Compliance and Other Considerations

There are many areas of compliance that intersect with the development of proposals and management of sponsored projects. These areas of regulatory compliance include following protocols for research involving human subjects or animals subjects, export control considerations, intellectual property requirements, responsible conduct of research requirements, and financial conflict of interest.

The following is information on financial conflict of interest for those sponsors that require disclosure at the time of the proposal.

Financial Conflict of Interest

NIH (and selected other PHS sponsors including IHS, HRSA) full list FCOI Agencies Using the PHS FCOI Regulations

If your proposal will be submitted to the NIH, one of the PHS sponsors that follows the PHS Financial Conflict of Interest regulations (42 CFR 50 subpart F), you are required to disclose significant financial interests by completing a Financial Conflict of Interest Disclosure Form before your proposal may be submitted. This is in keeping with federal regulations and CSUSM/CSUSM Corporations COI Policy. Additionally, if the project is funded you will be required to submit the disclosure form annually (and in the event of changes to your disclosures). Any investigator responsible for the design, conduct, and reporting of research must complete a disclosure (includes consultants and senior personnel, as well as subrecipient personnel).

NEW – DISCLOSURE IN CAYUSE CSUSM is adopting Cayuse, a research administrations software. Conflict of Interest disclosure will now be done in the Cayuse Other Interests Module. Visit https://csusm.app.cayuse.com/ and use your CSUSM credentials to get started. View the Guide for Research-Based Disclosure for instructions.

TRAINING As you may have questions about what interests should be disclosed, we are strongly encouraging investigators to complete the Financial Conflict of Interest training now. It will be required of you in the event of a NIH award and should be renewed at least every four years. The FCOI training is available in CITI (steps listed below). You may upload your training certificate to Cayuse.

Training is completed in CITI.

When you log in, Go to “View Courses”
Scroll down and click “Add a Course”
Scroll to the bottom of that page and click “Continue to Question 1 at this time”
The COI item is Question 8.

REFERENCES/RESOURCES

National Science Foundation

The National Science Foundation’s Proposal and Awards Policies and Procedures Guide (Chapter IX.A) discusses institutional and investigator responsibilities regarding the financial conflicts of interest. As an investigator, you are required to disclose significant financial interests (which also includes those of your spouse or dependents) by completing a Financial Conflict of Interest Disclosure Form before your proposal may be submitted. The significant financial interests that should be disclosed are those (i) that would reasonably appear to be affected by the research or educational activities funded or proposed for funding by NSF; or (ii) in entities whose financial interests would reasonably appear to be affected by such activities.

The term "investigator" means the PI/PD, co-PI/co-PDs, and any other person identified on the proposed project who is responsible for the design, conduct, or reporting of research or educational activities funded or proposed for funding by NSF.

TRAINING As you may have questions about what interests should be disclosed, we are strongly encouraging investigators to complete Financial Conflict of Interest training. This training is specifically designed for those proposed to the NIH, however there is much in common in terms of what should be disclosed (threshold difference with the NSF is $10K rather than $5K).

Training is completed in CITI.

When you log in, Go to “View Courses”
Scroll down and click “Add a Course”
Scroll to the bottom of that page and click “Continue to Question 1 at this time”
The COI item is Question 8.

REFERENCES/RESOURCES

Non-Governmental Sponsors

If your proposal will be submitted to a non-governmental sponsor, as the PI, you must complete a 700U Conflict of Interest Disclosure Form in accordance with the Fair Political Practices Commission Title 2, Division 6, California Code of Regulations. This is required of the PI employed by the CSU who has principal responsibility for a research project if the project is to be funded or supported, in whole or in part, by a contract or grant (or other funds earmarked by the donor for a specific research project or for a specific researcher) from a nongovernmental agency. Disclosure is required prior to final acceptance of a contract or grant, or within 30 days after funding is renewed.

Our procedure is to collect this form electronically now at the time the proposal is in development, and in the event of an award, you will need to submit a hard copy of the 700U to Human Resources. Additionally, at the time of an award, you will be required to complete Conflict of Interest Training through CSU Learn.

NEW – DISCLOSURE IN CAYUSE CSUSM is adopting Cayuse, a research administrations software. Conflict of Interest disclosure will now be done in the Cayuse Other Interests Module. In the case of the 700U, the Form 700U will be uploaded in Cayuse. Visit Cayuse and use your CSUSM credentials to get started. View the Guide for Research-Based Disclosure for instructions.