As a general rule, all research activities initiated at AAU that involve research-ethical aspects must be assessed by the AAU Research Ethics Committee.The purpose is to ensure that the research activity is conducted in an ethically sound and responsible manner.
However, certain activities are exempt. You can read more about these exemptions below.

If you are unsure whether your research activity involves ethical aspects, you can read more on our page - How to use the form

The following research activities are exempt from the requirement for ethical approval by the AAU Research Ethics Committee:

• Research activities that fall under the Danish National Committee on Health Research Ethics system*
• Research activities that fall under the Danish Animal Experiments Inspectorate
• Research activities funded by the European Defence Fund (EDF)
• Research activities involving classified military information 
  Research activities involving only register data historical data, or data that are publicly available through the Danish National Archives
• Research activities that do not involve ethical aspects
  If you are unsure whether your research activity involves ethical aspects, read more here

* You can read more about the notification requirements under the Danish National Committee on Health Research Ethics system here 

A Research activity is a specific and clearly defined part of a research undertaking with a clear purpose, a specific method, and a known participant and data basis.

It is at the level of the research activity that the ethical assessment is carried out. This means that the committee assesses the specific activity, including how research participants are recruited, how data are collected and processed, and what risks or burdens there may be for the research participants.

A research activity may, for example, be an interview study, an observational study, a survey, or a secondary analysis of existing data.

A research project is the overall framework for the research.
A project may extend over a longer period of time and consist of several different research activities involving different methods, participant groups, and risk profiles.
Some parts of a project may be ethically relevant, while others may not. Therefore, as a general rule, it is the specific research activities, rather than the entire project, that must be assessed by the committee.

As a general rule, the AAU Research Ethics Committee only considers applications concerning specific research activities.
However, if a research project as a whole is clearly defined and sufficiently described from the outset, it may in some cases be possible to apply for ethical approval of the project as a whole. The decisive factor is whether the committee can carry out a meaningful and proportionate ethical assessment on the basis of the submitted material.
If a project contains several different activities involving different risks or methods, it will generally be more appropriate to apply at the level of the individual research activity.

If you are unsure whether your research activity is subject to the requirement for research ethics approval, you may find guidance in the instructions for the notification form. The guidance page can be found here. 
The guidance provides a brief introduction to the research ethics aspects covered by the requirement for approval by the AAU Research Ethics Committee.
If you are still unsure, you are also welcome to contact the secretariat etik@adm.aau.dk.

Primary Data are data that are collected directly for the specific research project. This will typically be data collected by the researcher, for example through interviews, questionnaires, or observations.

Secondary data are data that have been collected for another purpose but are reused in a new research project. This may, for example, be an existing dataset to which the researcher has access.

You apply for ethical approval via AAU’s combined notification form, which guides you step by step through a series of questions about your research activity.
The form is based on a decision tree and helps determine whether your activity must be notified in relation to research ethics, the processing of personal data (GDPR), or both. You only need to submit the information once, after which the case processing will be distributed internally.
You can find the combined notification form here. (LINK TIL NY BLANKET)

You must apply for ethical approval before the research activity begins.
The decisive factor is the point in time when the activity itself starts, for example when research participants are recruited, data are collected, or other research-related involvement of research participants or data begins.
It is not decisive when the project idea arose or when an overall project description was prepared.
The purpose of prior approval is to ensure that the activity can be conducted in an ethically responsible manner from the outset.

Depending on the nature of the research activity, you may be asked to attach supplementary material. This may include recruitment material, participant information sheets and consent declarations, documentation of the data collection, or documentation of an ethical assessment or approval from an external collaborator.
It is important that the material is sufficient and relevant so that the Committee can make a specific assessment of the activity.

No. The Committee cannot provide ethical approval retrospectively for a research activity that has already been completed.
The purpose of the research ethics assessment is to prevent ethical concerns and to ensure that research participants, data, and methods are handled responsibly from the outset.
Once a research activity has been completed, it is no longer possible to change or remedy any ethical issues, for example in relation to consent, information provided to research participants, or the choice of method. Therefore, research ethics committees cannot, as a general rule, assess or approve applications with retrospective effect.

If you are an AAU researcher responsible for a research activity, the activity must generally still be assessed at AAU, even if it forms part of a research project that has been approved at a foreign university or another Danish university.
External ethical approvals may be attached and will be included in the Committee’s assessment.

Once you have submitted your notification, the research activity will be categorized as either low risk or high risk.

High-risk activities are assessed by the full Committee at its scheduled Committee meetings. You can read more about Committee meeting dates and submission deadlines for applications here.

