Financial Conflict of Interest in Research – Training and Disclosures
As explained in Policy 435: Financial Conflict of Interest in Research, the VSC takes the following steps to mitigate real or perceived financial conflicts of interest associated with externally-funded research:
TRAINING: All PIs and co-PIs on research projects must complete online conflict of interest training through the Collaborative Institutional Training Initiative (CITI). Conflict of interest training must be completed every four years.
Click here for instructions on how to create a CITI account and register for training.
DISCLOSURES: On an annual basis, all PIs and co-PIs on research projects must complete Form D: Conflict of Interest Disclosure, and, if applicable, Form E: Significant Financial Interests Disclosure.
A disclosure is also required if a new investigator is added to the project, an investigator acquires a new significant financial interest, or if an investigator has a previously existing, undisclosed significant financial interest.
IRB
To protect human subjects from physical, psychological, or social injury resulting from research, each VSC institution maintains a process for reviewing and approving research requests that involve human subjects. Anyone planning to conduct research on human subjects must receive institutional approval before proceeding. For those VSC institutions with an Institutional Review Board (IRB), their processes will comply with 45 CFR 46 – Protection of Human Subjects and 21 CFR 56 – Institutional Review Boards.
Responsible and Ethical Conduct of Research – Plans and Procedures
National Science Foundation
As required by the National Science Foundation, all students who conduct NSF-supported research must receive training in the responsible conduct of research (RCR).
RCR Training Plan:
- The PI will notify all undergraduate students paid from an NSF award that they must complete the RCR Basic Training Course offered through the Collaborative Institutional Training Initiative (CITI).
- The PI will provide the VSC Office of Sponsored Projects with a list of students paid from NSF awards. The Office of Sponsored Projects will notify the PI when each student has completed the RCR Basic Training Course. The Office of Sponsored Projects will also follow up with students who have not completed the course in a timely manner.
- Students should complete the training before beginning work on the project.
Resources:
CITI Registration and Instructions
NSF RCR Requirement
NSF RCR Frequently Asked Questions
National Institutes of Health
NIH requires that all trainees, fellows, participants, and scholars receiving support through any NIH training, career development award (individual or institutional), research education grant, and dissertation research grant must receive training in RCR.
RCR Training Plan:
PIs are required to include an RCR Training Plan in their proposals. The plan should incorporate substantial face-to-face discussions among the participants. Online courses from the Collaborative Institutional Training Initiative (CITI) can be a supplement to the RCR training, but NIH doesn’t consider online courses adequate as the sole means of instruction.
NIH recommendations for subject matter include the following:
- Conflict of interest
- Policies regarding human subjects, live vertebrate animal subjects, and safe laboratory practices
- Mentor/mentee responsibilities and relationships
- Collaborative research
- Peer review
- Data acquisition and laboratory tools; management, sharing, and ownership
- Research misconduct and policies for handling misconduct
- Responsible authorship and publication
- The scientist as a responsible member of society
- Contemporary ethical issues in biomedical research
- Societal impacts of scientific research
The PI will oversee the required RCR training and will maintain records documenting that all NIH-funded trainees, participants, and scholars received training.
Resources:
CITI Registration and Instructions
NIH RCR Requirement
NIH Research Training Website
National Institute for Food and Agriculture
The USDA National Institute of Food and Agriculture requires that anyone participating in a NIFA-funded research project receive training on research ethics, with particular emphasis on authorship and plagiarism, data and research integration, and reporting misconduct. NIFA also requires that the institution document and maintain records of the training.
RCR Training Plan:
- The PI will notify all NIFA-funded faculty, staff, and students that they must complete the RCR Basic Training Course offered through the Collaborative Institutional Training Initiative (CITI).
- The PI will provide the VSC Office of Sponsored Projects with a list of these names. The Office of Sponsored Projects will notify the PI when each person has completed the RCR Basic Training Course. The Office of Sponsored Projects will also follow up with those who have not completed the course in a timely manner.
- The training should be completed before beginning work on the project.
Resources:
CITI Registration and Instructions
NIFA RCR Requirement