3-9 Conflict of Interest Guidelines
About CMU's "Conflict of Interest Policy"
This policy sets standards and criteria to ensure the ethical management of conflicts of interest and potential conflicts of interest.
NOTE ABOUT PBF VERSION: The PDF is the official text of the policy. If there are any incongruities between the text of the HTML version and the text within the PDF file, the PDF will be considered accurate and overriding.
- Effective Date of this Revision: December 4, 2025
- Contact for More Information: Finance and Administrative Services or Office of Research and Graduate Studies
1. PURPOSE
The purpose of the Conflict of Interest Policy is to promote objectivity and integrity across CMU and foster high ethical standards for performance by ensuring that actual or apparent conflicts of interest are appropriately managed. This includes ensuring that transactions and activities across the university are free from bias resulting from Conflicts of Interests and/or Conflicts of Commitment.
2. APPLICABILITY
This policy is divided into three (3) categories with applicability dependent on the employee’s role within CMU:
- General: Applies to all faculty and staff of the university.
- Research and Other Sponsored Projects: Applies to faculty and staff engaged in research and sponsored activities at the university. This includes the project director/principal investigator, co-project director/co-principal investigator, and any other person at the university who is responsible for the design, conduct, or reporting of research, creative endeavors, or other educational activities funded or proposed for funding through a sponsored project or that is Human Subjects Research.
- Clinical Care: Applies to faculty and staff that provide clinical care in the College of Medicine (CMED) and The Herbert H. & Grace A. Dow College of Health Professions.
3. CONFIDENTIALITY
CMU shall maintain the maximum confidentiality allowed by law concerning the records pertaining to each Financial Disclosure Statement. Access to such records will be limited to the university personnel carrying out their duties, the faculty/staff member, the Conflict Review Committee (CRC), the Provost, and others on a “need to know” basis as determined by the CRC.
4. Table of Content
- PURPOSE
- APPLICABILITY
- CONFIDNETIALITY
- TABLE OF CONTENT
- DEFINITIONS
- GENDERAL (ALL FACULTY/STAFF)
- DISCLOSURES
- PERSONAL INTEREST REVIEW AND MANAGEMENT
- RECORD RETENTION
- GUIDELINES
- CONTRACTING WITH FACULTY AND STAFF
- CONTRACTING WITH OTHERS
- EDUCATIONAL MEETINGS AND USE OF CMU RESOURCES
- SOLICITING CLIENTS FOR AN EMPLOYEE'S PRIVATE BUSINESS
- USE OF UNIVERSITY MATERIAL AND EQUIPMENT IN A FACULTY OR STAFF MEMBERS' PRIVATE BUSINESS
- LIABILITY PROTECTION
- PERSONAL GIFTS
- ADVANCEMENT ACTIVITIES
- ROYALTIES
- BOARD OF TRUSTEES
- RESEARCH AND OTHER SPONSORED PROJECTS
- DISCLOSURE
- SFI REVIEW AND RFCOI MANAGEMENT
- RESEARCH SUBAWARDS
- PUBLICLY AVAILABLE INFORMATOIN OF RFCOI
- INVESTIGATOR TRAINING
- REPORTING
- RECORD RETENTION
- REFERENCES
- CLINICAL CARE
- EXPECTATIONS OF CLINICAL CARE PROVIDERS
- PERMISSIBLE EXTERNAL ACTIVITIES
- PROHIBITED EXTERNAL ACTIVITIES
- EXTERNAL ACTIVITES REQUIRED PRIOR TO APPROVAL
- REPORTING
- EXPECTATIONS OF CLINICAL CARE PROVIDERS
5. DEFINITIONS
| Term | Definition |
| Affiliated Hospitals | Any hospital, governmental unit, organization, or health system with an academic affiliation agreement with CMU. |
| Clinical Care Providers | CMU employees appointed as faculty and staff for the CMU College of Medicine (CMED) or College of Health Professions (CHP), both on-campus and off-campus. |
| Community Healthcare Facility | Any organization’s facility or building, in addition to an Affiliated Hospital, where CMU Clinical Care Providers see patients or engage in educational activities and are required to adhere to organizational policies, procedures, guidelines, bylaws, etc. while there. |
| Conflict of Interest (COI) | A Personal Interest in an external organization or corporation either seeking to do or doing business with the university, funding a sponsored project, or providing goods or services under a sponsored project in which the facility/staff member is participating in any capacity where the faculty/staff (and those of the faculty/staff’s Family/Household):
A COI also includes the use of an individual’s official positions and influence to further personal gain or that of their families or associates. |
| Conflict of Commitment (COC) | A Personal Interest that may interfere with a faculty/staff’s ability to fulfill their CMU expectations, obligations, and/or responsibilities; or competes with CMU’s interests, including its educational, research, or service missions, regardless of whether financial remuneration is received, including accepting more than the equivalent of one full-time appointment. This definition shall not be interpreted in a way which is inconsistent with any collective bargaining agreement or employee policy on the subject. |
| Conflict Administrator (non-research) | The conflict administrator will be the Director of Contracting and Purchasing Services, or designee, to support the implementation of this policy and assist in identifying and informing the Conflict Review Committee of potential conflicts for review and determination. |
| Conflict Administrator (research) | The conflict administrator will be the Executive Director, Research and Innovation, or designee, to support the implementation of this policy and assist in identifying and informing the Conflict Review Committee of potential conflicts for review and determination. |
