In response to increased public scrutiny and concern about conflicts of interest at research Institutions, the Public Health Service (PHS) has redrafted its conflict of interest regulations (42 CFR Part 50 Subpart F, 45 C.F.R. Part 94). This increased public scrutiny is a result of both the increase in relationships between researchers and industry and the increased rate at which research is brought from the bench to the market place. Strengthening the existing regulation on managing financial conflicts of interest is key to assuring the public that the institutions PHS supports are taking a rigorous approach to managing the essential relationship between the government, federally funded research institutions, and the private sector. These revised regulations are effective August 24, 2012. Submissions on or after 8/24/12, or awards with an issue date of 8/24/12 or later are subject to the following:
Required prior to submission for all federal and federal flow-thru money (except Dept of Education) or other sponsors adopting the new FCOI regulations (ex. American Heart Assoc, American Lung Assoc):
Step 1: UMKC Investigator Form
Step 2: CITI Training - Conflict of Interest - Is required by all investigators
identified on the UMKC Investigator Form. Training is required prior to submission
of the proposal and every 4 years thereafter. Instructions for how to get to the Conflict of Interest mini-course can be found here.
Step 3: UMKC General Financial Disclosure Form- Now an annual process, faculty will need an account set up in Osprey by making a request of Linda Daugherty (firstname.lastname@example.org). Please send the investigator's legal first and last name, email address, College and department in which they are employed, and a copy of the CITI Conflict of Interest Training certificate. Once an account is created, the investigator will be contacted to complete the disclosure form. Annually, the investigator will be prompted when it is time to submit a renewal. If anything changes in the information submitted, the investigator should update their disclosure.
Please include the UMKC Investigator Form with your PeopleSoft pages.
Note: We will ask you to review the Investigator Form at time of award and to update it when changes occur throughout the life of the project.
Required prior to submission for non-federal, Dept of Education; or sponsors not adopting the new FCOI regulations:
Step 1: UMKC General Financial Disclosure Form (Rev. August 2012)
Agencies and Organizations using the Regulation:
Administration for Children & Families
AHRQ-Agency for Health Care Research & Quality
ATSDR-Agency for Toxic Substances & Disease Registry
CDC-Center for Disease Control and Prevention
FDA-Food & Drug Administration
HRSA-Health Resources & Services Administration
IHS-Indian Health Services
NIH-National Institutes of Health
Office of the Secretary
SAMHSA-Substance Abuse & Mental Health Services
Alliance for Lupus Research
American Heart Association
American Cancer Society
American Lung Association
American Lung Association of Michigan
JDRF-Juvenile Diabetes Research Foundation
Lupus Foundation of America
Susan G. Komen Foundation
NIH Financial Conflict of Interest Information -
2011 Revised Regulations:
The U.S. Department of Health and Human Services (HHS) has issued a final rule in the Federal Register that amends the Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94). The final rule includes a compliance implementation timeline as outlined in the "Compliance Dates" section.
- Federal Register Notice (08/25/2011) - (PDF - 369 KB) - Issuance of the Final Rule on Financial Conflict of Interest Regulations - Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding is Sought and Responsible Prospective Contractors
- NIH Guide Notice (08/23/2011) - NIH Guide Notice to announce the publication of the Final Rule on Financial Conflict of Interest Regulations - Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding is Sought and Responsible Prospective Contractors
- Summary Slide Set for the revised 2011 FCOI Regulation (09/12/2011) - (PowerPoint - 3.84 MB) - Summary slides that describe the major changes to the 1995 regulations on Financial Conflict of Interest (FCOI) - Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding is Sought.
- Summary of Major Changes (08/23/2011) - (MS Word - 43 KB) - Table summarizing major changes between the 1995 regulation and the 2011 regulation.
- General inquires about the FCOI regulation for grants and cooperative agreements may be directed to: FCOICompliance@mail.nih.gov.
- General inquires about the FCOI regulation for contracts should be directed to email@example.com.