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:

What fees will I be charged?

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

Timescales and outcome

Updated 2023-02-23