Each project is different and so the documentation required for different projects is different too. Below you will find some examples of study documentation, which you may use as a guide when producing your own.
General Tips
Use simple words and sentences.
Ensure the information is easy to follow - consider how you format the text and whether to use flowcharts/diagrams.
Ask rather than demand.
Avoid using jargon.
Use the active (not passive) voice, e.g. 'We invite you...' instead of 'You are invited to...'
Tailor your material to the audience, e.g. consent forms for preschool children will be different to those for young adults.
by completing the HRA IRAS form (if NHS/HSC Research Ethics Committee approval required)*
*Note, if you are unsure whether your study requires NHS/HSC REC approval, you should complete the University Online Ethics Form first, which will notify you accordingly if NHS/HSC REC approval is needed.
Ethics application forms will ask the researcher for key information about the research project, including:
Principal Investigator contact details
Project description
Proposed project start and end dates
Details of the risks associated with the research
Proposed measures to prevent/minimise the risks
Additional details, as applicable
The information provided should be written for a lay audience, and supporting documentation should be attached with the application form (e.g. information sheets, consent forms, data management plans and other relevant research materials, including for example research questionnaires, recruitment materials).
The Participant Information Sheet (PIS) provides participants with sufficient information about the research study to allow them to make an appropriate (fully informed) decision about taking part. For further information, please see the Human Participation - Informing Participants section.
On receiving the information about the research study (typically through a Participant Information Sheet), the participant should be allowed time to consider whether or not to take part. If they wish to take part, typically participants will sign a Consent Form. For further information, please refer to the section on Human Participation - Acquiring Voluntary Consent and the University's Informed Consent Guidelines.
The University has also developed an Example Consent Form that can be downloaded and adapted to the research project.
A research data management plan outlines how a researcher will collect, use and store data, during and after the research study. For further information, please see the Data - Governance considerations for research data section.
A Privacy Notice sets out how personal information will be processed in accordance with the UK General Data Protection Regulation (GDPR). Participants in a research project should be provided with a Privacy Notice alongside a Participant Information Sheet (PIS), and have the opportunity to ask questions before they sign a Consent Form.
To support researchers, the University has created a template form that can be downloaded and adapted to the project.
If you wish to recommend any changes to the information above, or have any example documents that may help other researchers, please contact res.policy@ncl.ac.uk.
