Associate PI Scheme - FAQs

• General questions
• Applying to be an Associate PI
• Registering a study

For everyone

General questions

1. Where can I get more information about the Associate PI Scheme?

   There is an overview of the scheme, a list of registered studies and online forms for completion on our Associate PI page. If you have any questions about the registration process or eligibility of a study or applicant  after reading the FAQs, please contact the NIHR Associate PI Scheme Team at associatepischeme@nihr.ac.uk.

2. What specialities are supported by the Associate PI scheme?

   A list of the current supported Specialities can be found on our Associate PI page.

3. Which Royal colleges currently endorse the Associate PI scheme?

   A list of the current Royal Colleges who endorse the scheme can be found on our Associate PI page.

4. Where can I check which studies are registered on the Scheme?

   To see which studies are currently registered for the scheme, please check the list of registered studies (spreadsheet).

Applying to be an Associate PI

• Individual questions
• Processes
• COVID-19 studies

Individual questions

1. What are the requirements to register to be an Associate PI?

• You are a healthcare professional based in the UK who wants to gain knowledge of what it means to deliver an NIHR portfolio trial.

• You are able to commit to six months of working on a study registered on the scheme at my local site.

• You have spoken to the local PI and gained approval from them that they are happy to support you before they apply for the scheme.

• You don’t currently work in research and would like the opportunity to gain experience and mentorship from a local study PI.

Applicable to ‘Fellows’ only:

2. Who is eligible to be an Associate PI?

   The scheme is open to healthcare professionals who do not have research as a core part of their role but wish to gain skills and experience in participating in NIHR Portfolio research. This includes, but is not limited to, doctors, nurses, pharmacists, and so on. We encourage all healthcare professionals to consider taking part, however please note the information below before applying:

• I am not receiving funding to work on the study I am applying for.

• Clinical Lecturer or Fellow:

  If a Clinical Lecturer or Fellow would gain provable additional skills from working on a study outside of their funded capacity / job role, then they may be eligible to register for the Associate PI Scheme. Enrolment in these cases will be made on an individual basis.

• Research nurses:

  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. For this reason Research Nurses are ineligible to apply for this scheme. However we strongly advise looking at the NIHR Career Development page.

• Students:

  Students are not eligible to be Associate PIs, because the scheme requires significant input over at least six months and this is not compatible with most student placements. Students must qualify before becoming eligible to join the scheme. We strongly encourage students to become involved in clinical research in other capacities in a way that fits with their training.

3. Do I need to be based in the UK to take part in the Associate PI Scheme?

   Yes, only applicants working in sites in the UK (including Scotland, Northern Ireland and Wales) can take part in the Associate PI Scheme.

4. How long does the scheme take to complete?

   Applicants will generally be involved in a study at a single site for five to six months. This may be partly during the set-up phase and during follow-up of patients, but must include recruitment.

5. Do I need to complete GCP training?

   Yes, it is mandatory that each Associate PI trainee who registers for the Scheme must complete GCP training.

6. When am I officially recognised as an Associate PI?

   You do not officially gain Associate PI Status until you have completed your 6 month tenure on the Associate PI Scheme and completed and submitted your Associate PI Scheme Checklist. Once you have submitted your checklist, you will receive a certificate that officially recognises you as the Associate PI.
   
   You are not an Associate PI as soon as you start the Associate PI Scheme. You may be referred to as the Associate PI trainee and you may use this title but you will not be officially recognised as an Associate PI until you complete the scheme and receive your checklist.
   
   You can continue to work on the study you worked on as the Associate PI once you have completed your Associate PI Scheme tenure. You just will no longer be working on the study as part of your tenure on the Associate PI Scheme, so this means we can offer the place to someone else to complete their tenure on the scheme for the study. You will still be officially recognised as the Associate PI for that study, you just won’t be completing a tenure on the Associate PI Scheme as part of working on that study - you will have completed it.

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

   No. A person can only be an Associate PI trainee for one study at once. This is to allow a greater number of individuals to take part in the scheme and enable each Associate PI trainee to devote the necessary time and attention to the study that they are involved in delivering.

8. Is there any funding available to support my time on the scheme?

   No. The scheme allows Associate PI trainees to gain experience while in their usual paid non-research role.

9. I’ve previously completed the Associate PI Scheme, can I take part again?

   Yes, upon completion of the scheme you are eligible to apply again, as long as it is for a different study, or a different site.

10. If I’m interested in a study which lies under a department/speciality which is different from my own, can I still apply to be an Associate PI on that study?