| Conflict Review Committee (CRC) | The CRC is responsible for evaluating potential COI and/or Research Financial Conflict of Interest (RFCOI) and will take actions as required to appropriately manage COI and/or RFCOI. The CRC is tasked with reviewing staff, faculty, and investigator disclosures of outside activities and interests. The CRC’s role is to determine whether a relationship with an external entity creates a situation that could introduce bias or undue influence into the activities conducted at CMU, and, if found, to recommend and implement strategies to reduce, manage, or eliminate the conflict. The CRC is comprised of the Vice President for Research and Innovation, the Director of Contracting and Purchasing Services, and the Senior Vice Provost for Academic Administration and Resources, or respective designees, advised by the General Counsel. In the event that the committee determines that additional expertise is necessary, it reserves the right to invite persons with such expertise to participate in its discussion. |
| Continuing Medical Education (CME) | Medical education programs provided by organizations accredited through the Accreditation Council for Continuing Medical Education. |
| Contract | Any agreement between CMU and another party, which is enforceable by law, whether or not it is titled “Contract.” A Contract includes any agreement made on behalf of the university in which legally enforceable commitments are made by or to the university. Other terms that are sometimes used to include agreement, letter of agreement, letter of understanding, memorandum of understanding, affiliation agreement, consortium, operating agreement, grant, cooperative agreement, etc. |
| Designated Institutional Official (DIO) | The CMU official with the overall authority and responsibility for the oversight and administration of the Conflict of Interest Policy related to research. The DIO authorizes the CRC to evaluate potential Research Financial Conflict of Interest (RFCOI) and take action to appropriately manage RFCOI on behalf of the institution. The DIO is the Vice President for Research and Innovation, or designee. |
| Family/Household | This includes the faculty/staff’s immediate family (spouse, domestic partner, parents, and children), and persons living at the same residence as the faculty/staff, except their tenants or employees. |
| Financial Disclosure Statement | The disclosure of Personal Interests and Significant Financial Interests by faculty/staff to CMU. |
| Human Subject | A living individual about whom an investigator (whether professional or student) conducts research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable specimens (DHHD, Code of Federal Regulations, 45 CFR 46.102 (e)(1)). For research covered by FDA regulations (21 CFR 50 and 56), “human subject” means an individual who is or becomes a participant in a clinical investigation, either as a recipient of the test article or as a control. A subject may be in normal health or may have a medical condition or disease. In the case of a medical device, a human subject/participant also includes any individual on whose tissue specimen an investigational device is used or tested. |
| Human Subject Research | Any activity that meets the definition of “research” and involves “human subjects” as defined by either the Common Rule or FDA Regulations. |
| Management Plan | A formal plan implemented when there appears to be overlap between an individual’s outside relationships and/or interests and their professional responsibilities to CMU. |
| Institutional Conflict of Interest (ICOI) in Research | A situation in which the financial interests of the university, or an official who has authority to act on behalf of the institution, might affect, or reasonably appear to affect, research conducted by, or on behalf of the institution. Examples include, but are not limited to: an individual or entity influencing an award or contract terms, based on a past, present or future gift; a donor seeking leverage from a research compliance committee seeking exceptions to the review process for a project sponsored by a company in which CMU has financial interest; a donor seeking to influence a research, academic, or patient care process based on commercial or financial benefits. |
| Institutional Responsibilities | A faculty/staff member’s professional responsibilities on behalf of CMU. Examples include, but are not limited to: activities such as research, consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards |
| Investigator | 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 externally funded research, or proposed for such funding, which may include, for example, collaborators or consultants, or responsible for carrying out Human Subjects Research activities. |
| Personal Interest | A relationship that could impair the faculty/staff member’s ability to act impartially and in the best interest of CMU when performing in their CMU role, regardless of whether remuneration is received. |
| PHS-Awarding Component | The organizational unit of the Public Health Service (PHS) that funds research. |
| Research | For purposes of this policy, the term research is defined as conduct of research, creative endeavors, or other educational activities funded or proposed for funding through a sponsored project or that is Human Subjects Research. |
