Do Multisite Studies Need Approval From Every Participating Institution?

If Your Study Has Ten Sites, Do You Need Ten Sets of Approvals?

You design one protocol to be conducted at several hospitals, schools, universities, clinics, companies, or community organizations. The participants follow the same procedures and the study has one coordinating research team.

Must every participating institution independently approve everything?

Not necessarily.

Multisite governance often separates study-wide review from site-specific authorization. A single or centralized ethics review may sometimes cover several participating institutions, while each site retains responsibility for determining whether it can and will undertake the research activities assigned to it.

The correct approval pathway depends on the jurisdiction, research type, institutions involved, and any formal reliance or centralized-review arrangements.

Every Site May Need Authorization Without Every Site Repeating the Same Ethics Review

Separate the Study-Wide Decision From the Site-Level Decision

Multisite research creates two different governance questions

The first question concerns the study itself: is the protocol ethically acceptable, scientifically appropriate, and compliant with the study-wide requirements of the applicable framework?

The second concerns each participating institution: can and will this organization undertake the activities assigned to it?

These questions overlap, but they do not necessarily need to be answered by the same body or repeated at every site.

Single ethics review is designed to reduce unnecessary duplication

Requiring several ethics committees to independently review an identical protocol can create inconsistent requests, repeated administrative work, and delays without necessarily adding proportional participant protection.

Research systems have therefore developed mechanisms for single, centralized, or mutually recognized ethics review.

In Australia, national research-governance work has explicitly supported a national approach to single ethical review for eligible multicentre research, while participating institutions retain responsibilities for site assessment and authorization.

In England and Wales, HRA and HCRW Approval combines governance and legal assessment with an independent ethical opinion through a coordinated application process for applicable NHS research.

The underlying principle is important: avoiding duplicate ethics review does not mean eliminating local institutional responsibility.

One ethics review does not necessarily activate every site

A favorable ethics decision tells you something important about the study. It does not automatically establish that every participating institution has the staff, facilities, contracts, resources, permissions, or local arrangements needed to deliver it.

Current UK guidance makes this distinction concrete. Research sites have responsibilities for demonstrating suitability and establishing local roles. For relevant NHS organizations in England and Wales, participating organizations assess and arrange their capacity and capability proportionately to their role. Formal confirmation is required in some studies, while HRA guidance expressly provides more streamlined arrangements in others.

Researchers should therefore avoid converting the useful principle "one ethics review" into the inaccurate principle "one approval authorizes every institution."

Not every participating organization necessarily needs the same site process

Even within one study, participating organizations may perform different activities.

One hospital may recruit participants and administer an intervention. Another may only identify potentially eligible participants. A laboratory may analyze samples without interacting with participants. A university may hold the central database.

Current HRA guidance uses a proportionate approach to capacity and capability. Depending on the organization's role, formal confirmation may be required, confirmation may be expected within a specified timeframe, or formal confirmation may not be required at all.

This is a useful reminder that "participating institution" is not itself a complete description of governance responsibility.

What might each site still need to establish?

Depending on the research and applicable framework, a participating institution may need to establish:

• whether it has sufficient staff, facilities, equipment, and participant population;
• whether local investigators and research personnel are appropriately qualified;
• whether contracts or agreements are complete;
• whether costs and financial arrangements are acceptable;
• whether local data, privacy, safety, or information-security requirements are satisfied;
• whether the institution can fulfill the protocol;
• whether local responsibilities and reporting pathways are clear; and
• whether the organization is formally ready for the research to begin.

The exact list varies substantially. Do not treat these examples as a universal site-approval checklist.

A site can sometimes rely on assurances rather than repeat another body's work

Good multisite governance does not require every institution to independently re-investigate matters already assessed competently elsewhere.

The UK Policy Framework specifically expects research sites to accept reliable assurances from parties in a position to provide them. These can include assurances concerning ethics, safety, legal compliance, confidentiality, contracts, costs, and the competence or indemnification of research-team members not employed by the site.

That allows a site to focus on what genuinely needs local assessment rather than reproducing study-wide review.

Site agreements can serve as part of authorization

In some research systems, the agreement between the sponsor and participating institution is more than a financial document.

Current HRA guidance states that, for most research projects involving participating NHS organizations, an agreement between the sponsor and each participating organization is expected before research begins there. The agreement can formally confirm the organization's capacity and capability to deliver the project, although the sponsor and site should establish whether execution itself authorizes immediate activity or whether additional site-initiation or sponsor green-light steps remain.

This is a good example of why "approval" can be too vague a word. The relevant start signal may be an ethics decision, institutional authorization, executed agreement, confirmation of capacity and capability, sponsor activation, or some combination.

Adding another site after approval can trigger additional governance steps

A multisite study is not necessarily frozen at initial approval.

If another site is added later, the research team may need to notify or modify the approved study and complete the new site's local authorization process.

Current HRA standard conditions, for example, require the relevant participating-organization process when a new research site is added, a new local principal investigator or collaborator is appointed, or another significant change occurs in the site's conduct or management.

Researchers should therefore maintain a current list of authorized sites rather than assuming that an approved protocol permits unlimited expansion.

Different jurisdictions may still require separate ethical review

Single-review systems have boundaries.

An ethics committee's authority or a reliance agreement may cover particular institutions, jurisdictions, or categories of research but not others. International multisite research can therefore require additional ethical or regulatory review in participating countries.

Local review may also be important where cultural, legal, linguistic, population-specific, or institutional issues cannot adequately be assessed by a distant central committee.

The correct question is not whether centralized review is inherently better than local review. It is whether the relevant institutions and authorities legitimately recognize the reviewing body and whether the arrangement adequately addresses both study-wide and local ethical issues.

Sites may have different start dates

Multisite research does not always begin everywhere simultaneously.

Site A may complete its contracts and staffing arrangements in March. Site B may still be resolving data access. Site C may require additional equipment before it can participate.

Where the governance framework permits site-by-site activation, one ready site may begin while another remains pending. The sponsor and research team should track authorization status accurately so that no site starts simply because another has done so.

Institutional approval does not mean every institution is equally responsible

Each site's authorization concerns its own role. A hospital recruiting and treating participants has different responsibilities from a laboratory that only analyzes coded specimens.

This is why multiple institutions can share responsibility for one study without all becoming responsible for every aspect of it.

Central ethics review should not become central control of everything

A centralized ethics committee should not be mistaken for the project sponsor, lead institution, regulator, or site management office.

Ethics review determines ethical acceptability within its remit. Sponsor oversight, institutional authorization, site readiness, investigator responsibility, regulatory decisions, and participant consent remain distinct governance functions.

This returns to the central distinction between ethics approval and institutional approval. Multisite research simply makes that distinction harder to ignore.

One Ethics Review, Three Different Site Decisions

The protocol received one ethics review, but site readiness was not identical. This is not inconsistent governance. It reflects the difference between assessing the study and authorizing particular organizations to deliver their respective parts of it.

Common Mistakes in Multisite Approval

Build an Approval Matrix for Every Participating Site

For multisite research, do not track the project with one checkbox labeled "approved." Track the decisions that matter at study level and site level.

A simple site matrix can record ethics coverage, local authorization, agreements, principal investigator or local lead, data arrangements, regulatory requirements, and activation date. In a large study, this humble spreadsheet may prevent a surprising amount of governance archaeology later.

Before Activating Each Site in a Multisite Study

Questions About Approvals for Multisite Research

One Ethics Review Can Cover Many Sites, but Every Site Still Has a Governance Role

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