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) should click on the "Register Here" link to initiate the registration process (Figure 1). Existing users, please jump to Figure 4.

Figure 1

Training 1

The following registration screen will appear. Select "University of Massachusetts Worcester" from the "Participating Institutions" drop-down box (circled in Figure 2).

Figure 2

Training 2

Follow the remaining information to complete your registration. 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 you have successfully created your account and logged in, the following screen will appear. Please fill in the requested information and click "Submit". You will then see the screen shown in Figure 3; please fill in the information required, as indicated by red asterisks.

Figure 3

Training 3

New users, please click "Submit" and jump to Figure 6.

Existing users, please follow the steps in Figures 4 and 5 below:

Figure 4

Figure 4

Existing users, after logging in select the "Add a Course" link, as shown in Figure 5 below. When done, jump to Figure 8:

Figure 5

Figure 5

New users: after clicking "Submit", the "Select Curriculum" page will appear. To choose the COI training module, select "Yes" in answer to Question 3 and click the "Submit" button.

Figure 6

Training 4

Following this page, CITI will ask whether you want to register with another institution. Select "No".

Figure 7

Training 5

The Main Menu will appear with your course selection:

Figure 8

Training 6

To enter the course, click on the "Enter" link under "Status."

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 Key Personnel 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 Diego Vazquez, Assistant Vice Provost, Research Funding Services at 508-856-5600 or via e-mail at diego.vazquez@umassmed.edu.