Low-risk activities are assessed on an ongoing basis by the Chair of the Committee in collaboration with the Committee member representing the relevant faculty.
Based on current experience, the vast majority of notified activities are expected to be categorized as low risk.

The response time depends on whether the research activity is assessed as low risk or high risk.

Low-risk research activities
The Committee members aim to provide an initial response within approximately 10 working days. However, longer response times may occur during holiday periods.
High-risk research activities
For high-risk research activities, an initial response can be expected after the Committee meeting at which the application has been considered.
Regardless of whether the application concerns a low-risk or high-risk research activity, the initial response may take the form of either:

• an approval, if the application can be approved without further consideration; 
• a request for supplementary material or clarification of specific questions before a final decision can be made.

No. Students cannot apply for ethical approval of student projects through the AAU Research Ethics Committee.
If a student project is carried out as part of research at AAU, or if data from the project may be or are expected to be used in research together with an AAU researcher, the supervisor or the responsible AAU researcher must submit the application.

If a supervisor determines in advance that a student project is highly likely to lead to a scientific publication with both the student and the supervisor as authors, the supervisor, as an AAU-employed researcher, must apply for ethical approval of the data collection carried out as part of the student project. This ensures that the data later used in the scientific article have been collected in an ethically responsible manner.

Does this also apply if the data are later anonymized?Yes. If data from a student project are expected to be used in research together with an AAU researcher, an application must be submitted before data collection begins, even if the data are later anonymized. It is the activity and the purpose of the collection and subsequent use that are decisive.

In some cases, it may be possible to use previously collected student data in a new research activity involving secondary use of the data. This requires, among other things, that the planned secondary use is compatible with the original purpose and that there is an appropriate basis for using the material, for example permission from the data owner where relevant. However, the Committee cannot retrospectively approve the original data collection.

Research-ethical consent means that a participant voluntarily agrees to take part in a research activity on the basis of adequate information.
The key requirement is that the participant understands the purpose of the research, what participation entails, any risks or disadvantages, and their right to withdraw without negative consequences.
Therefore, it is not only the form of the consent that matters, but in particular the quality of the participant information provided.

Not necessarily. The requirement depends on the nature of the research activity, the methodology used, and the degree of intervention.
However, research participants must always receive adequate and understandable information about the research activity.
Even when consent is obtained orally, or when participation in the specific situation may be regarded as implied, it is essential that research participants have received sufficient information to enable them to make a genuine and informed decision about whether to participate.

Research-ethical consent and a GDPR legal basis are not the same.
Research-ethical consent concerns whether it is ethically justifiable to involve individuals in research and whether research participants voluntarily and on an informed basis agree to participate.
A GDPR legal basis, on the other hand, concerns the legal basis for the processing of personal data.

Read more here

➡️ You can find them here

No. The research ethics assessment and the data protection assessment remain two separate evaluations.
At AAU, however, the notification process has been integrated into a single, shared system, so that researchers only need to submit their information in one place.
The research ethics assessment is then handled by the Research Ethics Committee, while the GDPR-related assessment is handled by AAU Grants and Contracts office.

AAU has prepared guidance material on research-ethical informed consent, participant information, and the relationship to GDPR.
Read more here, where you can also find various templates for consent and GDPR legal bases

If you have questions regarding the processing of personal data in research, you can contact the AAU Grants and Contracts via persondata@adm.aau.dk.

AAU Grants and Contracts are responsible for the data protection assessment of research activities and can provide guidance on GDPR-related matters.

If significant changes are made to, or additions are introduced to, a research activity that has already been approved by the Committee, the changes must be reported to the Committee.
Please note: It is only necessary to report changes that may affect the research ethics assessment.

Examples include:

• Changes to the target group of research participants (for example, new inclusion or exclusion criteria)
• Changes to methods or interventions
• New types of data, including new or more sensitive personal data
• Changes to the consent basis or participant information materials provided to research participants

If you are uncertain whether a planned change is significant, you should contact the Committee for guidance

Changes must be reported by email to etik@adm.aau.dk. The email should briefly describe the changes or additions proposed in relation to the originally approved research activity. 
The Committee will then assess whether the changes can be accommodated within the existing approval or whether they constitute a new research activity that requires a new notification. 
This procedure replaces the previous process involving supplementary applications.

Adverse effects are unwanted or unintended effects experienced by research participants as a result of their participation in a research activity.

If you become aware of adverse effects or serious incidents in connection with a research activity, you must send an email to etik@adm.aau.dk containing information about the incident.

Adverse effects must be reported to the Committee to help it assess whether the research activity can continue to be conducted in an ethically responsible manner and whether any follow-up action or changes are required.