| Research Financial Conflict of Interest (RFCOI) | A Significant Financial Interest (SFI) that could directly and significantly affect the design, conduct, or reporting of research. |
| Senior/Key Personnel | The Project Director (PD) or Principal Investigator (PI) and any other person identified as senior/key personnel in CMU’s grant application, progress report, or any other report submitted to external sponsors by CMU. |
| Significant Financial Interest (SFI) | Applicable to Research. A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s Family/Household) that reasonably appears to be related to the Investigator’s University Responsibilities. For purposes of this definition, remuneration as outlined below includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value; venture or other capital financing:
|
6. GENERAL (ALL FACULTY/STAFF
A. DISCLOSURE
Faculty/staff must submit a Financial Disclosure Statement of their Personal Interests as least annually and within 30 days of acquiring a new Personal Interest that was not previously disclosed to CMU. Faculty/staff should contact Contracting and Purchasing Services or the Office of Research and Graduate Studies (if a research based disclosure) to submit a revised disclosure form.
In addition to disclosing Personal Interests on the Financial Disclosure Statement, faculty/staff members are required to disclose Conflicts of Commitment to their respective supervisor prior to the activity commencing. Faculty and staff may receive compensation from an outside entity for performing any of the professional services for which they were employed, as approved by their appropriate units.
Faculty/staff accepting more than the equivalent of one full-time appointment must also disclose this to their respective supervisor at least annually.
B. PERSONAL INTEREST REVIEW AND MANAGEMENT
CMU’s Conflict Review Committee (CRC) will review all Personal Interest disclosures elevated by the designated Conflict Administrator as potential COIs. The CRC will determine whether the Personal Interest can be managed or requires elimination. As appropriate, CRC will consult with other appropriate leaders to identify a management plan to eliminate or manage the risk. Management plans may be modified from time to time, as needed, to comply with the expectations set forth in this policy.
C. RECORD RETENTION
CMU will maintain records of all Financial Disclosure Statements and of all actions taken to resolve or manage Conflicts of Interest under this policy in accordance with CMU’s Records Management Policy and Records Retention Schedule.
D. GUIDELINES
- CONTRACTING WITH FACULTY AND STAFF
- The university may enter into Contracts with university faculty/staff and business in which they have a Personal Interest so long as there is compliance with the reporting requirements and limitations outlined below. Contracting and Purchasing Services, along with other departments who have been granted authorization, are delegated the responsibility of monitoring and approving all bidding and purchasing of equipment, goods and supplies, leases and rentals, and Contracts for professional services from university faculty/staff or business in which university faculty/staff have a Personal Interest.
- The reporting requirements and limitations set forth apply to all Contracts except those which create or supplement employment relationship agreements between the university and the faculty/staff. This regulation covers, but is not limited to, the purchase of equipment, goods and supplies, Contracts for construction, renovation and repair, leases and rentals, and Contracts for professional services.
- University offices may adopt more restrictive regulations (with the permission of the appropriate Vice President) than those outlined in this Policy in order to serve the special needs of their area.
- The university does expect employees with budgetary funding authority to use reasonable care to follow the established criteria, particularly in the use of university credit cards and non-purchase order purchases, and to see that the university makes quality purchases for the lowest prices and to avoid patterns of preferential purchasing from businesses owned or operated by university faculty/staff or other businesses in which university faculty/staff have a Personal Interest.
- When Contracting with a business in which faculty/staff have a Personal Interest, where possible, that faculty/staff member should not be the signatory for the business. If that is not possible, the Vice President of Finance and Administrative Services must also sign the Contract.
- Reporting Requirements when Contracting with faculty/staff or their Family/Household’s Business
- It must be demonstrated that the business is an ongoing pre-existing one, based on the following criteria:
- The business must have been in existence for at least one year prior to doing business with the university.
- The business cannot generate 50 percent or more of its gross annual sales from sales to the university.
- The faculty/staff must have a Financial Disclosure Statement on file with Contracting and Purchasing Services before the business is eligible to contract with the university. The Financial Disclosure Statement must be updated annually as required by this Policy.
- The faculty/staff or their Family/Household may not sell or lease products or services to the faculty/staff’s own department/unit or to departments they supervise.
