A PIC is an NHS/HSC organisation such as a GP Practice that identifies potential research participants for a research study
Potential participants can be identified through searches of patient databases based on searches using a study’s eligibility criteria
The study sponsor will provide search and screen instructions to participating PICs to process GP medical records
The processing of personal data is completed securely and safely in line with Data Protection guidelines
A GP or other healthcare professional from the GP Practice will screen the list of potentially eligible participants to ensure it is appropriate for potential participants to receive an invite to the study
Potential participants will receive an invite letter or text message from their GP Practice directing the participant to the study team or research site for further information about participation in the study
A GP Practice is not acting as PIC site if:
It is required to be responsible for any research protocol activities such as:
Screening tests or assessments which determine participant eligibility
Taking informed consent
The delivery of research activities within the practice
Advertising a study is not PIC activity, such as displaying a poster in a GP waiting room. No formal agreement is needed for advertising.
A GP Practice will act as a Research Site if:
If the research protocol requires a GP Practice to undertake any research activity such as informed consent, data collection, assessments, treatment/intervention or medical record review, these activities constitute research site activities.
Increases access to research opportunities and can be a great introduction to research
It brings research to patients who might not have heard of research, or had a chance to participate in research before
It is a chance to be a part of research which may improve care, treatment and services for the future
Increases awareness of research, and helps to build a culture promoting research involvement for patients, healthcare professionals and organisation wide
In RRDN West Midlands once the study has received the required approval HRA, REC or other regulatory body as appropriate, a Lead Research Facilitator from the Primary Care Delivery Team will support a local capacity and capability review for PIC site involvement.
The capacity and capability review provides GP Practices with the assurance that by acting as a PIC:
The roles, responsibilities of delivering the PIC activities are clearly understood
The financial and resource implications have been identified and agreed. This includes service support costs for search and screen activities. If a GP practice completes a mail out of study information, this is a research cost and is reimbursed by the study team to the GP Practice.
Contracting arrangements are in place. A model commercial or non-commercial PIC Agreement will need to be in place. Further information on model agreements for PIC sites can be found on the IRAS website https://www.myresearchproject.org.uk/help/hlptemplatesfor.aspx#PIC-contracting
Once capacity and capability has been confirmed and all agreements have been signed, the GP Practice can open as a PIC site.
RRDN Primary Care Delivery has trained Research Facilitators who work with GP Practices to support them in setting up PIC activities, so your organisation will be fully supported.
If your GP Practice would like to find out more about research in the West Midlands and participating as a PIC site in a study, you can express an interest here: Expression of Interest Form
Visit the Research Site Initiative Scheme (RSI) page to find out more about the support available to practices that engage in research with the RRDN.
For any queries please contact: wm.rrdn@nihr.ac.uk or studysupportpc.crnwestmidlands@nihr.ac.uk
Resources: IRAS Site Specific Information