Applicant Guide: Consideration of study protocols by HSE

Introduction & Background

HSE is often asked to comment on draft study protocols in order to confirm that the design and methodology is appropriate and will potentially address a specific data gap. This is particularly the case for more complex higher tier studies for which some novel method or approach is necessary that is not covered by existing guidance.

In light of the work involved in assessing such requests, and the detailed discussion that often takes place between HSE specialist assessors and the applicant, it is considered appropriate to recover the costs associated with this work through the charging of a fee proportionate to the work involved.

Consequently such requests are considered via submission of an application to the Applications sift: [email protected].

What Information should I submit?

You should submit:

• A covering letter clearly setting out the context of the proposed trial and its objectives including any specific data requirements it is designed to address. The covering letter should also detail all relevant information (for example GAP or conditions of use that you are seeking to support), clearly specify the questions you would like to be answered and clarify who is applying and the address for invoicing.
• The draft trials protocol.

What fees will I be charged?

The following fees will be charged which reflect the work involved in commenting on trial protocols.

• Sift fee
• Reasoned Case fee (For particularly complex studies requiring significant specialist assessor consideration it may be necessary for HSE to charge an additional data module fee in the relevant specialist area to fully recover the costs associated with this work. HSE will advise the applicant in advance of applying this additional fee should it become necessary).

Further information on fees is available here

Timescales and outcome

• HSE's assessment of draft protocols will take no longer than 6 weeks to produce. You will be provided with a copy of our conclusions and recommendations upon completion.
• Please note that our consideration of the protocol does not guarantee the outcome of the study or that it will adequately address the relevant data requirement.
• It should also be noted that HSE's conclusions represent a UK point of view and that other competent authorities may have different opinions.