- If the purchase exceeds the minimum bid limit, competitive pricing is required.
- No contracts will be made with a university faculty/staff’s, or their Family/Household’s business if that faculty/staff has been involved in negotiating that contract on behalf of the university.
- It must be demonstrated that the business is an ongoing pre-existing one, based on the following criteria:
- Exceptions
- The President or designee may approve exceptions to this Policy, which involve university faculty/staff. Faculty/staff must process their request for an exception through their appropriate Vice President. Exceptions involving the President must be approved by the Board Chair and Chair of the Finance and Facilities Committee of the Board of Trustees. Approval of all exceptions must be in writing and include a disclosure of the parties to the transaction, the subject matter of the transaction, and reasons for granting the exception. If approved, the signed exception must be forwarded to Contracting and Purchasing Services.
- The university may enter into Contracts with university faculty/staff and business in which they have a Personal Interest so long as there is compliance with the reporting requirements and limitations outlined below. Contracting and Purchasing Services, along with other departments who have been granted authorization, are delegated the responsibility of monitoring and approving all bidding and purchasing of equipment, goods and supplies, leases and rentals, and Contracts for professional services from university faculty/staff or business in which university faculty/staff have a Personal Interest.
- CONTRACTING WITH OTHERS
- Individuals other than faculty/staff may have special relationships with the university (e.g., retirees or persons supplying independent contractor services). University faculty/staff should use care to be sure that decisions to purchase or enter into other Contractual situations with these individuals are made int the best interest of the university. Faculty/staff should use care to protect the university from the appearance of impropriety, as well as actual impropriety. In addition, proper university Contracting policies must be followed.
- EDUCATIONAL MEETINGS AND USE OF CMU RESOURCES
- CMU recognizes the importance of continuing education and industry support of educational meetings. Industry is allowed to provide meeting support for CMU and other CMU educational events. Industry support may be in the form of unrestricted educational Contracts or meeting sponsorships at tiered levels of support. Industry may display and distribute materials outside of the presentation room in exhibit rooms or spaces designated for attendee networking. Industry speaker bureau presentations are held outside of their regular office hours.
- Use of CMU space for the training of industry personnel may improve the ability of industry to better meet the needs of the CMU community. However, such activities require prior review and approval by the Director of Contracting and Purchasing Services or designee.
- No CMU resources (faculty, staff, space, equipment, supplies, etc.) are to be utilized in the provision of outside services unless the employee has the written approval of the Director of Contracting and Purchasing Services or designee.
- SOLICITING CLIENTS FOR AN EMPLOYEE'S PRIVATE BUSINESS
- Some offices of the university provide services to other university offices or to outside agencies, business or people (e.g., a public-school district). If the university office cannot accommodate a request, the offices or agencies needing assistance then look elsewhere. Sometimes they end up directly paying a university faculty/staff to complete the work as supplemental assignment. Some university faculty/staff perform services or provide consulting, both as university employees and as private independent consultants. A person should not decide whether the university office can provide services to another university office or to an outside business, agency or person, if that same person also might undertake the work as a private consultant. In such situations, the request must be referred to either the Vice President for Research and Innovation or the Director of Contracting and Purchasing Services, who will make the decision.
- University faculty/staff must disclose in writing to their Vice President what services and consultations they have provided privately to persons or agencies that made their first inquiry through the university.
- Employees who operate an investment business are not permitted to sell securities or services to other university employees as part of the university’s retirement plans.
- USE OF UNIVERSITY MATERIALS AND EQUIPMENT IN A FACULTY OR STAFF MEMBERS' PRIVATE BUSINESS
- Any university faculty/staff who undertakes outside employment or consultation for a fee should not fulfill their outside business commitments on university time or with the use of university resources.
- University faculty/staff who operate a private business may not state or imply that their business is operated, endorsed or approved by the university, unless they have a written agreement with the university to do so. Faculty/staff must process their request for approval through their appropriate Vice President. Such approval must be obtained from the Office of the President. Faculty/staff must not use CMU communication systems (e.g., telephones, fax electronic mail, copy machines) to regularly conduct a private business.
- Faculty/staff may not list a university address, phone number, fax number or electronic mail address on stationery, business cards, advertisements, etc. as a contact for their private business nor may they use CMU stationery in conducting their private business.
