Learning objectives

When you have completed this lesson, you will be able to:

Describe what ethical and legal approvals are.
Identify when ethical and legal approvals are required.
Describe what steps are necessary when initiating a project involving human participants.

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What are ethical and legal approvals?

Some research projects require ethical or legal approvals. If your project requires approval, you typically cannot start collecting and working with research material or data until the approval has been issued. Applying for approvals can take some time, and your supervisor may already have applied for approval before you started your project. In general, it is your supervisor who is responsible for ensuring that such approvals are in place in bachelor and master projects, where this is relevant. Nonetheless, it is important for you as a student to know when ethical or legal approvals are required and to understand what this means for your project. You may need to support your supervisor in the application process, and you may need to apply for ethical or legal approval yourself in the future if you continue in research.

Ethical approvals
Ethical approvals are approvals granted by ethics committees or boards. These ethics committees assess the ethical implications of research projects for which approval is sought. They weigh risks against benefits and evaluate whether the potential for harm to human participants and animals is minimized.

Examples of projects where ethical approvals may be required are:

Clinical trials, such as studies where medical treatments are tested on human subjects
Psychological research, such as studies where human behaviour is explored in response to interventions.
Studies that involve vulnerable populations such as children, elderly people, individuals with cognitive impairments, individuals from certain cultural backgrounds, or marginalized groups.
Animal studies, such as those involving experiments conducted on lab animals.

The documentation submitted when applying for ethical approval should include a justification for the inclusion of human subjects and/or animals in the project. It should clearly describe any measures to safeguard the rights, well-being and dignity of human participants involved in the project. In animal studies, it should demonstrate adherence to (international) guidelines for animal welfare.

In Denmark, ethical approvals are typically granted by a National or Regional Ethics Review Committee (ERC) or by the Animal Experiments Inspectorate. In some cases, approval can be obtained from one of UCPH’s Institutional Review Boards (IRBs).

Legal approvals
Whereas ethical approvals focus on the moral and ethical aspects of research, legal approvals ensure that the research adheres to relevant laws and regulations. Legal approvals for research are typically issued by regulatory bodies, government agencies, or institutions, depending on the nature of the research and the relevant legislation.

Examples of projects where legal approvals are required are:

Clinical studies testing new pharmaceuticals or medical devices. Here, approvals are required from the Danish Medicines Agency (Lægemiddelstyrelsen) for compliance with Danish regulations and the EU Clinical Trials Regulation.
Research involving environmental samples or studies in protected areas. These projects may require legal approvals from the Danish Environmental Protection Agency (Miljøstyrelsen).
Personal data projects. Any projects involving humans or human biological material (biobanks) must be registered in the UCPH’s joint record of projects containing personal data.

The above lists of research projects where ethical and legal approvals are required, are not exhaustive. There may be other types of research where ethical and legal approvals need to be collected. Discuss with your supervisor whether this is relevant for your project and clarify how you can contribute to the process of obtaining approvals.

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In focus: projects involving human participants

The majority of bachelor or master projects that require ethical and/or legal approval, are projects involving human participants. Human participants in your project could, for example, be observed in social settings, contribute to surveys or questionnaires, participate in health studies measuring physiological responses or be interviewed by you.

Below, we summarize some of the most important things to know when starting a project involving human participants. We strongly recommend that you also consult the page ‘How to collect and process personal data’ available on your study’s information pages before you start your project.

1. Projects involving human participants may require ethical approvals

Depending on the type of project and the methodology to be used, some projects may need ethical approval. As mentioned above, this is for example the case in clinical studies. Check with your supervisor whether this is required in your project.

2. Projects involving personal data and human biological material are subject to GDPR

It is very important that you as a student can identify when you are dealing with personal data. Research data is considered personal data when it is possible to identify a person from the data, either directly or indirectly by combining different datasets. Personal data include, among others, names, addresses, e-mail addresses, CPR numbers, photos, fingerprints and biological material. When you work with personal data, the General Data Protection Regulation (GDPR) will apply to your project.

The GDPR is an EU regulation designed to give individuals greater control over their personal data and harmonize data protection laws across EU member states. The GDPR introduces requirements for organizations (e.g. universities) when processing personal data. You can learn more about the GDPR in the separate online course ‘GDPR for Students’. All students working with human participants in their project are recommended to take this one-hour course at the start of the project.

Human biological material refers to samples or substances derived from the human body, including various types of tissues, cells, fluids, or other biological specimens. When human biological samples can be used to identify people (for example because they provide information about genes), they are also subject to the GDPR.

