Current as of August 2026. Most guidance circulating online about IRAS still describes the system as it existed before 2026 and is now out of date on two key points: (1) the Health Research Authority (HRA) is phasing out IRAS, HARP and TOPS in favour of a new service, Plan and Manage Health and Care Research, and (2) Combined Review — the single application to MHRA and a Research Ethics Committee (REC) — became the standard statutory route for UK clinical trials of investigational medicinal products (CTIMPs) from 28 April 2026. This page reflects the HRA’s current published position; where the rollout is still in progress, that is stated explicitly rather than presented as finished.
Anyone planning health or social care research in the UK eventually runs into the same three questions: does my project count as “research” at all, which approvals does it actually need, and where do I go to get them. This page walks through the current answer to all three, plus what a compliant Participant Information Sheet (PIS) needs to contain, and what the retirement of IRAS means for a study that’s already underway.
Is my project research? (the decision tool)
Not everything that looks like research is treated as research for HRA/REC purposes, and not everything that clearly is research needs full ethics committee review. The Health Research Authority’s Research Ethics Service maintains a short, structured decision tool at hra-decisiontools.org.uk/research that walks through a series of yes/no questions based on the Research Ethics Service’s “Defining Research” table. The tool states its outcome can be treated as authoritative — you do not need to separately confirm the answer with an ethics committee or the HRA.
The HRA is explicit that responsibility for the classification decision sits with the managing organisation, not with the HRA itself. In practice that means the sponsoring university, NHS trust, or company should be able to point to a decision-tool outcome (or an equivalent documented rationale) before treating a project as exempt from REC review. Activities the HRA’s own guidance flags as commonly confused with research — service evaluation, clinical audit, and most public health surveillance — generally fall outside its scope and outside REC review, though local governance sign-off may still be required.
Do I need HRA approval? A decision table
“HRA Approval” and “REC favourable opinion” are not the same thing, and neither is the same as a participating NHS site confirming it has capacity and capability to deliver a study. The table below summarises what a given study type typically needs — always confirm the specific case using the decision tool above, since edge cases (multi-nation UK trials, non-NHS settings, data-only studies) can shift the answer.
| Study type | REC review | HRA Approval | NHS confirmation of capacity & capability | MHRA / Combined Review |
|---|---|---|---|---|
| CTIMP (clinical trial of an investigational medicinal product) in the NHS | Required | Required | Required at each participating site | Required — Combined Review is the standard route since 28 April 2026 |
| Clinical investigation of a medical device | Required | Required | Required at each participating site | MHRA notification/authorisation runs alongside, on its own track |
| Other NHS-based research involving patients, service users, staff, tissue or identifiable data (qualitative, quantitative, basic science) | Usually required — confirm via decision tool | Required | Required at each site | Not applicable |
| Research operating under an existing research tissue bank or research database’s generic REC approval | Not required for the individual project (covered by the bank/database’s own approval) | Not typically required | Depends on site arrangements | Not applicable |
| Non-NHS Phase 1 trial (healthy volunteers, non-NHS setting) | May still require REC review depending on setting | Not required — HRA Approval covers NHS research in England and Wales | Not applicable | MHRA clinical trial authorisation still required for a CTIMP |
| Service evaluation, clinical audit, most public health surveillance | Not required — falls outside the research definition | Not required | Local governance sign-off, not HRA process | Not applicable |
| Research accessing confidential patient information without consent | Per study type above | Per study type above | Per study type above | Also needs Confidentiality Advisory Group (CAG) / Section 251 support |
HRA Approval vs. REC favourable opinion vs. NHS capacity and capability
These three approvals are frequently conflated because, for most NHS research, an applicant now applies for the first two through a single process. It is worth being precise about what each one actually is:
- REC favourable opinion is the independent ethical opinion issued by a Research Ethics Committee. See CASRAI’s Favourable Opinion (NHS REC) entry for what “favourable” specifically means and how it differs from a provisional or unfavourable outcome.
- HRA Approval, launched in April 2018, is the HRA’s own assessment of governance and legal compliance for research taking place in the NHS in England and Wales. Since its introduction, HRA Approval has combined that governance/legal review with the REC’s independent ethical opinion into one application and, for most study types, one combined decision — so a researcher submits once rather than separately to the HRA and a REC.
