Study Submission

Patient Information Sheet (PIS) and Consent Forms

• General guidance on format and content of a PIS and consent form is provided here.

Primary and Community Care Flowcharts

• NIHR (Portfolio) studies

• Non NIHR (non-portfolio) studies

• Student Projects

Protocol

To help you, the HRA have provided templates that can support you with developing your research protocol.

• Protocol guidance and template for use in a Clinical Trial of an Investigational Medicinal Product (CTIMP)

• Protocol guidance and template for use in qualitative research

REC-proportionate review

For low-risk research studies, (i.e qualitative, student projects) ethics review via the proportionate review service is now available.

It is a fast-track review process for studies which present minimal risk or burden for participants.

• Proportionate Review Information and Guidance for Applicants

• PR toolkit

Research Passport

The research passport algorithm helps researchers to identify the type of research activity that they will be conducting and assess whether they need a letter of access or honorary research contract in place

Please read our guidance on completing and submitting a research passport guidance

• Non-NHS researchers (university) will need to apply for a Research Passport form

• NHS researchers need to complete an NHS to NHS confirmation of engagement checks form

For a template research CV, please follow the HRA Guidance on Submission of CV.

Service support costs in CRN: Eastern

• Service support costs need to be agreed by CRN: Eastern please get in touch with the study delivery officer Nicola Ward or Paloma Amigo

Study Submission

This section covers the procedure for submissions to HRA/REC. It includes:

• Research flowchart

• Research Passports