- The university does not consent to the regular use of work site materials or to use of more costly supplies and services (e.g., computer time, long distance telephone calls, regular use of telephones for local business calls, clerical services, darkroom supplies, special supplies, photocopying, large amount of paper) by faculty/staff working on private projects, and it does not consent to removal of tools and equipment from the university premises. Some departments or units may adopt restrictions or prohibitions even on minimal uses on the basis of potential liability; skill needed to operate equipment, past problems, wear and tear, or other reasons.
- Exceptions
- The President or designee may approve exceptions to this Policy, which involve university faculty/staff. Faculty/staff must process their request for an exception through their appropriate Vice President. Exceptions involving the President must be approved by the Board Chair and Chair of Finance and Facilities Committee of the CMU Board of Trustees. Approval of all exceptions must be in writing and include a disclosure of the situation, the subject matter of the transaction, and reasons for granting the exception. If approved, the signed exception must be forwarded to Contracting and Purchasing Services.
- No statement above shall be interpreted in a way, which is inconsistent with the Intellectual Property Rights Policy.
- LIABILITY PROTECTION
- CMU does not provide liability protection (insurance) for any personal business activities, unless approved in writing by CMU Risk Management.
- PERSONAL GIFTS
- A gift or bequest is defined as anything of value except as excluded in 7.d.i. For example, a gift or bequest may be in the form of money, goods (e.g., golf balls, candy), gift certificates, entertainment (theatre, concert tickets), lodging, services, and/or price concessions (discounted rates).
- University faculty/staff shall not accept a gift or bequest from an individual or organization that has or may have a business interest with the university (i.e., is either currently engaged in business with CMU or may benefit in future business transactions or from a decision the faculty/staff member may make or influence).
- When circumstances require a gift or bequest to be accepted by a faculty/staff member, a disclosure statement must be filed with the President or their designee OR if the gift or bequest is accepted by the President or a Board Member, a disclosure statement must be filed with the CMU Board Chair and Chair of the Finance and Facilities Committee. Disclosure statements shall describe the gift or bequest, its source, and its disposition (e.g., donated to CMU; donated to a charitable organization kept by the recipient). If the recipient wants to keep the gift or bequest for themselves, the aforementioned disclosure statement must also then include a justification for doing so. The disclosure statement then must be approved before the recipient will be allowed to keep the gift or bequest.
- The university recognizes that some faculty/staff members will receive gifts or bequests from personal friends who also do business with the university. The faculty/staff member shall file a disclosure statement with the President or designee if the value of all gift(s) or bequest(s) from a personal friend exceeds $250 during a university’s fiscal year (7/1 – 6/30).
- University faculty/staff shall not accept a gift or bequest from a student or prospective student when the faculty/staff member is, or is likely to be, in a position to make or affect decisions about that student. This Guideline is intended to avoid the appearance of influence in the awarding or grades or other decisions affecting the student. The exception 7.d.i.(1) below does not apply to this specific guidelines. Faculty/staff members may accept gifts from students after their relationships as faculty/staff – student is ended, so long as the gifts were not reasonably anticipated (flowers or a book or product of an international student’s home country, given as the student is graduating and after final grades have been posted and the degree or credential conferred).
- Exceptions
- A gift or bequest for purposes of this Conflict of Interest Policy does not include:
- Items received from one specific individual or organization with an aggregate value less than $250 during the university’s fiscal year.
- Food, flowers, or other consumables or perishables which the recipient makes available to guests, visitors or the entire office.
- Items won at a conference, meeting, etc., where all attendees were given equal opportunity to win.
- Items made available to all faculty/staff or to the general public.
- Food or beverages consumed at a business function or entertainment which is included as part of a business function.
- Attendance at professional meetings and/or consumer events, at which a faculty/staff member’s expenses are underwritten in whole or in part by a business or commercial enterprise, so long as attendance is not prior to potential CMU purchase and the meeting/event is not being offered solely for CMU.
- Attendance/participation at a sponsored fundraiser which is underwritten in whole or in part by businesses or commercial enterprises.
- Staying or dining with a personal friend at their residence.
- The President or designee may approve additional exceptions to this Policy, which involve university faculty/staff. Faculty/staff must process their request for an exception through their appropriate Vice President. Exceptions involving the President must be approved by Board Chair and Chair of the Finance and Facilities Committee of the CMU Board of Trustees. Approval of all exceptions must be in writing and include a disclosure of the parties to the transaction, the subject matter of the transaction, and reasons for granting the exception. If approved, the signed exception must be forwarded to Contracting and Purchasing Services.
- A gift or bequest for purposes of this Conflict of Interest Policy does not include:
- ADVANCMENT ACTIVITIES
- Federal tax laws prohibit the university from providing charitable gift receipts for monies given to the university to benefit any specific individual. Hence, individual faculty/staff or members of their Family/Household will not receive charitable gifts receipts if they give funds to the university to benefit themselves or Family/Household directly.
