For questions regarding scientific progress or changes to your award, please contact the Program Officer assigned to your grant.
For questions regarding fiscal and administrative issues contact RGPOgrants@ucop.edu.
CONDITIONS OF AWARDS
PRIOR TO FUNDING
GRANT ADMINISTRATION MANUAL
POLICY REGARDING SCIENTIFIC MISCONDUCT
POLICY REGARDING CONFLICT OF INTEREST
Awardees are expected to account for the expenditure of grant funds and for the performance of work as agreed upon in a timely manner, so that TRDRP may file reports and answer inquiries from the legislature and the public. Allowable expenses include salaries and fringe benefits for professional and support personnel, supplies, equipment, travel, and indirect costs incurred after the start date of the award. TRDRP award funds may be used only for expenditures necessary to carry out the approved research.
Awardees are also expected to contribute to the stated goals of the Proposition 99 legislation, which include the systematic dissemination of research results to the public. The Institutional Official’s and Principal Investigator’s signatures on the cover page of the application signify that the individuals are aware of the following conditions for receiving a grant from TRDRP:
Provide human and animal subject assurances from federally licensed review board
Modify titles and lay abstracts, if requested
Submit revised budgets, if required
Resolve other administrative issues identified during the review or funding decision process
If all assurances, budgetary matters, and administrative matters are not resolved within nine (9) months of the date of this letter, the award offer will be withdrawn.
Use award funds only as approved by TRDRP, maintain accounts, records, and other evidence pertaining to work performed and costs incurred
File annual progress reports and a final scientific report on time
File annual fiscal reports and a final fiscal report on time
Participate in TRDRP-sponsored activities to disseminate research results as able and as requested
Communicate with the public about the funded work
Attend TRDRP Conferences and participate as requested
Acknowledge the support of TRDRP on all publications resulting from the funded research
The University of California manages the Tobacco Related Disease Research Program in general accord with the policies and procedures employed by the National Institutes of Health (NIH), including those that apply to scientific misconduct. The Department of Health and Human Services’ (HHS) Office of Research Integrity is responsible for implementing HHS regulations regarding scientific misconduct in research conducted with NIH and other support from the US Public Health Service.
The administrative actions imposed by HHS include the following: correction of the scientific literature; special plan of supervision to ensure integrity of the scientific research; certification of the accuracy of the scientific data; certification of the accuracy of sources and contributions for scientific ideas and writings; prohibition against service on PHS advisory committees or as a consultant; and debarment from receipt of Federal funds. These actions are for a specified duration, depending on the nature and seriousness of the misconduct. TRDRP follows these guidelines and remedies involving scientific misconduct.
Applicants for or recipients of grants from the TRDRP must promptly inform the University of an administrative action or notification of disciplinary action by HHS, either at the time of application or within 30 days of the notification of disciplinary action or imposition of the administrative action. In general, the University will apply the same administrative or disciplinary action. For example, if HHS has debarred an investigator from applying for or receiving NIH awards for a specified period of time, that investigator would also be excluded from applying for or receiving awards from the TRDRP. To take another example, if an investigator has entered into a voluntary agreement with HHS for a special oversight and supervision of the investigator’s grant applications, research, and publications, that agreement would apply to that investigator’s grant applications to, or awards from, the TRDRP.
Grant applicants or recipients may request that HHS administrative actions be waived or modified with respect to a grant application or awards from TRDRP. In such case, the application must present a justification for the request. The TRDRP must be notified promptly of any administrative action taken by any funding agency or the institution against a TRDRP-funded investigator.
I. Introduction Prudent stewardship of public funds that support research programs requires that appropriate steps be taken to ensure high quality results. The TRDRP is therefore adopting this policy to:
a. Require institutions that receive research funding from the TRDRP (“recipient institutions”) to establish safeguards to ensure that the design, conduct, and reporting of research funded under TRDRP awards (e.g., grants, cooperative agreements or contracts) will not be, or appear to be, biased by any significant conflicting financial interest of those investigators responsible for the research.
b. Provide guidance on standards and procedures that recipient institutions are to use in implementing such safeguards.
These standards and procedures are based on those of the U.S. Public Health Service and the National Science Foundation and are consistent with University of California policy (http://www.ucop.edu/research/policies/ucpols.html).
II, Requirement that Recipient Institutions Have a Conflict of Interest Policy Each institution receiving TRDRP funds must have written, enforced policy guidelines on avoidance of conflict of interest. The institution’s policy guidelines should reflect federal, state and local laws and must cover significant financial interests, gifts, gratuities and favors, nepotism, and other areas such as political participation and bribery. The institution’s policy guidelines must indicate how an investigator’s outside activities, relationships, and significant financial interests will be reviewed by a responsible institutional official in order to determine whether those activities or interests amount to a conflict of interest in research.
III. Required Disclosure, Review and Management Procedure
a. A recipient institution must require each investigator who is planning to participate in the research proposed for TRDRP funding to disclose to an official(s) designated by the institution a listing of his or her known Significant Financial Interests (and those of his or her spouse or registered domestic partner and dependent children):
i That would reasonably appear to be affected by the research for which TRDRP funding is sought; and
ii In entities whose financial interests would reasonably appear to be affected by the research.
b. The designated institutional official(s) must review all financial disclosures and determine whether a conflict of interest exists. A conflict of interest exists when the designated official(s) reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the research for which TRDRP funding is sought. If the designated official determines that a conflict of interest exists, he or she must determine what actions should be taken by the institution to manage, reduce, or eliminate the conflict of interest.
c. Prior to the expenditure of any funds awarded by TRDRP, a recipient institution must report to TRDRP the existence of any conflicts of interest found by the institution and assure SRP that the institution has acted to protect TRDRP-funded research from bias due to the conflict of interest by ensuring that the interest has been effectively managed, reduced, or eliminated.
The following definition of “Significant Financial Interest,” adopted by TRDRP, comes from the federal regulations promulgated by the U.S. Public Health Service (PHS) (42 CFR Part 50 Subpart F 50.603):
Significant Financial Interest means anything of monetary value, including but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights). The term does not include:
(1) Salary, royalties, or other remuneration from the applicant institution;
(2) Any ownership interests in the institution, if the institution is an applicant under the SBIR Program;
(3) Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities (4) Income from service on advisory committees or review panels for public or nonprofit entities;
(5) An equity interest that when aggregated for the Investigator and the Investigator's spouse and dependent children, meets both of the following tests: Does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a five percent ownership interest in any single entity; or
(6) Salary, royalties or other payments that when aggregated for the Investigator and the Investigator's spouse and dependent children over the next twelve months, are not expected to exceed $10,000.
a. This policy applies to all TRDRP recipient institutions that also have awards from PHS or NSF and that therefore have conflict of interest policies and procedures in place that, comply with those agencies’ rules.
b. Recipient institutions that do not have PHS or NSF funds must develop and follow policies and procedures pursuant to this policy. TRDRP staff will assist in this process, for example, by providing model language from other institutions or facilitating the cooperation of partner institutions.
c. However, recipient institutions that do not have PHS or NSF funds and believe their investigators have no conflicts of interest related to the research to be funded by TRDRP may request a waiver from the requirement to develop written policies and procedures. In order to receive such a waiver, an institutional official must certify in writing that he or she has reviewed the TRDRP policy and has determined that no investigator who is planning to participate in the research proposed for TRDRP funding has a conflict of interest related to the project to be funded by TRDRP.