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Financial Conflicts of Interest


Addgene is dedicated to maintaining public trust in the integrity of our research-related activities, especially those publicly-funded activities. This webpage contains information about Addgene’s Financial Conflicts of Interest (FCOI) Policy and Training.

Certain federal agencies have specific requirements for disclosure and management of personal financial interests related to their sponsored research projects. The focus of these requirements is to ensure responsible stewardship of federal funds and to promote research free from bias resulting from Investigator financial conflicts of interest. Agencies with such requirements include the Public Health Service (PHS) and related components such as the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA) as well as the National Science Foundation (NSF).

This policy is not only crucial for compliance with federal regulations, but it is consistent with Addgene’s position on open science and is vital in safeguarding research objectivity.

Process

Addgene’s FCOI Policy can be downloaded here:

All Addgene employees are expected to read, understand and abide by the guidelines and procedures set forth in Addgene’s FCOI Policy. This policy is especially relevant for employees applying for and funded by federal grants, including Addgene staff defined as “Investigator” or “Senior / Key Personnel” and members of the FCOI Team.

Please note that the Disclosure Procedures listed below are meant to offer a high-level overview of the process and that the full policy should be referenced for more information.

Disclosure Procedures

Step One: Complete a Financial Conflict of Interest Disclosure
All Investigators and Senior / Key Personnel, including both Addgene and any applicable subrecipients must disclose all significant financial interests (SFI), including those of their spouse and dependent children, that could reasonably be related to their Addgene Responsibilities and their work on the respective federally funded research by completing the applicable SFI Disclosure Form and submitting it to Addgene’s FCOI Team.
Step Two: FCOI Committee Review
Addgene has designated its FCOI Team to assume the review responsibility for its Investigators. Designated Officials will review recurring and transactional / ad hoc disclosures submitted by applicable Addgene employees and subrecipient Investigators. Prior to expenditure of funds, the review and management of any FCOI must be completed. Addgene’s FCOI Team will report any identified FCOI to the PHS, NSF or other applicable agency.
Step Three: Management Plans
If a SFI is determined to constitute an actual or apparent FCOI, Addgene’s FCOI Team, in conjunction with the affected Addgene technical and/or financial teams, will develop a Management Plan that contemplates the conditions and/or restrictions to eliminate, reduce, or manage the FCOI. The Designated Official(s) signs the Management Plan, and appoints an individual to monitor the project until completion of the funded research. A copy of the approved Management Plan will be held by Addgene’s FCOI Team who will report all instances of FCOI to PHS, NSF, or other sponsor.

Training

Each Investigator and Senior / Key Personnel must complete training regarding Addgene’s policy on financial conflicts of interest, the Investigator’s and Senior / Key Personnel’s responsibilities regarding disclosure of significant financial interests, and of these specific federal sponsor requirements.

Training must be completed prior to engaging in research related to any federally-funded grant. Unless an immediate need for a new FCOI Training arises, all Investigators and Senior / Key Personnel must complete this training at least every four (4) years thereafter as well as under the following circumstances (in the timeframes noted in parentheses):

  • When Addgene’s FCOI policy changes such that investigator requirements are affected (within 60 days).
  • When an investigator is new to Addgene (prior to engaging in PHS-funded research).
  • When Addgene finds that an investigator is not in compliance with the Policy or a management plan, as applicable.

Forms and Policies

Up-to-date PDFs of all relevant documents and forms:

  1. FCOI Training Acknowledgement (PDF, 65 KB)
  2. Disclosure of Significant Financial Interest (PDF, 94 KB)
  3. Review of SFI Disclosures (PDF, 98 KB)
  4. Management Plan (PDF, 60 KB)
  5. Employee FCOI Noncompliance (PDF, 66 KB)
  6. Retrospective Review & Mitigation Report (PDF, 83 KB)
  7. Subrecipient Disclosure of Significant Financial Interest (PDF, 81 KB)
  8. Subrecipient FCOI Policy Certification (PDF, 93 KB)
  9. Public Financial Conflict of Interest (FCOI) Report (PDF, 67 KB)
  10. Review of FCOI Public Request Forms (PDF, 67 KB)

Contact/Request Information

Addgene is committed to overseeing the conduct of its programs in a manner that ensures the integrity of its staff and sponsors.

Pursuant to the PHS regulation on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F), members of the public may request information about FCOIs associated with Investigators and Senior/Key Personnel on PHS-supported projects at Addgene.

To request information, please contact [email protected].