Disclosing
- Why Disclose?
- What if an Investigator does not have a Conflict of Interest?
- Who Reports?
- What is Reported?
- When is Reporting Required?
Why Disclose?
The purpose of disclosure and evaluation is to identify any real or potential conflicts of interest between an Investigator's sponsored project obligations and personal financial interests or obligations. This is to comply with policies set forth by the State of California, Public Health Service (PHS), National Science Foundation (NSF), University of California, and several extramural sponsors who have adopted the federal requirements.
The Institutional Review Boards (IRB) at UCI have instigated a policy on conflict of interest in human subjects research that is applicable regardless of whether the project is sponsored or unsponsored. When human subjects are involved, Lead Researchers are required to disclose their financial interests to the IRB, and make known any possible conflict of interest on the informed consent.
The State, Federal, and IRB disclosure requirements differ as to who reports, what is reported, and when to report. See below for more descriptive information or visit Reporting Requirements for a complete list of which disclosure forms are required.
What if an Investigator does not have a Conflict of Interest?
Investigators who do not have financial or management interests in outside entities are also required to report their status under State, Federal, and UCI policies. This is considered a "Negative Disclosure."
Who Reports?
- For proposals to non-governmental sponsors, State of California law requires the principal and co-principal investigators to disclose financial or management interests.
- For proposals to the PHS (including NIH), NSF, and several non-governmental agencies adopting the federal requirements, all individuals "with responsibility for the design, conduct or reporting of the research" must disclose.
- Proposals to several of the programs within the University of California Industry-University Cooperative Research Program (BioSTAR, DiMi, CoRe, LSI, and UC-SMART) have their own reporting requirements. Principal investigators and co-principal investigators are required to disclose under both the state and federal policies. All other investigators are only required to disclose according to the federal requirements. For more information, visit UC IUCR.
- For any research involving human subjects, disclosure is required by the Lead Researcher on the Application for IRB Review, under Section Q.
What is Reported?
California policy has a lower threshold for disclosing income and investments than the Federal regulations. State, Federal, and UCI policies require investigators to disclose financial and management interests for themselves and in certain situations their spouse and dependent children.
- California policy requires disclosure of interests in the non-governmental sponsor of a research project. Visit Non-Governmental Sponsors for list of interests to be disclosed. (Educational institutions and many non-profit foundations are exempted sponsors.)
- Federal policies require investigators to disclose interests in outside entities that are "Significant" and "Related" to the research described in the proposal. For definitions and threshold levels, visit PHS and NSF Requirements.
- UCI's IRB Policy on Conflict of Interest in Human Subjects Research applies if the research involves human subjects. Disclosure of significant, related interests, consistent with the federal definitions, is required.
When is Reporting Required?
- The California disclosure is filed:
- at the proposal submission stage;
- when additional funding is requested.
- Federal policy requires disclosure:
- at the time of proposal submission or when funding appears likely, prior to award acceptance;
- annually with non-competing continuation funding;
- new investigators are added to the project; and
- when investigator's financial interests change.
- The IRB policy requires disclosure:
- when submitting the Application for IRB Review; and
- with any Continuing IRB Application.
