果冻影院

View instructions for FCOI-R Training in eBridge (PDF)

 

Financial Conflicts of Interest in Research Policy

Introduction
The United States Department of Health and Human Services (DHHS) made significant revisions effective August 24, 2012 to two of its regulations regarding Financial Conflicts of Interest:

These regulations affect 果冻影院 when applying for or receiving PHS/National Institutes of Health (NIH) funding from a grant, cooperative agreement or contract.  These revisions were drafted to provide further assurance to the public that PHS funded research is conducted without bias and with the highest scientific and ethical standards.

Helpful and updated Frequently Asked Questions on the NIH Website can be found here:

果冻影院 Corporate Policy RS.GN.020
果冻影院’s research collaboration with pharmaceutical firms, medical device companies and other entities is important to make certain that patients benefit from the translation of biomedical research into the clinical practice.  The rules require that 果冻影院 identify and where appropriate manage potential financial conflicts of interest that may arise from these collaborations to safeguard the protection of human research subjects as well as the integrity of 果冻影院’s research effort.

果冻影院 updated and posted its Corporate Policy on Financial Conflicts of Interest in Research on August 24, 2012 in order to meet all of the requirements of the regulations.  

•  (intranet access required)

In August, 2021, the 果冻影院 Financial Conflicts of Interest in Research corporate policy was revised to include investigators engaged in research sponsored by a Covered Award, which includes awards funded by a PHS entity, by any federal funding agency, by one of the select nonprofit sponsors that have adopted the federal FCOI-R regulations, and by an industry sponsor (Covered Award is defined in 果冻影院 Corporate Policy RS.GN.020).  In addition, the definition of a reportable financial interest was revised. Review a summary of these changes in the FCOI-R Policy Changes Summary (PDF).  

果冻影院 Significant Financial Interest (SFI) Disclosure Process

• 果冻影院 Corporate Policy RS.GN.020 requires an investigator or key personnel (Covered Person as defined in the policy) to disclose to 果冻影院 any Significant Financial Interests (SFIs) that could reasonably appear to be related to that persons professional responsibilities at the 果冻影院 (Significant Financial Interests are defined in the policy).  These SFI(s) must be disclosed by the Covered Person to 果冻影院 at the following intervals:

• Each time a person is an investigator on a new proposal for a Covered Award OR is named as a ‘key person’ on such an award,
• At least annually during the 果冻影院’s Annual Conflicts of Interest and Outside Professional Activities process,
• Within 30 days of a Covered Person discovering or acquiring any new SFI.

Significant Financial Interest Upload Instructions with Screenshots (PDF)
Significant Financial Interest Upload Instructions Condensed (PDF)
Description of SFI Form (XLSX)

果冻影院 Required FCOI-R Training
Another significant change to the revised regulation requires all 果冻影院 Covered Persons to receive training on the rule and 果冻影院 policy.  Federal regulations (mirrored in the 果冻影院 Policy) require training for investigators/key personnel (果冻影院 Covered Persons) at the following intervals:

• Prior to engaging in any research study funded by a Covered Award,
• Every four years thereafter,
• Any time that 果冻影院 revises its policy,
• If a Covered Person is new to 果冻影院, or
• If a Covered Person is found to be in non-compliance with 果冻影院’s policy
  
  

果冻影院 Financial Conflict of Interest in Research Contact Information
If you have questions about the FCOI-R Training or 果冻影院 Policy please feel free to contact the Research Compliance Office:

Alicia Martin, Manager of Research and Academic Compliance, amartin@mcw.edu
Ellen Manning, Compliance Coordinator, elmanning@mcw.edu
Lisa Henk, Compliance Coordinator, lhenk@mcw.edu