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 commonplace in research. Please find out more about this below:

Information sheet

An information sheet should cover the following topics:

• Nature and purpose of the research.
• Nature of involvement.
• Benefits and risks of participating.
• Procedures for withdrawal.
• Information on a lawful basis that is being used to collect personal data.
• 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, and how to file a complaint.

Consent form

We recommend that consent forms include three key sections to ensure clarity and transparency for participants. These sections, outlined in our practical guide for researchers on consent for data sharing, are:

Participating in the research

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.

The use of information in the study

This section of the consent form should explain how participants’ data will be used as part of the study. For example:

• Data handling procedures.
• 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.
• Outlining processes for analysing and reporting.
• Granularity such as separately asking for data that contain personal information, such as text, audio recordings, videos or pictures.

By clearly outlining these details, this section helps manage participants’ expectations and fosters trust by guaranteeing the confidentiality and security of their data.

Future use and reuse of information

This section is vital for obtaining consent for the potential future use of participants’ data, ensuring they understand how their information might be used beyond the study. For example:

• Communicating that the data will be deposited for future use.
• Procedures for maintaining confidentiality of information about the participant and information that the participant shares, especially in relation to data archiving and reuse.
• Specifying in which form the data will be deposited, e.g. de-identified, anonymised transcripts, audio recording, survey database, etc.
• Specifying whether use or access restrictions will apply to the deposited data in future, e.g. exclude commercial use, apply safeguarded access, etc.

This is especially significant in the context of open science and data archiving. Securing consent for future use is a cornerstone of responsible data management and promotes a culture of transparency and accountability in research.