Patient Identification Centres

A PIC is a site where participants for a research study are identified but referred on to a research site responsible for an assessment and consenting to take part in the study. Using PICS can be useful when there are unlikely to be sufficient numbers of patients presenting at the research site. It can open out recruitment of a study beyond the confines of a research site – allowing patients from neighbouring localities to have access to participation in a research study. The recruiting site can be a variety of settings including a primary care site.

A PIC is not classed as a research site because it is not responsible for doing research procedures. Research sites are defined as organisations responsible for conducting research procedures specified in the study protocol such as screening, taking informed consent and conducting interventions. Traditionally primary care sites refer potential participants to secondary care sites but the PIC approach applies equally between secondary care to secondary care and primary care to primary care.

Examples of research scenarios: 

• Due to the complexity of the protocol of a study taking place in a hospital, local GPs may be required to search their database for patients meeting the inclusion/exclusion criteria to send them information about the study. 

• The study may involve a rare patient group so the numbers of participants that can be recruited from one site are so low it is necessary to recruit from multiple sites but refer into the one centre conducting the study.

• The study may require GPs to identify patients to receive questionnaires or letters for a study which is co-ordinated by a university-based research team.

A PIC is responsible for:

• Identification only of participants which may include a database search and a mail out of an invitation letter or approaching patients opportunistically within a routine consultation

•  The healthcare of the patient outside the research

A PIC is NOT responsible for: 

• The duty of care of a participant in relation to the research study 

• Undertaking research procedures specified in the research protocol 

• Maintaining the safety of participants in relation of the delivery of the protocol 

• Providing indemnity or insurance for the research procedures specified in the protocol.

The study team or sponsor should ensure that*: 

• The PIC approach to recruitment is detailed in the study application forms completed using the Integrated Research Application System (IRAS) 

• The participation invitation letter provided by the PIC to potential participants has been approved by the NHS Research Ethics Committee 

• The site has agreed to act as a PIC 

• Correct PIC authorisations are in place. This can be done via the NIHR Coordinated System for gaining NHS Permission (CSP) in liaison with the lead Local Clinical Research Network

• The PIC is remunerated for its activities. For example to cover the time spent undertaking the note search, GP checking the list of potential participants, sending out the invitation letters and postage costs.

An NHS/HSC organisation is operating as a PIC when it:

Identifies potential research participants by processing personal data (e.g. through carrying out a search of patient records database to identify individuals that meet a study’s eligibility criteria);

and

Is following the sponsor(s) instructions in identifying potential research participants;

and

Directs these potential participants elsewhere without undertaking any further research activity for that study (i.e. the research occurs at another legal entity).

However, an NHS/HSC organisation is not a PIC when it is:

Within the legal entity where the research that it is identifying potential research participants for it taking place (e.g. the NHS/HSC organisation is a hospital identifying potential participants to be referred to another hospital within the same NHS/HSC Trust or Health Board). In this instance the whole legal entity is treated as an investigator site or participating NHS/HSC organisation;

or

Responsible for research activities, such as:

• Any protocol-specified assessment to determine whether the potential participant is eligible for the research study (e.g. a screening blood test or x-ray)

• The recruitment (informed consent) of participants into the research study

• The delivery of research procedures as specified in the research protocol.

or

Identifying potential research participants through normal clinical activity (e.g. a routine clinic) and referring these individuals to a research study in order to gain access to clinical intervention(s).

or

Advertising opportunities to participate in a specific study, for example via posters in waiting rooms.