    Yes, the Associate PI Scheme is guided by the studies available and the CI, CTU, and Local PI would need to agree that your involvement in a study would enable you to meet the mandated Associate PI checklist criteria. If you meet this criteria, then you must first obtain approval from the Local PI before you submit your application for the Scheme. You then need to complete the Associate PI Scheme Applicant Registration Form.

11. What approvals from Deaneries/Colleges are required for Doctors in training? - Given the additional tasks they will take on during this time/impact on rotas, etc.

    We have endorsement from the GMC and most of the Royal Colleges and they fully endorse the Scheme and process. Please see the complete list of supported specialities and royal college endorsements.

12. Must I be working in an NHS trust with a registered trial to be part of this scheme? What if there are no trials registered on the Associate PI Scheme in my Trust?

    Yes, you must be working at the same site where you apply to become an Associate PI. We are always looking for more studies to join the scheme, so if you discover a study that interests you at your site but is not registered, then we would encourage you to get in touch with the Study Team and introduce them to the scheme.

13. What if there are no trials registered on the Associate PI Scheme in my NHS Trust?

    We are always looking for more studies to join the Associate PI Scheme, so if you discover a study that interests you at your site but is not registered, then we would encourage you to get in touch with the study team and introduce them to the scheme.

14. Should I recommend the Associate PI Scheme to clinicians/consultants that aren't research active? Could it work as a buddy system?

    Yes, increasing awareness and activity of research amongst non-research-active professionals is one of key aims of the scheme, so please do spread the word.

Processes

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

For you to register to become an Associate PI trainee for a study, you must find a study which is:

a. Registered to the Associate PI Scheme.
b. Open to recruitment at your site (or in setup and due to open to recruitment shortly).

To see which studies are currently registered for the Scheme, please check the list of registered studies (spreadsheet).

To see a list of studies that your local site is participating in, please visit ODP (the Open Data Platform). Once you've made an account and logged in, you should be able to see a dedicated Associate PI Scheme dashboard. Once you’ve accessed this dashboard, navigate the tabs at the top and look for Where Can I Take Part? All the instructions on using the dashboard are included at the top of the page on the correct tab.

Once you have found a study that is registered to the scheme, and is also open at your site, you can apply to become an Associate PI traineeby completing and submitting this form here - Associate PI Scheme Applicant Registration Form.

2. 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, that means the CI/CTU Director has not registered their study onto the Associate PI Scheme. If this is the case, we advise you to contact the CI and Trial Manager to clarify the situation. If you’re unsure who the CI is then we suggest searching the NIHR CRN Public Search.

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.

3. Do I have to prospectively register for the Associate PI Scheme?

Yes, either when you start in your role at a site or ahead of moving there, but it is imperative that you discuss your registration plan with the local PI first, to ensure that there is not already an Associate PI on the study with whom you would overlap. The local PI will be informed of any registrations at the site for their study.

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

Yes, as long as the study you are currently working on is running at your new site. If you are transferring to another site, you must make the Associate PI Scheme team aware by emailing them at associatepischeme@nihr.ac.uk and letting them know the details of your new site, and who your new Local PI will be.

You will need to seek approval from the Local PI at your new site to ensure that they are happy to have you continue your tenure on the scheme alongside them on the study as the Associate PI trainee.

If there is already an Associate PI trainee at the new site working on the study, then when you are having your conversation with the Local PI to ensure they are happy for you to continue your tenure on the scheme, you will also need to ask if they are happy to have two Associate PI trainees.

The Associate PI Scheme team will then follow this up and will also gain approval from the Local PI to ensure they would be happy to have 2 Associate PIs.

Both your original Local PI and the new PI at your new site will need to sign off your checklist. We recommend that you ask your original Local PI to sign off the checklist before you leave your old site, then when you have finished your tenure at your new site, get your new Local PI to add their name and signature.

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

The checklist is structured with ‘core activities’ and ‘additional activities’. The core activities are mandatory so must be completed in order to receive Associate PI status.

6. What do I do with my completed checklist?

Towards the end of a 6 month tenure or rotation, the Associate PI trainee should meet with the local PI and research nurse in order to review the checklist.

If completed satisfactorily, the PI and Associate PI trainee should sign the checklist. The Associate PI trainee should then send it to the CTU representative for signature. Once the checklist has been fully signed off by all parties, it should be submitted via NIHR Learn or sent to the NIHR Associate PI Scheme Team at associatepischeme@nihr.ac.uk for checking.

