Investigator’s Name: ________________________
Department: ________________________
Date of Disclosure: ________________________
Information pertaining to the individual above has been disclosed or identified that warrants a COI Management Plan (MP). The following is a guide and provides key information to be addresses in the MP.
1.
a.
For Clarkson employees with an equity interest in the Entity provide: i.
Information on the relationship between the Clarkson employee and the Entity: ii.
Describe the Entity and the relationship of the employee to the
Entity. iii.
Describe the potential or actual conflict iv.
Is this a start-up Entity?
1.
Who founded the Entity?
2.
What is the intellectual property on which the Entity is based? a.
Who owns the IP? v.
Discuss the expected time commitments to the Entity. vi.
Describe any potential relationship of students, graduate students, or postdoctoral students to the Entity. vii.
Discuss the potential use of Clarkson University equipment and/or facilities by the Entity. b.
For books or course materials, describe the type of materials: i.
Textbook, lab manual, workbook, etc.
ii.
Is the material a required purchase for Clarkson students?
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iii.
Who owns copyrights? iv.
How will the purchase prices be determined? v.
What is the royalty or compensation rate?
2.
a.
Describe how the PI shall ensure that all researchers in their respective groups are notified of the: i.
relationship with the Entity, ii.
existence of this management plan, iii.
names of contacts for the researcher personnel to notify with any concerns. b.
Include explanations of the: i.
investigator’s relationship with the Entity, ii.
rights of students and staff to bring concerns about the effect of the Investigator’s relationship with the Entity on their work, studies, or progress towards degree to the Department Chair,
Dean, Provost, designee, or the COI Committee. iii.
a summary of the information for each researcher iv.
documentation that this process has occurred (to be provided to the COI Committee within 45 days of receipt of this management plan) v.
a process for distribution of the MP to individuals who subsequently join the group vi.
frequency of updates to the COI Committee, typically annually c.
Discuss how the PI will ensure that students adhere to Federal employment regulations.
NOTE: The PI’s relationship with the Entity shall not impose restrictions on the scholarly and research activity of any Researcher, including but not limited to publishing of data for research and scholarly activity. Further PI’s shall not participate in any activity of or receive any sponsorship from the
Entity without approval from the COI Management Committee. Sponsorship of research activity shall not inhibit students from meeting degree requirements. Sponsorship may require a modification of this COI MP to appropriately manage student activity.
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3.
a.
State that an appropriate update to the COI MP shall be in place before the university accepts any research support for projects where financial or management conflict is identified. b.
State that all of the PI’s research activity with the Entity must be conducted under the standard university research agreements. c.
State that the Entity shall not direct the use of university resources.
Examples include: i.
university-owned equipment in the Investigator's laboratory ii.
activities of graduate students and other personnel paid on grants from the Entity to the University. d.
Discuss how the PI shall direct any research personnel with significant financial interests in the Entity to disclose outside activities in accordance with the COI Policy. e.
Discuss how the PI will not be directly involved with decisions involving financial transactions with the Entity using funding under their control.
These contractual arrangements shall be delegated to an impartial party, who is not under the PI’s supervision or control, i.e. Department Chair or
Dean, or someone designated by the Chair or Dean. f.
Describe how any intellectual property developed by the Investigator, any Researcher, or any employee of the Entity will be disclosed to the
University’s Office of Technology Transfer. Ownership of such intellectual property shall be determined in accordance with Clarkson
University’s IP Policy and in accordance with agreements between the
Entity and University. g.
State how communication with government regulators such as the NIH,
FDA, EPA, USDA or CDC will be handled.
a.
Discuss when and how the PI will notify the COI Management Committee of any and all changes in his/her relationship with the Entity (e.g., the name of the Entity changes or the Investigator becomes a Board
Member). b.
If an oversight committee will be used to manage conflict, specify its: i.
Membership ii.
Functions iii.
Frequency of reporting iv.
Report content v.
Frequency of meetings vi.
Report delegation (to whom do reports go) vii.
Scope of authority (e.g., decide, recommend)
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viii.
Method for receipt of complete, accurate and timely information c.
Discuss how all University work commitments will be met and acknowledge that the Investigator must discuss and receive permission for plans to use regular working hours to work for Entity. Evenings and weekends do not need permission.
5.
a.
Publications may be delayed for the purpose of pre-publication review and intellectual property protection, however, the relationship with the
Entity shall not restrict publications or presentations. b.
The Investigator and all Researchers must disclose the relationship with the Entity in publications and academic presentations where disclosure is possible and appropriate. Examples disclosures can be found here .
6.
a.
State how the use of university facilities or services by the Entity will be in compliance with all relevant university policies. Arrangements for use of university facilities or services must be made through written agreement.
This includes use of computers, laboratory equipment, and supplies that reside in the PI’s University laboratory.
a.
Term of the plan (generally, plans are valid for one year from filing or from the filing date until June 30 whichever is shorter, and must be updated annually thereafter). b.
Conditions under which the plan may be amended
8.
a.
Please use this section to address other concerns or unusual circumstances that need oversight.
Prepared By: _______________________________ Date: _______________
Reviewed By: ________________________________ Date: _______________
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March 18, 2015