Ethical requirements by external research funders

Information about research ethics that focuses on external research funders’ requirements, and what applies if you, as a researcher, plan to collaborate with a university or company located in a country other than Sweden.

In order to conduct research on humans, human tissue or sensitive personal data in Sweden, an ethical approval from the Swedish Ethical Review Authority  is required (read more about what should be included in a human ethical application.

If you as a researcher collaborate with a university or a company from another country, there might be ethical differences between the countries’ t laws, rules and routines that are important to know. If you are applying for or have received a grant from an external funder, there may also be certain ethical requirements that you as a researcher must meet in order for you to receive/retain the grant.

Below is a summary of what may apply. At the bottom of this page, you can find the document “Ethical support FAQs” with more detailed information and examples of common questions that may arise.

Differences between Sweden and other countries

In many countries, both within and outside the EU, the ethical review is done locally at the hospital/university where the research/data collection is to be carried out. There may also be annual reviews or renewal of ethical approval requirements. In Sweden, we have a National Ethics Review Board, which processes all applications regardless of where in Sweden the research is to be conducted, and there are no annual reviews or renewal of ethical approval requirements.

There may also be differences concerning when an ethical review must be done. In the US, for example, ethical approval is only required for research on living people, and not the deceased.  In Sweden, on the other hand, ethical approval is required for research collecting materials from both living and deceased people. It is important that you as a researcher identify the specific requirements in the country you are to collaborate with, and determine if  their rules are compatible with Swedish legislation

If data is to be sent from KI and/or processed by another party/country (within or outside the EU/EEA), a data processor agreement or a material transfer agreement must be established between the parties. Agreements may also be needed if KI is to receive data or process data on behalf of another party/university. Templates can be accessed by the legal department: avtal@ki.se

Requirements from external research funders

It is important that you as a researcher find out what requirements the research funders have when it comes to research ethics, because this may differ between different funders. For example, grants that fall under Horizon2020/Horizon Europe and ERC (European Research Council Grants) require the researcher to complete an “ethics self-assessment”, which must be sent together with the application. For ERC-projects, an ethics advisor or an ethics advisory board can also be requested.

Many of the reviewers at funding agencies lack knowledge of Swedish legislation, and the differences that exist between different countries. It is, therefore, the researcher’s responsibility to explain the Swedish legislation and its system for the reviewer.

FAQs

Contact the Compliance & Data Office (CDO)

For questions concerning ‘ethical requirements by external funders’, please contact us at: compliance@ki.se