Guidelines for the AU Research Ethics Committee

Background

The background for the Aarhus University (AU) Research Ethics Committee is that AU researchers are increasingly required to obtain ethical approval for projects not regulated by the Research Ethics Review of Health Research Projects Act (Consolidated Act no. 1338 of 1 September 2020) from the relevant university department.

This requirement is imposed by, for example, international journals and the EU’s framework programme for research (EU Regulation 1291/2013, EU Regulation 1290/2013 and H2020 Grant Agreement, article 34), and the EU recommends a central interdisciplinary approval committee. The AU Research Ethics Committee will ensure a professional, consistent and responsible framework for the approval of these projects and make it easier for AU researchers to obtain EU grants and publish.

Objectives

  • The AU Research Ethics Committee (hereinafter ‘the Committee’) is a service provided to AU researchers whose projects are required, by funders or journals, to document ethical approval, but which are not regulated by the regional research ethics committees. 
     
  • The Committee must ensure that the research conducted as part of projects that are required to apply for ethical approval complies with the university’s guidelines for responsible conduct of research, and with the Helsinki Declaration and other research ethics guidelines relevant to the project in question, e.g. the American Psychological Association’s (APA) code of conduct regarding the handling of study participants.

Projects assessed (limitations)

  • The Committee exclusively approves projects requiring ethical approval which fall outside of the existing research ethics committee system, and which are headed by researchers employed at AU.
  • The Committee only approves empirical projects that collect data from volunteer study participants, including observation studies and questionnaire-based studies that involve the collection of data from individuals.

Composition of the Committee

The Committee has 11 members: 10 ordinary members and one chair. Each dean appoints two ordinary members based on the recommendations of 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 constitutes a quorum when six of its members are present. In cases where the Committee requires a more detailed understanding of the scientific characteristics of a project, it may seek the support of an independent researcher with insight into the project methodologies.

Sub-committees:

From among its members, the Committee appoints a sub-committee at each faculty, possibly a joint sub-committee for academically related faculties with relatively few cases.

Each sub-committee is composed of two faculty representatives + one representative from another faculty.

Each sub-committee chooses its chair and can decide on research-ethical applications within the faculty’s area if all members of the sub-committee are in agreement. If not, the application must be processed by the joint committee.

The Committee will decide on the procedure for the composition of sub-committees, including the appointment period and any rotation scheme.

Specific tasks

Based on descriptions of the planned studies, the Committee or sub-committee will assess the studies on the basis of the following three considerations:

1) Informed consent:

The study subjects’ participation in research projects must take place based on informed consent. The informed consent should include the following information:

  • The name of the primary investigator
  • The purpose of the research project
  • The research project’s funding sources
  • The process for recruiting study participants
  • The methodology/approach of the research project
  • Expected risks/adverse effects
  • Who will benefit from the results of the research project
  • How the project results will be communicated (including feedback to participants)
  • How personal data will be protected
  • Opportunities for leaving the study
  • Opportunities to view and, if applicable, comment on transcriptions of interviews and quotes, if relevant
  • Debriefing opportunities, if relevant

2) Purpose and risks:

The purpose declaration must demonstrate that the beneficial outcome of the project is balanced against the human resources involved in the project and the risks/adverse effects that they may be exposed to in connection with recruitment, study and reporting. The declaration must also demonstrate that the social group represented by the study participants will benefit from the outcome of the project.

3) Anonymised data collection and publication:

Methods for the anonymisation of data and the publication of results must be outlined in the project description.

Approval process and authority

The Committee should make every effort to meet six times a year. The Committee’s administrative support staff will notify the responsible researcher of the assessment outcome as soon as the project 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 may grant conditional approval in cases where additional information is required in order to grant final approval.  

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 stop a project from being conducted. However, it may advise that projects that do not comply with AU’s guidelines, or which have not applied for the requisite approval, be stopped.

Projects that are approved will be awarded an approval number, and the researcher may elect to state in a later publication that: “the project was approved by the Institutional Review Board at Aarhus University, approval #: [approval number]”.

Appeals procedure

Researchers whose applications for approval are rejected may submit an appeal to the Committee/sub-committee that includes the grounds for appeal within 14 days of receiving notification of the application’s rejection. The Committee/sub-committee will then reassess the application.

Reporting

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.