Participant Identification Centres (PICs)

Participant Identification Centres (PICs) are NHS and HSC organisations (including independent contractors of NHS services such as GP Practices) whose only role in a particular research project is to identify potential research participants (patients/service users) for that project. A PIC might be an NHS Trust or Board, or an independent contractor of NHS primary care services, such as an NHS general practice. To be a PIC, an NHS organisation must be processing the personal data of potential research participants for research purposes only, to help identify them and/or to direct them to a research site. PICs are not research sites and should not be treated in the same way as research sites.

Whilst this guidance is for NHS and HSC organisations, the principles of identifying participants and managing the organisations which do this can be applied to non-NHS organisations.

This guidance is divided into three areas:

• Defining a PIC
• Setting up an NHS/HSC PIC
• Frequently asked questions about setting up and managing a PIC

Defining a PIC

 

An NHS/HSC organisation is a PIC when it meets all the following criteria:

• it identifies potential research participants by processing their personal data and/or processes their personal data to inform them about a research project for which they may be eligible. For example, through carrying out a search of patient records database to identify individuals who might meet a project’s eligibility criteria;

and


• it follows the sponsor’s instructions in identifying potential research participants and/or directing them to a research site, for example by acting at the request of the sponsor (or a research site acting on behalf of the sponsor) to run such a database search;

and


• it directs these potential participants elsewhere (by facilitating contact with the research team or sending them to another organisation) without undertaking any further research activity for that project (the research occurs at another legal entity)

An NHS/HSC organisation is a research site and is not a PIC when:

• the participant identification activity is part of the same legal entity as the research site. For example, a hospital within an NHS/HSC organisation identifies potential participants and refers them to another hospital within the same NHS/HSC organisation. In this instance the whole legal entity is treated as a research site, with no PIC agreement necessary or possible between the two hospitals;


• it is responsible for research activities, such as:
  
  
  • any protocol-specified assessment to determine whether the potential participant is eligible for the research project, for example, a screening blood test or x-ray (this does not include using the project inclusion criteria to conduct searches or consider potential eligibility, when the final determination of eligibility will be undertaken at a separate research site);
  
  
  • the recruitment (informed consent) of participants into the research project (this does not include taking consent to pass contact details of potential participants to research sites);
  
  
  • the delivery of research procedures that require Principal Investigator oversight as specified in the research protocol
  
  
When NHS/HSC organisations carry out research activities, they are research sites.

An NHS/HSC organisation has no role in the project when it does activities associated with the research, but it is not a research site (the activities do not require Principal Investigator oversight) and it is not a PIC (it is not processing personal data at sponsor instruction primarily for the purpose of the research).

For example:

• identifying potential research participants through normal clinical activity (for example, a routine clinic appointment) and referring these individuals to a research project in order to gain access to treatment. This includes seeking consent to pass on the potential participant’s contact details to the research team. In this instance, as long as it is not expected to perform any follow up activities, the organisation is neither a PIC nor a research site; it is conducting its usual clinical activity of patient care and is not processing personal data on the sponsor’s direct instructions. The organisation has no role in the project.


• physically advertising opportunities to participate in a specific project, for example, via posters or on-screen adverts in waiting rooms. In this instance, the organisation would be neither a PIC nor a research site as long as they are not processing any personal data. The organisation has no role in the project.

Where an NHS/HSC organisation provides information to potential research participants about a research project but acts as neither a PIC nor a research site, the usual non-research policies and procedures of that organisation should be followed. For example, any standard procedures for agreeing posters to be displayed or leaflets to be made available, or management of clinical referrals. The NHS/HSC organisation should still ensure that appropriate regulatory approvals are in place before providing information to potential research participants. The research office at the NHS/HSC organisation may be consulted as part of these non-research processes but the activity does not require confirmation of capacity and capability. This also means that no contract is needed, and the organisation does not need to be listed in any regulatory application forms or added as an amendment. If any generic advertising material (not related to a specific research study) related to research is to be displayed in an NHS/HSC organisation, there is no requirement or policy expectation that NHS Research Ethics Generic Review must be undertaken prior to this. Researchers are advised that this is best practice, but not a requirement. If the advertising material relates to a specific research study, then ethical review is required prior to display/distribution.

The following table provides some scenarios to help you determine if your NHS/HSC organisation is acting as a PIC, a research site, or has no role in the project:

