Your ethics application asks what patients changed. Most answers are one paragraph.
The IRAS form asks how many people you involved, what they did, and how it made your clinical trial more acceptable to the people taking part. The Health Research Authority's checklist for applicants says: "Participant information developed without public involvement will not normally receive a favourable opinion from REC."
We put your protocol synopsis, information sheet, consent form, recruitment strategy and site selection plan in front of matched members before the plan is fixed, and hand you a report that answers the question properly. If you have EU sites, the same report gives you the patient involvement wording for the CTIS application: the Part I protocol and the Part II participant materials.
What it costs and how long it takes
A pilot on one document is £7,500. When we already hold your condition, a pilot usually takes about ten working days from the day you send the document to the day the report lands; if we have to recruit first, allow about four weeks. We quote the exact number of working days before anything starts, and we hold to it. Survey answers come back in hours to days; the report takes longer because we write it.
If you're a UK affiliate
Global protocols arrive fixed. What you own is the UK version of the information sheet, the invitation, the site list and the recruitment plan, and that's where we work: put the UK documents in front of matched UK members in the weeks you have before submission, and hand global a report that shows the UK affiliate did it properly.
If you're in patient engagement
You're asked to bring patient insight into clinical trial design, regulatory strategy and product development, at every stage of a medicine's life. Advisory boards and roundtables give you a handful of voices a few times a year. We give you people living with the condition, matched to who has it, whenever you have a question, and a report showing who said what and what changed. It grows with your portfolio, and it sits alongside your advocacy partnerships rather than replacing them.
If you're in market access
When a submission needs patient-reported burden, treatment acceptability or the experience of a particular group, we ask matched members through surveys, video diaries and voice notes and break the answers down by age, sex, ethnicity and deprivation. It's patient-reported data collected for your question, written up as an appendix or as briefing for patient experts. It isn't medical records data, and every report says so. A survey of 300 matched members with video diaries is quoted per piece of work, usually between £15,000 and £20,000.
If you're in clinical operations
We don't promise enrolment. What we do is put your recruitment strategy, site list and materials in front of the people you need before the sites open, and show you where people with the condition live. If your CRO drafts the documents, the CRO can send them to us and receive the report; we invoice the sponsor or the CRO, whichever you prefer.
Compliance
Members are paid for their time at the NIHR rate, never for their answers, and never to join a clinical trial. Your material stays inside our platform.
Safety
Members are told when they join how to report a side effect to their doctor and to the MHRA's Yellow Card scheme. Every survey answer, voice note and video diary is screened by our team before it reaches you. Anything that mentions a side effect, a product complaint or a safety concern about a named medicine is passed to your pharmacovigilance contact within one working day, and we close every piece of work with a reconciliation log of what was passed on and when.
Works alongside Be Part of Research
If you're recruiting through NIHR's free registry, you'll write an invitation email and study pages that go to thousands of people. We'll put them in front of matched members first and tell you where people stop reading, what puts them off, and what's missing, before the emails go out.
Source: HRA, checklist for applicants on public involvement and ethical review.