The establishment of Generic Protocols is intended to allow named investigators to use the same set of procedures/techniques involving human participants as part of a number of different research projects, without needing to submit an enhanced submission to the Ethics Review Sub-Committee on each occasion
Generic Protocols are for procedures/techniques involving human participants that are used on a regular basis, and which form all or part of subsequent research projects or taught modules.
A LEON submission should be completed for each study involving the procedure/technique. The Generic Protocol number should be quoted in the space provided to obtain approval.
The procedure for the initial approval of generic protocols is similar to that used for research proposals. Applications should be submitted through LEON by selecting the Generic Protocol option. This should not be used for one-off research projects.
If you, or one of the investigators on your project, are using a procedure covered by a Generic Protocol, please ensure the relevant individuals are on the list of approved investigators for that Generic Protocol. If this is the case you should quote the Generic Protocol number on the submission. If you, or the individual using the procedure, are not a named investigator the study would not be covered by the protocol.
The above list of approved Generic Protocols will be updated regularly. Please notify the Ethics Review Sub-Committee Secretary of any errors or omissions.
Each approved generic protocol is reviewed, and updated as necessary, every three years. An archive of approved generic protocols is available on request. Please contact the Secretary if you wish to obtain a copy of an approved Generic Protocol.
- For minor amendments or adding investigators to Generic Protocols that have been added to LEON you should complete the Generic Protocol Amendment form. If you are a named staff investigator you will be able to access the protocol in your list of projects. Click on the Protocol title in LEON then select 'Create Sub-Form' on the left hand side. Select 'Generic Protocol Amendment' and then complete the details. (Substantial amendments can be submitted by the Lead Investigator following the process described in the LEON - Amendment Guidance.)
- To submit amendments to an existing Generic Protocol which is not on LEON please complete the Generic Protocol Amendment Form.
- To add a new investigator to a Generic Protocol which is not on LEON, please complete the Generic Protocol Amendment Form (Investigators).
Completed word document amendment forms should be submitted to LEON@lboro.ac.uk.