What is the Process in Creating a Management Plan?
What is the Process in Creating a Management Plan?
1. Background Information
- A conflict of interest arises when an academic staff member is in a position to influence either directly or indirectly University business, research, or other decisions in ways that could lead to gain for the academic staff member, the staff member’s family, or others to the detriment of the University’s integrity and its missions of teaching, research, and public service. (University Policy)
- A conflict of commitment exists when the external activities of an academic staff member are so substantial or demanding of the staff member’s time and attention as to interfere with the individual’s responsibilities to the unit to which the individual is assigned, to students, or to the University. (University Policy)
- A conflict of interest or commitment is in the situation, not one’s behavior. All situations involving a conflict must be managed to help prevent a perception that one’s behavior might be suspect. Management always begins with disclosure and sometimes involves formal Conflict Management Plans.
- UIC encourages active participation by academic staff members in outside activities that enhance the professional skills of staff members, or constitute a public service activity. (University Policy)
- Conflicts of commitment and interest occur because of the type and scope of activities engaged in by the University and its academic staff members. The mere existence of a conflict, real or potential, will not necessarily exclude a particular activity since conflicts can span a wide spectrum, from those that are minor and inconsequential to those that have serious consequences and cannot be permitted. The University and its academic staff members have ethical and legal obligations to conduct themselves and their University activities in accordance with the highest standards of integrity. (University Policy)
- University guidelines are generally to allow (with prior approval), the equivalent of up to one day per week for full-time faculty, or about 52 days per calendar year appointment, and 40 days per academic year appointment. The amount approved will vary among individuals, from discipline to discipline, from one type of proposed activity to another. Because conflicts are based in a situation, the regulations and policy are not concerned with the precise timing of the activities. The University contract period includes evenings, weekends and holidays during the term of employment.
- Family, according to University Policy, is one’s spouse or domestic partner, parents, siblings, and children.
- A Significant Financial Interest (SFI) (42 CFR 50.603) is identified when:
- The value of any remuneration received from an external entity at present or in the 12 months preceding the disclosure that when aggregated for the individual and family totals or exceeds $5,000. The $5,000 threshold also applies to salary, royalties, and other payments aggregated for the individual and family.
- Publicly-traded equity if the value of the equity (plus any remuneration) meets or exceeds $5,000.
- Any level of ownership of privately-held equity regardless of the dollar value.
2. Types of Management Plans
Please go to the START myDisclosures for the following forms:
- Report of Non-University Activities (RNUA)
All paid academic staff, as defined by the University Policy on Conflicts of Commitment and Interest, must complete the RNUA form at least annually and update the form during the year if the academic staff member experiences changes in the disclosed activities.
- Significant Financial Interest-Disclosure
The purpose is to document the disclosure and management of Investigator significant financial interests (SFIs) related to the Investigator’s University responsibilities.
- Significant Financial Interest Management Plan
When the SFI disclosed is deemed by University Designated Officials to be reasonably related to the sponsored research and present a potential Financial Conflict of Interest (FCOI), then the Investigator will complete a management plan to document the management and monitoring of the SFI.
- Report of Non-University Activities (RNUA)
3. Tips for Developing a Department Monitoring Plan
The Unit Executive Officer (UEO) is obligated to administer the University’s Policy on Conflict of Commitment and Interest. The guidance provided below may require considering additional circumstances that may present conflicts of commitment or interest. While the guidance below may provide good oversight practices to apply as a departmental management plan, if the UEO deems additional measures beyond those suggested below are needed, then the UEO should apply those additional measures and document the management mechanisms in the department’s management plan. The department should also follow-up as needed with the academic staff member and document any follow-up a department oversight report.
- Status of the intellectual property. When will the company license the IP? The conflicted academic staff member will require the full RNUA-Management Plan before the license will be executed. It typically takes 2-3 months to complete the full RNUA-MP. We encourage the academic staff member to work with the COI Office and allow for enough time to get the management plan through the review process.The management plan is completed through the Report of Non-University Activities (RNUA) process, available on START myDisclosures.
- Status of company research/activities. What research is the company doing? Is the company applying for grants? Will the company contract with the University? Will the company apply for SBIR/STTR grants?
- Guidelines for conflicts that arise from SBIR & STTR applications.
- Status of University academic research. Is the company’s product being used, tested, evaluated, or otherwise in any University research? If so, has it been disclosed? Is there a protocol specific management plan (SFI-DMP) in place? Are they following the management mechanisms described in the SFI-DMP?
