Associate Principal Investigator (PI) Scheme
Associate Principal Investigator (PI) Scheme
- This Associate PI Scheme will develop junior doctors, nurses and allied health professionals to be PIs of the future.
- The scheme will increase opportunities for patients to be involved in high quality research to improve care.
- The scheme aims to engage, recognise and promote junior doctor, nurse and allied health professional engagement in NIHR portfolio research.
- The scheme is being rolled out for surgical research studies with the aim that every NIHR portfolio trial, led or co-supported by the Surgery Specialty, will have an Associate PI at each open site.
- The scheme has been developed by the West Midlands Research Collaborative, Birmingham Surgical Trials Consortium, Birmingham Clinical Trials Unit and the West Midlands NIHR Clinical Research Network.
- The Associate PI scheme has been endorsed by the NIHR Clinical Research Network’s (CRN) Cancer, Surgery and Oral & Dental Specialty Cluster and the Royal College of Surgeons (England).
Aims of the scheme
- To integrate clinical research as part of routine clinical training.
- To develop a structure for junior doctors, nurses and allied health professionals to gain experience in local leadership of clinical trials, supported by mentors.
- To recognise junior doctor, nurse and allied health professional engagement in a standardised and consistent manner across all NIHR portfolio trials.
Structure of the scheme
- An accessible scheme open to any junior doctor (FY1-St8 or equivalent), nurse or allied health professional willing to make a significant contribution to the conduct and delivery of a surgical study at a local level.
- For the majority of studies, there will be one Associate PI per site, per study, at any given time.
- Some studies may accommodate Associate PIs from multiple different specialties at the same site (if the study requires significant input from multiple specialties).
- The Chief Investigator and Clinical Trials Unit (CTU Director or Deputy Director) of each study that wishes to participate in the Associate PI Scheme will need to subscribe to the nationally agreed terms of reference (see checklist).
- Participation in the Associate PI Scheme does not absolve local PIs of their responsibilities at site. The Local PI remains responsible for the oversight of the study at site, including the activities of the Associate PI.
- The Associate PI scheme will be promoted through Clinical Trials Units, local CRNs, trainee research collaboratives, at junior doctor training sessions and at sites with open NIHR portfolio surgical studies.
- Associate PI status is awarded by the NIHR Clinical Research Network (Cancer, Surgery and Oral & Dental Health Specialty Cluster) based on the recommendation of the local PI and the Clinical Trials Unit (Study Coordinator/Trial Manager).
- It is anticipated that a commitment of at least 6 months will be required for gaining Associate PI status.
- The NIHR CRN (Cancer, Surgery and Oral & Dental Health Specialty Cluster) will issue a certificate to confirm Associate PI status.
- Associate PIs will be acknowledged in the primary publication(s) from the study, which will be defined upfront on an individual trial basis.
Joining the Associate PI Scheme and award of Associate PI status
- NIHR portfolio surgical studies which are either led, or co-supported, by the Surgery or ENT Specialties are eligible to join the scheme.
- In order to be registered for the scheme, studies should have at least 6 months of recruitment activity left to run in order to allow sufficient time for the Associate PI to undertake the activities in the checklist.
- The study must first be registered with the NIHR CRN Cancer, Surgery and Oral & Dental Specialty Cluster through completion of The Associate PI Scheme Study Registration Form which confirms agreement of the Chief Investigator and the Director/Deputy Director of the CTU.
- The list of studies registered for this scheme is available on the NIHR website.
- Applicants wishing to join the scheme should first check that the study they wish to be involved in is registered for the scheme and then obtain approval from the local PI and Clinical Trials Unit (Study Coordinator/Trial Manager). They should then register for the scheme by completing the Associate PI Scheme Applicant Registration Form and inform their local CRN.
- The Checklist should be completed during the course of involvement in the study and towards the end of the rotation or time period, the Associate PI applicant should meet with the local PI in order to review the Checklist and if completed satisfactorily, the PI should sign this off. The Checklist should then be forwarded to the Clinical Trials Unit for final sign off.
- The CTU should email a scan of the completed form to the NIHR CRN (associatePIscheme_surgery@nihr.ac.uk).
- The NIHR CRN will then issue a certificate confirming Associate PI status.
If you wish to make any comments about this scheme or have any queries, please contact us at: associatePIscheme_surgery@nihr.ac.uk.
This scheme has been developed by the West Midlands Research Collaborative, Birmingham Surgical Trials Consortium, Birmingham Clinical Trials Unit and the West Midlands NIHR Clinical Research Network. The Associate PI scheme has been endorsed by the NIHR Clinical Research Network’s Cancer, Surgery and Oral & Dental Specialty Cluster and the Royal College of Surgeons (England).
Version 2.0 May 2019