3.4 Participant agreements including consent forms

The participant agreement (sometimes described as consent forms) detail the objectives of the research project to the participant and outlines the commitments required on the part of both the project and the participant. Participants should be made aware of their legal rights regarding their participation and their data. The participant agreement must clarify these issues to enable the participant to make an informed decision about whether to take part or not.  Information can be provided within an annexure to the agreement, or often these are provided by way of a separate document known as an information sheet.  In this case the consent form will then refer to the information sheet. A person can only give informed consent if they understand the nature of the research and what is being asked of them. Research involving human participants can involve asking personal information and personal opinions, or asking participants to be actively involved in a research activity such as driving a vehicle. It is important to be clear on the purpose for which their data will be used during and after the project, and other rights which they have such as the right to withdraw.

From a data-sharing standpoint, participant agreements or information sheets should cover the topics included in Table 2:

Table 2: Data-sharing topics in participant consent/agreements

TopicIssues to be considered
Data collectionWhat data is to be collected, being specific about audio and video or any personal/sensitive data
Data storageHow, where and for what length of time will the data be stored
Governance and administrationWho is responsible for the data? Who do the participants contact to take action in respect of their data? How can they withdraw?                                                              
AccessWho will have access to the data
Data useWhat will the data be used for including areas of future research
Security and data protectionProcedures for anonymisation and pseudonymisation