OHSU members should visit the Disclosure Requirements page on O2.
Who must complete a disclosure?
Anyone not employed by OHSU who conducts research, with respect to a research protocol, designing research, directing research or serving as the principal investigator, enrolling research subjects (including obtaining subjects' informed consent) or making decisions related to eligibility to participate in research, analyzing or reporting research data, or submitting manuscripts concerning the research for publication.
Note: You may be exempt from OHSU's disclosure requirement if your home institution's CoI policy is compliant with federal regulation 45 CFR Part 94.
What must be disclosed?
Interests that meet our definition of a Significant Financial Interest (SFI), that are not already disclosed as an outside activity, including those interests held by spouse, domestic partner or dependent child all must be disclosed.
This includes compensation and/or equity as follows:
- Anything of monetary value including, but not limited to, salary, gifts, consulting fees, honoraria or other payments for services that totals more than $5,000 over the last twelve (12) months;
- Equity interests of any amount in a non-publicly traded entity; or Equity interest or entitlement to equity valued at greater than $5,000 (at the date of disclosure) in publicly traded company;
- The aggregated value of equity and compensation from publicly traded company that exceed $5,000 over the last 12 months;
- Royalty income or the right to receive future royalties under a patent license or copyright agreement; or
- Serving in an executive position (any position that includes responsibilities for a material segment of the operation or management of a business, including a position on a Board of Directors)
Project disclosures must be submitted when new research, grants, and SRAs related to your Significant Financial Interests are planned. Although this process is also managed in the eCoI system, it occurs on a separate form than your annual disclosure. This affords us the opportunity to only ask questions pertaining to the research project and previously disclosed activities or financial interests.
Some examples of questions you can expect are:
- What is the name of the entity associated with the research?
- What is the relationship between your financial interest and the research?
- What is your involvement in design, conduct, data collection, data review/analysis and reporting?
- What factors might mitigate potential conflicts or the introduction of bias?
- What is the current state of the research?
- What involvement do students or trainees have (if any)?
Note: Much like the annual CoI disclosure, the expectation is that this form will be filed whenever relevant.