How to get support from the MHRN
All discussions about commercially-sponsored research projects are completely confidential.
There is a two-stage formal process to make sure each individual study gets the support it needs. The first stage is ‘Feasibility’, and the second stage is ‘Adoption’. Our industry liaison officer Divya Chadha is available to offer advice during the whole process.
Feasibility
The first step is to send a study proposal, protocol synopsis or other brief document describing the proposed research to the MHRN for review.
We have a pool of expert reviewers who have all signed the National Institute for Health Research confidentiality agreement. Many of them have been involved in producing National Institute for Health and Clinical Evidence (NICE) guidance or have been involved with government evaluations and policy-setting panels. We ask four of them with relevant expertise and experience to comment on the proposal.
Their comments will take into account:
• potential future benefits for NHS patients;
• compatibility of the research question with UK clinical practice;
• the availability and anticipated interest of collaborating NHS-based investigators;
• the prevalence of the target patient population.
We return comments and initial recommendations to the sponsor within two weeks.
Adoption
The next stage is to complete a NIHR Industry Study Submission Form and NIHR costing template and submit these for review along with a full study protocol. There is detailed guidance about the costing template available on the NIHR Clinical Research Network Coordinating Centre website and our industry liaison officer Divya Chadha is available to offer advice.
It is helpful to submit supporting documents such as patient information sheets to inform the in-depth review that is now carried out to ensure we can deliver what we promise before formally discussing ‘adoption’.
The questions we ask in the review include:
• can the MHRN help identify sufficient numbers of participants?
• can the MHRN recruit target numbers within the required time-frame?
• is the MHRN currently supporting any conflicting studies?
• is the proposed budget adequate for the requirements of the protocol?
• where will recruitment succeed? – which sites should we recommend?
The proposal is then considered by a specially-convened adoption panel.
This panel will include clinicians and academics with relevant expertise, and representatives from our regional offices who have a wealth of practical experience of study administration. It will also include someone with personal experience of mental health problems.
The panel is set up and convened within four weeks and usually make a decision on the same day. Occasionally, further discussion or clarification will be needed before a decision can be made.
Study milestone schedule
After adoption, we agree a study milestone schedule with the sponsor company. This forms the basic of resource planning and performance metrics when the study is underway.
Ongoing support and advice is available from our industry team – Divya Chadha and Professor Tony David – throughout the life of the study.
page last updated 6 December 2011