The funder approval clause and the commercially sensitive readmission finding
You manage publications for a device manufacturer. A secondary analysis of a 22,000-patient national registry examines 30-day readmission after implantable cardiac monitors. The analysis was designed and executed by the registry's biostatistician, who is not proposed as an author because, the clinical lead says, statisticians do not meet authorship criteria. The draft reports a higher readmission rate in the subgroup implanted by low-volume operators (HR 1.31, 95% CI 1.04-1.65, pre-specified in the registry analysis plan). The commercial team calls the finding commercially sensitive and probably confounded, and wants it removed. The funding contract states that the funder shall approve the final manuscript and may require removal of content. A patient partner on the steering committee rewrote the plain-language summary, attended all four steering meetings, challenged the interpretation of the operator-volume finding, and asks to be an author. The target journal follows ICMJE recommendations and requires a data-sharing statement.
1. Determine authorship for the statistician and the patient partner, and explain your reasoning.
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Statistician. The stated reason for exclusion is wrong as a matter of principle: job title is not a criterion. The ICMJE criteria ask whether the person made a substantial contribution to design, analysis or interpretation. Designing and executing a pre-specified secondary analysis of a 22,000-patient registry is a substantial contribution. The remaining tests are drafting or critical revision, final approval, and accountability. If those are met or can be met - the statistician reviews the methods and results and agrees to be accountable - the statistician is an author. If the statistician declines accountability or does not engage with the manuscript, acknowledge the contribution instead. Decide it on the four criteria with the statistician present, not by assertion at a meeting.
Patient partner. Apply the same four criteria rather than a separate, softer standard. Attending steering meetings and rewriting the plain-language summary is a meaningful contribution, but the analysis in question is authorship on a scientific manuscript, and a plain-language summary may or may not be part of it. If she shaped the research question, challenged the interpretation and critically revised the manuscript, she can meet criterion 1 and 2. Ask her directly whether she wants authorship and is willing to approve the final version and be accountable for it. If not, offer a named acknowledgement with her consent, and ensure her contribution to the plain-language summary is credited.
Publish the contributor statement. Readers should be able to see how the analysis was designed and by whom, whichever route is taken.
2. What do you do about the contract clause allowing the funder to require removal of content?
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The clause cannot be operated as written for this manuscript. ICMJE requires that authors have full control over the decision to publish and over the content, and journals ask for a declaration to that effect. A contractual right to delete findings is incompatible with authorship under those terms, and exercising it would expose the authors to a misconduct finding and the company to reputational damage.
Practical route.
- Send the clause to legal and to the publication steering committee immediately, with a note that this is a live issue, not a hypothetical.
- Negotiate an amendment for this and future registry agreements: the funder may review for factual accuracy and for disclosure of confidential information, and may comment, but may not suppress findings or determine conclusions. A common formulation gives a defined review window and requires that any disagreement be disclosed in the manuscript.
- Put the arrangement in the manuscript's role-of-the-funder statement.
If the clause cannot be changed before submission. Do not submit a manuscript that the funder can veto. Options are: delay until the amendment is agreed; submit with a transparent disclosure of the funder's review rights; or, in the worst case, decline authorship and let the registry team publish independently. Choose deliberately and record the reasoning.
Governance fix. Add a publications clause review to the contracting checklist, so the next registry agreement does not arrive with an unworkable approval right.
3. The commercial team wants the operator-volume finding removed as confounded. How do you handle the finding itself?
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Assess the science, not the commercial exposure. The finding was pre-specified in the registry analysis plan, the confidence interval excludes 1, and it concerns operator volume - a plausible mechanism, not a random result. The right question is whether the analysis adequately adjusts for confounding, and the answer belongs in the limitations, decided by the statistician and the steering committee.
What the manuscript should contain. The result reported as pre-specified, with the adjustment set described, the residual confounding acknowledged explicitly, and a caution against causal interpretation. If the steering committee concludes the model is inadequate, the response is a sensitivity analysis or a stronger limitations statement - not deletion. Removing a pre-specified finding because it is inconvenient is outcome-driven reporting and would be indefensible if the analysis plan were compared with the paper.
Handling the commercial team. Explain that the finding will be published, that the limitations paragraph protects against over-reading, and that a monitored device with an operator-volume signal is better handled through training and post-market surveillance than through silence. Offer them a route: a company response or a field safety communication can accompany publication. What they cannot have is editorial control over the result.
Paper trail. Record the request, the standards applied, the steering committee decision and the statistical rationale. Send the manuscript and the data-sharing statement to the steering committee for final approval in writing before submission.