Conflict of Interest and Sponsored Research

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retrieved on Dec 23 2008 - 12:36pm

SPOTLIGHT:

Synopsis:

In addition to the required annual disclosures, PIs and PDs are asked to declare whether or not a conflict of interest exists for each project proposed, either on their part or that of others named in the proposal.

The Duke individuals listed below are required to submit a COI form online if they fulfill any of the following criteria at any point during the disclosure period:

All individuals with faculty status
All postdoctoral scholars/affiliates
Any individuals participating in the design, conduct, and reporting of the research
All exempt employees who receive(d) any salary support from the following WBS Element codes: 30x-xxxx, 31x-xxxx, 32x-xxxx, 33x-xxxx, 34x-xxxx, 353-xxxx, 383-xxxx, and 393-xxxx

Graduate and Undergraduate Students are exempt from this requirement unless indicated as key personnel on a sponsored program.

PreAward Procedure:

PROCEDURES: ROLES AND RESPONSIBILITIES
DEPT	:: Assures the PI/PD updates his/her COI form online, if it is not current :: Requests that all co-PIs/co-PDs and senior personnel listed in the personnel roster submit or update COI forms online if they have not done so :: All individuals who are required to submit an annual COI Disclosure form sign off on the final page of the DPAF indicating whether a real or potential COI exists for the work being proposed
ORS	:: AD/P reviews DPAF(s) and roster and verifies submission of COI form by PI prior to signoff :: If a potential COI exists and/or if all required DPAF forms are not submitted with the proposal, AD/P contacts AD/C for review and follow up :: AD/C secures the remaining DPAF signatures and reviews any real or potential COI to determine if it must be addressed prior to award

SPECIAL NOTES
The following link will take you to a website which lists the status of compliance requirements for each of the individuals included in a proposal: COI Compliance Tracker (Duke NetID required) [2]

PostAward Procedure:

PROCEDURES: ROLES AND RESPONSIBILITIES FOR NEW AWARD
DEPT	:: In accordance with the New Award Notification Memo [3] PI/PD checks to assure that s/he has a current COI form filed and approved :: Checks to see that all co-PIs or co-PDs and senior personnel on the roster also have current COI forms filed and approved :: As TBD positions are filled, sends names to AD/C and requests that new hires fill out COI forms if they meet the requirements above
ORS	:: AS reviews roster and verifies approved COI forms exist for all personnel listed :: If TBD positions are listed in the award, file is transferred to the AD/C for follow-up :: Within 120 days of award AD/C asks DEPT who has been hired and checks that they have filed COI forms if required :: AD/C monitors COI forms to ensure approval and resolution if a conflict is disclosed :: If a COI must be managed, reduced, or eliminated, AD/C works with the conflicted individual, PI, and the Campus COI Committee to address the conflict :: If required (e.g., for NIH), AD/C notifies sponsor whether a COI has been managed, reduced, or eliminated

PROCEDURES: ROLES AND RESPONSIBILITIES FOR NON-COMPETING RENEWAL OF AN AWARD
ORS	:: AS processes award and submits the file to the AD/C for on-going monitoring :: AD/C checks with SAP R/3 for personnel changes and additions and verifies COI status :: AD/C contacts individuals who are required to submit a COI form and have not done so :: AD/C monitors forms to ensure approval and resolution if a conflict is disclosed :: If required (e.g., for NIH), AD/C notifies sponsor whether a new COI has been managed, reduced, or eliminated

DOCUMENTATION: OFFICES OF RECORD
ORS	:: COI monitoring database with notes

SPECIAL NOTES
The following link will take you to a website which lists the status of compliance requirements for each of the individuals included in a proposal: COI Compliance Tracker (Duke NetID required) [2] [2]

:
[1] http://ors.zaloni.net/spotlight/contacts-collaborations
[2] https://adgapps.duhs.duke.edu/compliance/login/login
[3] http://ors.zaloni.net/sites/default/files/vo-nan.pdf