Conflict of Interest Requirements for PHS-Compliant Agencies

PHS CompliantIn compliance with Federal Regulation 42 CFR 50, Subpart F, Promoting Objectivity in Research, the University of Kansas requires investigators who work on or submit project proposals to PHS-compliant agencies to follow the procedures below.

Definition of Investigator

As per 42 CFR 50, Subpart F §50.603, the federal definition of investigator is "the project director or principal investigator (PD/PI) and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, persons who are sub grantees, contractors, consortium participants, collaborators or consultants." 

The PD/PI is responsible for identifying individuals who will be participating at the investigator level on the project. Usually, at a minimum, the PI, co-I and key personnel are designated investigators. While the federal definition of investigator is quite broad, keep in mind that its application to an individual is dependent on the individual’s contribution to the project and may not apply to everyone.

Requirements

  1. Financial Conflict of Interest (FCOI) training: Award funds for PHS-compliant projects must be withheld until all project investigators have completed the FCOI training. To satisfy the training requirement for KU-Lawrence, training is provided through the CITI Program
  2. Certification of disclosed financial interests per PHS-compliant project: Each investigator must submit a special conflict of interest certification ("Research Certification") prior to each PHS-compliant proposal submission. This requirement must be completed for all investigators associated with the project prior to the availability of funds for PHS-compliant projects pending or renewing the award.
  3. Research Certification process: In consultation with the PI, pre-award staff will generate an email that contains a link to the COI reporting system to each investigator on the project. All investigators must complete their certifications in the eCompliance system before the proposal is submitted.

Additional Information

The current list of PHS-compliant agencies, as of 9/15/2015, follows:

Public Health Service (PHS) Agencies (updated 9/15/2015)

  1. Agency for Healthcare Research and Quality (AHRQ)
  2. Agency for Toxic Substances and Disease Registry (ATSDR)
  3. Centers for Disease Control and Prevention (CDC)
  4. Food and Drug Administration (FDA)
  5. Health Resources and Services Administration (HRSA)
  6. Indian Health Service (IHS)
  7. National Institutes of Health (NIH)
  8. Office of Global Affairs (OG)
  9. Office of the Assistant Secretary for Health (OASH)
  10. Office of the Assistant Secretary for Planning and Evaluation
  11. Office of the Assistant Secretary for Preparedness and Response (ASPR)
  12. Office of Public Health and Science
  13. Substance Abuse and Mental Health Services Administration (SAMHSA)

Non-PHS Agencies that have adopted the PHS standard (updated 3/10/2015)

  1. Alliance for Lupus Research (ALR)
  2. Alpha-1 Foundation
  3. American Asthma Foundation
  4. American Cancer Society (ACS)
  5. American Heart Association (AHA)
  6. American Lung Association (ALA)
  7. Arthritis Foundation (AF)
  8. CurePSP
  9. Juvenile Diabetes Research Foundation (JDRF)
  10. Lupus Foundation of America (LFA)
  11. Patient-Centered Outcomes Research Institute (PCORI)
  12. Susan G. Komen for the Cure

Source: http://nrc59.nas.edu/pub/fcoi_agencies_phs_regs.html

Please contact Bob Szrot (864-3319), coi@ku.edu, or Susan MacNally (864-4148) if you have questions about conflict of interest requirements for projects proposed to PHS-compliant agencies.