Permits and ethical review
On 1 January 2004 the Act Concerning the Ethical Review of Research Involving Humans (2003:460) was introduced. Among other things, the act applies to research involving physical intervention on a research individual or research conducted with a method intended to affect the research person physically or psychologically and studies of the biological material of individuals that can be traced back to them.
Through a change in the law in 2008, more types of research are covered by the law: Now, research that involves the processing of sensitive personal data is to undergo ethical review regardless of whether or not the participant has consented, and research conducted with a method that clearly risks injuring the participant is to always be subject to ethical review, which can also apply to questionnaires or surveys.
For research not covered by the law, review of the project may still be advisable. Many publications and conferences require a research ethics permit to publish research or allow delivery of a lecture, or researchers/students may want to obtain ethical advice when the project seems sensitive in other respects than what is covered by the law. In that case, a recommendation should be obtained.
Apply for ethical review
The application for ethical review is from October 7, 2019, to be submitted via the Swedish Ethical Review Authority’s own registration form (information only available in Swedish).
Clinical pharmaceutical trials involving interventions require permits from Medical Products Agency Sweden (MPA), according to the Swedish Medicines Act (SFS 2015:315). The MPA’s Drug Administration Regulations and Guidelines (LVFS 2004:10) on the deliberate release during clinical trials of pharmaceutical products containing or consisting of genetically modified organisms establishes additional requirements for such clinical trials, including the need for a permit from MPA.
The application can be submitted via Eudralink, a CD, USB or as email attachments.
Processing of personal data
In accordance with the Data Protection Act, personal data is to be reported and registered. This means that you, as a researcher, are required to report research projects that process personal data to the University’s data protection officer.
According to Sweden’s Animal Welfare Act, approval from an Animal Experiment Ethics Board is required for the use of experimental animals in research. Applications from Uppsala University are submitted to:
Uppsala Animal Experiment Ethics Board
Uppsala District Court
SE-751 41 Uppsala
Tel.: +46 (0)18-167200
For general information about animal experiments and the importance of animal experiments for medical research, see www.djurforsok.info
For clinical research projects that expose subjects to ionising radiation, a permit is required from a local radiation safety committee, Strålsäkerhetsmyndighetens föreskrifter om grundläggande bestämmelser för tillståndspliktig verksamhet med joniserande strålning – SSMFS 2018:1 (in Swedish)
Radiation Safety Committee, ethical assessment
c/o Enn Maripuu
Uppsala University Hospital
SE-751 85 Uppsala
Maintaining a biobank requires a permit from the Swedish Health and Social Care Inspectorate. The biobank should be reported by the health care provider or other accountable authority that has decided to set up a biobank. The form should also be used to report changes in previously reported information. When tissue samples preserved in a biobank are made available to someone other than the accountable authority, this is also to be reported.
Swedish Health and Social Care Inspectorate
Department for Examination of Permit Applications
SE-104 30 Stockholm, Sweden
Genetic resources and/or associated traditional knowledge acquired from abroad may need permissions and agreements with the country granting access in accordance with EU ABS Regulation No. 511/2014. This applies if the country from which the material is to be obtained is a party to the Nagoya Protocol and has enacted Access and Benefit Sharing (ABS) legislation. According to the ABS regulation, a genetic resource is genetic or organic materials from plants, animals or microorganisms or of other origin containing functional units of genetic make-up as well as associated traditional knowledge. If you conduct your research in Sweden, you need to show that you are complying with the legislation of the country providing access by filing a “declaration of due diligence” with the Swedish Environmental Protection Agency.
Exceptions are research on the human genetic heritage, pandemic influenza virus that is covered by the WHO’s PIP framework, genetic material that has been obtained from international waters, and plant genetic material that is included in the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGFA).
Dual-use items are “items, including software and technology, which can be used for both civil and military purposes, and shall include all goods which can be used for both non-explosive uses and assisting in any way in the manufacture of nuclear weapons or other nuclear explosive devices” (Council Regulation (EC) No 428/2009, Article 2 (1)).
The export of dual-use items is regulated to prevent the proliferation of weapons of mass destruction. If you are exporting a dual-use item you may need authorization to do so, particularly if the item is being sent to a destination outside the European Union.
If you are working with a country under international sanctions, or an individual affiliated with such a country, you may need to apply for authorization from the Inspectorate for Strategic Products (ISP) first.