Committee on Research Priorities
Research funding and policies impacting research have always been primary concerns of the UCSF Senate and Committee on Research (COR). COR informs the Senate and advises the Chancellor of budgetary needs in support of research and research travel. It is also responsible for making recommendations regarding policy on allocation of research funds and other matters pertaining to research. COR also impacts research funding and policies by having representatives on the campus Research Advisory Board, the Office of Sponsored Research Advisory Board, and the Resource Allocation Program Executive Committee.
UCSF’s research administration, infrastructure, and services help support investigators and advance health through discovery. However, the administration and faculty must respond to ever-changing legal, regulatory, and political climates that continues to present new challenges and opportunities for UCSF’s research enterprise.
UCSF recently appointed a new Vice Chancellor of Research, Lindsey Criswell, MD, to lead the Office of Research. It oversees various units including Research Infrastructure and Operations; Office of Sponsored Research; Industry Contracts Division; Research Development Office; Research Resource Program; Laboratory Animal Resource Center; Environment, Health and Safety; and the Office of Clinical Research. UCSF also appointed a new Interim Chief Ethics and Compliance Officer, Brian Smith, JD, MBA, who has responsibility over UCSF’s conflict of interest program, export control program, and institutional review board. Over the last year, COR has developed and maintained strong relationships with the VCR of Research and the Interim Chief Ethics and Compliance Officer. During the next year COR will continue to work with campus leadership to advance several policy priorities that impact faculty researchers.
Export Control Compliance Program
On June 21, 2018, after two years of policy development, UC issued a new Policy on Export Control, which was designed to bring UC into compliance with federal export control laws and regulations. As violations of export control laws and regulations can result in individual liability, UCSF faculty have a stake in ensuring that UCSF maintains a local program that assures legal and regulatory compliance.
UC’s “principal strategy for compliance with the U.S. export control regulations is based upon maintaining an open, fundamental research environment.” However, at present, neither UC nor UCSF have enacted an Openness in Research policy. Furthermore, the Fundamental Research Exclusion may not apply to all transactions, items, or activities, and therefore some instances may call for an export license, control plan, or other approach.
The new policy mandates that each campus manages its own Export Control Compliance program. It states that: “Each UC Location is responsible for creating a local Export Control Compliance program that is consistent with this policy and all U.S. export control laws and regulations. Each UC Location shall establish practices and procedures for effective implementation, taking into consideration its local environment and infrastructure.”
The UC Policy requires campuses to create an Export Control Compliance Program that is documented. At present, UCSF is developing such a program that satisfies this mandate. It currently has an Export Control website that provides information about export control basics. That information likely will need to be revised and supplemented with additional information to ensure clarity for faculty. Moreover, the website may need to include information about procedures for an Export Control Compliance Program.
The UC Policy also requires the establishment of an export control committee or workgroup comprised of various responsible offices and stakeholders. The Academic Senate can request representatives on this committee or workgroup.
Another mandate is the designation of an individual as Export Control Officer (ECO). The ECO must monitor the local Export Control Compliance program, and audits of export licenses, exceptions, and control plans are required.
COR is especially concerned with the impact of implementation of the UC Policy on faculty. Faculty will need to be made aware of all required training assigned by the ECO. Faculty will also need to identify potential export control issues, including issues that may need assistance from the ECO.
The new UC Policy on Export Control identifies situations when faculty will need to work directly with the ECO:
- Research, shipping, or exchange of goods or services involving export-restricted materials, items, information, or software
- Bringing export-controlled items, information, or software onto a campus or research setting
- Traveling to, or conducting University transactions with countries subject to Office of Foreign Assets Control sanctions
The development and maintenance of a local Export Control Compliance Program is a significant undertaking for UCSF that may require commitment of additional resources.
COR will continue to engage campus leadership to ensure that UCSF affords this important issue the attention it deserves so that faculty are fully aware of the requirements under export control regulations.
Conflict of Interest Program
In March 2018, UCOP issued Proposed Presidential Policy on Disclosure of Financial Interest and Management of Conflicts of Interest in Private Sponsors of Research and Revised APM – 028, Disclosure of Financial Interest in Private Sponsors of Research. The proposed policy was designed to give UC campuses more flexibility in their processes for reviewing disclosures of financial interest.
UCSF policies on conflicts of interest are covered by Campus Administrative Policies 100-33, 100-34, and 100-35. These policies may need to be revised to reflect the changes expected from the proposed UC presidential policy. In addition, UCSF may need to create and disseminate education and training material to research faculty in order to comply with the proposed policy.
In addition to Campus Administrative Policies 100-33, 100-34, and 100-35, UCSF, through the Chancellor's Conflict of Interest Advisory Committee (COIAC), has been enforcing “Rule 11,” which provides: Faculty who have, or participate in, a privately sponsored clinical study shall not concurrently receive any compensation from the sponsor, including honoraria and consulting fees, during the course of the study. In addition, they shall not have any investment in, or serve in a decision- making capacity (such as service on the Board of Directors or management committee), or be an officer or employee of the company sponsoring the clinical study. If you have questions about this, please contact coiac@ucsf.edu
During the 2017-2018 term, the Academic Senate considered Rule 11 and its impact on faculty. COR met with campus administrators and received information about the history and application the rule.
Rule 11 was not a rule but one of several enumerated guidelines pertaining to conflict of interest dating back to 1994. In September 2001, the Senate established a Task Force on Conflict of Interest (TF-COI). The TF-COI reviewed the 1994 guidelines and published a report with recommendations. In particular, the TF-COI recommended eliminating Rule 11.
Subsequent to the TF-COI final report, UCSF implemented Campus Administrative Policies (CAP) 100-33, 100-34, and 100-35. Although the campus policies make no reference to Rule 11, COIAC maintains that Rule 11 is still in effect.
COR is currently working with the administration to examine Rule 11 to determine whether its implementation is still appropriate and necessary. As the Chancellor retains authority over the creation and interpretation of campus policies, the Senate will continue to represent to the administration the experiences of faculty adversely affected by Rule 11.
The Senate will continue to track developing issues and respond to changing policies by collecting input from a diverse array of faculty and updating all faculty. COR will continue to advocate on behalf of faculty for improvements to UCSF’s research administration, infrastructure, and services. Toward that end, COR will continue to invite UCSF leaders to meet with the committee.