Listen to this web page Listen

|  Text size: decrease text size increase text size   |  Contact  |  Svenska

To the webpage of the Swedish Research Council To the webpage of Uppsala University

Research with registers

Often, researchers use personal registers, which can be an indespensable part of a research project. In longitudinal studies, the research is conducted over a longer time - up to thirty years is not uncommon - and aims at following things such as changes in health and social situation for certain population groups to, for example, learn about how certain work conditions affect us in the long term.

In Sweden, there are great opportunities for significant research involving registers. On the one hand, each individual has a unique personal identification number, on the other, we have for a long time run registers and archived data on people and their lives. Unfortunately, it is hard to get an overview over existant registers. However, the Swedish National Data Service is an excellent service organisation for Swedish research within the humanities, social sciences and health sciences. SND help enable Swedish and international researchers gain access to existing data within and outside of Sweden. SND provides support and guidance to researchers throughout the whole research process. Also the National Archives of Sweden and Statistics Sweden have extensive knowledge on what data are available.

Register research is essential but the personal information used therein can be sensitive in nature. As the handling of personal information entails risks of infringing on the integrity of the person in question, and moreover can be rather costly, a research project's benefit must be weighed carefully against the costs and risks associated with the handling of personal information. For more on handling personal data, see this page.

To create registers

The collection of data for unspecified future research must in Sweden be allowed by a specific regulation, otherwise the demand is for a specific and particular purpose, as stated in the act on ethical review. The scope and sensitivity of these registers have implied that the government and parliament should maintain control over their creation. Today it is hardly possible to create large prospective databases or registers for unspecified future research purposes.

From 1st of Decemeber 2013, a new act about health research on environmental and genetic causes of disease gives Swedish universities the possibility to create research registers as long as data providers give their explicit consent. Anonymised data can then be released from these registers for specific research projects, as long as they have been approved by an ethics review board (in the background is the unclear situation for the Lifegene project at Karolinska Institutet which was stopped by the Swedish Data Protection Authority). The Government has initiated a public inquiry on register research and therefore this act - after it now has beeen extended - is valid through the 31st of december 2020.

For public authorities, there is a common demand that they shall archive such data that is needed for later research to be possible. The Swedish registers relies on a law on official statistics (SFS 2001:99), a law on health data registers (SFS 1998:543), a law on forensic psychiatry research registers (SFS 1999:353), an ordinance on medicinal side-effect registers (SFS 1997:143) and an ordinance on medical service registers from the National Board of Health and Welfare (SFS 1993:1058). Also important is Arkivlagen (SFS 1990:782), which states the demand mentioned above in its third paragraph, and Arkivförordningen (SFS 1991:446).

Getting the data

First, there is a need to know what data is collected and saved. In the act on official secrets it is stated that authorities must list and describe the registers they hold, so that the public can be aware of them and use them. The archives of such public authorities must also be documented.

Data collected by public authorities are often official and may therefore be considered public (the Swedish principle of public access to official records) when secrecy does not apply. There is no right to access data in registers or archives, the release shall always be accompanied by a test to see if the data can be disclosed without any harm to the persons who has provided the data. If not, secrecy might apply. To have gained an approval from the ethical review board is thus no guarantee that one will gain access to data. While the act on ethical review regulates what research might be performed, the Public Access to Information and Secrecy Act govern when data may be released and GDPR how data are used. These concepts are further defined and explained, as is the legal ground for using personal data in research, in the page on the handling of personal data.

As a researcher, one might be able to get data that have been partially deemed confidential (and thus only partly anonymized or released, for example) or the secrecy might be transferred from the releasing part to the researcher, that is, the data should be equally protected by the recieving part (this is the common case when a resercher is working in public organisations). When asking for a release of data, it is thus very important to be able to describe the protection given to personal data in the research project.

Informed consent

Research on data from a living person will fall under the act on ethical review, the personal data act and associated rules and guidelines. Compared to invasive and risky research, the demand for getting informed consent is here somewhat lessened for research on registers. Instead of the extensive instructions in the act on ethical review, the personal data act states that information does not have to be given to participants in such researh if it is impossible to give or would be to cumbersome. If those criteria are present is decided by the ethical review board when trying the ethical review application. If the board so thinks, and also considers the research 'necessary' in accorde with EPL, a waiver for informed consent might be issued. On the other hand, then the demand for consent put forth in the Helsinki declaration might presents a problem, which states basically the same criteria for a waiver ("where consent would be impossible or impracticable to obtain") but also that a waiver only can be issued "exceptionally".

For register or archive research on people no longer living, there is only ethical guidelines to advise. They are usually summarized in four principal demands; on giving information, on collecting consent, on keeping confidentiality and on restricting the use to the research purpose. When doing such research, one should ponder whether to inform and get authorization from relatives to the deseased.

Sharing data

To create registers and to submit data to them is of great importance for research. Many ethical guidelines talk of a duty upon researchers to make their data available for further research when they have finished their own project. That would mean less duplicate research, make possible new combinations of data, and save both money and time. Usually such data is anonymized. Otherwise the new project must fulfill the demand stated in the personal data and ethical review acts that it is in line with the "previous purpose". There are many policies on data sharing from national authorities such as the American NAS and NIH, and the Brittish MRC. See here reports on sharing data from the Wellcome Trust and NRC. A guide for how to handle the sharing of data while keeping standards of confidentiality has been proposed in the article 'Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers'.

A researcher working in the public sphere in Sweden is constrained by the public access to official records principle, and therefore has a legal obligation to archive data so that they might be used by others. See the page on handling data and material for further information.

Last updated: 2019-04-22

Rules & guidelines

See further

CODEX, Centre for Research Ethics & Bioethics, BMC, Husarg. 3, Uppsala | Webmaster | About the web site