The Midlands and East Region pilot for issuing NHS HRC contracts in Primary Care
‘One researcher, one set of checks and one access agreement’
Researchers who want to conduct research in the NHS must have permission for on-site access from the relevant HR department.
The National Institute for Health Research (NIHR) Research in the NHS: Human Resource (HR) Good Practice Resource Pack describes the process for handling these Human Resource (HR) arrangements in the NHS.
Prior to April 2013, Primary Care Trusts (PCTs) carried out many of the HR arrangements for research activity in primary care. With their abolition in April 2013 some functions were transferred by PCTS to other teams for example local NHS Trusts and Comprehensive Local Research Networks (CLRNs) but some PCTs did not and this has created some confusion about who can and should deal with HR arrangements.
The changing environment and the creation of NHS England and Public Health England provide an opportunity to review current practice in primary care and to test new streamlined processes.
NHS England and the Department of Health with the support of the NIHR Clinical Research Network (NIHR CRN) and Health Research Authority (HRA) have launched a pilot to test a single operating model for issuing Honorary Research Contracts (HRCs) and Letters of Access (LoAs) to researchers undertaking research in primary care.
This represents a step change in practice to streamline, standardise and simplify the overall research passport and HR agreement process to enable primary care research to take place nationally within an agreed operating procedure. The objectives are to reduce bureaucracy and remove uncertainty and risk aversion in the current process under the umbrella of ‘one researcher, one set of checks, and one access agreement’.
The pilot has some key principles including:
- Simplifying the process of authorising HRCs and LoAs in primary care through a collaboration of NHS England Area Teams and existing teams in primary care that currently issue the contracts and letters, for example, the CLRNs, which, for the purpose of this pilot are referred to as ‘Primary Care Research Support teams’.
- Using NHS England (through its Area Teams) as the appropriate body to authorise the issuing of HRCs and LoAs in primary care.
- Using existing Primary Care Research Support Teams who have the skills and knowledge to manage these arrangements to do so on behalf of NHS England.
- NHS England Area Teams and Primary Care Research Support Teams working collaboratively to accept the assurances of each other in issuing HRCs and LoAs particularly in the case of multi-site studies where one NHS England Area Team and one Primary Care Research Support Team can be nominated to act across boundaries.
- Sharing appropriate information to enable effective monitoring of casework and the escalation of any issues.
NHS England Area Teams in the Midlands and East region and CLRN-funded staff will operate the pilot, which will run from November 2013 for up to three months. The pilot will focus on CRN Portfolio studies, but the testing processes will be appropriate to both Portfolio and non-Portfolio studies. Non-Portfolio studies may be included in the pilot, where local funding arrangements allow for this.
Indemnity: The issue of appropriate indemnity in primary care has led to confusion. This pilot does not seek to confer any additional rights or obligations in terms of indemnity other than those set out in existing guidance. However for clarity:
- NHS England is a member of the Clinical Negligence Scheme for Trusts (CNST) and this extends to the Area Teams.
- CLRN Research Management and Governance (RM&G) staff acting within the Primary Care Support Teams are, as employees of NHS organisations supported for any negligence by them by the Liabilities to Third Parties Scheme (LTPS).
As a result appropriate indemnity is in place.
Accountability and Monitoring: NHS England Area Teams and Primary Care Research Support Teams have agreed arrangements for monitoring studies in the pilot with accurate records to enable reporting, an escalation process and a process for providing HR assistance in relation to specific risk assessment and advice where any issue of concern is raised in reviewing criminal record checks or occupational health evidence attached to a Research Passport.
New Tools: The pilot has developed new local tools to help recording and monitoring:
- A primary care research passport appendix: completed for each new project to describe the research activity being undertaken and assess risk against the corresponding activity listed in the Research Passport Algorithm.
- A shared primary care HR agreement database to log the status of a researcher and appropriate HR agreements.
- Primary care HRCs and LoAs letters based on existing HR Good Practice Resource Pack templates for primary care.
Next Steps: The pilot will report its findings to NHS England and the Department of Health for consideration with plans for wider implementation by March 2014. A letter is available for the Regional and Area team Directors and Medical Directors, giving further information of the pilot and details of indemnity arrangements.
More information: Will be made available on the NIHR website when possible. If you have specific enquiries please contact: firstname.lastname@example.org or email@example.com or firstname.lastname@example.org.
Acknowledgements: We would like to thank NHS England Area Teams and Primary Care Research Support Teams for their significant contribution in setting up and running the pilot and for the support of the NIHR CRN and Health Research Authority.
- NHS England Shropshire & Staffordshire Area Team
- NHS England Arden, Herefordshire & Worcestershire Area Team
- NHS England Birmingham, Solihull & the Black Country Area Team
- Birmingham and Black Country CLRN
- West Midlands North CLRN
- West Midlands South CLRN