7. What recognition do I receive for being an Associate PI?

   The signed checklist will be reviewed by the NIHR Associate PI Scheme Team. If accepted, 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 are encouraged to acknowledge all Associate PIs 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.

8. Is there an interview as part of the Associate PI application process?

   Not necessarily, though we do expect for you to have a conversation with the local PI of the study you're interested in, prior to registering for the scheme.

9. As an Associate PI, can I add people to the delegation log and sign them off to recruit people?

   Yes you can add people to the delegation log, but the PI must sign these activities off.

10. Can an Associate PI sign off the delegation log?

    No, the PI would still need to sign off the delegation log. Associate PIs would assist in its maintenance ensuring the current team members are signed up, in date CV/GCP etc.

11. What is the working time equivalent (WTE) of the scheme? How many hours per week are expected?

    We recommend a couple of hours per week but this is study dependent so it's always a good idea to have the discussion with your local PI first to gauge how much time you will need to commit.

COVID-19 studies

1. Can there be more than one Associate PI trainee at a site?

Since COVID-19 trials usually involve several specialties or departments at a site, it is permissible for there to be more than one Associate PI trainee at a site simultaneously, providing they are from different pre-approved specialties. For more information, please contact associatepischeme@nihr.ac.uk.

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

Each independent site is eligible to have its own Associate PI trainee, as long as there is a corresponding PI for each Associate PI trainee. As per HRA guidelines "each independent operating site should have a PI", which translates to eligibility for the Associate PI Scheme.

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

We would encourage Associate PIs to continue being part of the scheme as they move around to different rotations/sites. Due to the size of the many COVID-19 studies, Associate PI status can be transferable between sites (maximum two) - each time period at each site is regarded as the same placement and the time periods will be combined. For example, if someone is based at a hospital in Huddersfield for four months, if they then move to a different hospital, i.e Leeds, for two months, they would be eligible to be an Associate PI as long as they are still working on the same trial at both sites.

4. 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. The exception to this rule, specific to the RECOVERY trial, is the section on the delegation log as several sites are not utilising one in their delivery of the trial.

Registering a study

• Individual questions
  • Principal Investigators
  • Clinical Trials Units
• Processes
  • Principal Investigators
  • Clinical Trials Units

Individual questions

1. I am a Chief Investigator or member of staff based within a CTU and would like my study to take part in the scheme. How do I organise this?

The scheme is currently open to non-commercial, interventional, multi-site UK studies on the NIHR CRN Portfolio. It is now fully launched and open to a wide range of specialties, for a full list of supported specialties please see our supported specialities and royal college endorsements.

If your study falls under any of these specialty areas and has at least six months of recruitment left, please complete the Associate PI Scheme - Study Registration Form.

2. Can an observational study be part of the Associate PI Scheme?

Yes, provided that it offers the opportunity for Associate PIs to develop skills relating to the local implementation of studies and to be 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 some observational studies will not help develop these skills, inclusion of observational studies in the scheme will be made on a case-by-case basis.

3. Can there be more than one Associate PI trainee at a site?

Most studies will have one Associate PI trainee per site. If a study is recruiting at several sites within a large Trust, then each site that has its own local PI can have its own Associate PI trainee.

If a study requires significant engagement and input from more than one specialty or department, it is possible to have one Associate PI trainee per specialty, per study, per site, in order to assist with delivery of that study. If you think that a study at your site should have more than one Associate PI trainee, please check with the local PI or study manager if this has already been considered. If it has not, please contact associatepischeme@nihr.ac.uk. This decision is taken on a case-by-case basis.

Principal Investigators (PIs)

1. 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 trainee work alongside you does not change this.

2. What are the benefits, for me as a PI, of having an Associate PI?

Teamwork is integral to the successful delivery of portfolio studies and the Associate PI helps as part of this team. As part of their remit, Associate PIs are expected to assist in specific areas of trial delivery (see the Associate PI checklist). It is hoped, and demonstrated, that an Associate PI increases the efficiency of trial delivery at site.

The Associate PI may achieve this by the dissemination of the trial across a department(s), or by leading local research team meetings and dealing with the multitude of queries that occur when undertaking research. The Associate PI can also help by improving compliance with delegation logs and screening logs.

It is important to note that the role of the Associate PI is not to just recruit patients to a study. While recruitment is an important aspect of an Associate PI’s experience, it should not be the sole focus.

3. What are my responsibilities as a PI to my Associate PI?

As a PI you will still be legally responsible for the study at your site. You may delegate appropriate responsibilities and tasks to the Associate PI, but ultimate responsibility remains with you as the PI.

