Research Conflict of Interest

The Parkland Conflict of Interest Policy is presently under development. The following is intended as general guidance.

In accordance with Public Health Service (PHS) regulation 42 CFR Part 50, Subpart F Responsibility of Applicants for Promoting Objectivity in Research and consistent with the provisions of the National Science Foundation (NSF) NSF 60 FR 35820, Parkland Health & Hospital System has developed its policy on financial conflict of interest (FCOI) for investigators applying to or holding grants from federal sponsors, including but not limited to, the National Institutes for Health and the National Science Foundation. Since the initial promulgation of the PHS regulations in 1995, the issuance of a final rule to amend the regulations was issued in the Federal Register August 25, 2011. An institution applying for or receiving PHS funding from a grant, contract, or cooperative agreement must be in full compliance with the revised regulatory requirements. The regulation “promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from investigator financial conflicts of interest.” 

Significant Financial Interest (SFI)

Investigators on applicable projects must disclose Significant Financial Interests (SFIs), including those of a spouse or dependent children, when the interest reasonably appears to be related to the investigator’s institutional responsibilities. Disclosure requirements also apply to investigators on PHS funded projects whose travel related to institutional responsibilities was either sponsored by or reimbursed by an external entity.

An outside interest is considered significant when the investigator or their family members) has one or more of the following:

• Received remuneration (e.g., compensation, loans, items of value) from an external entity, whether publicly or non-publicly traded, in the previous 12 months that, when aggregated, exceeds $5,000
• Ownership (i.e., equity, stock, stock options) in an external entity related to your Parkland job responsibilities
• Received income from intellectual property (IP) rights and interests (e.g., patents, copyrights, royalties from the rights) including your IP licensed/optioned through Parkland and/or other institutions (excludes book royalties)
• A management position (e.g., officer, trustee, director) with an external entity which includes a fiduciary (i.e., legal or ethical) obligation to act in the best interest of the entity

An SFI Disclosure must be submitted:

• Prior to submission of a proposal
• Prior to the expenditure of awarded funds
• Annually on the anniversary of prior disclosures
• Within 30 days of acquiring an additional SFI

Policies and Guidance

Parkland Health & Hospital System

Institutional Conflict of Interests Policy (Parkland Policy #SYSTEM.COMP.POL.014)

Financial Conflict of Interest in Research Policy (Parkland Policy #Pending)

Federal Policies and Guidance

• NIH Conflict of Interest Website
• NIH Financial Conflict of Interest FAQ
• DHHS Final Guidance Document: "Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection"
• NSF Conflict of Interest Policy

Agencies/Organizations Following PHS COI Regulations

These federal agencies and other organizations utilize the Public Health Service (PHS) financial conflict of interest (FCOI) regulations as their COI policy.  This list may help you in determining outside interest disclosure and COI management requirements when one of these agencies sponsors your research, either directly or via subcontract.

Public Health Service (PHS) Agencies

• Agency for Healthcare Research and Quality (AHRQ)
• Agency for Toxic Substances and Disease Registry (ATSDR)
• Centers for Disease Control and Prevention (CDC)
• Food and Drug Administration (FDA)
• Health Resources and Services Administration (HRSA)
• Indian Health Service (IHS)
• National Institutes of Health (NIH)
• Office of Global Affairs (OG)
• Office of the Assistant Secretary for Health (OASH)
• Office of the Assistant Secretary for Planning and Evaluation
• Office of the Assistant Secretary for Preparedness and Response (ASPR)
• Office of Public Health and Science
• Substance Abuse and Mental Health Services Administration (SAMHSA)

Non-PHS Agencies

• Alliance for Lupus Research (ALR)
• Alpha-1 Foundation
• American Asthma Foundation
•  American Cancer Society (ACS)
• American Heart Association (AHA)
• American Lung Association (ALA)
• Arthritis Foundation (AF)
• CurePSP
• Juvenile Diabetes Research Foundation (JDRF)
• Lupus Foundation of America (LFA)
• Patient-Centered Outcomes Research Institute (PCORI)
• Susan G. Komen for the Cure

Federal Demonstration Partnership (FDP) list of agencies using PHS FCOI regulations.