Scenario	Is this a PIC or a research site?
An NHS/HSC organisation searches patient records or other databases to identify potential participants at the request of the sponsor, based on the protocol’s inclusion and exclusion criteria. The organisation might provide potential participants with more information about the project, such as an outline participant information sheet. The organisation might obtain consent from the potential participants to share their personal details with a research site, who would then make contact, or the potential participant might be given details allowing them to contact the research site. The potential participants are directed to another legal entity for any research activity, such as screening and consent to participate.	PIC The organisation processes personal data for the project sponsor but does not undertake any research activity.
An NHS/HSC organisation searches patient records or other databases to identify potential participants, based on the protocol’s inclusion and exclusion criteria. The organisation provides potential participants with more information about the project, and seeks informed consent from them to participate in the project. Participants then go to another organisation to complete the research activities.	Research site The organisation processes personal data for the project sponsor and seeks consent for participation in the project. Seeking consent is a research activity.
A clinician is aware of an interventional research project taking place at another organisation and, through normal clinical activity (such as a multi-disciplinary team meeting (MDT) or clinic visits) becomes aware of a patient who might benefit from the treatment offered by the research. The clinician discusses the research project with their patient, contacts the Principal Investigator at the research site and consequently makes a clinical referral for their patient to the research site.	No role in the project - neither a PIC nor a site This is a normal NHS/HSC organisation activity. The clinician is making the referral in the best interests of the patient, on the understanding that it might provide them with access to novel care. Because the primary purpose of the clinical referral is care, not research, the NHS organisation is acting on its own behalf, it is not processing personal data on behalf of the sponsor (even where personal data is being processed for the clinical referral). It is a clinical decision to refer the participant elsewhere and no research activity is taking place at the organisation.
An NHS/HSC organisation provides information to patients, carers and other service users about a potential opportunity to take part in research at another organisation, but does so without targeting specific patients/carers/service users. This might be by displaying a poster in a waiting room, providing leaflets in a patient area, including an advert in a routine newsletter or similar. Anyone interested in the research opportunity may make direct contact with the research team, at the research site.	No role in the project - neither a PIC nor a site The NHS/HSC organisation is only advertising the research. They are not involved in processing any personal data to identify potential participants and they are not involved in any research activity, such as consent.

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Setting up an NHS/HSC PIC

NHS/HSC PICs are not research sites and should not be treated in the same way as research sites.

Research sponsors should:

1. Consider the use of PICs at the project design/feasibility stage.
   
2. Approach relevant NHS/HSC organisations to discuss their support to act as a PIC in principle (or request that their sites undertake such discussions on their behalf).
3. Detail all activities and resource requirements proposed for PIC organisations within the IRAS Form.
   1. Non-CTIMPs: Answer YES to A73 to reveal the secondary PIC questions and include the contact details and activities of PICs associated with research sites (except where the activity is limited to displaying leaflets or posters only). Enter details of any PICs already identified in Part C of the form.
   2. CTIMPs: Answer Yes to question A3 in Project Information Administrative Details. List any PICs already identified in a cover letter, not in the IRAS form.
4. Include the relevant model PIC agreement in the IRAS submission
5. Ensure PIC activity only begins once relevant requirements are in place (see “When can PIC activity begin?”).

PICs do not receive the UK Local Information Pack as part of their set-up process. Instead, they should only receive documents which are relevant to their participation in the research. This may include, as relevant to the individual project:

• Relevant model PIC agreement
• Protocol
• Consent to contact forms
• Participant information sheet (where the PIC is providing this directly to potential participants; includes summary PIS for consent to contact)
• Invitation letters
• Posters
• Any other documents to support recruitment activity at the PIC

As PICs are not research sites, they do not need:

• a Principal Investigator (PI) or Local Collaborator (LC) to be appointed. However, the sponsor or recruiting site do need to be in touch with an appropriate person (a Local Collaborator at the PIC to make the appropriate arrangements to set up and manage the PIC
• an organisation information document (non-commercial research only)
• a Schedule of Events (SoE) or Schedule of Events Cost Attribution Tool (SoECAT) (non-commercial research only)

When can PIC activity begin?

• NHS organisations in England and/or Wales – PIC activity may only begin once HRA and HCRW Approval has been issued, capacity and capability has been confirmed by the NHS research site (where applicable), and there is an appropriate agreement in place with the NHS organisation acting as a PIC.
• HSC organisations in Northern Ireland – PIC activity may only begin once HSC RD Approvals has been issued, capacity and capability has been confirmed by the research site, and there is an appropriate agreement in place with the HSC organisation acting as a PIC.
• NHS organisations in Scotland – PIC activity may only begin once NHS R&D permission is granted by both the research site and the PIC site and there is an appropriate agreement in place with the NHS organisation acting as a PIC.

What will be reviewed by the PIC?

Organisations that are considering whether to act as an NHS/HSC PIC will primarily rely on the completed project-wide governance review (Scotland / Northern Ireland) and/or HRA and HCRW Approval (England / Wales) being in place. The organisation acting as a PIC will only consider the basic practicalities and resource implications for the PIC.

What contracting arrangements should be put in place with NHS/HSC PICs?

By definition, a PIC is an organisation processing personal data on behalf of another legal entity. A controller and processor relationship is created between the sponsor and PIC. The UK PIC agreements meet the GDPR requirement for data processing agreements (GDPR Article 28(3)). There are three template UK PIC agreements:

• Commercial Site to PIC
• Non-commercial Site to PIC
• Non-commercial Sponsor to PIC

For commercial research, the sponsor contracts with a site, using the appropriate UK template site agreement, without modification. The site, where applicable and in accordance with instructions in their site agreement, may then contract with PICs. This is a sub-contract that creates a relationship between sponsor, site and PIC of data controller, processor and sub-processor.

