Regulatory/Compliance Requirements

Last updated on September 13, 2019

Overview

UCSF faculty members are required to conduct research and manage the financial aspects of research in compliance with University policy, federal and state laws, and sponsor requirements. Principal Investigators must ensure that they, their fellow investigators, students and staff meet compliance requirements, including any necessary training.

Below are the frequent areas of compliance to consider when preparing a proposal and before an award can be accepted.


 

Conflict of Interest (COI)

Researchers may have financial interests in research sponsors and/or entities with business interests closely related to their research. These interests must be disclosed. Before an award can be setup and transmitted to CGA, it must be released by the Conflict of Interest Division (COI).  The RSC requests this release either at the Just-in-Time stage, or during Award Set-Up.  This release can only occur after the PI makes the proper disclosures and COI approves them. If required, the type of grant or contract will determine the kind of disclosure necessary.

Visit UCSF’s Conflict of Interest division website for detailed information.

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Coverage Analysis

Coverage analysis is the independent review of a human research study to determine which patient care costs are billable to insurance and which are not.  Learn more about coverage analysis here. Awards involving human subjects’ research require coverage analysis and budgets review. To initiate Coverage analysis email: [email protected]

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Cost Sharing

Cost sharing is a financial commitment to an external sponsor to augment its sponsored project budget. Cost sharing is tracked by CGA. More information can be found on the Controller’s Office website.

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Harassment and Discrimination Protections

In accordance with Title IX of the Education Amendments of 1972, Federally-supported research and training must occur in a civil, safe, and respectful environment, free from discrimination and unlawful harassment, sexual or otherwise. Harassment of any kind including sexual harassment is not tolerated at institutions that receive Federal funding or anywhere that Federally-funded activities are conducted. 

NOT-OD-19-029 implemented the requirement of an additional institutional Letter of Support in NIH Training Grant Applications, ensuring that the University has proper policies, procedures, oversiight, and practices in place to prevent discriminatory harassment and other discriminatory practices, and esuring that the institution has adopted procedures to request prior approval of a change in the status of the PD/PI or other senior/key personnel if administrative or disciplinary action is taken that impacts their ability to continue in their role on the NIH award as described in the application.

The RPAC Policies & Guidance webpage for Discrimination and Sexual Harassment is available to provide links to polices and resources necessary to meet specific sponsor requirements.

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Human Subjects

The UCSF Human Research Protection Program (HRPP) is responsible for ensuring the ethical and equitable treatment of human research subjects, as well as ensuring comploiance with Federal Regulations, State Statues and Guidance

The Institutional Review Board (IRB) - formerly known as the Committee on Human Research (CHR) - reviews and makes decisions on all research involving human subjects performed by UCSF faculty, staff and students, regardless of funding source or the location of the research.  

Awards that require these types of approvals may be processed before the IRB has issued an approval number. However, in such cases, research is restricted to activities not involving human subjects.  Research activities involving human subjects may only proceed after IRB has given a final approval and number. In order for the approval to be valid the Sponsor (or funding source), and Key Personnel must be listed on the IRB applications.  See the HRPP website for instructions to add a funding source, or Key Personnel

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Animal Subjects

The Institutional Animal Care and Use Committee (IACUC) oversees all UCSF research and instruction that involves vertebrate animals. The IACUC ensures that the highest ethical and animal welfare standards are met. 

Awards that require these types of approvals may be processed before the  IACUC has issued an approval number. However, in such cases, research is restricted to activities not involving animal subjects.  Research activities involving animal subjects may only proceed after IACUC has given a final approval and number. In order for theapproval to be valid the Sponsor (or funding source), and personnel must be listed on the applications.  See the IACUC website for further instructions.

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 Foreign Influence and Export Control

The Office of Ethics and Compliance collaborates with the UCSF community and senrior leadership to coordiante and guide compliance efforts across the campus.  The foreign Influence and export control page provides information to assit researchers in satisgying certain reporting and dislosure obligations. 

 

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Safety Committees

Safety Committees are campus committees that are mandated by regulatory and policy requirements.

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Human Resources Administration

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Resources: 

UCSF Policies

There are many campus policies involved in the research administration process.  These policies are primarily located in the Academic Administration (100), Financial Administration (300), and Contracts and Grants (400) sections of the Campus Administrative Policies.

Following are other UCSF policy links:

In addition to actual shipment of a commodity out of the United States, export regulations also control the transfer, release or disclosure of technical data about controlled commodities to foreign persons in the United States.

  • Integrity of Research: Along with the Integrity of Research campus policy (100-29), Academic Affairs offers further procedures on Integrity of Research.

 

UCOP and Regents’ Policies

Federal Policies and Regulations

San Francisco and Bay Area Counties

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