Regional Pointers: The EU, the UK and Elsewhere

Part of Conflict of Interest in Clinical Research: GCP and International Expectations.

About 5 minutes. Free, in your language, no account needed.

Expert review pending. CRLN wrote this lesson against the primary sources listed under References. A subject-matter expert has not yet reviewed it. Where your institution's policy or your sponsor's instructions are stricter, follow them.

Orientation, not legal advice. This lesson points you to where conflict of interest requirements sit outside the United States. It does not state the full law of any country. Your sponsor, your ethics committee and your institution's legal or regulatory office are the authorities for the rules that apply to your site.

Why this matters

Many sites run trials for sponsors in several countries, and many staff move between jurisdictions in their careers. The ideas in this course travel: identify interests, disclose them, let independent reviewers decide, manage them in writing. The forms, thresholds and routes do not travel. A US financial disclosure form is not how an EU trial application handles investigator interests, and the reverse is also true.

The European Union: Clinical Trials Regulation

In the EU, clinical trials of medicinal products are governed by Regulation (EU) No 536/2014, the Clinical Trials Regulation. Two parts of it bear on conflicts of interest at the site.

Suitability of the people doing the trial. Article 49 requires that the investigator be a medical doctor as defined in national law, or a person following a profession recognized in the Member State concerned as qualifying for an investigator because of the necessary scientific knowledge and experience in patient care. Other individuals involved in conducting the trial must be suitably qualified by education, training and experience to perform their tasks.

What the application dossier must show. Annex I lists the content of the application, with some parts provided per Member State concerned:

• Under the section on the suitability of the investigator (section M), any conditions, such as economic interests and institutional affiliations, that might influence the impartiality of the investigators shall be presented (point 66).
• Under financial and other arrangements (section P), the dossier includes a brief description of the financing of the trial (point 69), information on financial transactions and compensation paid to subjects and to the investigator or site for participating (point 70), and a description of any other agreement between the sponsor and the site (point 71).

In practice, this means an investigator at an EU site is typically asked by the sponsor for a declaration of interests and a CV that go into the trial application, and the site's financial arrangements are described in the dossier the ethics committee and national authority assess. Member States may add national requirements, so the form and wording vary by country.

The United Kingdom

In the United Kingdom, trials of investigational medicinal products are governed by the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031), as amended. The Health Research Authority lists the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 as the current legislation and states that the updated regulations came into force on 28 April 2026. If your training on UK trials predates that change, check the current requirements for investigator declarations and site arrangements with your sponsor and the Health Research Authority rather than relying on what you learned before.

Everywhere else

ICH E6(R3) is the shared baseline in many countries, and it asks that the financial aspects of a trial be documented in an agreement between the sponsor and the investigator or institution (Annex 1 §3.5). Beyond that, national law sets the detail. When you work under a new jurisdiction, ask four questions:

1. What must investigators declare, and on what form? Ask the sponsor or the contract research organization's start-up team.
2. Who reviews it? The ethics committee, the national authority, the institution, or all three.
3. Are other staff covered? Some systems focus on investigators; your institution may cover everyone.
4. What must participants be told? Check the approved consent template and the ethics committee's guidance.

Multinational trials

A global sponsor may ask you for its own declaration form that combines several countries' requirements, plus a US Part 54 form if US marketing applications are planned. Complete each one you are given. Answering one form does not excuse you from another, because each serves a different reviewer.

In practice

A coordinator moves from a US site to a site in Spain working on the same sponsor's program. At her new site, the investigator's declaration of interests went into the trial application months ago. When the investigator later signs a consulting agreement with the sponsor, the coordinator asks the sponsor's local study manager how the change should be reported under the national rules, and files the reply in the site file.

Key takeaways

• The principles of conflict management are international; the forms, thresholds and routes are local.
• In the EU, the Clinical Trials Regulation requires suitably qualified staff (Article 49) and an application dossier that presents conditions, such as economic interests and institutional affiliations, that might influence investigator impartiality (Annex I, point 66), plus the trial's financial arrangements (points 69 to 71).
• The UK has its own clinical trials legislation, updated by regulations that came into force on 28 April 2026; check current requirements with the sponsor and the Health Research Authority.
• Everywhere, ask the sponsor and the ethics committee what must be declared, by whom, and to whom.

References

• Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC: Article 49; Annex I, section M point 66 and section P points 69 to 71.
• The Medicines for Human Use (Clinical Trials) Regulations 2004, SI 2004/1031, as amended (legislation.gov.uk).
• Health Research Authority, Clinical trials of investigational medicinal products (CTIMPs) page: the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, in force 28 April 2026.
• ICH E6(R3), Step 4, 6 January 2025: Annex 1 §3.5.