Ethical aspects

What ethical issues are raised by your research, and what ethical considerations should you take into account? In the final section of the project description, you should account for any ethical issues and considerations arising from your project. Researchers in the health sciences should always address ethics in their proposals.

Examples of ethical issues:

• The use of informed consent
• Research involving human embryos/fetuses
• Research that involves private life (for example, tracking or observing people, the use of genetic or sensitive personal information)
• Research that involves children and vulnerable individuals
• Laboratory experiments involving animals or people       
• Research involving developing countries (for example, the use of local resources such as animals and plants, capacity development, etc.)
• ‘Dual use’ research (potential military applications, risk of misuse by terrorists/criminals)
• Research involving environmental considerations (the use of environmentally hazardous products, work on threatened flora/fauna, protected areas, etc.)

All relevant notifications and registrations must be included in the ethics section, and you must include reference numbers for permits already granted. In the schedule for the project, you should include the time it takes to obtain permits. If your project involves sending data or samples abroad, for example in connection with collaboration with a researcher in another country, you should be aware that other ethical guidelines and rules may apply, depending on the country in question.

Read more about ethics and permits

• The Helsinki Declaration describes the ethical principles for medical research on human subjects: http://www.wma.net/en/30publications/10policies/b3/index.html.

• The Committees on Health Research Ethics handles applications for approval of health sciences research projects: http://www.rm.dk/sundhed/faginfo/forskning/de-videnskabsetiske-komiteer/.

• The Danish Data Protection Agency ({3>http://www.datatilsynet.dk/<3}{4}) is the central independent authority which ensures that research projects are in compliance with the Danish Act on Processing of Personal Data (Persondataloven). Please note that the procedure for reporting projects containing sensitive personal information was revised in the summer of 2015: It is no longer necessary to report project to the Danish Data Protection Agency. Instead, they must be reported internally to AU, which has overtaken the processing and administration of these reports. The Danish Data Protection Agency now has a supervisory role in relation to the university. Please send your report and any questions about rules and procedures to Senior Consultant Tove Bæk Jensen (tbj@au.dk).

• The Danish Animal Experiments Inspectorate processes applications for authorisation to carry out animal testing: http://www.foedevarestyrelsen.dk/fvst_ansvar_opgaver/Sider/ Dyreforsoegstilsynet.aspx? Indgang=Dyr&Ind.

• The Danish Medicines Agency processes applications for authorisation to perform clinical trials: http://sundhedsstyrelsen.dk/da/medicin/regulering/kliniske-forsoeg. Before a clinical trial may begin, it must be approved by both the National Committee on Health Research Ethics and the Danish Medicines Agency.

You can get help in planning and performing clinical trials in accordance with Danish legislation and ‘good clinical practice’ from the GCP units: http://www.gcp-enhed.dk/forside/.