In accordance with § 38, paragraph 8, of the Act No. 1338 of 1 September 2020 on the ethical review of health science research projects and health data science research projects (hereinafter referred to as "the Act"), the following is established:
Composition and Constitution
§ 1. The Minister of the Interior and Health appoints the National Scientific Ethics Committee, consisting of 13 members (members who are active in health science research and lay members).
§ 2. As soon as the committee is appointed, it convenes to elect its vice-chairperson from among the appointed members.
Paragraph 2. The final constitution of the National Scientific Ethics Committee must take place no later than the 2nd ordinary meeting after the new appointment of the committee.
Tasks
§ 3. The tasks of the National Scientific Ethics Committee are stated in § 15, paragraph 1, § 24, paragraph 3, § 26, paragraph 1, and §§ 32 and 33 of the Act.
Paragraph 2. A complaint about a decision made by a regional scientific ethics committee or a scientific medical committee in cases under the committee law can be submitted by individuals or organizations/associations for whom the decision has a significant individual interest.
Paragraph 3. A complaint about a regional scientific ethics committee's or a scientific medical committee's case handling (compliance with guarantee provisions in the Administration Act), submitted simultaneously with a complaint about the approval of a specific project, cf. paragraph 2, can be submitted to the National Scientific Ethics Committee.
Paragraph 4. A complaint about a regional scientific ethics committee's or a scientific medical committee's decision on access to records regarding a health science research project treated under the committee law can be submitted to the National Scientific Ethics Committee.
Committees/Working Groups
§ 4. The National Scientific Ethics Committee can, as needed, establish committees/working groups and appoint members to these, also outside the committee's circle of members.
Paragraph 2. The National Scientific Ethics Committee sets the terms of reference for the committees/working groups.
§ 5. The chairmanship can make decisions on behalf of the committee in cases that are not deemed to raise doubts.
Paragraph 2. The following categories of cases typically fall within the authorization in paragraph 1:
- Decision on notification obligation regarding complex cases, cf. § 2 of the notification ordinance
- Decision on the rejection of cases where it is unquestionable that the case falls outside the committee's competence, including
- complaint cases, cf. the Act's § 26, paragraph 1
- minority cases, cf. the Act's § 24, paragraph 3 or
- principle questions, cf. the Act's § 32, paragraph 1
- Decision on rejection of complaint cases where the deadline in the Act's § 26, paragraph 1, is exceeded
- Decision on rejection of complaint cases where the complainant is not entitled to complain
- Rejection of reconsideration where no new significant information of importance to the case's decision is stated
- Decisions or complaints about decisions on access to records under the Public Administration Act
Paragraph 3. The chairperson and vice-chairperson, or the vice-chairperson alone, make decisions on the approval of supplementary protocols where it is deemed that the case is uncomplicated and does not contain scientific-ethical aspects requiring presentation to all members of the committee. In special cases, the chairperson may authorize members of the committee (a member active in health science research and a lay member) to make decisions on the approval of supplementary protocols. The chairperson can authorize the National Center for Ethics to make decisions on the approval of supplementary protocols where there are only minor changes to the experiment that do not involve ethical issues.
Paragraph 4. The committee is subsequently informed about decisions under paragraph 1 and paragraph 2.
Case Handling
National Center for Ethics
§ 6. The Minister of the Interior and Health provides the necessary secretariat assistance for the committee.
Paragraph 2. The National Center for Ethics organizes the committee's work, determines the time, place, and agenda for the committee's meetings, decides on the involvement of external consulting assistance, prepares case presentations, and takes care of the execution of the committee's decisions.
Paragraph 3. The management or substitute thereof regularly participates in the committee's meetings.
Paragraph 4. The chairperson may allow other employees from the National Center for Ethics to participate in the committee's meetings.
§ 7. The National Scientific Ethics Committee's case handling takes place in meetings, which are scheduled for the coming year no later than October.
Paragraph 2. The chairperson may call for extraordinary meetings, if possible, with at least 1 week's notice, indicating the agenda and relevant material. The chairperson may decide that a meeting is conducted virtually.
Paragraph 3. Dispatch of meeting materials for ordinary meetings is sent electronically, if possible, at least one week before the meeting and consists of the agenda and the material necessary for the committee to make a decision.
Paragraph 4. In connection with the meeting invitation, the chairperson may appoint one or more members to present cases at the meeting. If it concerns purely legal matters, no appointment is made.
Paragraph 5. Depending on the nature of the cases or if necessary to comply with the committee law's time limits for case handling, the chairperson may exceptionally decide that case handling takes place through written voting.
