Danish Committee Law and System

The Danish committee system for research ethics began in 1980 on a voluntary basis among biomedical researchers, inspired by the Nuremberg Code and the Helsinki Declaration. The system was formalized with the passage of law no. 503 on June 24, 1992, which established legally binding frameworks for the ethical review of health science research projects. The law has undergone several revisions to incorporate new international bioethics standards.

Denmark has a comprehensive system of research ethics committees, including the National Committee on Health Research Ethics (NVK) and regional committees. These committees ensure that health-related research projects are conducted ethically, prioritizing the rights, safety, and well-being of research participants over scientific and societal interests.

The Danish Medicines Agency (Lægemiddelstyrelsen) plays a crucial role in regulating clinical trials and ensuring the safety and efficacy of medicinal products. It oversees the approval and monitoring of clinical trials, ensuring compliance with ethical standards and legal requirements.

There is no national legislation in Denmark for research outside the scope of health science research. Majority of the universities in Denmark have implemented research ethics committees for the review of non-health related research. The committees are implemented in various ways. Some universities have centralized committees at the institutional level, while others have decentralized committees at the faculty level. This variation allows universities to tailor their ethical review processes to their specific research environments and needs.

Research Ethics Committees for Non-Health-Related Research at Aalborg University (AAU)

The AAU Research Ethics Committee (REC) was established following a decision by the Aalborg University Directorate on December 18, 2019. The committee's primary purpose is to ensure that non-health related research conducted at AAU adheres to internationally recognized ethical standards. This includes evaluating research proposals to safeguard the rights and well-being of participants, ensure the integrity of the research process, and promote transparency and accountability.

The AAU REC comprises five members appointed by the deans of the various faculties at AAU. These members represent different research areas and possess expertise in ethical issues relevant to their fields. The committee includes a chairperson and a vice-chairperson, both elected from among the members.

The AAU REC follows a structured process for reviewing research proposals:

• Researchers submit their proposals to the REC for evaluation through our digital form. The application form has a built-in screening algorithm that sorts the applications into one of three categories:
  • No-Risk Research: The research activity falls outside the AAU Research Ethics Committee's criteria for ethical approval and consequently is exempt from review by the committee.
  • Low-Risk Research: The low-risk research activities are assessed continuously by the committee chairperson and relevant faculty member.
  • High-Risk Research: The high-risk research activities are evaluated during regular committee meetings, held ten times a year. Additional ad-hoc meetings may be convened for urgent matters.
• The committees decisions are made based on a thorough review of the application, considering ethical principles, legal requirements, and the potential impact on participants and society.
• The committee issues either an approval, a conditional approval requiring modifications, or a rejection with detailed reasons.
• The decision is communicated to the researcher, along with any required modifications or reasons for rejection.

REC Support

The AAU REC is supported by a secretariat responsible for administrative tasks, including organizing meetings, maintaining records, and communicating with researchers. The secretariat ensures that the committee operates efficiently and that all procedures are followed correctly.

Review Volume and Timespan

The  AAU REC reviews approximately 300 non-health-related research protocols per year. The average timespan from submitting a protocol to the finalization of the review is typically 4-6 weeks depending on if it is high risk or low risk and also how long a correspondence the committee will have with the researchers regarding their application. This timeframe can be shorter for low-risk research or amendments to previously reviewed research activities.

Challenges and Good Practices

Typical challenges faced by the AAU REC when reviewing non-health-related research include:

• Ensuring comprehensive data protection and privacy measures.
• Addressing ethical issues in research involving vulnerable populations.
• Balancing the need for thorough ethical review with the demand for timely decisions.

Good practices related to the ethics review of non-health-related research at AAU include:

• Providing clear guidelines and templates for researchers to assess ethical issues.
• Offering ethics advice and support through the secretariat.
• Ensuring transparency and accountability through detailed documentation and reporting.

Non-Human Participant Research

The AAU REC also reviews research projects that do not involve human participants, such as those in the fields of artificial intelligence and data science. Good practices in this area include:

• Developing specific guidelines for ethical issues related to non-human participant research.
• Ensuring that research involving data science adheres to strict data protection and privacy standards.
• Promoting awareness of the ethical implications of emerging technologies.

Digital Solutions and GDPR Compliance at Aalborg University

At Aalborg University, we have implemented a digital solution for managing research ethics reviews, which includes provisions for GDPR compliance. This system ensures that all personal data is handled securely and in accordance with data protection regulations, providing transparency and accountability in the review process.

Report contributor and national contact:

Thomas Ploug

Chair of the Research Ethics Committee at Aalborg University, Denmark