- Similarly, employees with budgetary funding authority should not provide faculty/staff with monies for personal use that are proportional to the gifts that such individuals have donated to the university. If any employee approached by potential donors who suggest that their gift is contingent on explicit or implicit agreements about services to be provided them by the university, the employee should contact their Vice President before entering into any such agreement. Only the Vice President of Advancement is authorized to accept gifts to the university that may require additional donor-stipulated conditions be satisfied.
- ROYALTIES
- The Office of Research and Graduate Studies oversees the university’s intellectual property processes and management. In addition, the university’s Intellectual Property Rights Policy provides specific information regarding the distribution of royalties for intellectual property owned by the university.
- Ownership retained by creator:
- Neither the university nor any of its employees should benefit financially from the sale of materials that are developed solely for sale to CMU students (e.g., course packs);
- It is understood that royalties will accrue from materials that are developed for sale to an audience broader than just CMU students. However, university employees may not retain the royalties from the sale of these materials to CMU students if either of the following conditions are met:
- Students purchased the materials in conjunction with a course taught by the employee who will earn the royalties, or
- The employee who will earn the royalties was involved in selecting the materials that students are expected to purchase.
- Royalties accruing from the sale of materials to CMU students, as described in Section 9.b.ii will be given to the employee’s Dean’s office.
- These funds should be used directly or indirectly to encourage and support research and creative endeavors within the college.
- BOARD OF TRUSTEES
- The entirety of Section 6 also applies to the CMU Board of Trustees of Central Michigan University, except where it is clear they only apply to university faculty/staff.
- Exceptions involving individual Trustees must be approved by the Board Chair and Chair of the Finance and Facilities Committee of the CMU Board of Trustees.
7. RESEARCH AND OTHER SPONSORED PROJECTS
A. DISCLOSURES
- Investigators must submit a Financial Disclosure Statement of their Significant Financial Interest (SFI) at least annually. Investigators must have disclosed SFI to CMU no later than the time of application for research, finalization of any Contract or subcontract issued to CMU, or submission of a protocol to the IRB, whichever is earlier. Additionally, Investigators must submit an updated Financial Disclosure Statement within 30 days of acquiring a new SFI or identifying an SFI that was not previously disclosed to CMU.
- If a non-CMU investigator is participating in Human Subjects Research at the university, the Office of Research and Graduate Studies will identify whether CMU’s COI policy or the investigator’s home institution policy will apply. If CMU’s policy applies, the Office of Research Compliance will obtain a disclosure from the non-CMU investigator prior to participation in the research. If the home institution’s policy applies, when there is an executed reliance agreement, the institution will notify the Office of Research Compliance of any conflicts requiring management.
- When the university develops agreements with external partners (e.g., subawards, contractors), the partner agreement will outline the terms of fulfilling Conflict of Interest, as necessary, and how the sponsor and university requirements will be met (reference Section 7.A.C.).
B. SFI REVIEW AND RFCOI MANAGEMENT
- As authorized by the CMU’s Designated Institutional Official (DIO), the Conflict Administrator will review SFI disclosures to determine whether SFI is related to the Investigator’s research. For ongoing research projects, review and management of new or amended SFIs associated with such ongoing research projects will occur within 60 days of receipt of all necessary information and records by the DIO or designee necessary to complete the review and establish a management plan. If a full management plan cannot be finalized within the 60 day period, an interim plan will be established.
- SFI is related to the research when the DOI can reasonably determine that the SFI could be affected by the research or is in or associated with an entity whose financial interest could be affected by the research. If an SFI is related to the research, the CRC will review the SFI to determine whether it constitutes an RFCOI. An RFCOI exists when the CRC, with support from the Conflict Administrator, will develop and implement a management plan to ensure, to the extent possible, that the design, conduct, and reporting of the research will be free from bias. The CR will determine who will monitor Investigator compliance with the established management plan(s) until the completion of the project(s).
- With regard to Human Subjects Research, if this CRC determines an individual SFI presents an RFCOI, or an institutional financial interest presents an ICOI in research, a management plan will be developed to protect the rights and welfare of human research participants and ensure that the design, conduct, and reporting of research will be free from bias. The CRC will communicate the management plan to the IRB, for its consideration and review. The CMU IRB has final authority to decide whether the RFCOI and its management, if any, allows the research to be approved. If the IRB is not satisfied with the management plan, they may require additional conditions to the management plan. The Office of Research Compliance will monitor Investigator compliance with the established management plan(s) until the completion of the project(s).