Paragraph 6. The chairperson can authorize the Management in the Unit for Science and Ethics to perform the chairperson's tasks under paragraph 1 – 5.
§ 8. The chairperson leads the committee's meetings. Cases are presented orally by the chairperson or the members appointed by the chairperson, cf. § 7, paragraph 4.
Paragraph 2. In the absence of the chairperson, the meetings are led by the vice-chairperson.
Paragraph 3. The committee is quorate when more than half of the committee's members are present, including the chairperson or vice-chairperson.
Paragraph 4. If the committee does not have the necessary quorum in connection with the decision of a specific project or another specific case, the chairperson may decide that the meeting's decision is presented in writing to the absent members to obtain their endorsement or rejection of the decision.
Paragraph 5. The committee's decisions should, as far as possible, be made unanimously. In the event of a vote, cases are decided by a simple majority. In case of a tie, the vote of the chairperson (or in their absence, the vice-chairperson) is decisive.
Paragraph 6. Committee members are obliged to vote in a vote.
Paragraph 7. If a case is decided by vote, this may be done by a show of hands or, if a single member wishes it, in writing.
§ 9. The National Scientific Ethics Committee's meetings are not public.
Paragraph 2. The chairperson or vice-chairperson of the committee, cf. § 8, paragraph 2, may decide that particularly knowledgeable persons may participate in the committee's discussion – but not decision – of a case.
§ 10. Brief summaries of the National Scientific Ethics Committee's discussions are prepared, indicating decisions made and any voting results, cf. § 8, paragraph 5.
§ 11. The National Scientific Ethics Committee's decisions are issued in writing with reasoning and sent electronically, possibly with a digital signature. The decision states the names of the members who participated in the evaluation. A possible vote is not referred to in the decision.
Paragraph 2. The committee must make a decision within the deadlines stated in the Act's §§ 23 and 27, paragraph 3.
§ 12. The National Scientific Ethics Committee is independent in its activities from instructions about the individual case's handling and decision.
Paragraph 2. Complaints about legal matters in decisions on research projects involving particularly complex areas can be submitted to the Minister of the Interior and Health, cf. the Act's § 26, paragraph 2.
Paragraph 3. The committee's other decisions cannot be appealed to another administrative authority.
Paragraph 4. If new and significant information for the decision of the case emerges in a case already decided by the committee, the committee will reconsider the case and decision. The same applies if significant errors have been made in the case handling.
Incompatibility
§ 13. The National Scientific Ethics Committee's members are covered by the law and the Administration Act's rules (§§ 3-6) on incompatibility in the exercise of their activities for the committee.
Paragraph 2. Members of the National Scientific Ethics Committee must annually declare their financial and other interests within health science research and health data science research to the committee they are attached to.
Paragraph 3. A committee member must notify the committee of circumstances that may affect their incompatibility, just as any committee member aware of such circumstances must inform the committee.
Paragraph 4. A committee member may not participate in the handling of a specific research project in which the member or their close relatives have a personal or financial interest. The same applies if the member is part of the management of or otherwise closely connected to the institute, department, or company involved in the project, or if there are other concrete circumstances that may raise doubts about the member's impartiality. For the definition of considerations that can justify incompatibility, refer to the Act's 38a, Guidelines for Incompatibility in the Scientific Ethics Committee System, and the Administration Act's § 3. The concerned member must leave the room during the discussion and possible vote on the case.
Paragraph 5. If a committee member is unsure of their incompatibility, the question can be discussed with the National Center for Ethics before the meeting.
Paragraph 6. The committee decides whether a committee member can participate in the handling of a case. The member may not participate in the handling and decision of the question of their incompatibility. In the case of a tie, the vote of the chairperson or vice-chairperson is decisive.
Paragraph 7. If the committee will lose its quorum, the provision in paragraph 4 does not apply, cf. the Administration Act's § 4, paragraph 2.
Confidentiality
§ 14. The National Scientific Ethics Committee's members are subject to confidentiality in the exercise of their activities for the committee, cf. the Administration Act's § 27.
Paragraph 2. Members may not disclose received material and must securely destroy the material after use. This applies regardless of how the material was received.
Contact with the Public
§ 15. In specific cases, the National Scientific Ethics Committee decides whether a statement on behalf of the committee should be made and, if so, in what form.
Paragraph 2. The chairperson, and in their absence the vice-chairperson, manages contact with the media on behalf of the committee, unless otherwise decided by the committee.
Paragraph 3. If the press contact concerns purely factual information, the National Center for Ethics can undertake the task. Based on a concrete assessment of the question, the National Center for Ethics subsequently informs the chairperson.
Commencement
§ 16. This rules of procedure come into effect after approval by the Minister of the Interior and Health.