Qualitative protocol guidance and template

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 is developing 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.

Background

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:

  1. Support researchers developing protocols where the sponsor does not already use a template
  2. Support sponsors wishing to develop template protocols in line with validated guidance
  3. 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.

Where will the guidance and template be available for use and comment?

The guidance and template can found here.

To inform future guidance and templates, user feedback will be requested from all stakeholders whether authors, reviewers or users of completed protocols.

How do I provide feedback?

We are requesting comment until Wednesday 30 September 2015, when the feedback will be analysed and the guidance and template, revised as appropriate.

Feedback can be emailed to HRA.Protocols@nhs.net.  Please contact us via this email address if you would prefer to provide feedback in person or by telephone, and we can arrange a time to speak with you.