Training - Financial Conflict of Interest on Sponsored Projects

The Public Health Service (PHS) has promulgated a Financial Conflict of Interest (FCOI) Regulation in the Federal Register which takes effect no later than August 24, 2012. The UMMS Policy for Promoting Objectivity in Biomedical Research is the means by which the University of Massachusetts Medical School will comply with the FCOI Regulation, making it applicable to all sponsored-research funding sources at UMMS.

One requirement of the newly implemented regulation is that all investigators must complete FCOI training before engaging in research. An investigator is defined as the principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of the research. UMMS Principal Investigators will determine who meets this definition on their projects. UMMS provides training in Financial Conflict of Interest for medical-school investigators via the Collaborative Institutional Training Initiative (CITI).

 

Click here for a printable version of CITI training documentation for UMMS personnel who have not previously registered for a CITI certification training module.
Click here for a printable version of CITI training documentation for UMMS personnel who have previously created a CITI account.

 

The UMass Medical School Plan to Provide FCOI Training

Each individual meeting the regulation's definition of investigator must complete FCOI training prior to engaging in a research project and again every four years thereafter.

UMMS offers a specific FCOI training class that will satisfy the regulatory requirement. FCOI training is offered through the CITI Online training module and can be accessed at http://www.citiprogram.org/.

Investigators should take the mandatory training as soon as possible. Once taken the training is valid for four years. After four years, investigators will be required to take the training again.

New CITI users (those who have never taken the CITI research training modules in Human Subjects or Responsible Conduct in Research) should click on the "Register" button under the "Create an Account" section to initiate the registration process (Figure 1). Existing users, log in to CITI and choose from the list of available course the Conflict of Interest Mini Course. 

Figure 1

Training 1

The following registration screen will appear. Begin typing "University of Massachusetts Worcester" into the "Search for organization: Enter full or partial name" search field (circled in Figure 2) and click "Continue to Step 2".

Figure 2

Training 2

Fill in the remaining information shown in Figure 3. Please use your umassmed e-mail address as your user name and the "preferred" e-mail address when registering (you can provide an non-umassmed e-mail address as your secondary e-mail). Once completed, click "Continue to Step 3"

Figure 3

Training 3

Enter the required information "Continue to Step 4".

Figure 4

Figure 4

Enter the required information and click "Continue to Step 5".

Figure 5

Figure 5

Enter the required information and click "Continue to Step 6".

Figure 6

Training 6

Enter the required information and click "Continue to Step 7".

Figure 7

Training 7

The Main Menu will appear with your course selection - Scroll to Question 3 and choose the "Yes" radio button to take the Conflict of Interest mini course and click the "Complete Registration" button. 

Figure 8

Training 7

Verification of FCOI Training

Research Funding Services is responsible for verifying that investigators on sponsored projects have received FCOI training. RFS will not set up projects in PeopleSoft until investigator training has been confirmed.

It is the PI's Responsibility to Ensure that Each Project's Investigators are Trained.

PIs have the responsibility to ensure that all individuals meeting the regulation's definition of an investigator have taken the mandatory FCOI training prior to engaging in the project's research.

Questions

If you have any questions, please contact Janice Lagacé, Interim Director, Office of Sponsored Programs at 508-856-8980 or via e-mail at janice.lagace@umassmed.edu.