Conflict of Interest Disclosure: Using the ICMJE Form

The ICMJE form asks thirteen questions across two time frames. Here is how to read each one broadly, coordinate co-authors, and turn the forms into a published statement.

Guide · 10 min read · Directive Publications Editorial Team

What the ICMJE form is for

The ICMJE Recommendations put the responsibility on authors: when you submit a manuscript of any type, you are responsible for disclosing all relationships and activities that might bias your work, or be seen to bias it. To standardise that, the International Committee of Medical Journal Editors publishes a single Disclosure Form. ICMJE member journals require authors to use it, and the committee encourages other journals to adopt it.

Three practical facts to know before you start:

• It is a Word document you complete offline. The ICMJE page labels the current form "Updated February 2021." Download a fresh copy for each paper rather than reusing a file saved years ago.
• You never send it to the ICMJE. The committee does not receive or accept forms. Save the completed file and submit it to the journal in the way that journal specifies.
• Some journals use something else. A journal may use its own form, a field in the submission system, or a disclosure section on the title page. Check the instructions for authors before you start.

The underlying principle matters more than the paperwork. The ICMJE's guidance on author disclosure states that perceptions of conflict of interest are as important as actual conflicts, and that readers must be able to make their own judgements. Your job is to give them the information, not to decide for them that a relationship does not matter.

Deciding what counts as related

Every item on the form asks about relationships related to the content of your manuscript. The form defines "related" as any relation with for-profit or not-for-profit third parties whose interests may be affected by the content of the manuscript.

The form also tells you to read this broadly. Its own example: if your manuscript is about the epidemiology of hypertension, declare all relationships with manufacturers of antihypertensive medication, even if their medication is not mentioned in the paper.

Use that example as your decision rule. Ask two questions for each relationship:

1. Could this company, funder, or organisation gain or lose from what the paper concludes, including through competing products or services?
2. If a reader learned about the relationship after publication, would they reasonably wish they had been told?

If either answer is yes, or you are unsure, disclose it. The form states plainly that disclosure represents a commitment to transparency and does not necessarily indicate bias, and that when in doubt it is preferable to list the relationship.

Do not stop at money. The ICMJE Recommendations note that financial relationships are the easiest to identify, but other interests, such as personal relationships or rivalries, academic competition, and intellectual beliefs, may also represent or be perceived as conflicts.

The two time frames on the form

The form uses two different windows, and it is easy to apply the wrong one.

• Item 1 has no time limit. It covers all support for the present manuscript since the initial planning of the work: funding, provision of study materials, medical writing, article processing charges, and similar support.
• Items 2 to 13 cover the past 36 months. These are your wider relationships with third parties whose interests the manuscript could affect.

So a consultancy that ended two years ago, before the study began, still belongs on the form if the company's interests relate to the paper. A grant that paid for the study's early planning five years ago still belongs under item 1, because support for the present work has no time limit. Individual journals can set different requirements, so check if you are not using the ICMJE form itself.

The 13 items and what to check

Each item has a None checkbox, a column to name every entity, and a comments column. The comments column is where you prevent misreadings, such as a grant being taken for a personal payment.

How to complete the form, step by step

1. Get the current form and the journal's instructions. Download the Word form from the ICMJE website, then confirm whether the journal wants the file uploaded, pasted into its system, or replaced by its own form.
2. Fill in the header. Enter the date, your name, the manuscript title, and the manuscript number if you have one. Use the exact manuscript title so the form can be matched to the right paper.
3. Report all support for this manuscript. Under item 1, list every source of support since the initial planning of the work. If the study was funded, item 1 is not None.
4. Work through items 2 to 13. For each, list related relationships from the past 36 months or tick None. Answer every item; do not leave rows blank.
5. Add specifics in the comments column. Name each entity and say whether payments went to you or to your institution. The form notes that you can use the tab key to add rows.
6. Certify, save, and send it to the journal. The form ends with a statement certifying that you have answered every question and have not altered the wording of any question. Do not edit the questions or delete items. Save the file and submit it to the journal.
7. Match the manuscript statement to the forms. The published disclosure and funding statements must agree with what every author reported.

Coordinating forms across co-authors

Each form carries one author's name, and the ICMJE Recommendations say disclosure information for each author needs to be part of the manuscript. In practice the corresponding or senior author ends up collecting them, and the job goes more smoothly if you treat it as part of manuscript preparation rather than a submission-day chore.

• Send the form early. Circulate it with the first full draft, when co-authors still have time to check their records.
• Share the manuscript's scope, not just the title. Co-authors can only judge what is related if they know which products, conditions, and organisations the paper discusses.
• Check consistency. If the study had a funder, compare how each author reports it under item 1, and make sure the comments column shows who received the support.
• Recheck at revision. New consulting work or a new grant during review can make a form out of date. Tell the editorial office if anything changes before publication.

Keeping forms in a shared project folder also helps if a question arises later. Our guide to the research integrity responsibilities of a lab lead covers how to build habits like this into the way a group works.

Wording the statement in the manuscript

The form supports a published statement; it does not replace one. The ICMJE Recommendations say articles should be published with statements or supporting documents declaring authors' relationships and activities, sources of support for the work including the sponsor's role, and whether the authors had access to the study data.

Keep the funding statement separate from the disclosure statement. The Recommendations say the funding statement should include only direct support of the work, and should distinguish institutional support for an author's time, with the example: "This study was funded by A; Dr. F's time on the work was supported by B."

Adapt these templates to the journal's own heading, which may be Competing interests, Disclosures, or Declaration of interests:

If a sponsor did have a role, describe it in the same structure instead. For a study sponsored by a funder with a financial interest in the outcome, editors may ask an author to sign a statement such as "I had full access to all of the data in this study and I take complete responsibility for the integrity of the data and the accuracy of the data analysis."

If the journal uses double-blind review, a named grant or consultancy can identify you, so check whether disclosures belong on the separate title page. If your cover letter mentions competing interests, make sure it says the same thing as the manuscript.

If a disclosure was missed

Before publication. Contact the editorial office as soon as you notice, send a corrected form, and update the manuscript statement. An omission the authors raise during review is much simpler to handle than one a reader finds after publication.

After publication. COPE's flowchart on undisclosed conflicts of interest in published articles sets out what editors typically do. The editor contacts the authors, obtains the missing details, and considers whether the interest unduly affected the article or its peer review. If it did not, the flowchart points to a correction to the competing interests statement. If it did, the editor may publish a correction to the statement and the article text, or a retraction, and may consider informing relevant institutions.

Intent matters. The ICMJE describes purposeful failure to report relationships specified on the journal's disclosure form as a form of misconduct. The best protection is to raise the omission yourself; our guide to correcting the published record explains how to approach the journal.

Before you submit

1. Every author has completed and certified their own form, or the journal's equivalent
2. Item 1 lists all support for the work, with no time limit applied
3. Items 2 to 13 cover the past 36 months and read "related" broadly
4. The comments column says whether payments went to the author or the institution
5. No question wording was changed and no item was left blank
6. The funding statement lists only direct support for the work
7. The disclosure statement, funding statement, and cover letter agree with the forms

Directive Publications states on its author resources page that its policies follow the COPE Core Practices and the ICMJE Recommendations, including on competing interests. When your forms and statements are ready, the submission page asks you to confirm that you have disclosed any conflicts of interest in the manuscript.