NIHR

National Institute for Health Research - data and IT requirements

"The mission of the National Institute for Health Research (NIHR) is to maintain a health research system in which the NHS supports outstanding individuals, working in world class facilities, conducting leading edge research focused on the needs of patients and the public.

The Institute manages its activities through four main work strands:

  • NIHR Faculty: supporting the individuals carrying out and participating in research
  • NIHR Research: commissioning and funding research
  • NIHR Infrastructure: providing the facilities for a thriving research environment
  • NIHR Systems: creating unified, streamlined and simple systems for managing research and its outputs."

(NIHR Website)

 

UoL DMP Document - Non-RCUK

NIHR data and IT Requirements - Introduction and summary

Information correct as at July 2013.

Please refer to the full Non-RCUK data mangement planning guidance document.pdf

Please also refer to the University guide 'Introduction to Managing Research Data – For Researchers and Students'

The NIHR commissions and funds NHS, social care and public health research essential for delivering responsibilities in public, health and personal social services. Its role is to develop the research evidence to support decision making by professionals, policy makers and patients, make this evidence available, and encourage its uptake and use.

Its key objective is to improve the quality, relevance, and focus of research in the NHS and social care by distributing funds in a transparent way after open competition and peer review.

NIHR Applications
Since 1 April 2009, all applications to NHS Research Ethics Committees have been made using Integrated Research Application Service (IRAS) .

IRAS is a single online system for applying for permissions and approvals for health and social care/community research in the UK. It streamlines the process for seeking relevant approvals, as researchers no longer need to enter the details for a single project in separate application forms.

The IRAS form can be accessed via the ‘myresearchproject’ website .

The Integrated Research Application System (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.
  • Retains familiar aspects of the NRES form system.

Data issues within the IRAS form
Unsurprisingly management of confidential data is a critical theme of the IRAs form, issues including:

  • Storage and use of personal data during the study.
  • Physical security arrangements for storage of personal data during the study.
  • Ensuring the confidentiality of personal data.
  • Policy and procedures for ensuring confidentiality, e.g. anonymisation or pseudonymisation of data.
  • Whether identifiers will be held in the same database as the clinical data, or in a separate database.
  • Who will have access to participants' personal data during the study.
  • Storage and use of data after the end of the study.
  • Where the data generated by the study will be analysed and by whom.
  • Who will have control of and act as the custodian for the data generated by the study.
  • How long personal data will be stored or accessed after the study has ended.
  • For how long research data generated by the study will be stored.
  • Long term arrangements for storage of research data after the study has ended.
  • Whether identifiable patient data will be accessed outside the care team without prior consent at any stage of the project.
  • Review of the statistical aspects of the research.
  • The methods of analysis (statistical or other appropriate methods, e.g. for qualitative research) by which the data will be evaluated to meet the study objectives.
  • If using identifiable personal data, how anonymity will be maintained when publishing the results.
  • Informing participants of results.

With such an emphasis on all aspects of data management it is advisable to create a data management plan early in order to inform the IRAS submission and for on-going support of the conduct of research.

Open Access to research
NIHR encourages initiatives that increase the potential for quality research to be widely disseminated and freely accessed. They support the principle of Open Access to research as set out in its statement supporting Europe PubMed Central.