CITI Training

Responsible Conduct of Research

Conducting and reporting research ethically is fundamental to academic research. Researcher behavior must inspire trust with the public and within the scientific community and among colleagues. UW-Green Bay strives to foster the highest scholarly and ethical standards among its students, faculty and staff. The University has policies for reporting and dealing with research misconduct and ways for you to learn more about research ethics.

Federal Requirements

The National Science Foundation (NSF) and the National Institutes of Health (NIH) require that all undergraduate students, graduate students, and post-doctoral researchers who receive financial support for research through NSF or NIH receive training and oversight in the responsible conduct of research (RCR).

UW-Green Bay RCR Guidelines

All key personnel employed at UWGB who are submitting proposals through the Office of Grants & Research (OGR), federal or otherwise, must complete the CITI RCR training on an interval of no less than once every four years. All faculty, staff and students supported by NSF or NIH funding must complete the CITI RCR training module before beginning NSF or NIH-funded research.

Conflict of Interest

Faculty and staff are encouraged to participate in outside activities and share expertise to the private sector. Sometimes, your participation in outside activities may generate conflicts between the needs of the institution and the outside entity. UW-Green Bay understands that these conflicts are common, unavoidable and can often be appropriately managed. To appropriately manage any potential conflicts of interest (COI) when the outside activities or collaborations are funded with extramural funds, Universities of Wisconsin, the federal government and UW-Green Bay have policies and procedures that project key personnel must follow.

Requirements

1. Outside Activities: Policies of the University of Wisconsin Board of Regents, federal government and UW-Green Bay require disclosure of all outside activities related to your institutional responsibilities. All faculty, regardless of appointment, all academic staff with 50% or greater appointment and all individuals listed as participants on human subject protocols or on federal grants are required to fill out an annual Outside Activities and Interests Form (doc) and update whenever new outside activities are undertaken.
2. Training: In practice, all project key personnel employed at UW-Green Bay who are submitting proposals through the OGR, federal or otherwise, need to complete the Collaborative Institutional Training Initiative (CITI) COI training on an interval of no less frequently than once every four years. Key personnel are defined as those individuals essential to the project who would be named in the agency Notice of Grant Award.

UW-Green Bay understands that in business transactions where sec. 946.13 Wis. Stats. may apply, elements of the agreement must be reviewed. UW-Green Bay further understands there may be occasions where a necessary employee may be required to enter into a management plan issued by the OGR and confirmed by University Administration. In matters where the combination of: the outside organization, the work being performed by the employee with that organization, and research or deliverable creates a potential conflict of interest, it should be reported to the Office of Grants and Research for further review.

Financial Interest Review

After you submit an Outside Activities and Interest Form, an evaluation will be done at that time to identify any business for which you have a “significant” financial interest. It is your responsibility to identify any financial interest you may have in a research project.

Financial interests and research projects become associated when a University employee has a personal financial interest (personal compensation, royalties, ownership, fiduciary duty, etc.) in an organization or company that also seeks to sponsor research at the University. If a significant financial interest is determined to exist, we will determine if it intersects directly with a research project. When these two circumstances converge, then a financial conflict of interest in research is created. 42 CFR 50.603

• For publicly traded entities:
  The value of remuneration received from an entity in the twelve months preceding disclosure, in combination with the value of any equity interest in the company as of the date of disclosure, equals $5,000 or more;
• For non-publicly traded entities:
  • The value of any remuneration received from the entity in the twelve months preceding disclosure equals $5,000 or more;
  • Any equity interest in the company;
• Any income from intellectual property rights that are not assigned to UW-Green Bay;
• Service in positions with fiduciary responsibility.
  This includes executive positions, senior management positions or membership on boards of directors; and
• For those that receive federal funding, reimbursed or sponsored travel.

If There Is Significant Financial Interest

When a possible conflict is identified, you should report the possible conflict to us. We are responsible for reviewing disclosure reports and determining all instances of significant financial interest. If a conflict is confirmed, we will provide additional processes to determine whether the conflict will prevent the agreement from being completed.

If an activity meets the definition of a SFI, we will next make a recommendation that the matter requires or does not require a management plan. If a management plan is required, a staff member will review the reported activity to:

• Determine whether there is a nexus between an investigator's research and the significant financial interest. A significant financial interest is a financial conflict of interest if the interest could directly and significantly affect the design, conduct, or reporting of research;
• Determine whether a financial conflict of interest (FCOI) exists; and
• Discuss possible management plans to mitigate any conflict of interest under applicable policy.

You are responsible for all the management plan's terms and conditions and must cooperate with the University's efforts to monitor compliance with the management plan. Funding that is related to a management plan will not be available for spending until the employee has electronically accepted the management plan.

Retrospective Review

If an employee does not report a significant financial interest in a timely manner or if a conflict is discovered after the work has begun, a retrospective assessment of financial interests will still need to occur to determine if there is a conflict of interest. The retrospective review must determine whether any work conducted during the period of noncompliance was biased in its design, conduct, or reporting.

If the retrospective review determines possible conflict or bias, the OGR will notify the sponsor of its findings, along with a mitigation report that includes: (1) the key elements documented in the retrospective review; (2) a description of the impact of the bias on the research project; and (3) UW–Green Bay’s plan of action for eliminating and mitigating the effects of the bias.