The Declaration of Helsinki on Funding and Conflicts

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.

Why this matters

The World Medical Association's Declaration of Helsinki is the best-known statement of ethical principles for medical research involving people. It is not a regulation, but many national laws, ethics committees and sponsors refer to it, and it speaks directly about funding and conflicts of interest. The current version was adopted by the 75th WMA General Assembly in Helsinki in October 2024.

Helsinki follows one thread on conflicts from start to finish: write them down in the protocol, let an independent committee see them, tell the people who are asked to take part, and declare them when the results are published.

In the protocol

The Declaration says the research protocol should describe, among other things, the sources of funding, any potential conflicts of interest, and incentives for participants (paragraph 22).

For a site, the protocol is usually written by the sponsor. But investigator-initiated studies are written at the site, and the investigator who drafts one should put the funding source and any potential conflicts in it from the first version, rather than waiting to be asked.

Before the ethics committee

The protocol must be submitted to the research ethics committee for consideration, comment, guidance and approval before the study begins. The committee must be transparent in how it works and must have the independence and authority to resist undue influence from the researcher, the sponsor or others (paragraph 23).

That independence is the reason committee members with an interest in a study step out of its review, as ICH E6(R3) and US rules also require.

In the conversation with participants

Each potential participant must be adequately informed about, among other things, sources of funding and any potential conflicts of interest, and about incentives for participants (paragraph 26).

This is broader than many national rules, which do not list conflicts among the required consent elements. Where your local law, IRB or management plan requires a conflict disclosure in consent, Helsinki is part of the reason. Where none does, Helsinki is still a useful test: if you would be uncomfortable telling a participant about an interest, that discomfort is information.

In publication

Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication (paragraph 36). Site staff who become authors, including coordinators who earn authorship on a site-led paper, make these declarations too.

Connecting Helsinki to daily work

Helsinki states principles; it leaves procedures to law and institutions. Read together with the rules in Modules 2 and 3, it gives you a simple sequence for any interest you hold:

  1. Record it where your institution and sponsor ask: the disclosure form, the conflict office, the study file.
  2. Let the independent reviewers see it: the conflict office and, where your process requires, the IRB or ethics committee.
  3. Tell participants when the management plan, the IRB or the law requires it, using approved wording.
  4. Declare it in any presentation or paper.

Why disclosure is not the whole answer

Disclosure tells people about a risk; it does not remove it. A participant who is told that the investigator holds a patent is better informed, but still relies on the investigator's judgment. That is why the rules pair disclosure with structural steps such as blinding, independent assessment and changing who does a task. FDA's rule makes the same point when it lists design features that can protect against bias from a disclosable interest (21 CFR 54.5(b)). Module 5 covers those management steps.

In practice

A site investigator is drafting an investigator-initiated study of a device for which she holds a patent. In the first protocol draft she states the funding source and her patent in the section on funding and conflicts. She raises it with her institution's conflict office before submission, and the ethics committee receives both the protocol and the office's management plan together.

What this looks like when it goes wrong

A study team presents results at a conference without mentioning that the presenting investigator receives royalties from the product. A journalist finds the royalty in a public database. The team now has to explain why the declaration was missing, and the audience wonders what else was left out.

Key takeaways

References