Governance Archives - Newcastle Joint Research Office (NJRO)

How long does it take for my study to be confirmed for capacity and capability?

For a high risk study it would be a minimum of 6 weeks however, this can be quicker depending on the study queries.

For low risk studies it would be a minimum of 3 weeks however, this can be quicker depending on the study queries.

Is my study research and how do I find this out?

We would advise using the HRA Decision Tool to identify if your study is research. If your study is research please contact nuth.genericqueries@nhs.net and someone can advise appropriately. If your study is a Service Evaluation or not considered to be research we would advise contacting the Clinical Effectiveness Manager at NuTH.

What is a Principal Investigator (PI) and Chief Investigator (CI) and do I need one for my study?

A PI is an individual responsible for the conduct of the research at a research site. There should be one PI for each research site.

A CI is an individual who is responsible for the conduct of the whole project in the UK.

All Research Studies running at NuTH will need a local PI, this is someone clinical who is employed by NuTH who is a specialist in that area. It can also be someone who is not employed by NuTH but holds a Clinical Contract with the Trust.

What is the HRA?

Our core purpose is to protect and promote the interests of patients and the public in health and social care research. In order to achieve this we:

Make sure research is ethically reviewed and approved

Promote transparency in research

Oversee a range of committees and services

Provide independent recommendations on the processing of identifiable patient information where it is not always practical to obtain consent, for research and non-research projects (HRA, 2017)

What is IRAS?

Is a single system for applying for the permissions and approvals for health and social care / community care research in the UK

Enables you to enter the information about your project once instead of duplicating information in separate application forms

Uses filters to ensure that the data collected and collated is appropriate to the type of study, and consequently the permissions and approvals required

Helps you to meet regulatory and governance requirements (IRAS, 2019)

Do I need a sponsor for my study?

All Research Studies running through NuTH will always require a study Sponsor. There are instances when conducting smaller projects for instance, prospective tissue collection studies will not require a sponsor.

Newcastle Joint Research Office (NJRO)

Supporting researchers in the development, implementation and delivery of world-class experimental, translational and clinical research.

FAQ Group: Governance