UREC Example Documentation and Guidance
To assist you in producing accurate and up to date documentation for your project, we have a number of resources available:
Please note, if your study has a component which was approved by the HRA, you should follow the relevant GDPR guidance on the HRA website and discuss as appropriate with your University’s Sponsor Representative.
NEW GDPR Compliant PIS and Consent Form Templates
Please note that for all projects approved from the 25th of May 2018 onwards, the following templates for participant information sheets and consent forms MUST be used for any study which gains approval from a Division/School Committee, Proportionate UREC or full UREC. Please ensure you choose the appropriate template for your study (in particular if you are using special category data):
- Participant Information Sheet Template for General Studies
- Participant Information Sheet Template for Medical Studies
- Participant Information Sheet Template for Special Category Data
- Easy Access Participant Information Sheet Template
- Consent Form Template for Medical Studies
- Consent Form Template for Non-Medical Studies
Important changes: The most important changes to the information sheet include the link to the University’s Privacy Notice for Research Participants as well as the explicit mention of the legal basis for processing personal data, a requirement of the GDPR.
- These templates have been created to provide additional guidance and examples of the content that should feature in your participant information sheet and consent form. The required information in relation to GDPR can be found in all templates but is worded differently depending on the nature of the study. Therefore you should select the template which is best suited to the type of research you will be conducting.
- The template for general studies is applicable to most research, except those using special category data. If you will be conducting interviews, focus groups, distributing questionnaires, performing observations or other activities then this template should be suitable (providing you are not collecting special category data and your study is not medically focused as described below).
- The template for medical studies should be used if your study has a specific medical component (i.e. taking blood, taking tissue samples, accessing medical records, etc). The content of the medical templates contains specific guidance information and examples (such as circumstances in which you may wish to contact the GP of the participant) for these types of studies but the content in relation to GDPR is the same as the other templates. If your study has a medical component but is also obtaining special category data from participants, please use the Special Category template.
- The template for special category data should be used if you will be collecting information as listed below.
Note: special category data includes (but is not limited to) data about an individual's:
- ethnic origin
- political affiliation
- trade union membership
- sexual orientation
Research with Children
The following participant information templates have been produced for research with children. Please note that these are examples which have been created for a fictitious study but that contain wording that is written in age appropriate terms. Please consider the possible differences in reading vs chronological age when drafting your own information sheet and ensure that you produce a version which is suitable for the youngest participant within the group.
- Participant Information Sheet for Children 5-11 years
- Participant Information Sheet for Children 12-15 years
Important note: According to the GDPR regulations every child has the right to access their personal data, know exactly what it is being used for and be provided with the details of someone they can go to if they have questions or concerns. To ensure that all children are adequately informed you must ensure you include age appropriate wording in your information sheet which specifically mentions these details. For older children you should also ensure you mention the legal basis for data processing and include a hyperlink to the Research Privacy Notice. Please see the example information sheets for children listed above for suggested wording.
Other Example Documentation
- Example Distress Policy adaptable for most studies
- Example Distress Policy for studies involving a high probability of distress *Please note this example was developed by Annabel Green under the supervision of Dr Sara Tai. We have been given permission to share for best practice.
- Example Distress Policy for Experimental Studies *Please note this example was developed by D. Talmi and tested extensively at her laboratory. We have been given permission to share for best practice.*
- Example Debrief Sheet ** Please note this example was adapted from a version created by the School of Psychological Sciences, Clinical and Health Psychology which we have permission to share for best practice**
- Examples of Children's participant information sheets for Under 5 years, 6-11 years and 12 years and over.
- Example of an easy access participant information sheet (for those who need additional visual aids, i.e. stroke patients) ***that has been kindly shared by staff members in the Institute for Cardiovascular Sciences***.
- Guidance on the Use of Emotional Media
- Guidance on the Use of Social Media
- Guidance from UKRIO on Internet-Mediated Research
- Guidance on the use of Survey Tools
- Guidance on Recording Participants in Research Projects
Researchers collaborating with other UK based institutions
If researchers are collaborating with another UK based institution where ethical approval is being sought at the other institution, the approach to GDPR will be determined by the data protection relationships that have been identified at the beginning of the collaborative agreement.
As an example, if the University of Manchester is listed as a data processor (but not the data controller) then it would be appropriate that the researchers follow the GDPR approach of the other UK based institution.
However if the University of Manchester is to be a joint data controller with the other UK based institution then the approach to GDPR compliance must be collectively agreed and this must be documented explicitly in the collaboration agreement.