Guide to the application for ethics review
Compliance & Data Office has drafted a “Guide to the application for ethics review” which has a KI perspective and provides additional information and support for researchers when they apply for human ethical review in the Swedish Ethical Review Authority’s application portal Ethix.
In the box below you can see some examples of what the Ethics Guide contains, and the Guide itself can be found at the bottom of this page under Documents. On this page you can also find information on how to proceed if you are going to order blood samples or blood components from the Blood Center (Blodcentralen) at Karolinska University Hospital.
The Ethics Guide
Some examples covered in the guide are:
- How to reason when choosing applying research principal (sökande forskningshuvudman).
- How to describe the research if one’s research project has several participating research principals (medverkande forskningshuvudmän).
- What is important when you receive or send samples and/or personal data within and outside the EU/EEA area.
- Which parts of the research that needs to be ethically reviewed if you will analyze research data that is collected abroad.
- How to reason around management, storage, and long-term storage for research data.
- If you will use blood samples from a blood bank.
- What the difference is between pseudonymized and anonymized personal data.
The guide also gives examples of different types of research and general information about ethical application and ethical review.
Ethics application to order blood samples/blood components from the Blood Centre (Blodcentralen) at Karolinska University Hospital
To be able to order blood samples/blood components from the Blood Centre (Blodcentralen) at Karolinska University Hospital, it is now required to attach a registration number for the relevant ethics approval. This is because the samples given out will always be pseudonymised, which means that the blood centre will have a code key with which they can link each sample back to an individual person. No personal data is sent to the purchaser, only the sample code and possibly age and gender if requested. However, as long as the code key exists, the samples are considered pseudonymized and ethics approval is therefore required. After receiving the samples, the purchaser can choose to delete the sample codes if they are not interested in them, however, the data will always be considered pseudonymised since the Blood Centre still holds the code key.
In the ethics application submitted to the Ethics Review Authority (Etikprövningsmyndigheten), the description can be kept relatively brief. The information to the research participants (Forskningspersonsinformation) can also be kept concise, but must include information on how the blood centre will use the extra samples. Below are some brief tips on what to consider.
- For samples/blood components that are used solely for development and routine purposes, ethical approval is only required if the results are intended to be published.
- In the Participant Information Sheet, the content should be concise, easy-to-understand information in Swedish where blood donors can approve that extra blood samples are taken and that blood that is not used in healthcare can be used for research, education and development.
- Since such samples are usually used in several different projects and analyses, it can sometimes be sufficient to only describe:
- categories of analytical methods, e.g. flow cytometry, mass spectroscopy, functional cell assays and
- an overall purpose, e.g. "to increase understanding of how XXX works, and to compare the functions and occurrence of cells and substances in blood from healthy people with those from sick people".
- Clearly describe in your ethics application that the samples you receive are pseudonymized.