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Working with data: Informed Consent

Guide on working with data

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On this page you will find information on understanding requirements for gaining informed consent from participants, tips on drafting your consent form and links to guidance on gaining informed consent. 

Informed consent for research

After obtaining the appropriate ethical approval, researchers collecting data from human participants must obtain freely given, informed consent to participate in the study, preferably in writing.

To facilitate the process of future data sharing and re-using data for new studies it is good practice to ask participants if they give consent for data preservation, sharing and use for new purposes. Options for data preservation, sharing and use for new purposes should be given as separate optional tick boxes on the consent form. Participation in the study should not be subject to agreement to data sharing. 

If the dataset is going to include any sensitive personal data, specific consent in writing is needed. Sensitive personal data (also known as 'special category' data) is information about an individual's:

  • race
  • ethnic origin
  • politics
  • religion
  • trade union membership
  • genetics
  • biometrics (when used for ID purposes)
  • health
  • sex life
  • sexual orientation
  • involvement in crime / criminal offences

Informed consent is needed even if the study participant is representing an organisation rather than themselves. While the personal element of the data may be minimal, they should still be given the opportunity to protect commercially sensitive or compromising information that may have entered into the data. 

Drafting your consent form

For guidance on drafting your consent forms and writing participant information sheets, please see the Ethics@Bath guidance.

If you are recruiting participants from the NHS there is guidance on developing participant information sheets and consent forms through the Health Research Authority (HRA) and Ethics@Bath (Sharepoint).

The UK Data Service also provides extensive guidance on gaining informed consent from study participants with examples of obtaining consent in a range of different scenarios, and examples of consent forms. In order to facilitate the process of data sharing, your consent form should provide the participant the option to opt in to the following actions: 

  • any use of the data might impinge on the participant's intellectual property, for example, quoting them verbatim
  • retention of the data in an archive
  • sharing the data, along with any restrictions or conditions of access you will impose, such as anonymising the data or requiring a data sharing agreement with other researchers
  • use of the data in future research (reuse for new purposes)

If you need legal advice before drafting your consent form please contact the University's Data Protection Team (dataprotection@bath.ac.uk).

You should reference the University's Privacy Notice for Research Participants on your consent form as this gives the legal basis for the collection of data for research being undertaken at the University.

Template Participant Information Sheets and Consent Forms can be found in the Help section of Ethics@Bath (Applications).

Links to guidance on gaining informed consent

In addition to the University of Bath Data Protection Team guidance pages you can find information on obtaining informed consent from these webpages. You can also contact your Department Research Ethics Officer to discuss gaining informed consent for your research.