Conflict of Interest in Research
California Lutheran University’s Conflict of Interest in Research policy promotes objectivity in research and establishes procedures and standards to ensure there is a reasonable expectation that the design, conduct or reporting of research funded under sponsored grants, contracts or cooperative agreements will be unbiased by any conflicting financial interests of an Investigator.
A conflict of interest is a situation in which an Investigator’s private financial interests or personal obligations have the potential to bias, or the appearance of biasing, a research project or cause harm to human subjects participating in a research project. It is important to note that having a secondary financial interest in research is not illegal or unethical, as long as such interests are disclosed to the university and managed appropriately.
Investigator is defined as principal investigator, project director, co-principal investigators, and any other person who is responsible for the design, conduct, or reporting of research, educational, or service activities funded, or proposed for funding, by an external sponsor -- including students, consultants, non-paid volunteers, and others. In this context, the term Investigator includes the investigator's spouse or domestic partner and dependent children.
Regulations
In accordance with federal regulations, the University has a responsibility to manage, reduce or eliminate any actual or potential conflicts of interest that may be presented by the financial interests of an Investigator. For grants from the National Institutes of Health, see U.S. Department of Health and Human Services’ Regulation, 42 CFR 50; Subpart F: Promoting Objectivity in Research. For grants from the National Science Foundation, see NSF Recipient Standards (PAPPG Chapter IX.A.3) (https://beta.nsf.gov/policies/pappg/23-1). Investigators receiving sponsored funds must also comply with the policies of their sponsoring agencies. The University must comply with federal Office of Management and Budget’s Uniform Guidance (2 CFR 200.112; Conflicts of Interest), which specifies that universities receiving federal funding must maintain a written and enforced policy on conflicts of interest.
Purpose & Scope
The purpose of the Conflict of Interest in Research Program is to identify and manage
significant financial conflicts of interest that have the potential to bias research
activities of the University. The policy applies to research funded under sponsored
grants, contracts or cooperative agreements and/or research involving human subjects.
View the full Conflicts of Interest in Research Policy
Disclosure of Personal Financial Interests
All Cal Lutheran investigators who submit applications for research funding to any federal or industry sponsors or other sponsors, and/or are engaged in research involving human participants subject to review by an Institutional Review Board (IRB) must disclose any personal financial interests that reasonably appear to be related to the project.
Requirements of Investigators
Prior to engaging in any sponsored or human subjects research project, Investigators must complete appropriate Conflict of Interest training through The Collaborative Institutional Training Initiative (CITI) Program and disclose any financial interests listed in the Financial Conflict of Interest Disclosure Form to the Research Protections Office using the COI Disclosure Form below. Disclosure Forms must be submitted at least annually, and on an ongoing basis within 30 days of discovery or acquisition of a new financial interest. In addition, Investigators should review and make any necessary revisions to a disclosure:
- With each new, continuation, or revised grant or contract application submitted to the Office of Sponsored Research & Programs,
- With each new protocol involving human subjects, and;
- When there is a new or previously unrecognized financial interest not previously reported.
Training
Investigators are required to complete financial conflict of interest training prior to engaging in research and no less than once every 4 years thereafter. University financial conflict of interest training consists of an online COI course through the Collaborative Institutional Training Initiative (CITI) program. Once an investigator completes the COI Basic Course, CITI will notify the learner to complete the COI Refresher Course 30 days prior to COI training expiration.
The Research Protections Office has access to CITI course completion records and maintains evidence of Financial Conflicts of Interest training completion.
A passing score of 80% or more is required for course completion.
CITI-COI BASIC Course Modules (Required)
- Financial Conflicts of Interest: Overview, Investigator Responsibilities, and COI
Rules (COI-Basic) (ID: 15070)
- Institutional Responsibilities as They Affect Investigators (COI-Basic) (ID: 15072)
- The following module is OPTIONAL: Conflicts of Commitment and Conscience (COI-Basic) (ID: 15073)
How to Complete CITI Training
- Choose California Lutheran University as your Institution.
- Click on "Learner Tools", then "Add a Course".
- Select Currciulum - Answer Question 7, for all other questions check "No", "Not at this Time" or leave unchecked. Click "Submit".