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Guidance and Resources

Financial Conflicts of Interest in Research

Based upon the revised federal regulations, VCOM personnel who conduct extramural research are required to take online education modules on financial conflict of interest.

Issued by the Department of Health and Human Services, the revised regulation applies to those research projects funded by the Public Health Service.  However, VCOM is applying this standard to all research regardless of funding source.

» An overview of the new regulations as well as VCOM’s Financial Conflict of Interest in Research Policy

The updates to the regulation are designed to promote objectivity in research by establishing standards on a reasonable expectation that the design, conduct and reporting of research will be free from bias resulting from investigator financial conflicts of interest.

VCOM investigators are required to take an on-line module through CITI prior to beginning any research project. Certification that the module has been passed must be presented either at the time the grant application is submitted to the Office of Research Administration or, if the project is not extramurally funded, at the time the IRB application is submitted to the IRB Coordinator.

The CITI modules consist of the following courses:

  • Overview, Investigator Responsibilities and COI Rules
  • Institutional Responsibilities as They Affect Investigators
  • VCOM-Specific Policies

The VCOM-Specific Policies module addresses the process used at VCOM to comply with this regulation.  This process includes the use of the Financial Conflict of Interest in Research Disclosure form, which must be completed as part of the grant application process.  Investigators must submit these forms for all appropriate research team members upon submitting the application to the ORA or the IRB application to the IRB Coordinator if applicable.  The form and instructions can be found on the ORA Forms web page.

Note that the revised regulations define “Investigator” as any person on the research team who has any responsibility in the design, conduct or reporting of the project, regardless of title or position. Thus, those who must comply include the principal investigator, co-investigators, lab technicians, collaborators or consultants. This includes the College full and part-time faculty, post-doctoral fellows, students, trainees and staff as well as all contracted faculty and staff.

To register for the Conflict of Interest course, please log in to CITI (https://www.citiprogram.org/) and choose “Add a Course or Update Learner Groups” under your VCOM Learner Tools. The VCOM Conflict of Interest Course can be chosen under Question 7. You may also contact the IRB Coordinator for assistance in signing up for this course.

Links to additional information:

Responsible Conduct of Research

Responsible Conduct of Research (RCR) includes those professional activities that make up a research career, which are coming under increased regulatory scrutiny.  As defined by federal agencies, RCR encompasses the following nine areas:

  • research misconduct
  • human participants
  • research involving animals
  • mentor/trainee responsibilities
  • data acquisition, management, sharing and ownership
  • publication practices and responsible authorship
  • peer review
  • collaborative science
  • conflict of interest

RCR is the practice of scientific investigation with integrity; it involves awareness and application of established professional norms and ethical principles in the performance of all activities related to scientific research.

RCR training is required for any students (graduate, undergraduate and postdoctoral) supported by National Science Foundation grants and programs.  The National Institutes of Health also requires training for students, trainees, fellows and others who receive support through NIH training awards, career development awards and research education grants.  If you are involved in a project receiving funds from NSF or NIH that meets the requirements, the Office of Research Administration will contact you to go over your responsibilities. For more information on what specific NIH mechanisms require RCR training, and how to meet the requirements, please contact the Office of Research Administration.

VCOM has contracted with the Collaborative Institutional Training Initiative (CITI) to provide an online RCR training program that covers the core principles of Responsible Conduct of Research. The NIH also requires additional face-to-face training such as classroom instruction, one-on-one sessions with a mentor, case studies and other training programs as deemed appropriate by the principal investigator or associate dean.

To take the training, go to the CITI webpage and log in.  If you do not have an account, click the register button and enter Edward Via College of Osteopathic Medicine, and then continue to enter all required information. Once you have registered, please click on “Add a course or update learner groups.”  Question 6 covers the RCR courses; please pick the course that most closely matches your area of research: Biomedical or Social and Behavioral.  You must complete all modules within a course and receive a passing grade of 80% overall.  Note that you do not have to complete the entire course in one sitting.

If you are required to complete the RCR training per NSF or NIH guidelines, you must have your training completed prior to the start of the NSF or NIH project.  Any individual who does not complete the RCR course prior to that time, will be removed from the award and will not be reinstated until the training is complete.  Any trainee on an NIH award who does not complete the RCR course will not be able to start their project until the training is complete.