3. Projects involving personal data and human biological material must be documented

Researchers, including PhD students, must register projects involving personal data and human biological material at their faculty using an online form. This may be relevant for you as a bachelor or master student, if you contribute to someone else’s research project at UCPH. If you collect personal data yourself for your own bachelor or master thesis, you do not have to submit a registration to the faculty. However, you do need to keep a record of data processing activities. UCPH has a template that you should use for this purpose. You can find it on the study information pages (see practical tips below).

4. Human participants involved in projects should be informed

Before you start your project, you must inform human participants in your study about:

The purpose of the study
How you will process their data.
When you will delete their data.
Their right to access the data you have collected from them.
Their right to receive a copy of their data.
Their right to have their data rectified if the data turn out to be inaccurate
Whom they can contact if they wish to withdraw their participation and have their data removed from your project. This is typically the university’s data protection officer.

The information must be presented in such a way that it is clearly understandable for the participant. As a general rule, you or the leader of the project should present information in a written document, but this can also be done orally, if appropriate.

5. Informed consent should be obtained before data collection

If you intend to collect data about human participants, you must ensure that the human participants in question not only are well-informed about your study (point 4 above) but also actively agree (consent) to your use and disclosure of their data in connection to your project. You must obtain consent in writing by asking the participants to sign a consent form. UCPH has a template you can use for this purpose, which can be found on the study information pages. The signed informed consent forms should be stored with the research data. Give the participant a copy of the consent form too. If your project involves children, you need the informed consent of the parents or legal guardians.

As a general rule, observations in the public space do not require informed consent. The same may apply to observations on online (social) media and internet forums as long as they are considered to be in the "public space". However, mining a questionnaire distributed on Facebook would still require you to protect the participants personal information which means you need to consider rules concerning GDPR.

6. You should only store personal data for as long as you need them

You should store personal data in a secure manner (see lesson 6. Data storage and security) during the project. You must always delete personal data when you no longer need them for your project. This means that you must delete data when your project/thesis has been assessed, and the deadline for complaints, as indicated in the informed consent document, has expired.

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Ethical and legal approvals in practice

Professor and supervisor Peter Sandøe, Faculty of Health and Medical Sciences, explains which ethical and legal approvals may be necessary when working with animals and humans.

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For English subtitles, please look for the CC icon in the lower right corner of the video and press English.

Rasmus Michael Sandsdal has carried out multiple projects at the Faculty of Health and Medical Sciences, where he worked with datasets that contain personal data. Rasmus explains which ethical and legal approvals had to be obtained in his projects.

Maya Haven Træsborg obtained informed consent from the people participating in her Bachelor project at the Faculty of Humanities. She explains how she created the informed consent form and what information it should to cover.

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Test yourself

Check whether you captured the main points of this lesson:

Quiz: Ethical and legal approvals

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Fill out your DMP

Please continue working on your project’s the data management plan (DMP) by answering the questions in section 4. Ethical and legal approvals:

4.a Does your project require ethical approval?
If yes, explain why and what approvals need to be in place before you can start. Who has collected, or will collect, this approval?

4.b Does your project require legal approval?
If yes, explain why and what approvals need to be in place before you can start. Who has collected, or will collect, this approval?

If you haven't begun filling out your DMP yet, you can find the DMP template here: UCPH DMP Template for Students

Remember to discuss the data management plan with your supervisor at the start of your project. Keep the DMP stored along with your data.

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Practical tips and resources for addressing ethical and legal approvals

If you as a student will work with personal data, take the short online course ‘GDPR for students’ and read the rules and regulations for working with personal data, and find templates on the study information pages of your study programme under Planning your studies > Rules and dispensations > How to collect and process personal data.
On UCPHs Research Portal’s pages on GDPR and research, your supervisor can read all about adhering to GDPR in research projects. Please note that rules may differ between research projects run by researchers (employees) and bachelor/master projects run by students. Supervisors can also read about rules for including students in research projects as paid or unpaid assistants on these pages.
Read about UCPHs ethical committees on Research Portal. Even though for some types of research, ethical approval is not necessary according to Danish legislation, some publishers or funders abroad may ask for ethical approval documentation as a requirement for publishing or funding a study. In these cases, one of UCPHs internal research ethics committees can be contacted for approval.

On UCPHs Research Portal pages about responsible conduct of research, your supervisor can find information, forms, policies and guidelines regarding conflicts of interest, use of genetic resources, international research collaborations, the practice committee, faculty specific research ethic committees and the forms needed for ethical assessment.
All PhD students at SUND and SCIENCE participate in PhD courses on responsible conduct of research. Browse through the associated textbook to learn more about GDPR, research ethics, research integrity and more.

Check this course’s RDM Glossary for definitions of terms used in this lesson and the other lessons.

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Published in 2024