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Associate PI Scheme- FAQs

 

Contents

Associate PI Scheme

Frequently Asked Questions

 

I am a Chief Investigator/member of a Trial Management Group and would like my study to take part in the scheme. How do I organise this?

The scheme is currently open to surgical studies (led or co-managed by the Surgery or ENT Specialties) on the NIHR CRN portfolio. If this is the case, please complete the study application form which can be found at https://www.nihr.ac.uk/nihr-in-your-area/surgery/our-studies.htm 

Can an observational study be part of the Associate PI scheme?

The scheme is intended to engage junior doctors, nurses and allied health care professionals in NIHR portfolio research. Although the scheme is primarily aimed at interventional studies, it is open to observational studies provided that the study offers the opportunity for Associate PIs to develop skills around the local implementation of studies and being personally involved in recruiting patients, reviewing screening and delegation logs, interacting with Clinical Trials Units/Trial Management Groups and engaging with and developing the local team to deliver a study. As not all observational studies will help develop these skills, inclusion of observational studies in the scheme will be on a case by case basis and at the discretion of the NIHR Clinical Research Network. 

I am a PI, does having an Associate PI change my legal responsibilities?

No, as the local PI you are legally responsible for the local delivery of the study and having an Associate PI work alongside you does not change this. 

Does the Research Ethics Committee (REC) need to be informed that a study is joining the scheme?

No, the REC does not need to be informed as participation in the 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. 

I would like to be an Associate PI at my next placement. What should I do?

The first step is to check to see if the trial that you would like to be an Associate PI on, is registered for the scheme (see below). If it is, you should contact the PI for this trial and find out whether there is already someone that has registered to be an Associate PI during your placement. If there is, it may be possible to be an Associate PI on a different trial at the site. You also need to contact the Study Coordinator/Trial Manager at the Clinical Trials Unit which is managing the study to obtain approval. You should then complete the online form available on the website.

Do I have to prospectively register for the Associate PI scheme?

Yes, it is important that each Associate PI registers for the scheme when they start in their role at a site. You may wish to register ahead of moving to a site but it is imperative that you discuss this with the local PI to ensure that there is not already an Associate PI that wishes to continue in the role. The local PI will be informed of any registrations at the site for their study so it is very important that you discuss this with them before registering. 

Can there be more than one Associate PI at a centre?

The majority of trials and centres will have one Associate PI per study per centre. However, if a trial requires significant engagement and input from more than one specialty or department, there may be one Associate PI per specialty per centre. If you think that your study or site should have more than one Associate PI please check with the local PI if this has already been agreed. If it has not, please contact associatepischeme_surgery@nihr.ac.uk. 

My Trust has several sites which are all involved in the study and all recruit patients. Can there be more than one Associate PI across the Trust?

Each independent site is eligible to have its own Associate PI. As per HRA guidelines each ‘independent operating site’ should have a PI and this translates to also being eligible to having an Associate PI. There may be more than one PI within a single Trust, for example if hospitals within a Trust contribute to a study independently from each other and each hospital has a PI for the trial, there could be an Associate PI at each of these hospitals to work alongside each PI. As a general rule, there can be as many Associate PIs as there are PIs within each specialty.

The caveat to this general rule, is when a trial involves significant collaboration from more than one specialty. For example, ROSSINI2 is recruiting elective and emergency laparotomies from general surgery, vascular surgery, gynaecology and urology. A site may require an Associate PI from some or all of these specialties to assist with the local delivery of the trial. This decision is taken on a trial by trial and site by site basis. If you are unsure of the arrangements, please contact the local PI or the trial manager for further details.

Can I transfer from one site to another and continue as an Associate PI?

We would encourage Associate PIs to continue being part of the scheme as they move around to different rotations/sites. This may be as part of the same trial or as an Associate PI for different studies. However, an Associate PI is not transferable between sites- each time period at each site is regarded as a separate placement and the time periods cannot be combined. For example if someone is based at a hospital for 8 months they can be an Associate PI for this site. If they then move to a different hospital for 4 months, they would not be eligible to be an Associate PI at this site. 

Can I be an Associate PI for more than one study at a time?

A person can only be the Associate PI for one study at a time. This is to allow a greater number of individuals to take part in the scheme and enable each Associate PI to devote the necessary time and attention to the trial that they are involved in delivering. 

Where can I check if a study that I am involved in has registered for the scheme?

A list of the studies which are registered for the scheme can be found on the NIHR website (https://www.nihr.ac.uk/nihr-in-your-area/surgery/our-studies.htm) where you can also find links to the Outline and Checklist documents. 

I want to register to be an Associate PI but the study that I want to be part of is not listed on the NIHR website. What should I do?

If the study that you wish to be involved in locally is not listed on the Associate PI study list, the CI/CTU Director has not applied for the study to be included. If this is the case we advise you to contact the CI and Trial Manager to clarify the situation. Please note that every effort is made to keep the registered study list up to date but there may be a short delay from a study being submitted to it being listed on the website as a number of checks and approvals need to be made.

I am a staff nurse/physiotherapist/dietician/AHP. Can I apply to be an Associate PI?

Yes, the scheme is open to junior doctors, nurses and allied health professionals. We are very keen to encourage members of all of these groups to take part. 

I am a Research Nurse. Can I become an Associate PI?

The Associate PI scheme is aimed at clinical staff who wish to gain skills and experience in participating in NIHR portfolio research and to provide them with formal recognition of the contribution they have made over and above the standard expectations of their role. Staff whose core role already includes research (eg. research nurses) are therefore unlikely to benefit from the scheme. If a research nurse is working on the study in their funded capacity/job role then they would not be eligible to register for the Associate PI scheme. If it can be demonstrated that the work the research nurse does on delivering the study is in addition to their core activities then enrolment of such staff will be considered on a case by case basis.

I am not a surgeon but would like to take part in the scheme with a non-surgical study. What should I do?

The Associate PI scheme has been developed through a collaboration between the West Midlands Research Collaborative, Birmingham Surgical Trials Consortium, Birmingham Clinical Trials Unit and the West Midlands NIHR Clinical Research Network. At the present time it is only open to NIHR portfolio surgical studies that are managed or co-supported by the Surgery or ENT Specialties. If the study is in a different specialty, we would encourage you to discuss the scheme with your local CRN and National Specialty Lead.

Do I need to fill in every box on the Associate PI checklist?

The Checklist is structured with ‘Core activities’ and ‘Additional activities’. Each of the core activities is mandatory in order to receive Associate PI status. 

What do I do with my completed checklist?

Towards the end of a rotation or time period as an Associate PI, the Associate PI applicant should meet with the local PI (and research nurse) in order to review the Checklist document and if completed satisfactorily, the PI should sign the checklist. The Associate PI applicant should also sign and the completed document should then be forwarded to the CTU representative for them to sign it off. 

What recognition do I receive for being an Associate PI?

Once your checklist has been checked for completeness and forwarded to the NIHR, you will be sent an NIHR-endorsed certificate to indicate the study, time period and centre at which you were an Associate PI. The study teams taking part in the Associate PI scheme have agreed that all Associate PIs will be acknowledged in the primary publication(s) from the study. The exact details of this should be included in the study protocol. Although a publication is a tangible output, of more significance are the enhanced skills and understanding around the delivery of NIHR portfolio research which you will gain through taking part in this scheme.