IRB Conflict of Interest Policy

A Researcher who is using human subjects and conducting research at UCSC or utilizing UCSC resources or facilities is required to disclose on the Application for IRB Review whether he/she has

• financial interests as defined by applicable state, federal and/or University policy for sponsored projects, or
• significant, related financial interests for studies that are unsponsored or sponsored by an agency that does not have provisions for financial disclosure.

If specimens (tissue, blood,urine, etc.) will be collected from a subject, appropriate language in the consent form should advise the subjects about their rights.

In addition, appropriate language is required in the consent document to inform subjects whether the Researcher has a disclosable financial interest as defined by this policy.

Prior to final approval by the IRB, the UCSC Independent Substantive Review Committee will review the disclosed financial interests and the proposed project to evaluate whether the potential conflict of interest is considered harmful. The Independent Substantive Review Committee recommendation will be forwarded to the VCR and IRB for their consideration prior to approving or disapproving the protocol and the informed consent document.

UCSC IRB COI Requirements

1. The Researcher is responsible for answering the questions regarding his/her financial interests on the Application for IRB Review. Financial interests of the Researcher include his/her spouse and dependent children.
2. Studies sponsored by non-governmental entities follow the financial disclosure thresholds of the University Policy on Disclosure of Financial Interests in Private Sponsors of Research.
3. Studies sponsored by the Public Health Service (PHS), including the National Institutes of Health (NIH), National Science Foundation (NSF), or other agency adopting the federal guidelines for disclosure of financial interests, follow the thresholds of the UCSC Policy for Disclosure of Financial Interests Related to Sponsored Projects for Assurance of Objectivity in Research.
4. Studies that are unsponsored or sponsored by entities that do not have provisions for financial disclosure require disclosure of significant, related financial interests. The terms "significant" and "related" are the same as defined in the federal regulations, Department of Health and Human Services 42 CFR Part 50, and University of California Policy on Disclosure of Financial Interests and Management of Conflicts of Interest Related to Sponsored Projects.C. Standard Consent Form Language:

Suggested COI Consent Language

The IRB has the authority to approve, disapprove or require modification in all informed consent language. The IRB committees will consider the language below as the expected standard for informing subjects; therefore, deviations from this language may result in approval delays.

A. For use when specimens may be retained. The following statement should be used for all studies for which the statement in B. (below) is not applicable.

" I understand that any specimen(s) (e.g., tissue, blood, urine) obtained for the purposes of this study will become the property of the University of California, Santa Cruz (UCSC) and that once I have provided the specimens I will not have access to them. I understand that the specimen(s) will be used for research and such use may result in inventions or discoveries that could become the basis for new products or diagnostic or therapeutic agents. In some instances, these inventions and discoveries may be of potential commercial value and may be patented and licensed by the University. I understand that I will not receive any money or other benefits derived from any commercial or other products that may be developed from use of the specimen(s)."

B. For use when commercialization is not anticipated and specimens will not be retained longer than for the uses specified in the protocol. The investigator is responsible for explaining in the protocol why the abbreviated language is preferred and when the specimens will be discarded or destroyed:

" I understand that any specimen(s) (e.g., tissue, blood, urine) obtained for the purposes of this study will become the property of the University of California, Santa Cruz (UCSC) and that once I have provided the specimens I will not have access to them. I understand that the specimen(s) will be discarded or destroyed once they have been used for the purposes described in the protocol."

C. For use in a study when the Lead Researcher or other researcher for a PHS- or NSF-sponsored study does not have financial interests that exceed the applicable thresholds.

" I understand that the Lead Researcher[s] has [have] no significant financial interest in the outcome of this study.”

D. For use in a study when the Lead Researcher or other researcher for a PHS- or NSF-sponsored study has financial interests that exceed the applicable thresholds:

" I have been informed that the Lead researcher has a personal financial interest in [name of the sponsoring company or other interested entity]. I also have been informed that the nature of this financial interest and the design of the study have been reviewed by the UCSC Independent Substantive Review Committee, and that this committee has determined that the investigator's financial interest would not compromise the quality or reliability of the study. Furthermore, the UCSC Institutional Review Board has determined that the investigator's financial interest will not adversely affect subject welfare."