- NHS confirmation of capacity and capability is a separate, local step. HRA Approval and a REC favourable opinion confirm a study is allowed to proceed nationally; each participating NHS organisation still has to confirm it has the staff, facilities and resources to actually deliver it before recruitment can start at that site. HRA Approval does not substitute for this local sign-off.
Research taking place in Scotland and Northern Ireland uses parallel arrangements — NHS Research Scotland permissions and, in Northern Ireland, Health and Social Care (HSC) research permissions coordinated with the HRA — rather than HRA Approval itself, which is specifically an England/Wales mechanism.
Combined Review: the statutory route for CTIMPs since 28 April 2026
Combined Review is the single application route for clinical trials of investigational medicinal products. A sponsor submits one application, through IRAS, that goes simultaneously to the Medicines and Healthcare products Regulatory Agency (MHRA) for regulatory review and to a Research Ethics Committee for ethical review, with HRA (and Health and Care Research Wales, for Wales-based elements) coordinating study-wide review. The regulatory and ethics assessments run in parallel; any requests for further information from either reviewer are raised jointly, and the process produces a single combined decision rather than two separate ones.
Following the domestic reform of the UK’s clinical trials regulations, Combined Review became the required route for CTIMPs from 28 April 2026, with separate MHRA and REC applications now permitted only in exceptional circumstances rather than as a routine alternative. For background on how MHRA’s own assessment (including Investigational Medicinal Product Dossier requirements) fits into this process, see CASRAI’s MHRA GCP Inspection entry and the related IMPD guidance in the clinical-research dictionary.
IRAS is being retired: what “Plan and Manage Health and Care Research” changes
IRAS (the Integrated Research Application System) has been the single online system UK researchers use to apply for HRA Approval, REC review, and a range of other approvals for over a decade. The HRA is now replacing it, along with two companion systems — HARP (the HRA Assessment Review Portal, used by reviewers) and TOPS (the system supporting over-volunteering prevention checks) — with a single new digital service called Plan and Manage Health and Care Research.
As of this writing, the rollout is phased and only partly complete:
- Since December 2025, invited early-adopter users have been using the new service to make changes (modifications) to certain eligible existing studies.
- From September 2026, the service is planned to support modifications that require Research Ethics Committee review only.
- From December 2026, support extends to modifications requiring both REC and study-wide review.
- March 2027 is the planned Government Digital Service beta assessment milestone.
- From April 2027, new applications for non-CTIMP studies are planned to move onto the new service.
- From November 2027, medical device study applications and modifications are planned to follow.
- From March 2028, CTIMP applications and modifications — the most complex category — are planned to move over last.
Until each stage of that migration reaches a given study, IRAS, HARP and TOPS remain in active use — the HRA has been explicit that most current users see no immediate change and that legacy systems stay live throughout the phased transition rather than being switched off on a single cutover date. If you are actively managing a study in IRAS today, the practical implication is: keep working in IRAS as normal unless the HRA has specifically invited your study to move, and watch for direct HRA communication rather than assuming a hard deadline applies to your project. Because this rollout continues through at least March 2028, treat any third-party guidance describing IRAS as fully replaced, or any specific migration date for your own study type, with caution unless it traces back to the HRA’s own published timeline.
The Participant Information Sheet (PIS): what the HRA expects
A Participant Information Sheet is the document a prospective participant reads before deciding whether to take part in a study and, where relevant, before signing a consent form. The HRA does not publish a fixed content checklist or a mandatory template — it is explicit that applicants are not expected to simply fill in a template — but its guidance sets out clear expectations for what “good” looks like:
- Proportionate, not exhaustive. The HRA’s stated principle is that people who volunteer for research “should be provided with succinct, relevant, user-friendly information in a proportionate manner” — the amount and complexity of information should scale with the study’s actual risk and burden, not default to maximal legal coverage.
- Plain, accessible language. HRA guidance on informing participants and seeking consent points applicants toward specific accessibility resources, including guidance on making written information easier to understand for people with learning disabilities, and expects information to be genuinely readable by a lay audience rather than written defensively for reviewers.
- Design and structure matter, not just content. The HRA’s online consent guidance tool (hra-decisiontools.org.uk/consent) sets out recommended content and structure for both the participant information sheet and the consent form together, and includes design-review principles rather than a rigid section-by-section script.
