Requirements for Public Disclosure of Potential Conflicts of Interest in Research
Public disclosure is a management plan element that serves to protect investigators and OHSU against any accusations of malfeasance by identifying all potential dual or competing interests that the investigator may have or appear to have in relation to their research, and including these in a statement in publications and presentations. Providing a full disclosure of these facts helps to dispel any belief that financial interests or other commercial interests in technology are being hidden from the public eye. As has been demonstrated at several other institutions, complete transparency related to competing interests is extremely beneficial to investigators and their institutions. Management of dual interests by mechanisms such as public disclosure allows OHSU investigators to continue in mutually beneficial commercial activities and industry partnerships that help to bring OHSU's exciting discoveries to the public benefit.
The CoIRC encourages investigators to contact the committee (firstname.lastname@example.org or 503-494-7887) with any questions about these requirements, to discuss particular management plans, or to discuss how conflict of interest issues are being handled at other institutions. The committee is willing to review changes in the committee's suggested language at any time and also to discuss with investigators whether a disclosure is required in a particular publication when it might fall into a "gray area".
When is public disclosure required?
Public disclosure is required in any public presentations (see definitions below) of data from research that is related to the investigator's financial interests. The statement must be included as applicable for all authors on the publication or presentation.
Note that it is the responsibility of each author with a financial interest to ensure that these public disclosures are included in relevant public presentations.
Public presentations include conferences, lectures, and any other speaking engagements, journal articles, including review articles, letters to the editor, etc.
Research related to the investigator's financial interests includes any research project that:
- Is fully or partially sponsored by the company in which the investigator has a financial interest
- Involves technology licensed to or owned by the company in which the investigator has a financial interest (including manufacturers of the investigational product used in the research)
- Any other research projects not covered above where the conduct or outcome of the research may appear to affect the company in which the investigator has a financial interest (including financial interests in companies that are direct competitors with the sponsor of the research or the manufacturer of the investigational product).
How is the public disclosure statement to be incorporated in presentation materials?
A public disclosure statement should be included in any journal article, Powerpoint or other presentation slides or documents, posters, etc. presenting research related to the potential conflict as described above.
- Investigators should follow the journal or scientific organization's policy for submission of financial disclosure information.
- If the journal or meeting host does not have a policy, the investigator should include a disclosure of their financial interests in a letter to the editor or meeting organizer and should indicate that OHSU requires a statement of these financial interests in the publication or presentation. It is the investigator's responsibility to assure that the statement is included in the final publication.
- If the journal has a template statement to use for the financial disclosure, it is appropriate to use that statement instead of the specific statement provided in the management plan. This does not need to be submitted for review by the CoIRC.
- If the journal does not have a financial disclosure template, the statement from the management plan should be used.
- The statement may be placed in any location in the article, slide, or poster presentation as preferred by the investigator. It only needs to be included in one location (not on every slide).
What if the journal or scientific meeting host's financial disclosure requirements are different than OHSU's?
So long as the public disclosure occurs, the exact wording and placement of that disclosure is very negotiable. Although the investigator must complete any financial disclosure statements required by the journal or by the meeting host, he or she must also include a public disclosure statement in the article or presentation materials as described above. If the journal or meeting host wishes to modify the wording approved by the CoIRC that is fine.
OHSU understands that there are differing definitions of "significant financial interest" (SFI) among universities and journals. OHSU's definition is in keeping with the preponderance of current national guidance. We recognize that it may be more stringent in some cases, but less stringent in others. Please see the resources below that include examples of some journals' CoI policies and reports from national organizations that provide an overview of SFI definitions used at other academic medical centers and at various journals
What happens if an investigator fails to include the public disclosure statement as required?
Upon annual update of the investigator's disclosure form, the CoIRC requests information from each investigator for evidence of the public disclosure statements he/she has made. The OHSU Research Integrity Office will also conduct random and for cause audits of the investigator's published journal articles to check for the public disclosure statement in articles presenting research related to the potential conflict.
Investigators will be required to contact the journal to publish an erratum for any missing or inadequate discolsure statement noted in the Committee's reviews. The CoIRC recommends that investigators confirm with the publisher, immediately before publication, that the correct disclosure statement is present. Additional corrective actions may also be required for non-compliance with management plan requirements.