The purpose of these guidelines and the establishment of the Aarhus University (AU) Research Ethics Committee (the Committee) is to help ensure that research involving study participants is carried out in an ethically responsible and proper way.
The Committee was established in response to the increasing requirement for researchers to obtain ethical approval from the university for projects not regulated by the Research Ethics Review of Health Research Projects Act (Consolidation Act no. 1338 of 1 September 2020). This requirement stems mainly from international journals and the EU’s framework programme for research and innovation (EU Regulation 2021/695, article 19 and H2020 Grant Agreement, article 34), wherein the EU recommends a central interdisciplinary approval committee. Based on this recommendation, the Committee at AU is composed of members from all of the university’s faculties.
The Committee has 11 members: 10 ordinary members and one chair. Each dean appoints two ordinary members based on recommendations from the Academic Council. The chair is appointed by the rector and must have a legal background. The Committee members are appointed for a term of three years. The Committee can form a quorum if six of its members are present. In cases where the Committee requires a more detailed understanding of the scientific characteristics of a study, it may seek the support of an independent researcher with insight into the study’s methodologies.
From among its members, the Committee appoints a sub-committee at each faculty or, if relevant, a joint sub-committee for academically related faculties with relatively few cases.
As far as possible, each sub-committee is composed of two faculty representatives + one representative from another faculty. In the event of conflicts of interest or other absences, the chair of the Committee can nominate another member of the Committee to join the sub-committee.
Each sub-committee chooses its chair and can decide whether to approve research-ethical applications within the faculty’s area if all members of the sub-committee agree. If not, or if the case is considered to be a matter of principle, the application must be processed by the joint committee.
The Committee decides on the procedure for the composition of sub-committees, including the appointment period and any rotation scheme.
Based on descriptions of the planned studies and the above-mentioned research ethical standards, the Committee or sub-committee will assess the studies with a particular focus on the following three considerations:
1) Informed consent:
The study subjects’ participation in research studies must take place on the background of informed consent. The informed consent should include the following information:
2) Objective(s), risks and ethical considerations:
The description of the study’s objective(s) and its expected benefits and risks must demonstrate that the beneficial outcome of the study is balanced against the human resources involved in the study and the risks/adverse effects that they and their environments may be exposed to in connection with recruitment, study and reporting. The description should include an explicit assessment and position on potential ethical problems as well as considerations on how to handle them.
3) Anonymised data collection and publication:
Methods for the anonymisation of data and publication of results must be outlined in the description of the study.
The Committee decides on and publishes a meeting schedule for each calendar year. The Committee’s administrative support staff will notify the responsible researcher of the assessment outcome as soon as the application has been reviewed by the Committee/sub-committee. The Committee/sub-committee must draft a statement explaining the grounds for approval/rejection. The Committee/sub-committee can request additional information before issuing approval, or it may issue approval on the condition that the specified additional information is provided.
The Committee/sub-committee is not responsible for ensuring that individual projects comply with research ethics or data protection regulations. Responsibility for this lies with the researcher/researcher group in question. Nor is the Committee authorised to prevent a study from being carried out. However, if a study does not comply with AU’s guidelines or has not applied for the requisite approval, the Committee may recommend that the study should not go ahead. The final assessment of whether a study should be stopped from being carried out rests with the department management.
Studies that are approved will be awarded an approval number, and the researcher may elect to state in a later publication that: “the study was approved by the Institutional Review Board at Aarhus University, approval #: [approval number]”.
A researcher who has received a rejection on an application for approval can within 14 days of receiving the rejection contact the Committee/sub-committee’s administrative support staff and request a reassessment based on new or elaborated information. The Committee/sub-committee will then consider whether there is a basis to reassess the application.
The Committee must prepare an annual report on the applications processed by the Committee and sub-committees for the AU Committee for Research and External Cooperation and for the senior management team.