- The PIS and consent form are treated as a linked pair, not independent documents. The information sheet is what a participant is expected to have read and understood before the consent form asks them to confirm specific statements (that they’ve read the information, had the chance to ask questions, understand participation is voluntary, and so on). A consent form that references information the PIS doesn’t actually cover — or a PIS written at a reading level the target population can’t reasonably access — is a common reason applications are sent back for revision.
For studies involving adults who lack capacity to consent for themselves in UK clinical trials, a distinct legal framework applies rather than a modified standard PIS/consent process — see CASRAI’s Simplified Consent Arrangements for Adults Lacking Capacity (UK Clinical Trials) entry.
Where data protection and tissue law intersect with HRA approvals
HRA/REC approval addresses research governance and ethics; it does not by itself satisfy every other legal requirement a UK study may trigger. Two areas come up especially often:
- Human tissue. Studies collecting, storing, or using relevant material from the living or deceased may separately need to comply with the Human Tissue Act (UK), including Human Tissue Authority licensing for storage, independent of whatever REC/HRA approval the study also holds.
- Confidential patient data without consent. Where a study needs to access or process confidential patient information without explicit consent, it will typically also need support from the Confidentiality Advisory Group (CAG) / Section 251 process, on top of REC and HRA Approval.
Neither of these is optional simply because a study already has a favourable REC opinion and HRA Approval — they are additional, parallel legal requirements, not alternative routes to the same approval.
Frequently asked questions
Do I need HRA approval for my project?
If your project is classed as research (confirmed via the HRA’s decision tool) and takes place in the NHS in England or Wales, you almost certainly need HRA Approval, alongside REC review where applicable and NHS confirmation of capacity and capability at each participating site. Non-NHS research, service evaluation, and clinical audit generally fall outside HRA Approval’s scope — but the decision tool, not intuition, is the step the HRA expects you to rely on.
What is the HRA decision tool, exactly?
It’s a short online questionnaire (hra-decisiontools.org.uk/research) that asks a structured series of yes/no questions, based on the Research Ethics Service’s “Defining Research” table, to determine whether a project counts as research requiring REC review. The HRA states the outcome can be relied on as authoritative without further confirmation.
Is IRAS shutting down?
Not immediately, and not all at once. The HRA is phasing IRAS (along with HARP and TOPS) out in favour of Plan and Manage Health and Care Research, but the rollout runs in stages through at least March 2028, and IRAS remains in active use for anything not yet migrated to the new service.
What replaced the old separate MHRA and REC applications for clinical trials?
Combined Review — a single application submitted through IRAS that goes to the MHRA and a REC at the same time, with a joint decision. It became the required route for CTIMPs, rather than an optional alternative, from 28 April 2026.
Does a Participant Information Sheet have to follow a fixed HRA template?
No. The HRA explicitly does not expect applicants to just complete a template — it expects proportionate, plain-language, well-structured information tailored to the specific study and audience, guided by its online consent tool rather than a fixed form.
Related CASRAI resources
- Favourable Opinion (NHS REC)
- MHRA GCP Inspection
- Human Tissue Act (UK)
- Confidentiality Advisory Group (CAG) / Section 251
- Simplified Consent Arrangements for Adults Lacking Capacity (UK Clinical Trials)
- Switzerland’s Clinical Trial Regulatory Framework: Swissmedic, HRA, and ClinO
- Is My Project Human Subjects Research? A Step-by-Step Determination Process (the equivalent US 45 CFR 46 determination)
- Clinical Trial Feasibility Assessment: How Sponsors Decide a Protocol Can Be Run — where UK regulatory/administrative timelines like HRA Approval factor into a sponsor’s country- and site-count planning.
Sources: Health Research Authority (hra.nhs.uk) — “What approvals do I need,” “HRA Approval,” “Combined Review,” “Informing participants and seeking consent,” and the Research Systems Programme’s “Plan and Manage Health and Care Research” pages, checked directly against the live site in August 2026. Because the IRAS-to-Plan-and-Manage transition and the Combined Review statutory change are both recent, always cross-check current status against hra.nhs.uk before relying on a specific date for your own submission.
