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VCOM Carolinas Campus

Guidance and Resources

Financial Conflicts of Interest in Research

Based upon the federal regulations, VCOM “investigators” involved in extramural research are required to take online education modules on financial conflict of interest.

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

The definition of “investigator” includes the Principal Investigator (PI) and any other person (regardless of title or position) whom the PI identifies as independently responsible for the design, conduct or reporting of the research.

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. 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.  Principal Investigators must submit these forms for all appropriate research team members upon submitting the application to the ORA.  The form and instructions can be found on the ORA Forms web page.

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.

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.

 

Federal Application Resources

 

NIH Investigator-Initiated Grants

Parent announcements are available for most research mechanisms including R01, R03, R21, R15 and R/U13. Please visit the NIH Parent Announcement Website for the most up to date FOA numbers.

 

Additional Resources