UTS175 Disclosure of Significant Financial Interests and Management and Reporting of Financial Conflicts of Interest in Research
Sec. 1 Applicability.
This policy applies to all University of Texas System institutions. It is intended to promote objectivity in research by requiring those institutions to establish standards that provide a reasonable expectation that the design, conduct, and reporting of research is free from bias resulting from researcher financial conflicts of interest. It applies to externally funded research, regardless of the funding source, as well as to research that does not have external funding.
Sec. 2 Federal Regulations.
This policy implements federal requirements pertaining to objectivity in research adopted by the Public Health Service of the U.S. Department of Health and Human Services, as well as those adopted by the National Science Foundation (42 CFR Part 50, Subpart F; 45 CFR Part 94; National Science Foundation Grant Policy Manual Section 510). However, this policy requires U. T. System institutions to adopt standards for the disclosure, management, and reporting of individual financial conflicts of interest in research that go beyond the requirements of the federal regulations.
Sec. 3 Model Policy.
Each U. T. System institution must adopt a policy for the disclosure, management, and reporting of individual financial conflicts of interest in research. To satisfy this requirement, the institution may, but is not required to, adopt the model policy applicable to its institution provided under Item 5 of this policy. If adopting the model policy, the institution may conform the organization and arrangement to those typical for the institution.
Sec. 4 Adoption of Policy Other than Model Policy.
If the institution does not adopt the applicable model policy provided under Item 5, the institution must adopt a policy that is at least as stringent as the federal regulations adopted by the Public Health Service of the U.S. Department of Health and Human Services pertaining to objectivity in research (42 CFR Part 50, Subpart F; 45 CFR Part 94). In addition, the institution's policy must be substantially similar to the applicable model policy and specifically must:
4.1 apply to research that has external funding, regardless of the funding source, as well as to research that does not have external funding;
4.2 require the disclosure of significant financial interests in a manner that is at least as stringent as the disclosure requirements provided by Chapter 2 of the applicable model policy; and
4.3 require the posting on the Internet of financial conflicts of interest in a manner that is at least as stringent as the requirements of Chapter 5 of the applicable model policy.
Sec. 5 Institutional Requirements.
Each institution must:
5.1 include the policy in its Handbook of Operating Procedures;
5.2 amend the policy as necessary to comply with the federal regulations referenced in Section 2; and
5.3 post the up-to-date policy on a publicly accessible website.
Sec. 6 Administration and Enforcement.
Each institution must administer and enforce the policy.
Sec. 7 Initial Implementation.
Each U. T. System institution must adopt its policy for the disclosure, management, and reporting of individual financial conflicts of interest in research as required by this policy as soon as possible, but the policy must be implemented beginning not later than December 31, 2011, for health institutions, and May 1, 2012, for academic institutions, with appropriate transitional provisions for research that is in progress on the effective date of the institutional policy.