The Public Health Service (PHS) Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought (42 CRF 50, Subpart F) regulation governs the identification and management of conflics of interest in research for investigators who receive or apply for funding from agencies of the PHS.

 

Who is Considered an Investigator?

PHS defines an investigator as any individual, regardless of title or position, who is responsible for the design, conduct, or reporting of research that is funded by PHS or proposed for such funding.

OSU's Research COI Program considers the following categories of individuals as "investigators" (also known as "covered persons"):

  1. Professorial faculty
  2. Research Associates
  3. Postdoctoral Fellows and Scholars
  4. Any individual listed by name on a PHS proposal, grant, or subaward/contract
  5. Any individual responsible for the design, conduct, reporting, or oversight of OSU research activities

Consultants listed on sponsored projects and defined by the Office of Sponsored Research and Awards Administration (OSRAA) are generally not considered responsible for the design, conduct, or reporting of research, but do undertake specific tasks.  The work of consultants on an OSU sponsored project is reviewed by the OSU investigator(s) who are designated as responsible for the design, conduct, and reporting of those research activities.

PHS Agencies:

  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. Substance Abuse and Mental Health Services Administration (SAMHSA)

Other PHS Components:

  1. Office of the Assistant Secretary for Health (ASH)
  2. Office of the Assistant Secretary for Preparedness and Response (APRS)
  3. Office of Global Affairs (OGA)

Non-PHS Agencies following the PHS Regulation (this list could be out of date - please check with your agency of interest):

  1. Administration for Children and Families (ACF)
  2. Alliance for Lupus Research (ALR)
  3. American Cancer Society (ACS)
  4. American Heart Association (AHA)
  5. American Lung Association (ALA)
  6. Arthritis Foundation (AF)
  7. Juvenile Diabetes Research Foundation (JDRF)
  8. Susan G. Komen for the Cure

 

What are the RCOI Requirements for PHS Investigators?

Disclose Significant Financial Interests

PHS requires the disclosure of significant financial interests held by PHS-funded investigators prior to submitting a PHS funding proposal and thereafter for the lifetime of the award on an annual basis or within 30 days of discovering or acquiring a new significant financial interest.

Significant financial interests include remuneration from and equity in publicly traded and non-publicly traded entities, as well as intellectual property (IP) rights and reimbursed or sponsored travel.

OSU facilitates the disclosure of significant financial interests of remuneration, equity interests, and intellectual property via the iRIS online system.  All OSU investigators are required to complete this form, regardless of funding source.  

OSU definition of significant financial interest: /coi/faq-what-significant-financial-interest-sfi

PHS definition of significant financial interest: http://grants.nih.gov/grants/policy/coi/coi_faqs.htm#3181

Disclose Travel Reimbursements and Sponsorship

PHS requires the disclosure of reimbursed or sponsored travel for PHS-funded investigators within 30 days of the occurence of the travel.  The travel must be related to the investigator's institutional responsibilities and be funded by an entity other than: a U.S.-based Federal, state or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an insttution of higher education.

Important Note: If the travel is sponsored or reimbursed by an entity that receives money from a U.S.-based government agency, institution of higher education, or any other excluded entities listed above, you must still disclose the travel when those funds come directly from a non-exemtped entity (e.g., you travel to a workshop funded by a federal funding agency, but your travel is funded by a professional society).

Complete COI Training on Regulations and Institutional Policy

PHS requires that investigators be informed of OSU's policy on financial conflicts of interest associated with research, their disclosure requirements, and PHS regulations governing conflicts of interest.  PHS also requires that COI training be completed by the investigator: at least every four years; when OSU's policy is revised; when an investigator is new to OSU; and if an investigator is found to be non-compliant with OSU policy, or their RCOI management document when one exists.

 

How Do I Meet the PHS Requirements?

Requirement How to Meet It
Disclose Financial Interests Complete and otherwise keep your COI disclosure form current at https://oregonstate.imedris.net (login using ONID credentials).
Update at least annually or it will expire The online system will notify you by email 15 days before your disclosure expires. Your will need to update and otherwise ensure your disclosure information is complete in iRIS.  Your annual expiration date will reset every time you update and submit your form.
Update within 30 days of new interest To update your information prior to your expiration date, login and create a new draft.
Disclose funded travel from non-exempt entities Update and otherwise ensure your travel disclosure reimbursement or sponsorship information is completed in iRIS. 
Complete COI Training (first time) Go to https://www.citiprogram.org and register as a new user. When you complete the required COI training modules, a notice of completion will be sent to the RCOI Program office.  See COI Training for more detailed instructions.
Re-take Training Instructions coming soon (only required four years after completing the training for the first time)