PHS Requirements

PHS Regulations

Public Health Service (PHS)-regulations laid out in HHS 42 CFR 50 Subpart F and the 2011 Final Rule lay out specific regulations regarding conflict of interest for anyone, regardless of their title, involved in the design, conduct, or reporting of PHS-funded research (except SBIR/STTR Phase I applications). Regulations require training on conflicts of interest and disclosure of significant financial interests, as laid out below.

List of 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)
Substance Abuse and Mental Health Services Administration (SAMHSA)
Office of the Assistant Secretary for Health (OASH)
Office of the Assistant Secretary for Preparedness and Response (ASPR, includes BARDA)
Office of Global Affairs (OGA)

Other federal agencies that follow PHS Conflict of Interest Disclosure requirements

Administration for Community Living (ACL)
Administration for Children & Families (ACF)
Administration on Aging (AoA)
Office of Minority Health Resources Center (OMH)
Office of Population Affairs (OPA)
Office of Public Health and Science (OPHS)
Office of Research Integrity (ORI)
Office of Research on Women's Health (OWH)
Office of National Coordinator for Health Information Technology

Many private sponsors have also chosen to adopted PHS FCOI regulations. Some of these include:

American Cancer Society (ACS)
American Heart Association (AHA)
American Lung Association (ALA)
Patient-Centered Outcomes Research Institute (PCORI)
Susan G. Komen for the Cure

Please note: this list of private sponsors using PHS FCOI regulations is not complete and is subject to change. Please verify the inclusion of PHS regulations in the proposal and award terms for each agency.

Training Requirements

Anyone involved in the design, conduct, or reporting of PHS-funded research must be trained in conflicts of interest:

1. Prior to engaging in PHS-sponsored research; UMB policy requires training prior to the submission of a PHS-proposal
2. At least once every 4 years
3. If new, within 60 days of hire
4. As required due to revision of UMB or PHS policy or as directed as a result of non-compliance

UMB provides the necessary COI training via the Collaborative Institutional Training Initiative (CITI). To take the required training, log-in to the CITI website, add the course titled "Conflicts of Interest," review modules 1-3, and take the quiz at the end of each module. If you have any questions or problems accessing the CITI training, please contact the UMB Conflict of Interest Office at disclosure@umaryland.edu.

Disclosure Requirements

All personnel involved with PHS-sponsored research must disclose significant financial interests (SFI) for themselves, spouses, or close relatives annually if it is reasonably related to the investigator's institutional responsibility, or certify that no SFI exists.
Disclosures should be made:

1. at or before PHS-proposal submission
2. at least annually
3. within 30 days of a new SFI being acquired or discovered

For SOM faculty, disclosures should be made via eDisclose. For non-SOM faculty, disclosures should be made using the SFI Disclosure Form and sent to disclosure@umaryland.edu.

Determination of a Financial Conflict of Interest (FCOI)

The UMB Conflict of Interest Officer will determine whether the significant financial interest is related to the PHS-sponsored research. If it is determined that an FCOI exists, the COI Officer will determine whether the SFI could affect the design, conduct, or reporting of the research. If yes, the COI Officer will inform the investigator, Chair, and SOM Dean's Office designee. The COI Officer will then work with the investigator to develop and implement a management plan to keep the PHS-funded research free of bias.