What is a Participant Identification Centre?
Participant Identification Centres (PICs) are organisations from which clinicians or clinical units refer potential participants to a research team based in another organisation, for assessment and possible recruitment to a study. PICs can include research units undertaking support functions, such as project management, site monitoring, data analysis or report writing
What are they responsible for?
Participant Identification Centres (PIC) are responsible for the identification of potential participants who are subsequently invited to take part in research through a different site which takes on responsibility for seeking consent and undertaking research procedures. The PIC retains responsibility for the healthcare of the patient outside the research, but the research site takes on the duty of care for them in relation to the research study.
How are these responsibilities met?
The PIC’s responsibility for an overall duty of care in relation to healthcare, provision of information, and referral is met through assessing issues of confidentiality, resource use and appropriateness of referral.
How is ‘referral’ defined?
The term ‘referral’ is used here to describe the process whereby a care clinician provides information about a research study to a potential participant who is the clinician’s patient, and either invites the patient to contact the research team, or obtains appropriate agreement (as described below) to pass on the relevant details of the patient to the research team. The use of ‘referral’ in this context is therefore not the same as used in a clinical context.
Are Participant Identification Centres (PICs) considered research sites?
Participant Identification Centres are not considered to be research sites. Research sites are defined as organizations responsible for participant-related research procedures specified in the protocol, including recruitment and informed consent.
What is my NHS Trust responsible for, should I decide to become a Participant Identification Centre (PIC site)?
The NHS organization responsible for the Participant Identification Centre is expected to review the request to refer patients (including any resource implications and other issues such as data protection) and agree to this in the form of an agreement letter. It is the site that conducts the protocol-driven procedures that is responsible for providing indemnity for the research activity, not the NHS organization responsible for the PIC.
Are there restrictions on the use of PIC sites?
Research studies being processed through NIHR CSP may have NHS and / or non-NHS research sites, whilst having NHS PICs. NHS PICs will not necessarily be referring participants to a research site within the same CLRN. A study may include NHS PICs but have its only research site listed as an academic institution or non-NHS research site.
What are the governance requirements for PIC sites?
A full governance review will not be undertaken for a study with NHS PICs referring to a non-NHS research site, since none of the research sites require NHS Permission. Outstanding PIC checks would not prevent CSP Sign-off occurring in CSP ReDA for NHS research sites, but the PIC would not be able to start referring patients until its checks are completed and the organisation responsible for the PIC has agreed to act as a PIC.
How do I identify PIC sites on the IRAS form?
Question A73 under ‘identification of participants’ – if any of the PICs are NHS organisations, details should be entered in Part C of the IRAS form. You will also need to describe (for NHS PICs), the use of staff, time and resources at each PIC site and the arrangements for covering these costs. This will involve estimating the time that will be taken to identify potential participants for the study at each centre, as well as the time taken to send letters of invitation or provide information to potential participants.
What documents does the investigator need to submit to the PIC site?
The Chief Investigator or Principal Investigators must provide a copy of the full R&D application with the relevant documents (listed on checklist) to the NHS R&D office for each PIC site. However, there is no need to complete a separate Site Specific Information Form (SSIF) for the PIC.
What if I need to add additional PIC sites following approval?
If additional NHS PICs agree to take part following initial approval of the study, the details should be added to Part C. Details should be submitted to the R&D office at the new PIC as mentioned in the answer above. The updated Part C should also be provided to the R&D office at the relevant research site.
What information do RECs need on PICs?
RECs do not require detailed information about PICs, only a general description of the procedures for identifying participants. The addition of new PICs is not a substantial amendment.