ 1. The Minister of Health appoints two medical research ethics committees, consisting of a total of 8 members (research-active and laypersons).
§ 2. The chairperson is appointed by the Minister of Health. As soon as the committee is appointed, it convenes to elect its vice-chairperson from the appointed members.
Subsection 2. The final constitution of an ethics committee shall take place at the latest by the 2nd regular meeting after the new appointment of the committee.
Subsection 3. The outgoing committee continues its work until new members are appointed, and the new committee is constituted.
Subsection 4. Committee members are appointed for a period of 4 years at a time. Reappointment of members can occur twice. Alternates can be appointed for members.
Subsection 5. The Rules of Procedure are approved by the Minister of Health.
Tasks
§ 3. The tasks of the medical research ethics committees are set out in Sections 5-6 of the Equipment Committee Act and Sections 13-18, and Section 21 of the Equipment Order.
Committees/Working Groups
§ 4. The medical research ethics committees can, if necessary, establish committees/working groups and appoint members to these.
Subsection 2. The committees determine the mandate for the committees/working groups.
Case Handling
§ 5. The committees handle cases, as a general rule, electronically.
Subsection 2. The committee issues a positive, conditionally positive, or negative statement to the applicant regarding an application for a clinical trial of a medical device according to Article 62, subsection 1, notifications according to Article 74, subsection 1, and trials for special purposes according to Article 82, and in connection with significant changes in clinical trials.
Subsection 3. If the Committee finds it necessary, it can request The Danish Medicines Agency to inspect a company, hospital, clinic, and other places where the trial is conducted. In collaboration with The Danish Medicines Agency, the committee can also decide that the secretariat, on behalf of the committee, participates in the inspection.
Secretariat
§ 6. The Minister of Health provides the necessary secretarial assistance to the committees.
Subsection 2. The secretariat organizes the committee's work, sets the time, place, and agenda for the committee's meetings, decides on the involvement of external consultants, and ensures the implementation of the committee's decisions.
Subsection 3. The section leader or his/her substitute participates regularly in the committees' meetings.
Subsection 4. The chairperson can allow other employees of the secretariat to participate in the committee meetings.
Duties and Powers of the Chairpersonship
§ 7. The chairpersonship can make decisions on behalf of the committee in cases that are not believed to raise doubts.
Subsection 2. The chairperson can determine that tasks and powers pursuant to subsection 1 are handled by the section leader.
Subsection 3. The chairperson and/or vice-chairperson make decisions on the approval of supplementary protocols when it is believed that the case is uncomplicated and does not contain ethical aspects that require submission to all committee members. In special cases, the chairperson can authorize committee members (a professional and a layperson) to decide on the approval of supplementary protocols.
Subsection 4. The chairperson can authorize the secretariat to make decisions on the approval of supplementary protocols where only minor changes in the trial are involved, which do not affect significant ethical issues.
Subsection 5. The committee is subsequently informed of decisions pursuant to subsection 1 and subsection 2.
Committee Meetings
§ 8. The committee's case handling takes place in meetings, which are determined at the latest in October for the following year.
Subsection 2. Approximately one committee meeting is held per month for each committee. These can be virtual.
Subsection 3. The secretariat can, in agreement with the chairperson, convene extraordinary meetings, if possible with at least 1 week's notice, indicating the agenda and relevant material.
Subsection 4. Dispatch of meeting material for regular committee meetings is sent electronically, if possible 3 days before the meeting, and consists of the agenda and the material necessary for the committee to make a decision.
Subsection 5. Depending on the nature of the cases or if it is necessary to comply with the committee act's deadlines for case handling, the secretariat can, in agreement with the chairperson, exceptionally determine that case handling takes place by written voting.
§ 9. The chairperson leads the committee meetings.
Subsection 2. In the absence of the chairperson, the meetings are led by the vice-chairperson.
Subsection 3. The committee is capable of making decisions when more than half of the committee's members are present, including the chairperson or vice-chairperson.
Subsection 4. If the committee, in connection with a decision on a statement regarding a project or another specific case, does not have the necessary quorum, the chairperson can decide that the statement is submitted in writing to the absent members to obtain their declaration of whether they can join the statement or not.
Subsection 5. The committee's decisions should, as far as possible, be made in agreement. In the event of a vote, cases are decided by a simple majority. In the event of a tie, the chairperson's (in his absence, the vice-chairperson's) vote is decisive.
Subsection 6. Committee members are obligated to cast a vote in connection with a vote.
Subsection 7. If a case is decided by a vote, this can be done by raising hands or, if a single member wishes, in writing.
§ 10. The committee's meetings are not public.
Subsection 2. The committee's chairperson or vice-chairperson can determine that specially qualified individuals can participate in the committee's discussion of a case, but not the decision on the final statement.
§ 11. Brief decision summaries of the committee meetings are prepared.
§ 12. The committee's statements are made in writing with reasons and sent electronically.
Subsection 2. The committees must make decisions within the deadlines set out in the law.
§ 13. The committees are independent in their activities from instructions on the individual case's handling and decision.
Subsection 2. The committee's other decisions cannot be appealed to another administrative authority.
Subsection 3. Complaints about legal matters regarding decisions on clinical trials can be submitted to the Minister of Health.
Subsection 4. If new and significant information for the case resolution emerges in a case that has been decided by the committee, the committee will reconsider the case for a renewed review and opinion. The same applies if significant errors have been made in the case processing.
Conflict of Interest
§ 14. Members of the committees, in the exercise of their duties for the committees, are subject to the Equipment Committee Act §16, subsections 1-2, and the administrative law rules on conflict of interest.
Subsection 2. One is considered to have a conflict of interest if one has a special personal or financial interest in the assessment of a research project. The same applies if one represents or has represented someone with such an interest, or if one is associated with a company, an association, or another private organization that has a special interest in the handling of a research project.
Subsection 3. A committee member is obliged to immediately notify the committee about circumstances that may lead to their conflict of interest. Likewise, any other committee member who is aware of such circumstances is also obligated to inform the committee about it.
Subsection 4. The member in question, deemed to have a conflict of interest in the processing of a specific case, must immediately leave the meeting during the case's processing and any subsequent voting on the case.
Subsection 5. If a committee member is unsure about their conflict of interest, the matter can be discussed with the secretariat before the meeting.
Subsection 6. The committee determines whether a committee member can participate in the processing of a case. The potentially conflicted member may not participate in the discussion and decision on their own conflict of interest. In the event of a tie, the chairperson or vice-chairperson's vote is decisive.
Subsection 7. If the committee loses its decision-making capability due to a member's conflict of interest and it is not possible to find a substitute, the provision in subsection 3 does not apply, cf. administrative law § 4, subsection 2.
Confidentiality
§ 15. Committee members, in the exercise of their duties for the committee, are subject to confidentiality, cf. administrative law § 27.
Subsection 2. Members may not disclose received material and must securely destroy the received material after its use. This applies regardless of how the material was received.
Contact with the Public
§ 16. In specific cases, the committees decide whether an opinion on behalf of the committee should be made and, if so, in what form.
Subsection 2. The chairperson, or the vice-chairperson in their absence, manages contact with the media on behalf of the committee, unless otherwise determined by the committee.
Subsection 3. Upon agreement with the chairperson, the secretariat can manage specific communication tasks.
Commencement
§ 17. This set of rules comes into effect after approval by The Danish Health Act.
The set of rules has been approved by The Danish Health Act on June 28, 2021.