Research projects are increasingly subject to requirements for research ethical approval by the university. This requirement stems mainly from the EU’s framework programmes and international journals, and relates specifically to studies that collect empirical data and are not covered by the Committees Act on regional scientific ethical committees, which only applies to research projects in the field of health sciences.
Aarhus University (AU) studies are approved by the Research Ethics Committee. The Committee’s responsibility is to ensure a consistent and responsible framework for study approval and make it easier for AU researchers to obtain grants and publish.
The Committee acts as an Institutional Review Board (IRB) in cases where researchers are required to demonstrate that the university has approved the ethical reserach aspects of their research.
The Committee distinguishes between a ‘research project’ and a ‘study’. Only empirical studies can be processed by the Committee. The object of assessment is the research design and the treatment of the people and environments involved in the studies. It is therefore only possible to apply for research ethical approval of an empirical study and not for ethical approval of a research project. Obtaining research ethical approval of an empirical study involves accounting for ethical considerations in the planned research procedures. For this reason, such considerations must be addressed. This means, for example, that it is not sufficient to simply note that a given study contains no ethical challenges. The rationale and explanation for the planned procedures must be described. In certain cases, the application may be returned to the applicant with a request for further explication of the ethical implications of parts of the study. The opportunity to apply for research ethical approval is new for most AU researchers. The Committee strives to clearly establish what this approval requires and entails, and it operates on the principle that the treatment of the people and environments affected by the research should be in focus.
Informed participation 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:
Informed participation consent
In principle, clear, active and informed consent must always be obtained from those participating in a scientific study (see more below in ‘Deception and debriefing’). In electronic questionnaires, informed consent can be given by selecting a given field or similar. If informed consent has not been obtained, this lack of consent must be justified in a satisfactory manner.
Please note that the requirement for informed consent is based on research ethical reasons that supplement, but are not identical to, the requirements for participant information and informed consent according to GDPR rules.
Informed consent regarding children and adolescents
If the participants are children/adolescents younger than 18 years old, informed consent must be provided from both the participants and their parents. Participant information must be targeted towards the relevant age groups. For younger children, verbal consent may be obtained and described in the protocol or a separate document, and, for very young children, informed consent from the parents can be sufficient.
Deception and debriefing
Participant information, informed consent and subsequent debriefing (when relevant) are fundamental research ethical requirements. For study designs that employ ‘deception’, a subsequent debriefing with the possibility to withdraw from the study is generally an essential requirement.
It is entirely voluntary for participants to participate in a study. This should be stated clearly in the participant information, for example: “Your participation in this questionnaire survey is entirely voluntary. It is your choice whether or not to participate. You can withdraw your consent and leave the study at any time.”
External panels and recruitment bureaus
The person(s) listed as responsible for the study guarantees the legal and research-ethical handling of data collected by the recruitment platform.
Methods for the anonymisation of data and publication of results must be outlined in the study description.
Collection of data in other countries
The Committee requires that approval for the study is also sought in other participating countries in which such approval is relevant or required. This is in order to ensure that the study and collection of personal data also meets the relevant national/local research ethical requirements and standards in these countries.
Fill out the information form with all appendices (in PDF format). Find the form here.
If you have any questions regarding the form, please send an email to firstname.lastname@example.org.
Please also fill out this protocol template. The protocol is compulsory and must be max. 5 pages.
Submit the appendices relevant to your study. In addition to the protocol (max. five pages in a compulsory template), the following material is usually required:
Participant information, possible questionnaires and the declaration of consent must be written in a language that the participants have an in-depth knowledge of, which is usually their native language. In case of Danish-language participants, it is only necessary to enclose the Danish-language version of the documents. There is no need to enclose published material, e.g. articles.
Description of purpose and risks: The description of the purpose and risks must demonstrate that the benefit of the study is balanced against the human resources involved in the project and the risks/inconveniences 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 study.
All participants in a study must be treated equally. If participants receive compensation, it should be the same for everyone.
The Committee’s approval is based on the specific documents in the application. If any significant changes are made subsequently, a new application must be sent to the Committee. The application for amendments of applications or individual documents can be sent to email@example.com.
The application for changes must include a short description of the change, and the changes in updated documents must be clearly indicated.