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.
Guidelines for the Ethical Review of Research within the HT Faculties, by Ulf Görman, Lund University,
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.
EU Clinical trials are governed in the EU by regulation 2014/536, also called the Clinical Trials Regulation (CTR), which is in force from January 31, 2022. Now the sponsor is to apply for permission in the EU portal CTIS. The application then passes the Swedish Ethical Review Authority for an opinion before forwarding the application to the Medical Products Agency who approve (or not). Only §§ 7-11 in the Swedish Ethical Review Act now apply. The general principle regarding CTs is that a clinical trial may be conducted only if the rights, safety, dignity and well-being of subjects are protected and prevail over all other interests, and it is designed to generate reliable and robust data. In addition to the regulation, it is the GCP guidelines and the Helsinki Declaration that give more detailed ethical guidance.
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
In order to access human samples for research, not only an approved ethics application is required, but also a biobanking application (if it concerns human samples covered by the Biobanks Act). A biobank application is sent to the relevant biobank in the region where the sample is taken. Uppsala Biobank is the only biobank for the Uppsala Region and Uppsala University.
For more information on which samples are covered by the Biobank Act, notification/registration of sample collection and application forms, please visit the Biobank Sweden website (www.biobanksverige.se/forskning). To apply for access to samples taken within Region Uppsala, please visit the Uppsala Biobank website: www.uppsalabiobank.uu.se
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).
Guidance on application of the Nagoya Protocol
If your research is affected by - or for information about the Nagoya Protocol, please contact Uppsala University´s Nagoya Protocol support.
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.