February 18, 2013

A. Dialogue on Conflict of Interest.

Vice President Sanchez reminded the Council that the Conflict of Interest policy had been in place at the University for some time in order to monitor objectivity in research.

The first question for the vice president was asked by Professor William Beckner (mathematics), who asked for clarification regarding the changes addressed by the policy. Vice President Sanchez said the policy follows federal regulations and its intent “has always been that potential financial interest will not affect the outcome of the research.” The new policy, which changed in August 2012, “was prompted primarily by a change in the policy of the Public Health Services” (PHS). He explained that the National Institute of Health (NIH), an important sponsor of many research projects at UT Austin, is a member of the PHS. The vice president said the new policy was discussed largely at the national level, has impacted all colleges and universities across the country, and has therefore prompted changes in the UT System’s guidelines for its member institutions.

Vice President Sanchez explained that the old policy had “applied only to externally funded research, irrespective of the sponsor,” whereas “the new policy applies to all research, irrespective of the source of funding, whether it’s internal or external.” Furthermore, under the old policy, the individual researcher was responsible for determinations of conflicts of interests. The new policy, however, “requires disclosure of financial interests that are reasonably related to institutional responsibilities,” which are to be determined “by the Conflict of Interest official at The University of Texas at Austin.” Should a conflict of interest be discovered, the new policy requires that a management plan be developed.

Vice President Sanchez then addressed Professor Beckner’s question regarding justification of the new policy by providing background information. He said Iowa Senator Grassley had made an inquiry regarding proper use of federal funds that unearthed cases of undisclosed financial conflicts, which led the NIH to develop a policy. Vice President Sanchez emphasized that no individual from UT Austin had any input in the development of The University of Texas System’s policy. He added that his own approach was a purely pragmatic one “to protect the research enterprise at UT by protecting the faculty members that do the research against the possible consequences of not following the policies.”

Next, Dr. Sanchez responded to questions from Professor Jon Olson (petroleum and geosystems engineering) regarding stock ownership by faculty members. He explained that stock ownership requires disclosure, and that the threshold for reporting ownership in publicly traded corporations is $5,000. Because valuations of ownership in non-publicly traded corporations is problematic, he said the threshold for reporting has been set at zero, meaning that all ownership interests must be reported. The vice president said it was his opinion that the policy on objectivity in research should not prompt faculty members to divest their stock holdings.

When Professor Alan Friedman’s (English) asked about the potential impact of the conflict of interest policy on faculty in the College of Liberal Arts, Vice President Sanchez responded that the policy impacts any research at the colleges and schools across the entire University.

Professor Nina Zuna (special education) had submitted a question regarding the new policy’s impact on student involvement in research. Vice President Sanchez said that the principal investigator (PI) of a research project is responsible for making the determination of student responsibility for conduct, design, and communication of the project at the time the research proposal is submitted. If students are not involved in any of these activities, they do not have to file disclosure documents, except for research that involves human subjects, which is subject to universal practices by the Institutional Review Board (IRB). He added that UT Austin’s accreditation agency requires that anyone involved in human subject research must abide by the institutional policies for conflict of interest. Although Professor Zuna said she understood the IRB requirement, she thought students involved in the implementation of a research project, but not in the design phase, would be overly burdened by the mandated financial requirements of the new policy. Dr. Sanchez explained that the process is very agile if there are no financial interests involved. In this situation, the students merely have to read ten PowerPoint slides and answer four questions. He stressed again, however, that the question of conflict of interest in human subject research is considered as important as adhering to the process of informed consent for research participants. He explained that involvement in human subject research requires that any administrative person who merely moves a file must comply with the requirements of the Conflict of Interest policy. He explained that this standard practice of zero tolerance in research involving human subjects has a long history.

Professor William Fisher (geosciences) inquired if there was a distinction made between conflict of interest and potential conflict of interest. To put the policy into context, Vice President Sanchez shared the following data: of 3,500 researchers who went through training, 2,500 had to disclose and about 500 of those declared some level of financial interest. For about 10 percent of those 500 researchers, a management plan had to be developed. Again, he stressed that this policy intent is to protect faculty members by ensuring that financial interests do not impact their research. According to the vice president, the management plan, in most cases, would ask researchers to disclose their financial interests, such as the funding source for the research, on any relevant publications. He said he knew of no cases thus far that required the elimination of a project.

Professor Daron Shaw (government) asked about the existence of a major database of disclosures that researchers were required to file. She was concerned about privacy issues because the information in the database could be subject to open records requests. Dr. Sanchez noted that this disclosure requirement would apply not just to UT Austin but also to all public universities across the entire country. He also noted that the Office of Sponsored Projects had nothing to do with the approval or disapproval of IRB protocols, which are reviewed by the IRB and largely involve faculty members and a few external members.

Professor Jody Jensen (kinesiology and health education) expressed her concern that, albeit, according to the statistics cited earlier, only a small number of faculty had to implement a management plan, thousands of faculty members had to disclose their finances and even those of their family members, making the data available and searchable online by people with good or not so good intensions. Dr. Sanchez pointed out that policy compliance is a condition for employment at UT Austin and is therefore periodically reviewed by internal audits. He also noted that while data related to the policy on objectivity in research are not entered into a publicly accessible database, it is subject to open records request just like NIH-funded research is. Of the 2,500 disclosures at UT Austin to date, he pointed out that none of them were on a public website.

When Professor Andrew Riggsby (classics) asked if the family-wide disclosure he provided to receive funding from the Archaeological Institute of America to study fifth-century BC masonry would exist as a record, the vice president confirmed that it would. 

When Professor Alberto Martinez (history) asked which UT Austin personnel had agreed to this conflict of interest policy, Dr. Sanchez again stated that the policy was not developed at UT Austin. He said the policy came from The University of Texas System and was “a mirror image of the policy that was implemented by federal regulation by the Public Health Sciences.”

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