Conflict of Interest Requirements
PROCEDURES FOR COMPLYING WITH CSUDH CONFLICTOF INTEREST (COI) AND RESPONSIBLE CONDUCT OF RESEARCH (RCR) TRAINING REQUIREMENTS FOR FUNDED GRANTS AND PROJECTS
Disclosure Required before Submission
CSUDH policy PM 01-09 (http://www.csudh.edu/pms/ ) requires each investigator submitting a grant to disclose significant financial interests (including those of the investigator’s spouse and dependent children) that would reasonably appear to be affected by the activities funded or proposed for external funding. The approved CSUDH policy includes a Conflict of Interest (COI) Form that all investigators must complete and sign as part of the grant proposal clearance process. The Office of Research and Funded Projects (ORFP) provides the required COI form and verifies the signature prior to submitting a grant for funding. A signed copy of this disclosure remains in the ORFP with pre- proposal materials. If a potential conflict of interest is disclosed, follow-up procedures noted in policy PM 01-09 will be followed.
Training Required of all PIs when Funded
For grants and projects that are funded, all principal investigators (PIs) must complete and document specific COI educational requirements before expending any awarded funds. When a new award account is set-up at the CSUDH Foundation, the PI’s name and contact information is forwarded to the ORFP. The ORFP will initiate a process to that provides each PI with a website address for on-line training in COI. The ORFP will maintain a database documenting referral for training, reminders sent (if necessary), and completion of training. PIs will automatically receive reminders to be trained every two years once entered into the training system.
Additional Training and Annual Disclosure Form Required for Public Health Service (PHS) Projects.
Effective August 25, 2012, all investigators funded by NIH (or any other Public Health Service (PHS) Division) must undergo additional COI training prior to engaging in the funded research activity. Details regarding these regulations are at: http://grants.nih.gov/grants/policy/coi/ . For these regulations, an “Investigator” means the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of the funded research, which may include, for example, collaborators or consultants. Therefore, more than one person associated with the grant may need to complete the training. The Foundation grant administrator will consult with the PI to determine which funded grant personnel should be trained. Contact information for newly funded NIH investigators will be sent to the ORFP by the Foundation when a new award account is initiated. The ORFP will provide a web site training referral to: http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm and will maintain a database documenting referral for training, reminders sent (if necessary), and completion of training. As the regulations require, the ORFP will require renewal of training each four years for investigators who remain funded beyond the initial four-year period. Following training, a PHS-funded research disclosure form must be completed and submitted to the grants administrator at the CSUDH Foundation. The form will be reviewed by the Director of Grants and Contracts who will contact the AVP for Research if a possible conflict of interest exists. Follow-up procedures noted in policy PM 01-09 will be used if necessary.
Additional Student/Post-Doc Training Required for NSF-Funded Projects
Effective January 4, 2010, the National Science Foundation (NSF) requires appropriate training in the responsible conduct of research (RCR) to undergraduates, graduate students, and postdoctoral researchers participating in a research project supported by NSF. Faculty Principle Investigators (PIs) are not required to take this training, but may wish to do so.
If an NSF proposal is funded, the CSUDH Foundation grant administrator assigned to the project will notify the ORFP of the award. After reviewing the statement of work and budget for the funded project, the ORFP will communicate with the Principal Investigator about student participation as necessary. If students or postdoctoral trainees are supported by NSF to “participate in research”, the PI will be notified to require the student to complete and RCR training at https://nationalethicscenter.org/index.php?option=com_rcrtutorial. Throughout the duration of the NSF-funded grant, the Foundation grant administrator will notify the ORFP when new students are hired. The ORFP will contact the PI with directions for the training requirements. At present, required training does not need to be completed by the PI.
The ORFP will maintain a database of students and post-doctoral fellows who need to meet the federal RCR requirements and those who have fulfilled the requirement. If the RCR trainee does not successfully fulfill the federal requirement by completing the on-line Responsible Conduct of Research course, the Associate Vice President for Research will implement procedures for removing the participant from the federally funded grant project until such time as the RCR course is successfully completed.