For non-commercial research, the sponsor chooses either to delegate contracting with PICs to its sites, or to directly contract with PICs itself. If the sponsor chooses to directly contract with its PICs, it can do this whether it is also a site or not. It is possible that the only NHS role can be that of a PIC, i.e. there is no requirement to have another NHS/HSC acting as the research site, as the research site can be a non-NHS organisation

 

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Frequently asked questions about setting up and managing a PIC

 

Setting up PICs FAQs

What format should the PIC agreement be in when submitting it for review?

Submit only the word version of the agreement for review. This makes it easier to compare against the model templates to ensure the agreements are unmodified before providing the assurance to the participating NHS/HSC organisations. Do not provide PDF versions of project agreements.

 

Should the sponsor sign the PIC agreement before submitting for review?

No. The PIC agreement should be tailored to the project but does not need to be signed at the point of IRAS submission. The PIC agreement should be signed when the PIC is ready to start identifying potential participants and the site it is supporting identification of participants to has also entered into an agreement.

 

When supplying a copy of the PIC agreements as part of the IRAS submission, does it need to include a draft of the financial appendix or project support arrangements?

The PIC agreement does not need a completed financial appendix (commercial studies) or a completed project support arrangements schedule (non-commercial studies) to receive approval. It should be unmodified within the agreement ready for completion before sending to PICs.

 

Is there a PIC agreement for non-NHS/HSC PICs?

No. PICs are NHS/HSC organisations (including independent providers of NHS contracted primary care services – such as NHS general practices). Other organisations may act similarly to PICs but are not within the definition of PIC. It is the sponsor’s decision to determine an appropriate agreement for use with non-NHS/HSC organisations.

 

Can the PIC agreement be used and adapted for non-NHS/HSC organisations?

The template PIC agreements are designed for use when contracting with NHS/HSC PICs. The sponsor can use the PIC agreements as the basis for templates to be used outside of the NHS/HSC at their own risk. The Four Nations Contracts Leads do not provide any assurance on their suitability for with non-NHS/HSC organisations processing personal data to identify potential research participants.

 

Does the project team need letters of access or other HR arrangements with NHS/HSC organisations to conduct online interviews with service users that have been recruited via PICs (where no access to a site is required)?

No, the job of the PIC is to refer or otherwise direct potential research participants to a separate research site. The research activity is undertaken under the duty of care of the research site, not of the PIC, which should be made clear to the potential participants.

 

Are PICs expected to complete a full capacity and capability review (or equivalent in Scotland) or receive the local information pack?

No. PICs will not receive full local information packs, but will receive documents relevant to their participation in the research. Whilst a PIC should consider the basic practicalities of providing the PIC function, we expect this to be light-touch and in line with the assurances provided in the UK project wide governance review.

 

Do I need to submit evidence of iCT submission for a project in which the only NHS/HSC involvement is PIC activity (that is to say, where there are no NHS sites)?

No, you are not required to submit evidence of the iCT submission for studies which only involve PICs in the NHS/HSC. However, the principles of NCVR still apply for NHS/HSC organisations operating under NCVR. The relevant PIC rate from the iCT tariff data should be accepted without negotiation, but the full NCVR resource review, including iCT submission, is not required. 

 

Managing PICs FAQs

Is an amendment needed to change an existing (approved) PIC to a research site?

Yes, you need to submit an amendment to add the organisation as a new research site. You should complete the amendment tool to determine what type of amendment it is, and which reviews are needed (if any).

 

Is an amendment needed to change an existing (approved) research site to a PIC?

Yes, you would need to submit an amendment to add a new PIC. You should complete the amendment tool to determine what type of amendment it is, and which reviews are needed (if any).

 

If the project team decides to conduct project activities (for example interviews) on the premises of the PIC, should the organisation then be classed as a research site?

It depends on who is taking responsibility for the project activities. If the organisation undertaking the PIC activities is assuming the duty of care for additional project activities, then they are no longer a PIC but a research site. If an external project team is visiting the physical location of the PIC organisation, and the substantive employer of the external research team retains the duty of care for these activities, and it is clear to the participants in the participant-facing materials that this is the case, then the PIC organisation is still a PIC as it is only responsible for PIC activities. See the interventional site set up guidance appendix on duty of care versus physical location for more information.

 

Can an organisation be both a PIC and a research site for the same project?

No, if the activities that are taking place at an NHS/HSC organisation are beyond the remit of PIC activity, then it is a research site. There are example scenarios to help you determine whether an organisation is a PIC or a research site.

 

Can a PIC be added to an approved project?

Yes. Use the amendment tool to add a PIC. The amendment tool will tell you the amendment category based on how you complete it. If the use of PIC sites for the study has been previously approved, then no amendment is necessary.

 

Can a project be amended to include the use of PICs for the first time?

Yes. Use the amendment tool to add PIC activity (you may add (an) individual PIC/s at the same time). The amendment tool will tell you the amendment category based on how you complete it.

 

What notification is required for the closure of PICs?

Complete and submit the amendment tool to see what notification is required for the closure of PICs.

 

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Page last updated: 01 April 2026