Documenting consent

Documenting consent

Typically, written consent documentation includes an information sheet and a consent form that is signed by the participant. This division allows the background information to be as detailed as necessary, while keeping the signature form short and concise.

It is also important to consider in advance how the personal information collected will be used in the research project and beyond, as the legal sharing of personal research data becomes more common place in research. Please find out more about this below:


An information sheet should cover the following topics:

  • Purpose of the research.
  • What is involved in participating.
  • Benefits and risks of participating.
  • Procedures for withdrawal.
  • Usage of the data during research, dissemination, storage, publishing and archiving.
  • Details of the research: funding source, sponsoring institution, name of project, contact details for researchers, how to file a complaint.

The consent form should be written in plain language, free from jargon, and should allow the participant to clearly respond to points such as:

  • The participant has read and understood information about the project.
  • The participant has been given the opportunity to ask questions.
  • The participant voluntarily agrees to participate in the project.
  • The participant understands that they can withdraw at any time without giving reasons and without penalty.
  • How confidentiality will be protected, e.g. Whether real names will be used or pseudonyms (with permission), how data will be anonymised, etc..
  • How information will be used in publications, e.g. Quotes.
  • Separate terms of consent for sharing of data that contain personal information, such as text, audio recordings, videos or pictures.
  • Signatures and dates of signing for the participant and the researcher.

For further information, see Documenting consent.

Where consent is being asked for processing personal information (e.g. Name, address and date of birth), then best practice would also be to provide information to participants on:

  • How personal information will be processed and stored and for how long.
  • Procedures for maintaining confidentiality of information about the participant and information that the participant shares.
  • Procedures for assuring ethical use of the data: Procedures for safeguarding personal information, maintaining confidentiality and de-identifying or anonymising data, especially in relation to data archiving and reuse.

For onward sharing of data, the GDPR applies, and further information needs to be provided:

  • The contact details of the data controller (the entity that determines the reason for processing personal data).
  • Who will receive or have access to the personal data.
  • A clear statement on the right of the participant to request access to their personal data and the correction (rectification) or removal (erasure) of such personal data.

Participants should be given a copy of the form and the researcher should retain the signed original.

As part of the ethical research process, it is important to tell participants about the purpose and benefits of sharing and archiving their research data for future research.

Sharing of anonymised information does not need explicit consent, but the information sheet is key to letting participants know what will happen to their contribution by taking part in the research.

Clauses can be used, such as individual responses, which will not be used in any way that would allow their identification. The information sheet should also provide details about any plans for sharing the anonymsied data.

Where activities, such as a nurse visit, taking samples, making physical measurements are included, then written consent is required, like the examples below:

For further information see Participant information about archiving.

Example consent form:
UK Data Archive model consent form

This form meets all requirements for depositing data and other materials at the Archive. We recommend using it, or at least the questions relevant to sharing of personal data.

We have gathered examples of the consent forms that have been used in real research projects where research data have been deposited with the UK Data service.

We are grateful to the contributors for allowing us to use their forms in this way. These forms include examples from a range of research projects, including audio-visual data, medical research, social media, diaries, focus groups, interviews and so on.

There are situations where special considerations are needed when seeking consent. This will include, for example, audio-visual recordings, medical research, internet research, research with children, etc. We highlight just a few of them and explain some implications for data sharing. See special considerations when gaining consent.