- Company use of University resources. There should be no use of University resources. Should the company need to use University resources it must go through the official contracting processes with the University (e.g., research contract = Office of Research Services; contract for use of facilities and services = Office of Business Development Services).
- Are there any other University faculty, staff, students involved in the company’s activities?
- Academic staff require approval to engage in outside activities; any other academic staff involved in the company activities should seek approval by updating his/her RNUA form.
- If there is any interaction with faculty, staff, students, the conflicted academic staff member should inform involved faculty, staff, or students of the potential conflict and provide them with information about who should be contacted in the department should there be a concern. Template letters are available for:
- Time commitment. The academic staff member should discuss his/her time commitment for the outside activity and address any issues or concerns with the Unit Executive Officer. The University guideline is 1 day per 7 day week of outside activities; however, a guideline is not a guarantee or an entitlement; it also does not imply that the conflicted academic staff member give up his/her University time commitment obligations to engage in outside activities.
- Fiduciary Responsibility. Define responsibilities for each entity. Provide a plan to mitigate any conflicting interests or oversight responsibilities (e.g., recusal in institutional decision-making, changing reporting lines for faculty, staff, or students that are overseen by the conflicted academic staff member).
4. Tips for Developing a Management Plan (RNUA-MP)
- Work with your Unit Executive Officer(s) to draft a management plan.
- Contact the Conflict of Interest Office to advise on which disclosure is should be completed and to address any questions about completing the management plan.
- If more than one university employee is in a conflict situation, each will need his or her own management plan.
- The Conflict of Interest (COI) Office will provide feedback to guide revisions. Works in progress should be exchanged with the COI Office via email. Continued work with the COI Office ensures the plan is sufficiently developed to be brought before a campus committee review process or administrative review process. Continued work with the Unit Executive Officer(s) facilitates the administrative review and approval process.
5. Proposal Develpment
The COI office will work with the conflicted investigator(s). Once the SFI-DMP receives administrative approval from the COI office, the COI office will confirm to the Office of Sponsored Programs (OSP) that the conflict has been managed.
For HHS/PHS/NIH sponsored research: To comply with the 2011 Public Health Services (PHS) Regulations, Department of Health and Human Services (HHS) 42 CFR Part 50 and 45 CFR Part 94, on Financial Conflicts of Interest (FCOI), SFI-Disclosure must be completed annually at the time of submission or prior to continuing review on an existing award by all Investigators, which includes any individual responsible for the design, conduct, or reporting of the research, and Senior/Key Research Personnel, which includes any person identified by the University on a grant application, progress report, or other report submitted by the University to the HHS, PHS, or NIH funding agency.
HHS/PHS/NIH Investigators and Senior/Key Research Personnel must complete mandatory training on financial conflict of interest.
For HHS/PHS/NIH grants and cooperative agreement, all FCOI reports, including revised FCOI reports and mitigation reports will be submitted through the Office of Vice Chancellor for Research, Conflict of Interest Office.
The University’s FCOI Report will include, at minimum:
- Project number;
- PD/PI or Contact PD/PI if a multiple PD/PI model is used;
- Name of the Investigator with the FCOI;
- Name of the entity with which the Investigator has an FCOI;
- Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium);
- Value of the financial interests (per specified ranges in the regulation) or a statement that the dollar value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.
- A description of how the financial interest relates to the NIH-funded research and basis for the University’s determination that the financial interest conflicts with such research;
- A description of the key elements of the University’s management plan, including:
- Role and principle duties of the conflicted Investigator in the research project;
- Conditions of the management plan;
- How the management plan is designed to safeguard objectivity in the research project;
- Confirmation of the Investigator’s agreement to the management plan;
- How the management plan will be monitored to ensure Investigator compliance; and
- Other information as needed.
For other sponsored research: Investigators will self-identify if any investigator has a significant financial interest (SFI) reasonably related to the study at the time of submission of a Proposal and the IRB Protocol Application form. When an investigator or PI identifies that an Investigator on the study has a significant financial interest reasonably related to the study, the COI Office will be informed of the disclosure and will request that the Investigator complete the SFI-Disclosure. In most cases, the Investigator will also complete the SFI-Management Plan.
6. Institutional Review Board (IRB) Applications
A COI committee on Human Subjects Research will evaluate whether the FCOIs are sufficiently disclosed and managed and make a recommendation to the IRB. The IRB has final authority for approving research protocols, which includes evaluating whether the conflict management techniques are sufficient to protect the rights and welfare of the subjects.
With rare exceptions, all FCOIs must be disclosed in the informed consent documents.
- Model language for disclosing financial conflict of interest to potential research participants.