COI Requirements for PHS Investigators
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 a PHS Investigator?
PHS defines an investigator as any individual, 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.
At OSU, we include the following categories of individuals as investigators:
- Professorial faculty
- Research Associates
- Postdoctoral Fellows and Scholars
- Any individual listed by name on a PHS proposal, grant or subaward/contract
Consultants as listed on sponsored projects and defined by the Office of Sponsored Programs are not considered responsible for the design, conduct or reporting of research, but instead undertake specific tasks that are reviewed by OSU investigators who are designated as responsible for design, conduct and reporting of research.
- 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)
Other PHS Components:
- Office of the Assistant Secretary for Health (ASH)
- Office of the Assistant Secretary for Preparedness and Response (APRS)
- Office of Global Affairs (OGA)
Non-PHS Agencies following the PHS Regulation:
- Administration for Children and Families (ACF)
- Alliance for Lupus Research (ALR)
- American Cancer Society (ACS)
- American Heart Association (AHA)
- American Lung Association (ALA)
- Arthritis Foundation (AF)
- Juvenile Diabetes Research Foundation (JDRF)
- Susan G. Komen for the Cure
What are the COI 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 rights and reimbursed or sponsored travel.
OSU facilitates the disclosure of significant financial interests of remuneration, equity interests and intellectual property through the online disclosure form. All OSU investigators are required to complete this form, regardless of funding source. The disclosure of reimbursed or sponsored travel only applies to PHS investigators and is disclosed separately.
OSU definition of significant financial interest: http://oregonstate.edu/research/coi/faq-sfi-definition
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 reimbursed or sponsored by an entity other than a 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 government agency or institution of higher education (or any of the excluded entities listed above), you must still disclose the travel if the funds came directly from the non-governmental or higher education entity (e.g., a workshop funded by a federal funding agency but organized by a professional society).
Complete COI Training on Regulations and Institutional Policy
PHS requires that PHS investigators be informed of OSU's policy on conflicts of interest, their disclosure requirements, and the PHS regulations governing conflicts of interest. PHS also requires that this training be conducted 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 COI management.
How Do I Meet the PHS Requirements?
|Requirement||How to Meet It|
|Disclose Financial Interests||Complete online disclosure form at https://secure.oregonstate.edu/research/coi/ (login using ONID credentials).|
|Update annually||The online system will notify you by email 30 days before your form expires.||Your previous disclosures will be copied and you will be asked to fill-in new interests and update previous disclosures.||Your annual expiration date will reset every time you update your form.|
|Update within 30 days of new interest||To update midway through your annual cycle, login and create a new draft.|
|Disclose Travel Reimbsurement or Sponsorship||Complete the Travel Disclosure webform. Or send an email to COI@oregonstate.edu detailing the purpose of the trip, the identity of the sponsor/organizer, the destination and the duration. Include in the subject line "PHS Travel Disclosure."|
|Complete COI Training (first time)||Go to https://www.citiprogram.org/ and register as a new user. Complete the three required training modules and a notice will be sent to the COI office of your completion. 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)|