Appropriate Governance

Exactly what process to follow will depend on where your project is taking place and who you are working with.

Outside the NHS:

As a rule if you are working outside of the NHS, in a 3rd sector organisation/ charity or council you will need permission from your manager or the person who holds the budget for your organisation.  Usually you will need to provide enough information in the form of a project plan or outline to allow this person to make an informed decision.

It is good practice to get a formal letter or at least an email stating that they support the project; that you can keep in your project file.

Inside the NHS:

Within the NHS (so if talking to staff or patients) you should work with your contacts to determine the best course of receiving approval.  The sorts of work that people tend to undertake using our methods can be classified as service improvement, service design or practice development.  There are some useful definitions of this sort of activity within this document ( )

Within many NHS organisations service review activity is dealt with under clinical governance processes rather than Research.  This might be through the audit or clinical effectiveness departments.

Research governance requires an onerous amount of bureaucracy and this activity is clearly not research, it is very much about generating locally applicable knowledge, and has been described as Patient and Public Involvement (PPI) activity.

Regardless to the classification of the project work there are certain things that any one working on a project in the NHS has to think about.

All organisations have responsibilities to their patients/users with regards to data protection.  So wherever or whenever you are collecting data from participants with or without consent you must work with the relevant department to discuss how they would like you to proceed.

One aspect of data protection will be that if you are not already employed by the NHS organisation you are working with you will need an honorary contract or letter of access, this process may involve a Criminal Records Bureau check.  The process ensures, and documents that you’re agreeing to abide by the confidentiality policy of the organisation.

The Honorary contract process also ensures from a human resources and health & safety perspective that you are covered to work in the hospital and that, where appropriate, you are covered by the hospital’s insurance in case anything goes wrong.

You should keep copies of emails or contracts in a safe place (a project file) so you can refer back to them throughout the project and provide evidence that you gained all the approvals you required.

Each organisation may do these things differently, or give them different names, but it is your responsibility to ensure all these issues are addressed BEFORE you start your project!