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 participant consent:
The participation of human subjects in a research study requires their informed consent. A declaration of consent and any accompanying additional participant information must be formulated in a language that enables persons being asked to provide their consent to understand what they are consenting to. Typically, the declaration of consent or participant information will include the following types of information:
As a matter of principle, obtaining informed, active and explicit informed consent from participants in research studies is always necessary (see additional information on deception and debriefing below). If electronic questionnaires are used to document informed consent, participants may provide their consent by filling out a form. In the absence of informed consent, the reasons for this must be substantiated in the application in a satisfactory manner.
Please note that the requirement for informed consent is based on research ethical considerations that supplement, but are not identical to, the requirements for participant information and informed consent according to GDPR rules.
Please also note that it may necessary to reconfirm participant consent; misunderstandings, challenges and difficult situations may arise during the study as it develops. In qualitative studies, the purpose of the study may also develop. It is always the researcher's task and responsibility to handle any challenges that may arise and ensure that the participants know what they are participating in. In the application, considerations in this regard must be elaborated on.
Voluntary participation
The duty to protect participants also involves sensitivity to power relationships and different interests and expectations with regard to the research results.
Participating in a research study should be entirely voluntary. This should be stated clearly in the participant information, for example: “Your participation in this survey is entirely voluntary. It is up to you to decide whether or not you wish to participate."
It should always be possible for participants to withdraw informed consent and delete information up until such time as the results or data from the study are published. Participants must be informed about how to do this and the timeframe for doing so. If at some point during the study the information is anonymised and it is therefore no longer possible to identify which data originates from the individual participants, the participants must be informed of this. If consent is withdrawn while data is being collected, participants must be informed whether or not data collected prior to the withdrawal of consent will be included in the study.
Informed consent regarding children and adolescents
While interviews with or observation of children and adolescents should not be conducted without the consent of parents/guardians, their consent alone is not sufficient: if the participants are children/adolescents under the age of 18, consent from both the participants themselves and the parents/guardians is necessary. Participant information must be tailored to relevant age groups, which means that it may be necessary to provide different information to parents and children respectively, and to different age groups. In the case of younger children, one possible approach to obtaining consent is asking them to repeat an oral statement of consent. In research involving young children without language, the researcher must continuously take stock of the situation. The application must explicitly account for how the researcher intends to do so.
There may be studies which cannot be carried out if the consent of the parent/guardian is a prerequisite for their performance. If this is the case, the applicant must carefully explain the reasons for waiving the requirement that the parent/guardian grant consent and describe how the participants will be protected, as well as the specific ways available to children/young people for opting in and opting out.
Deception and debriefing
Participant information, informed consent and subsequent debriefing (when relevant) are fundamental to ethical research practices. For research study designs that employ deception, a subsequent debriefing with the possibility to withdraw from the study is often an absolute requirement.
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 researchdata@au.dk.
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.
Equal processing
All participants in a study must be treated equally. If participants receive compensation, it should be the same for everyone.
Subsequent changes
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 researchdata@au.dk.
The application for changes must include a short description of the change, and the changes in updated documents must be clearly indicated.