Action Required: Statement of Financial Interests Submission
– Due March 1, 2012

Posted March 22, 2012

To: UT Southwestern Faculty and Individuals Covered by the Conflict of Interest in Research Policy

You are receiving this message because you have been identified as a “covered individual” (i.e., all faculty, study team members, IACUC, IRB, and COI committee members, Research Grants and Contracts and Technology Development staff) subject to reporting requirements under the new Conflict of Interest Policy.

Annual Collection of Statement of Financial Interests (Statements)

At this time, you are requested to:

• File an annual Statement of Financial Interests via the eCOI system; and
• Read and to adhere to the “Financial Conflicts of Interest in Research: Disclosure, Management and Reporting” (Policy# RES-401). Please note that access to the policy is limited to MyUTSW, UT Southwestern’s intranet.

The deadline for submitting statements is March 1, 2012.

New Process for Submitting Statements

A new system for the submission of Statements, called eCOI (i.e., electronic conflict of interest), has been designed to comply with the new policy and is part of the planned enterprise-wide management system for research. The eCOI system will replace the current iAIM system.

Prior Statements in iAIM will be maintained as read-only and printable during the initial submission process for your reference in the completion of new Statements in eCOI.

The first Statements in eCOI will be completed as “new” Statements. However, any subsequent updates and annual renewals of the Statement will retain the prior information so interests can be easily revised.

Assistance and Questions

We understand that a new policy and a new electronic system may generate questions. As such, we have several tools that are available to assist you with the new process:

• eCOI Online Tutorial
• eCOI Quick Reference Guide
• “Office hours” for individualized assistance will be in Room C1.210 on:
  
  • Mondays from 8 a.m.–Noon
  • Wednesdays from 10 a.m.–Noon
  • Fridays from 2–4 p.m.
• Key Contacts:
  
  • For “Office Hours” - Kimberly Taylor at 214-648-4043 or Kimberly.Taylor@UTSouthwestern.edu
  • For COI Office - Sheria Oswalt at 214-648-5398 or sheria.oswalt@utsouthwestern.edu
  • COI Website

New COI Training Requirement

Following the annual collection period for Statements, UT Southwestern will deploy the second phase of the new COI requirements. UT System and NIH Policy require that covered individuals complete a training course every four years. We have developed a web-based CITI course to meet this requirement and will deploy this training beginning March 1, 2012. We will contact you with additional information and instructions at that time.

I want to thank you in advance for your continued assistance and cooperation with this important institutional requirement.

Angela R. Charboneau Wishon, J.D.
Vice President for Research Administration
UT Southwestern Medical Center
5323 Harry Hines Blvd.
Dallas, TX 75390-9105
Phone: 214-648-0455
Fax: 214-648-4474
angela.wishon@utsouthwestern.edu

Important Information on Upcoming Statement of Financial Interests Submissions

Distributed Jan 19, 2012

To: UT Southwestern Faculty and Individuals Covered by the Conflict of Interest in Research Policy

You are receiving this message because you have been identified as a “covered individual” subject to reporting requirements under the new Financial Conflicts of Interest in Research: Disclosure, Management and Reporting (Policy# RES-401). The policy is only available on MyUTSW, UT Southwestern’s intranet.

The most significant policy changes include:

• A reduction in the de minimis threshold (i.e., the “cutoff”) for (allowable) significant financial interests from $10,000 to $5,000 (which is relevant if there is also a research interest in the same company).
• Reimbursed or sponsored travel related to services you personally provide to a business entity.
• Summary information regarding financial interests will be available via a publicly accessible website.
• Training is required at least every four years.

You are encouraged to begin planning now to obtain any necessary financial information for reporting. Prior statements in iAIM will be maintained as read-only and printable during the initial submission process for your reference in the completion of new statements in eCOI.

We understand that a new policy and a new electronic system may generate questions. Please contact the Conflict of Interest Office at 214-648-5398 or visit the COI website if you have any questions or require additional assistance. Please note that you will have access to printed instructions, online tutorials, and “Office Hours” if you require individualized assistance. Detailed information will be forthcoming in a follow-up email.

Thank you for your continued cooperation and compliance with institutional policies.

Angela R. Charboneau Wishon, J.D.
Vice President for Research Administration
UT Southwestern Medical Center
5323 Harry Hines Blvd.
Dallas, TX 75390-9105
Phone: 214-648-0455
Fax: 214-648-4474
angela.wishon@utsouthwestern.edu

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