News and Events from 2011

Important Information Regarding Conflict of Interest (COI) Policy Changes

Posted Nov 29, 2011

Dear Faculty Members:

In August 2011, the U.S. Department of Health and Human Services issued its final rule on financial conflicts of interest in research covering research funded by the Public Health Service, including NIH. UT Southwestern Medical Center must comply with this new federal rule. To that end, UT Southwestern has revised its COI policy titled, “Financial Conflicts of Interest in Research: Disclosure, Management and Reporting” (policy# RES-401) to comply with the PHS policy and UT System mandates. The UT Southwestern policy will go into effect on January 1, 2012.

One critical rule change is the reduction of the de minimis threshold for significant financial interests from $10,000 to $5,000. The COI Office is providing this advance notice so investigators who may have research affected by this change may begin planning to reduce, eliminate or manage any financial interests covered by the rule.

If you currently serve or anticipate serving as an investigator on a clinical study that is either sponsored by or is evaluating products or devices of a company in which you have annual earnings of (1) $5,000 or greater and/or (2) any stock ownership, you will need to reduce or eliminate your conflicts of interests to be compliant with the new rule. Potential management options include:

1. Agree to reduce annual earnings to less than $5,000 or divest stock while relevant clinical research and publication processes are active; or
2. Withdraw as an investigator on relevant clinical studies

Investigators involved in basic research who have annual earnings of $5,000 or greater or any stock ownership will need to manage, reduce, or eliminate your conflicts of interests. Potential management options include:

1. Have your financial and basic research interests reviewed by the COI Committee for consideration of development of a management plan;
2. Agree to reduce annual earnings to less than $5,000 or divest stock while relevant basic research and publication processes are active; or
3. Withdraw as an investigator on relevant basic studies

Please note that all faculty and research study team members will be asked to complete a new Statement of Financial Interests in January 2012 using the new eCOI system. More information and specific instructions will be distributed at that time.

If you believe you may be affected by this change in policy and would like further assistance, please contact the Conflict of Interest Office at 214-648-5398.

Angela R. Charboneau Wishon, J.D .
Vice President for Research Administration
UT Southwestern Medical Center
Phone: 214-648-0455
angela.wishon@utsouthwestern.edu