Conflict of Interest
ANNOUNCEMENT: New Conflict of Interest Regulations, Policy, and Disclosure Form
PHS has issued revised regulations related to Conflict of Interest (COI) that go into effect on August 24, 2012 (http://grants.nih.gov/grants/policy/coi/). These regulations apply to any institution that applies for or receives PHS funding. PHS governed agencies include: National Institutes of Health (NIH), Administration for Children and Families (ACF), Administration on Aging (AoA), Agency for Healthcare Research and Quality (AHRQ), Agency for Toxic Substances and Disease Registry (ATSDR), Centers for Disease Control and Prevention (CDC), Centers for Medicare & Medicaid Services (CMS), Federal Occupational Health (FOH), Food and Drug Administration (FDA), Health Resources and Services Administration (HRSA), Indian Health Service (HIS), Substance Abuse and Mental Health Services Administration (SAMHSA) and Public Health Service Commissioned Corps.
COI Policy and Applicability (Covered Individuals)
In response to the new regulations, UTA has revised its Conflict of Interest Policy (INTERIM) after careful consideration of academia best practices, and in cooperation with the UTA Faculty Senate. The scope ofthe new COI Policy applies to all Covered Individuals, defined as any Investigator (a person responsible for the design, conduct, or reporting of research) that is proposing or conducting 1. sponsored research, 2. non-exempt human subject research, or 3. animal research. The Policy also applies to an Investigator's Covered Family Members, defined as a spouse or dependent children. Covered Individuals are responsible for reviewing and understanding the COI Policy, understanding what constitutes a Significant Financial Interest (SFI) under the Policy, and reporting any known or potential SFIs via the Conflict of Interest Disclosure Form.
What Constitutes a Reportable Significant Financial Interest (SFI)
Significant Financial Interest is defined as a financial interest consisting of one or more of the following interests of the Investigator (and the Investigator's Covered Family Members) that reasonably appears to be related to the Investigator's Institutional Responsibilities:
- Remuneration or Equity Interest in a Publicly Traded Entity: A Covered Individual must report a financial interest in which the value of any Remuneration received from the entity in the 12 months preceding the disclosure and the value of any Equity Interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000;
- Remuneration or Equity Interest in a Non-Publicly Traded Entity: A Covered Individual must report a financial interest in which the value of any Remuneration received from the entity in the 12 months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator holds any Equity Interest;
- Intellectual Property: A Covered Individual must report receipt of income related to intellectual property, and any equity or business participation in an entity that sponsors the individual's research or licenses the IP.
- Reimbursed or Sponsored Travel: A Covered Individual that submits to or is awarded PHS fundingmust report the occurrence of any reimbursed or sponsored travel related to their Institutional Responsibilities. See "SFI Exclusions" below for travel that is not reportable.
SFI Exclusions: The term Significant Financial Interest (SFI) does not include the following types of financial interests:
- Salary paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution;
- Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;
- Income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education;
- Income from service on advisory committees or review panels for a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education;
- Travel that is reimbursed or sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.
COI Disclosure Form
A new Conflict of Interest Disclosure Form has been developed to comply with the 2011 COI regulations. It is fully electronic and accessible here:https://www.uta.edu/mentis/public/#coi/disclosure/my. Covered Individuals must submit the Disclosure Form at least annually, or within 30 days of discovering or acquiring a new, reportable SFI.
If you face any issues with submitting the COI Disclosure forms please contact the ERA Helpdesk at 817-272-1060 or email us at firstname.lastname@example.org.
A new training module has also been developed in response to the COI regulations. Investigators funded by PHS are required to complete the training before engaging in any PHS research, and every four years thereafter. Other Investigators are encouraged to complete this training voluntarily, as it contains some important information and a review of key terms. The training is brief and available electronically at the following link: https://www.uta.edu/ra/real/researchspace.php?view=7.
Summary of Changes Brought Forth by the New 2011 COI Regulations, and the University's Response
- New definition of Significant Financial Interest (SFI)
- Details -> SFI now includes consideration of remuneration, equity, intellectual property, and reimbursed or sponsored travel. The disclosure requirements apply to an Investigator, their spouse, and dependent children.
- Response -> UTA has updated the COI policy to include the new terms for SFI. The COI Disclosure Form is updated to prompt for and identify SFIs.
- Lower financial disclosure thresholds for payments or equity interests
- Details -> The threshold decreased from $10,000 to $5,000 and includes any equity interest in non-publicly traded entities.
- Response -> UTA has updated the COI policy to implement the new threshold.
- New conflict of interest training
- Details -> The regulations require training prior to engaging in PHS-funded research, and every 4 years thereafter.
- Response -> UTA has developed a new online training module to meet the requirement, which can be accessed here: Conflicts of Interest in Research: Disclosure, Management, and Reporting https://www.uta.edu/ra/real/researchspace.php?view=7.
- New public accessibility requirements
- Details -> The regulations require certain COI information to be made publicly accessible or available or upon request.
- Response -> UTA has updated the COI policy to indicate new accessibility requirements.
- Increased transparency for travel
- Details -> Investigators must disclose certain types of sponsored/reimbursed travel to determine potential for conflict of interest.
- Response -> UTA has updated the COI policy to include travel. The COI Disclosure Form is updated to prompt for and identify applicable travel disclosures.
- Development and implementation of management plans for all identified financial COIs
- Details -> Previously, the specific manner of compliance for COI was not regulated.
- Response -> UTA has updated the COI policy and new procedures will comply with this requirement for management plans.
2011 PHS Conflict of Interest Regulations, 42 CFR Part 50, Subpart F
UT Arlington Policy for Disclosure, Management, and Reporting of Financial Conflicts of Interest in Research(COI Policy - INTERIM)
UT Arlington COI Disclosure Form: https://www.uta.edu/mentis/
UT Arlington Training: Conflicts of Interest in Research: Disclosure, Management, and Reporting
NIH Conflict of Interest Page:http://grants.nih.gov/grants/policy/coi/
NIH FAQs: http://grants.nih.gov/grants/policy/coi/coi_faqs.htm
Summary of Major Changes from 1995 to 2011 COI Regulations:http://grants.nih.gov/grants/policy/coi/summary_of_major_changes.doc.
UT Arlington Research Administration, Regulatory Services: 817-272-1234, email@example.com
For Technical Questions regarding the COI Disclosure forms, contact ERA Helpdesk at 817-272-1060 or email us at firstname.lastname@example.org.