This HRA consultation has closed and is displayed for reference only. CTIMP protocol guidance and templates can be found in the protocol page of the research planning section of the site.
The HRA continues to work toward improving the quality and consistency of health research in the UK. As part of this, throughout 2015 the HRA developed a suite of protocol guidance and templates for different study types. Moving into the next phase we have produced protocol guidance and a template for qualitative studies.
The HRA is aware that the quality and content of protocols for Qualitative research varies widely. Strong feedback to the HRA highlighted that this considerable variability of protocols was causing delays to reviews. In response to this the HRA facilitated work to develop guidance and a template to assist organisations and individuals to improve the consistency and quality of their qualitative protocols.
A protocol which contains all the elements that review bodies consider is less likely to be delayed during the review process because the reviewers are less likely to require clarification from the applicant.
A multidisciplinary group from research active organisations provided expertise to the project which has produced this detailed guidance and template which are published for use and comment.
Is it mandatory to use this guidance and template?
No. The use of this collated consensus guidance and template is not mandatory. The guidance and template are published as standards to encourage and enable responsible research. The documents will:
- Support researchers developing protocols where the sponsor does not already use a template
- Support sponsors wishing to develop template protocols in line with validated guidance
- Support sponsors to review their existing protocol template to assess whether it is in line with national guidance.
Can sponsors continue to use their own protocol templates?
Yes. The HRA acknowledge that institutions have specific needs, including specialised additional material, and may have their own templates. The HRA asks that sponsors advise those preparing protocols how their template has regard for the HRA guidance and template. In addition, the HRA recommends that each protocol states clearly how it meets HRA guidance:
- The protocol has regard for the HRA guidance and order of content
- The protocol has regard for the HRA guidance
- The protocol does not have regard to the HRA guidance and order of content
What are the benefits of using the guidance and template?
By clearly defining the expected components of a protocol, the guidance and template help researchers to be sure that they have covered all the elements required by sponsors, Research Ethics Committees and NHS sites. In the future this will also apply to applications for HRA Approval. Protocols which have regard for the guidance and template are less likely to raise queries that can cause delays.
Who can use the template?
The template can be used by all individuals and sponsoring organisations involved in authoring Qualitative research projects.
How do I provide feedback?
The feedback period has now closed.