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Information about a project to research participants

Photo of two people having a conversation.

When research involves collecting data from identifiable persons the General Data Protection Regulation (GDPR) dictates that these persons are to be informed about the processing of their data. This is to be done when directly collecting data through for example interviews, questionnaires, or tests and/or when collection is conducted indirectly, via for example registers.

Anonymous or pseudonymized data

Anonymous data from a person is not to be confused with later pseudonymizing of data, such as when transcribing recorded interviews and, for example, leaving names and places out.

Only completely anonymous questionnaires, psychical notetaking of anonymous interviewees, access to registry data through ethical vetting etc. might be exempted from giving information.

Support

The information needed is quite extensive so to help with this, there’s a checklist on what to add. How this information is worded is up to the project and the project also need to be prepared to give the information orally, if demanded by the research subject.

Your faculty’s Research Data Advisor might be of assistance in looking at your wording of the information to the research subject.

Ethical vetting

If you have a project that needs ethical vetting, the information to the research subjects needs to be submitted as part of your application. There is a specific template for such information at the webpage of the Swedish Ethical Review Authority. Please observe that the application, as well as the information to the research subject, needs to be in Swedish. If you are anticipating English-speaking research subjects, an English translation can be added as well although it is the Swedish one that will be assessed by the Ethical Reviewing Authority.

Extra support at the ENT faculty

If you are working at the ENT-faculty, support in deciding whether ethical vetting is needed, review of the wording in the application and/or the information to the research subject is given by the Research Data Advisor.

Additional information

In addition, to make sure that the project has fulfilled its information requirements there might be a need to information about right of access to public records, journals demanding access to raw data to be able to review the results before accepting an article and/or demands on open access or re-usability of the collected data.

Below you will find some more explanations about each post.

Virtually all documents, data, results etc. produced at the university are public documents, including research data. This means that if someone makes use of the constitutionally protected right to request such data, it must be made available in some way, unless there is a legal obstacle.  Such an obstacle may be that the information is protected by confidentiality. This is something the research participant should be informed of along with the other parts in the checklist above.

Example on wording:

Request of data not directly accessible

Your information will be handled with care, which means that the researcher will follow the rules set out in the Public Access to Information and Secrecy Act and will not, on their own initiative, disclose information about who provided what information or what that information contained.

The data collected will be processed and stored in a secure manner and will be directly accessible only to those working on the project and administrative staff, when necessary. However, if a request for a public document is made, it will need to be addressed, which may lead to the release of information about you unless the document is or can be considered confidential (“classified”).

Requirement of open data

The right of access to public documents in case of open data requirements is addressed under the heading ‘Open access/reusable results and data requirements’.

Demands for open access to both raw data and results are increasing. Örebro University's research data policy strongly encourages the creation of open or reusable data, if necessary with certain restrictions because of confidentiality (“as open as possibly, as closed as needed”).

If the research project has a requirement for data to be openly available/reusable, this needs to be specifically communicated as this is not something that the individual research participant can be expected to know.

Example on wording:

Projects with open data requirements not needing ethics approval

The data used/generated by this research project will be made available for use by others. For you, this means that [the interview you participate in/survey you answer] will, upon request, be shared with researchers or other individuals who are interested in the information (data) that forms the basis of the study's results. Before the data is shared, a review will be made based on the secrecy legislation.

The main reason for making data available to others is to spread ideas and knowledge and to maximise the effect of the time and money used by this research project.

 

Projects with open data requirements needing ethics approval

The project has been granted ethics approval, which is a prerequisite for using the information collected about/from you during your participation in this study for  research. At the same time, the results and data from this research project have a requirement to be made available for use by others.

For you, this means that [the interview you participate in/ the questionnaire you answer] may, upon request, be shared with researchers or others who are interested in the information (data) on which the results of the study are based. Parts containing information requiring ethical review will only be disclosed for research purposes after review and confirmation by the necessary authorisations.

If an individual requests data as a public document, it may result in the data being released if there is no basis for refusing disclosure.

In some research areas, it is common for journals to want to access raw data before an article is accepted for publication. This is in order to verify the results presented in the article. It is not obvious to a research participant that such a review can take place. The participant therefore needs to be specifically informed about this if there is an intention to publish in such journals.

Our advice would be that you, at an early stage, find out what the review requirements of the journals you are interested in are, and to recognise that this may change in the time between your data collection and eventual publication.

The project also needs to decide how far it is willing to go to achieve publication; if the line is drawn at, for example, the possibility of reviewing pseudonymised transcripts of interviews, it is important to be clear about this with the research participant. It is also important to find out what the journal's reviewers will do with the information they have received once the review is complete.

Example on wording:

Data may be shared with reviewers of scientific journals who wish to confirm our results, to check the reliability of the conclusions presented. This can be by journals in all parts of the world.

[In this project, we have decided that for review purposes we can share written interviews without details that identify the interviewee but no more details than that.]

If you have any questions or concerns about this, please speak to [first name last name] who is the contact person for the research project.