Informed consent

The following statement has been adapted from an actual consent form: “Any information I give will be used for research only and will not be used for any other purpose“. Consider the implications for data sharing for any data generated using this consent statement. Do you have any suggestions for alternative wording or other changes?

  • Some comments/reflections:

    1. It is tempting to use such wording as a way of reassuring participants that their data will not be misused, but this may be overly restrictive.
    2. Perhaps the data—appropriately anonymised—could be equally useful for teaching, for example.
    3. In general, think very carefully about any wording that restricts – forever – uses of the data. If what you are trying to do is to build trust with participants, telling them how their data can be safely used in diverse ways is a better approach!
InformedConsent

Informed consent is the process by which a researcher discloses appropriate information about the research so that a participant may make a voluntary, informed choice to accept or refuse to cooperate.

Normally informed consent is given before the start of the research. Gaining informed consent is crucial to meet your legal and ethical obligations towards participants whilst simultaneously enhancing the value of your research data.

To obtain informed consent, researchers should:

  • Inform participants about the purpose of the research;
  • Discuss what will happen to their contribution (including the future archiving and sharing of their data);
  • Indicate the steps that will be taken to safeguard their anonymity and confidentiality;
  • Outline their right to withdraw from the research.

Consent needs to be freely given, informed, unambiguous, specific and by a clear affirmative action that signifies agreement to the processing of personal data.

Information sheets

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Information sheets play an important role in gaining a participant’s informed consent to take part in a research project. They help provide participants with the background information which is necessary to make an informed decision about whether to take part in the research project.

A good information sheet discusses the following topics:

  • The purpose of the research;
  • What is involved in participating in the research;
  • The benefits and risks of participating in the research;
  • Details of the research, e.g. the funding source, sponsoring institution, name of project, contact details for researchers and how to file a complaint;
  • The procedures for withdrawing from the research project;
  • The planned usage of the data during the research, dissemination, storage, publishing and archiving of the data;
  • The strategies for assuring ethical use of the data;
  • The procedures for safeguarding personal information, maintaining confidentiality and anonymising data, particularly in relation to data archiving, sharing and reuse.

Gaining informed consent for data archiving and sharing

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Gaining informed consent for data sharing is seen as 'one more small step' to gaining consent from participants to partake in your research project. As a researcher, you will already be acutely aware of the need to fully inform your participants about:

  • What taking part in your research project will involve;
  • How you will disseminate information from the project through publications or presentations;
  • The impact taking part may have on them.

By adding the discussion of data sharing and archiving you permit the participant to make an informed decision. This empowers them and puts them in charge of choosing whether they wish for their contribution to your research project – and their data – to be available for use in future research projects.

Granular consent

The best way to achieve informed consent for data sharing is to identify and explain the possible future uses of their data and offer the participant the option to consent on a granular level. For example, in a qualitative study, this may involve allowing the participant to consent to data sharing of the anonymised transcripts, the non-anonymised audio recordings and the photographs.

Below an example of what granular consent for data sharing could look like on a consent form is detailed:

Approaches to informed consent

Consent can be gained from participants in written or oral form, one-off or continuously throughout the research project, retrospectively or not at all. The form of consent sought will depend on the project. In the accordion below the details and considerations of all three are stated.

  • Written consent is typically seen as the preferred form of the two options, where possible, because the participant can be given detailed written information which can then be explained to them to ensure they fully understand what they are consenting to.

  • In cases where consent was not sought at the point of research, it may be possible to gain retrospective consent from the participants for the depositing of the data in a repository. However, if participants cannot be traced, depositing the data in a repository will need to be assessed on a case-by-case basis to identify whether it is appropriate to share it. This assessment will need consider various factors such as, the nature of the project, the consent sought, the questions asked and the anonymisation levels utilised.

    On the UK Data Service (2017b) website you can read a case study on gaining retrospective consent from a 30-month research project concerning the 2001 foot and mouth disease epidemic in the UK. A standing panel of 54 local people from North Cumbria produced more than 3,000 weekly diaries about the impact of the crisis and the process of regeneration.

Expert tips
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  • The GDPR requires that researchers document consent. Therefore, it will be essential to keep documented and accurate records of the consent obtained from participants.

  • Researchers should consider the participant’s needs, understanding and the best way to gain informed consent. This may, for example, require pictures to be used instead of lots of text – to make it clear and easy for the participant to understand – or for the consent form to be translated into the participant’s native language.

  • For surveys, where personal identifiers such as people's names are not collected or are easily removed from the data file, written consent is often not gathered. Instead, the information sheet given to participants or the survey introduction state that consent for the data being used for specified purposes is implied from participating in the survey, with a clause stating that an individual's responses would not be used in any way that would allow their identification. It is therefore vital that the information sheet provides details about plans for data sharing. This information should include where the data will be deposited and the potential future uses of the data.

  • There are circumstances where no form of consent can be obtained for research, e.g when the researcher collects the information from other sources than the persons themselves or when the data were already collected for another purpose. These situations are exceptional and will need case-by-case review and clear arguments before that research can be conducted. In jurisdictions which have Research Ethics Committees (REC) researchers will need to satisfy the requirements of these research ethics review boards. E.g. in Norway, NSD or the Norwegian Data Protection Authority would need to be informed and permit the research. A Notification form (NSD, n.d.c) listing the reasons why gaining informed consent isn't possible should be handed in.

European diversity in informed consent

Apart from being good scientific practice, in some countries gaining informed consent is mandated by law. In the accordion below, a consent requirement comparison for several European countries is given.

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