As PI you are asked to provide mentorship to the Associate PI. Your role is to provide support to them in order to help deliver the trial, whilst at the same time ensuring you have continued oversight of all aspects of the trial at site.

It is expected that you will meet regularly with the Associate PI, supporting the Associate PI to present the study at departmental meetings, assist and lead the Associate PI when dealing with challenging aspects of trial delivery or questions about how the trial will run, and to guide the Associate PI through interactions with R&D and other departments as appropriate.

Clinical Trials Units (CTUs)

1. What happens if the CTU leadership thinks the study should not be part of the Associate PI Scheme?

Anyone can submit a request to have a study registered for the Associate PI Scheme, but the study CI and Director/ Deputy Director of the Clinical Trials Unit (CTU) must confirm they agree with the request by replying to the confirmation email sent by NIHR Associate PI Scheme Team. If the CTU does not wish to take part, they should discuss their reasons with the study’s CI and tell associatepischeme@nihr.ac.uk. We would be interested in receiving feedback about this.

2. Can we refer to the Associate PI Scheme in the study-specific Standard Operating Procedures?

Yes, we would encourage CTUs and Study Coordinators/Trial Managers to include reference to the Associate PI Scheme in the study documentation.

3. How do I know if Associate PIs have been registered at sites participating in the study being coordinated by the CTU?

The NIHR Associate PI Scheme Team has created a dashboard on the Open Data Platform. The dashboard displays all the confirmed Associate PIs registered to the studies associated with the user (Study Coordinators/Trial Managers). Detailed instructions on how to access the information on the dashboard are sent to the study coordinator/ trial manager following study registration.

We ask that the Study Coordinator/Trial Manager uses this data to make contact with their Associate PIs to introduce themselves and explain to them what the role of the Clinical Trials Unit is in delivering an NIHR portfolio study. We want to encourage Associate PIs to build a working relationship with their Study Coordinator and the Trials unit so that they understand what interaction they would need with them if they were to be a PI on a study.

The Study Coordinator/Trial Manager should keep a careful record of all the Associate PIs registered for their study and their status. Study Coordinators/Trial Managers should enquire about the progress registrants have made after about six months have elapsed and prompt them to submit their checklists for signature.

The Study Coordinator/Trial Manager is also responsible for signing off the Associate PIs checklist at the end of their time on the scheme.

Processes

1. What do I do if I don’t think the study should be part of the Associate PI Scheme?

Anyone can submit a request to have a study registered for the Associate PI Scheme, but the study CI and Director/ Deputy Director of the Clinical Trials Unit (CTU) must confirm they agree with the request by replying to the confirmation email sent by the NIHR Associate PI Scheme Team. If the CTU does not wish to take part, they should discuss their reasons with the study’s CI and tell associatepischeme@nihr.ac.uk. We would be interested in receiving feedback about this.

2. Our study is currently in the set-up stage, should we wait until the study is open and recruiting before registering?

We would recommend that you register your study roughly 1-2 months before recruitment is due to begin (or after recruitment has already started if that's more convenient for you).

3. 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. PIs remain responsible for study oversight at the site, which includes the activities of the Associate PI.

4. Does a study need to be registered by the CI or CTU managing the study, or can it be registered by a participating site? (Who should fill in the application form?)

The study can technically be registered by anyone, but we would encourage that a member of the study team registers the study in the first instance. In any case, we would have expected that a conversation has taken place between the CI, CTU, and the person making the application. Additionally we require written approval form the CI and CTU as part of eligibility checks (though we handle this ourselves as part of the registration process).

5. What is the expectation for acknowledging Associate PIs in publications from the study?

Associate PIs should be acknowledged for their work in all primary outputs from a study. This should be done in a PubMed searchable way so it can be cited on their CVs if possible.

In line with the UK policy framework for health and social care research section 9.3.C, Associate PIs should be listed by name and/or by site in the list of collaborators or local investigators at the bottom of the manuscript.

6. Who should complete the study application form to register on the Associate PI Scheme ?

The study can technically be registered by anyone, but we would encourage that a member of the study team registers the study in the first instance. In any case, we would expect that a conversation has taken place between the CI, CTU, and the person making the application. Additionally we require written approval from the CI and CTU as part of eligibility checks (though we handle this ourselves as part of the registration process).