- RETROSPECTIVE REVIEW OF RFCOI
- If a RFCOI is not identified or managed in a timely manner, solely as required by applicable regulations, CMU will complete a retrospective review of the Investigator’s activities to determine whether the SFI is related to research, and if so, whether RFCOI exists. If RFCOI exists, the CRC, or its designee, will implement a management plan in compliance with this Policy. If bias was introduced into the research during the time of noncompliance, the CRC will develop a mitigation report and submit to the external funding agency, as required. Retrospective review by the CRC will be completed within 120 days of determination of non-compliance. Each retrospective RFCOI will be reviewed under the basis of university policy 3-29, Research Integrity and Misconduct, to determine if any additional steps are necessary to remedy.
C. RESEARCH SUBAWARDS
Prior to issuing subawards, the Office of Sponsored Programs will ensure the agreement terms specify whether CMU’s COI policy or the subrecipient’s RFCOI policy will apply to the subrecipient’s Investigators, as required by certain external funding agencies. If the subrecipient’s RFCOI policy complies with all applicable regulations and specifies the time period(s) for the subrecipient to report RFCOI to the university. If the university’s COI policy applies, the agreement terms will specify the subrecipient will comply with CMU’s Policy, as stated in this document.
D. PUBLICLY AVAILABLE INFORMATION OF RFCOI
For any RFCOI identified, information regarding the SFI held by the Investigator will be made publicly available via a written response to any requestor within five (5) business days, as required by certain federal agencies. The information provided will include the elements specified in applicable federal regulations. This information must remain available to written requests for at least three (3) years from the date that the information was most recently updated.
E. INVESTIGATOR TRAINING
- Federally Sponsored Research: Certain federal agency regulations require that all grantees complete training to enable them to meet their responsibilities for the disclosure of Significant Financial Interests (SFI). This training must be completed by investigators once a notice of award is received or when an Investigator is new to the university-and applies for or transfers in federal funding for which these requirements apply; the training must be completed at least every four (4) years thereafter. Additionally, CMU may require that Investigators complete this training at additional time points, such as after any revision of the COI policy which changes Investigator responsibilities, or after the identification of noncompliance with this policy or an RFCOI management plan. Investigators may not participate in research prior to meeting this training requirement.
- All Other Sponsored Research: The Conflict of Interest module included in CMU’s mandatory CITI initial and refresher courses or biomedical and social and behavioral human subject research satisfies all other COI training requirements. Refresher training must be taken every four (4) years.
F. REPORTING
CMU’s Office of Research and Graduate Studies will report any identified RFCOI and associated management plan to external funding agencies, as required, prior to the expenditure of research funds, and annually thereafter. In the case of RFCOI that is identified after the initiation of the research and/or the submission of the initial RFCOI report, CMU will submit RFCOI report within 60 days of identifying the RFCOI. Reports submitted to external funding agencies will include all required elements, as specified in any applicable regulations. In addition, when required by any external funding agency, the Office of Research and Graduate Studies will inform a specific funding agency, the Office of Research and Graduate Studies will inform a specific funding agency whenever the university is unable to satisfactorily manage/resolve an actual, perceived, or potential conflict of interest.
G. RECORD RETENTION
CMU will maintain records of all Financial Disclosure Statements and of all actions taken to resolve or manage Conflicts of Interest under this policy three (3) years after the submission of the final expenditure report or the resolution of anu action involving those records, unless other requirements apply (e.g., 45 CFR 74.53 (b) or 45 CFR 94.42(b)) or in accordance with CMU’s Records Management Policy and Records Retention Schedule, whichever is in alignment with the most restrictive retention requirement.
H. REFERENCES
- 42 CFR 50.604 Subpart F - Promoting Objectivity in Research
- 45 CFR 94 - Responsible Prospective Contracts
- Department of Energy Financial Assistance Letter. FAL 2022-02 (Dec. 20, 2021)
- 2 CFR Part 200.112 - Uniform Administrative Requirement. Cost Principles and Audit Requirements for Federal Awards - Subpart B - General Provisions - Conflict of Interest
- 2 CFR 200.318 - Uniform Administrative Requirement. Cost Principles and Audit Requirements for Federal Awards - Subpart D - Post Federal Award Requirements - Procurement Standards
- NIH Grants Policy Statement: Financial Conflicts of Interest
- NSF Award and Administrative Guide - Chapter IV - Grantee Standards - Conflict of Interest Policies
- Common Rule, 45 CFR 46
8. CLINICAL CARE
The requirements for Disclosure, Personal Interest Review and Management and Record Retention described in Section 6.A through 6.C also apply to Section 8.
