Research Requirements

Research Requirements

Application of the Conflict of Interest Policy in Research

The PHS Conflict of Interest  policy requires training and disclosure before initiating and throughout the life a project.  Questions about whether a specific project falls under the PHS Conflict of Interest policy should be referred to ORA.

Below is general information related to the PHS Conflict of Interest policy.  More detailed information is available on these pages:

What research is covered?

  • All federally funded research
  • All industry-sponsored research
  • Research sponsored by foundations or other organizations with COI terms and conditions
  • All research involving human participants and submitted to the IRB, regardless of funding source

See the list of Sponsors with COI Requirements for a list of foundations known to have COI requirements.

Who is required to follow this policy on the project?

Investigators must meet research-related COI training and disclosure requirements.  Investigator includes individuals responsible for the design, conduct, or reporting of research, regardless of position or title.  The Principal Investigator of a project is responsible for making the determination of what named personnel are Investigators. The Prime Investigator (PI) must designate all key personnel for proposal/project.

Tips:

  • Key Personnel are always considered Investigators by virtue of the definition of Key Personnel
  • Investigators may also include others (internal or external to OUHSC) who are independently responsible for research design, conduct, or reporting (i.e., individual(s) who have the authority to make independent decisions about the direction of the research and the subsequent conclusions about the results and/or are likely to be authors on manuscripts or to present research findings)
  • Investigators are not administrative personnel or individuals who perform routine, pre-defined, or incidental tasks related to the project

If an individual who is named on a project does not meet the definition of Investigator, that individual is not required to disclose for the particular proposal.  Hwever, general disclosure policies apply to everyone

Training Requirements

Financial Conflict of Interest Training is required every four years. To complete training:

  • Click here to begin your training
  • Login with your OUHSC credentials
  • Complete training
  • Print Certificate

Disclosure Requirements

Disclosure is required prior to initiating a project, within 30 days of receiving a new significant financial interest, and at least annually, even if acknowledging no change.

What must be disclosed?

Any Significant Financial Interests (SFI) of an Investigator (and those of the Investigator’s spouse and dependent children) related to the individual's OUHSC institutional responsibilities.

Significant Financial Interests fall into categories:

  • Payment or compensation totaling more than $5,000* in the previous 12 months
  • Ownership (e.g., stock) of a publicly-traded entity valued at more than $5,000
  • Any ownership or investment interest in a non-publicly traded entity, even if worth nothing
  • Royalties from IP rights totaling more than $5,000* in the previous 12 months that did not go through OUHSC's tech transfer office, Office of Technology Development (OTD)
  • Sponsored or reimbursed travel of more than $5,000* in the previous 12 months

The full definition of Significant Financial Interest includes additional details. If you have questions about what should be disclosed, please contact ORA.