When applying for HRA Approval you will need to check what supporting documents you will need to provide well in advance of when you expect to submit your application. This will avoid unnecessary delays to your application.
Make sure that you attach all of the required supporting documentation for your project, and that they are all dated and version-controlled. Lack of date and version number is one of the main reasons that applications can not be validated.
The documents you will require will include:
Protocol
Your protocol is a full description of your research study and will act as a ‘manual’ for members of the research team to ensure adherence to the methods outlined. More information on what your protocol should contain, and protocol templates can be found here.
Participant Information Sheet (PIS)
Your Participant Information Sheet (PIS) should describe clearly what a potential participant should expect if they agreed to take part in your study. Our online consent guidance contains more information and templates for creating a PIS. This guidance follows the requirements set out in the participant information quality standards and design review principles.
Other documents you may be asked to supply, depending on the type of research and the application being made could include:
Organisation Information Document and Schedule of Events
The Organisation Information Document should be used to provide information on participating NHS/HSC organisations in the UK. There are commercial and non-commercial versions available. An outline Organisational Information Document for each site type should be completed as part of your submission. For non-commercial studies it should be accompanied by a completed Schedule of Events. The two documents allow the sponsor to make clear what activities will be undertaken locally and the cost type for each activity. Our guidance for use with the Organisation Information Document will help you to complete the documents.
· Organisation Information Document
· The HRA provides a free eLearning module explaining the HRA Schedule of events.
Interactive costing tool
The Interactive Costing Tool (iCT) is a part of the National Contract Value Review (NCVR) process that covers costing and contracting for commercially sponsored research taking place in the NHS. Further information on the iCT and NCVR can be found on the NCVR page of the NIHR website.
Model Agreements
Any changes to the model agreement must be made clear in your application. You can find templates and further guidance on model agreements in the templates for supporting documents page of IRAS help.
Manuals
If you are using NHS facilities, a laboratory manual and a pharmacy manual should usually be provided.
Funding letter
This may be required if the study is applying for adoption to the NIHR Clinical Research Network Portfolio.
Curriculum Vitae
Guidance and a standard template for an investigator CV is provided for your use. This template would be suitable for submission of CVs by Chief Investigators, local Principal Investigators and academic supervisors (for submission with student applications).
Research passports and honorary contracts or letter of access
The Human Resource (HR) Good Practice Resource Pack in IRAS Help describes the process for handling HR arrangements for researchers and provides a streamlined approach for confirming details of the pre-engagement checks they have undergone with the NHS.
Helpful documents and resources
- HRA e-learning includes modules on HRA Approval and reviewing research design
- E-learning on attribution of costs for research in the NHS from the NIHR Clinical Research Network
- the document management for combined review applications page provides guidance on which documents you may need to submit for combined review applications