A. EXCEPTIONS OF CLINICAL CARE PROVIDERS
- DISCLOSURE, PERSONAL INTEREST REVIEW AND MANAGEMETN AND RECORD RETENTION
- The requirements for Disclosure, Personal Interest Review and Management and Record Retention described in Section 6.A through 6.C also apply to Section 8.
- PERMISSIBLE EXTERNAL ACTIVITIES
- Service is external activities can be beneficial to Clinical Care Providers, CMU, Affiliated Hospitals, their patients, students, and the public. These activities are generally permissible, subject to other applicable policies, provided that all of the following apply:
- Clinical Care Provider is able to fulfill their professional, clinical and employee obligations, as described in any relevant professional services or employment agreement, job description, bylaws, or other policies and procedures.
- No CMED or CHP resources (CMU staff, space, equipment, supplies etc.) are utilized in the provision of outside services unless the Clinical Care Provider has written approval as outlined in Section 6.D.4.
- The outside activities do not compete or conflict with CMU business activities or mission and do not result in the Clinical Care Provider divulging any proprietary information.
- COI policies are not meant to impede innovation related to quality improvement, value-based healthcare delivery or medical advances. Clinical Care Providers may engage in activities with these purposes and may have business relationships with external entities or from their own for-profit companies.
- Industry contracts for clinical research may only be for IRB-approved studies, must have scientific value and any restrictions on publication must be clearly defined in an agreement. Industry may provide financial support for Clinical Care Providers to attend meetings associated with the conduct of the research or presentation of the findings.
- Industry contracts or support for educational events such as attendance at a conference or seminar must be disclosed to CMED or CHP annually.
- Service is external activities can be beneficial to Clinical Care Providers, CMU, Affiliated Hospitals, their patients, students, and the public. These activities are generally permissible, subject to other applicable policies, provided that all of the following apply:
- PROHIBITED EXTERNAL ACTIVITIES
- Clinical Care Providers may not engage in purely marketing activities for pharmaceutical, device, software, biotechnology companies, etc.
- Offsite events such as meetings conducted in restaurants or other venues where food or liquor are provided by industry are prohibited.
- Clinical Care Providers are prohibited from receiving merchandise or gifts from individuals or organizations that have or may have a business interest with the university in accordance with Section 6.D.7.
- EXTERNAL ACTIVITIES REQUIRING PRIOR APPROVAL
- Clinical Care Provider interactions with industry marketing and sales representatives on CMED or CHP premises should not interfere with teaching or patient care. With prior approval from the designated Dean, industry representatives serving a technical support role are allowed to assist Clinical Care Providers and medical personnel. Industry interactions must not compete or conflict with CMED or CHP business activities or mission and may not result in Clinical Care Providers divulging any CMU proprietary information.
- CMU recognizes the importance of medical education and industry support of educational meetings in accordance with section 6.D.3. Industry is allowed to provide meeting support for Continuing Medical Education (CME) and other educational events. The agenda, speaker and content must be provided through or screened by the CMED CME Department, with CME accreditation where possible. Industry support may be in the form of educational Contracts or meeting sponsorships and tiered levels of support. Industry speaker bureau presentations are not permitted nor are the use of PowerPoint and other presentation materials prepared by industry, even if FDA approved. Industry may display and distribute materials outside of the presentation room in exhibit rooms or spaces designated for attendee networking.
- Use of CMU clinics for the training of industry personnel may improve the ability of industry to better meet the needs of the medical community. However, such activities require prior review and approval by the respective Dean or designee.
- Clinical Care Providers may not receive compensation from an outside entity for performing any of the professional services for which they are employed, or for allowing observation or shadowing at a CMED/CHP clinic or Affiliated Hospital, unless appropriate approvals have been obtained. No CMED or CHP resources (faculty, space, equipment, supplies, etc.) are to be utilized in the provision of outside services unless the Clinical Care Provider has the written approval of the respective Dean or designee.
B. REPORTING
- CRC will provide an annual summary of positive Personal Interest disclosures (those that required review) of Clinical Care Providers to the CMED or the CHP Dean, respectively. In addition, Clinical Care Providers are remined of public reporting records under the Affordable Care Act – Open Payments (Sunshine Act).
Central Michigan University reserves the right to make exceptions to modify or eliminate this policy and or its content. This document supersedes all previous policies, procedures or guidelines related to this subject.