Title of Study

Information Sheet for Participants

The information sheet should be written for a lay person to understand and should cover the following topics:

Purpose of the research

What is involved in participating

Benefits and risks – include a statement that the participant may not benefit directly from the research

Terms for withdrawal:

Participants have a right to withdraw at any time without prejudice and without providing a reason up to a specified date

Thought should be given to what will happen to existing, already provided data in the event of withdrawal

However, it must be clear that withdrawal after a specified date may not be possible as it would unduly affect the study.

Usage of the data:

During research

Dissemination

Storage, archiving, sharing and reuse of data

Strategies for assuring ethical use of the data:

Procedures for maintaining confidentiality

Anonymising data where necessary, especially in relation to data archiving

Details of the research:

Funding source

Sponsoring institution

Name of project

Contact details for researchers

Invitation to ask for more information with researchers’ names and contact details