Principal Investigators (PIs)

1. How often should I be meeting with my Associate PI?

We would recommend that you meet with your Associate PI at least once every 2 weeks to keep up to date on your Associate PI’s progress, and to ensure they feel supported and are having a chance to undertake all the tasks on their checklist. The PIs and Associate PIs who obtain the most benefit from the scheme tend to work very closely together and meet on a weekly basis.

2. How many Associate PIs will I be responsible for as a PI?

The general rule is that one Associate PI is permitted per study, per site. 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 if each hospital has a dedicated PI for the trial, there could be an Associate PI at each of these hospitals to work alongside each PI.

If you are the PI for more than one study, provided that each of the studies is registered with the Associate PI Scheme, you may have an Associate PI for each of the studies you manage locally.

3. What should I do if I don’t feel an applicant is appropriate for the Associate PI Scheme?

An applicant should have spoken to the local PI for the study before applying for the scheme. As part of the registration process, the central Associate PI Scheme Team will seek confirmation, via email, from the Local PI that they are happy for the applicant to join the scheme. If you, as PI, feel that the applicant is not an appropriate candidate for the scheme, then please respond to the email from the central Associate PI Scheme Team stating the reasons you feel the applicant is ineligible. The Associate PI Scheme Team will then inform the applicant of this decision. The applicant will also be advised to speak to the PI about the reasons for the decision and to help understand how they might make themselves eligible in the future

4. What is my responsibility in regards to signing off an Associate PI Checklist?

Towards the end of their period of time as an Associate PI (usually around six months) the applicant will formally meet with the local PI in order to review the checklist and ensure all targets have been met. By signing the checklist, the PI is taking responsibility for confirming that the Associate PI applicant has fulfilled the requirements to be recognised as an Associate PI.

Each of the "Core Activities" must have been completed. The "Additional Activities" are desirable but not mandatory. The Associate PI applicant should have evidence of consistent involvement in delivering the trial locally, plus evidence of either reacting to problems/events that have occurred or taking pre-emptive action to ensure continued efficient trial delivery.

The PI should discuss the completed checklist with the Associate PI, checking that each task has been completed and all of the stated activities undertaken. The PI should then sign the checklist and forward it to the CTU for their signature.

Clinical Trials Units (CTUs)

1. Who, in the CTU, should sign off the Associate PI checklist?

We think that the checklist is most appropriately signed off by the national Trial Manager/Study Coordinator, but it is up to each Trial Management Group and CTU to decide who is best to undertake this role. Checklists should be signed off by the CTU only if properly completed (with all core activities checked), and with signatures from both Associate PI and the site PI. The "additional activities" are desirable but not mandatory.

2. What responsibility is taken by the person signing off the checklist?

The person signing the forms at the CTU is taking responsibility for checking that the Associate PI applicant has fulfilled the necessary requirements to be recognised. The CTU representative will be able to assess how well or otherwise the study has performed at each individual centre. If a centre has performed badly with regard to local delivery of the study, the Associate PI checklist from that centre needs to be particularly carefully considered. If the CTU signatory is not convinced that the necessary requirements have been fulfilled, the checklist should be returned to the Associate PI applicant and local PI with feedback and recommendations about what further actions need to be undertaken in order to fulfil the criteria.

3. What does the CTU Signatory need to check on the checklist?

Each of the "core activities" need to have been carried out. The "additional activitie"’ are desirable but not mandatory. The Associate PI Scheme applicant should have evidence of consistent involvement in delivering the study locally, along with some evidence of either reacting to problems/events that have occurred or taking pre-emptive action to keep the study working well.

4. What should be done once the checklist has been signed?

Once the CTU has signed the checklist it should be sent back to the Associate PI so they can upload their completed and signed checklist on NIHR Learn. The NIHR Associate PI Scheme Team will then process this and issue a certificate confirming Associate PI status. It should be emphasised that the purpose of the NIHR Associate PI Scheme Committee is simply to endorse the decision of the CTU to confer Associate PI status. It is therefore imperative that CTUs uphold the rigour and status of the scheme by making sure that the criteria have been met. The NIHR Associate PI Scheme Committee will return checklists to the CTU if it considers that the quality is not of a high enough standard and reserves the right to remove a CTU from the Scheme if this happens several times.

5. What should we do when the study is no longer open for Associate PIs to join?

Please inform the NIHR Associate PI Scheme Team at associatepischeme@nihr.ac.uk and your study will be taken off the list of registered studies displayed on the NIHR website. Where a study is not being managed by a CTU, this process should be undertaken and followed by the CI’s Trust or University’s R&D Department (or equivalent).