Clinical Research and Trials

Find information and links on the changes and clarifications by NIH regarding clinical trials definition and regulations.

The National Institutes of Health (NIH) launched a series of initiatives that rolled out in 2017 - 2018 to enhance the accountability and transparency of clinical research. These initiatives target key points along the whole clinical trial lifecycle from concept to reporting of results. These initiatives include:

• Clarification of the definition of clinical trials (effective January 1, 2018)
• Good Clinical Practices training for clinical trials (effective January 2017)
• Clinical trial specific funding opportunities (proposals due on or after January 25, 2018)
• New PHS Human Subjects and Clinical Trials Information form (proposals due on or after January 25, 2018)
• Single IRB for multi-site research (effective January 2018)
• ClinicalTrials.gov registration and reporting requirements (effective January 2017)

For additional information, see:

• NIH Clinical Trial Requirements for Grants and Contracts page
• NIH video Overview of New NIH Policies on Human Subjects Research and Clinical Trials.
• NIH Clinical Trials FAQs page
• NIH Clinical Trial-Specific Funding Opportunities page
• NIH Clinical Trial-Specific Review Criteria page
• NIH "Open Mike" article "4 Questions for researchers involved with Human Subjects Research"
• NIH "Open Mike" article "Continuing to Clarify the NIH Definition of a Clinical Trial"
• NIH "Open Mike" article "Be Careful to Pick the Right Funding Opportunity Announcement (FOA)"

Clinical Trial studies may be conducted under a sponsor-initiated protocol or a UC principal investigator-initiated protocol.

In general, a clinical trial is considered PI-initiated when the protocol is authored by:

• UC investigators within the course and scope of their University employment, or
• UC investigators within the course and scope of their University employment jointly with an employee of another entity (e.g., an employee of another non-profit institution, an employee of the industry sponsor, etc.)

The Research Integrity and Compliance (RCI) Office is responsible for ClinicalTrials.gov Registration and Reporting Requirements. Refer to Research Compliance and Integrity Resource information to learn more about the CT.gov public registry aimed at increased transparency and improved public awareness of research.

Office of IRB Administration (OIA)

The Office of IRB Administration serves as the advocate for the rights and welfare of persons who participate in research programs conducted by UCSD faculty, staff, and students.  For more information, please visit the OIA page. 

Health Data Oversight Committee (HDOC)

The UC Office of the President has established a formal process to actively manage requests to share UC health data with third parties. The policy requires a UC Health campus committee to handle data-sharing requests according to UCOP guidelines. The UCSD Vice Chancellor of Health Sciences has established the UCSD Health Data Oversight Committee (HDOC) to perform this function.  Please see the HDOC page for more information.

Conflict of Interest (COI)

COI applies to clinical trials as it does to all sponsored research at UC San Diego.

For more information, go to the COI Office page.

PI Eligibility

The PI Exception process is also the same as it is for all sponsored research at UC San Diego.

For more information, go to the PI Exception page.

Office of Coverage Analysis Administration (OCAA)

Most clinical trials require a coverage analysis to determine what services are billed to insurance, billed to a sponsor, or billed directly to the patient. For more information, contact OCAA.

Export Control Office

Export Control identifies and manages export risks and provides export licenses in support of the research activities of university faculty, staff, and students.  For more information, contact the Export Control Office.

• Overview of New NIH Policies on Human Subjects Research and Clinical Trials (NIH.gov)
• NIH Clinical Trial Requirements for Grants and Contracts (NIH.gov)
• HIPAA - Health Information and Privacy Information (HHS.gov)
• Food and Drug Administration (FDA) Page on Running Clinical Trials (FDA.gov)

The University of California Biomedical Research Acceleration, Integration & Development (UC BRAID) developed tools to support clinical research at the University of California.  For more information, please visit the UC Braid Developing Tools page.

Depending on the sponsor, clinical trial budgets can look very different. Budgets might be based on a (1) capitated, per-patient basis or (2) include major cost categories similar to a sponsored research project.

Please work with your business office and the sponsor to develop your clinical trial budget.

Budget Best Practice Questions

• Are your Per-Patient Costs sufficient? 
• Will coverage analysis be required? Contact OCAA for more info.
• Are you receiving enough working capital up-front to cover the start-up costs of the study?
• Does the budget include all the necessary items to conduct the clinical trial (e.g. applicable IRB fees)?
• Does the Schedule of Events match the Payment Schedule in the budget?
• Is there a Hold-Back Provision for the final payment? Can this be prorated if the Payment Schedule is milestone-based?

IDC Rate for Clinical Trials

• Industry-funded clinical trials, both UC PI-initiated and Sponsor-initiated(initiated by a non-UC party), are subject to the clinical trial indirect cost rate of 33% on total direct costs (TDC), including the total cost of all subsites, for agreements effective January 1, 2024.
• Non-profit funded clinical trials are subject to the nonprofit sponsor policy for IDC. If a nonprofit sponsor policy does not exist, the federal negotiated rate applies.
• Federally funded clinical trials, including subawards, are subject to the applicable federal negotiated rate. 

The applicable IDC rate is based on the primary funding source and such rate is not altered should UCSD be serving as a subsite.  The University cannot subsidize budgets for industry-funded clinical trials and budgets must cover the entire cost of conducting the clinical trial, including the applicable institutional costs (e.g., IRB fees) and indirect costs.

For more information a list of UC San Diego’s IDC rates and a copy of UC San Diego’s Federally negotiated rate agreement please visit the Indirect Costs page.

ACTRI Services

The Altman Clinical and Translational Research Institute (ACTRI) provides clinical research services.  Please see their Center and Services page for services provided by ACTRI and recharge rates.

IRB Fees

Applicable IRB fees must be included in the budget.  Please see the Office of IRB Administration (OIA) IRB Review Fees page for current fees to be included in the budget.

Due to the complexity and high-risk nature of clinical trials, contracts must address a substantial number of areas such as intellectual property rights, publication and/or data rights, material transfer, indemnification, subject injury, confidentiality, and regulatory requirements.  Review by other compliance offices are often required.  As a result, contract review and negotiations can take additional time while the Sponsored Projects Office works with the sponsor to arrive at mutually agreeable terms.