Andson Biotech (“the Company”) is committed to ensuring that the design, conduct, and reporting of research funded by the Public Health Service (PHS), including the National Institutes of Health (NIH), is free from bias caused by Financial Conflicts of Interest (FCOI). This policy establishes the standards required to identify, manage, reduce, or eliminate FCOIs in accordance with:
This policy applies to all Investigators (as defined below) who are involved in PHS/NIH-funded research activities, including proposals, grants, contracts, and cooperative agreements, regardless of whether such funding flows directly to the Company or through a subcontract.
| Investigator | The Principal Investigator and any other person who is responsible for the design, conduct, or reporting of PHS-funded research, including collaborators, consultants, and co-investigators. |
| Financial Conflict of Interest (FCOI) | A Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research. |
| Significant Financial Interest (SFI) | A financial interest (of the Investigator and/or their spouse/domestic partner and dependent children) that reasonably appears related to the Investigator’s institutional responsibilities, including: (i) remuneration of >$5,000/year from a publicly traded entity; (ii) equity in a publicly traded entity worth >$5,000; (iii) any equity in a non-publicly traded entity; (iv) reimbursed or sponsored travel >$5,000; or (v) intellectual property rights with actual income >$5,000. |
| Institutional Responsibilities | All professional responsibilities performed by an Investigator on behalf of Andson Biotech, including research, teaching, service, and administrative duties. |
| PHS | Public Health Service, including the National Institutes of Health (NIH), CDC, FDA, HRSA, SAMHSA, and related agencies. |
| FCOI Report | The report Andson Biotech submits to the NIH identifying an FCOI held by a senior/key personnel Investigator prior to award. |
| Retrospective Review | A review conducted when an FCOI was not timely identified or managed, to determine if PHS-funded research was biased. |
| Management Plan | A written plan implemented to manage, reduce, or eliminate an identified FCOI. |
Disclosure of Significant Financial Interests
All Investigators must disclose their Significant Financial Interests (SFIs) to the Research Compliance Officer (RCO). Disclosures are required:
Investigators must disclose SFIs for themselves, their spouses or domestic partners, and dependent children that are reasonably related to their institutional responsibilities at Andson Biotech.
b. Exclusions from Disclosure
The following financial interests are excluded from the SFI disclosure requirement and do not require reporting:
c. Training Requirement
Every Investigator must complete NIH-compliant FCOI training:
Training records will be maintained by the RCO for at least three (3) years beyond the termination of the relevant award. NIH’s free online training module is available at: https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html
a. Review Process
Upon receipt of an Investigator’s disclosure, the Research Compliance Office will review each SFI to determine whether it:
The RCO may consult with the General Counsel or an external independent reviewer for complex cases. Reviews will be completed within 60 days of receiving a disclosure.
c. Determination Outcomes
The RCO will make one of the following determinations for each disclosed SFI:
a. Management Plan
Where an FCOI is identified, the RCO will work with the Investigator to develop and implement an FCOI Management Plan prior to the expenditure of PHS funds. Management conditions may include, but are not limited to:
Management Plans will be reviewed and updated at least annually and upon any change in the Investigator’s SFIs or the nature of the research. Investigators must comply with all terms of the Management Plan as a condition of participation in PHS-funded research.
a. FCOI Reports
Andson Biotech will submit an FCOI Report to the relevant NIH Awarding Component:
FCOI Reports will be submitted through the NIH’s eRA Commons system and will include: the Investigator’s name, the name of the entity, the nature and value of the financial interest (if publicly available), and a description of how the FCOI is being managed.
When Andson Biotech issues a subaward for PHS-funded research, the subrecipient’s investigators are subject to FCOI requirements. The subaward agreement will require the subrecipient to:
If a subrecipient does not have a compliant FCOI policy, it must follow Andson Biotech’s FCOI policy. The RCO is responsible for ensuring adequate FCOI oversight of all subrecipients.
Andson Biotech will maintain all records relating to Investigator SFI disclosures, FCOI determinations, Management Plans, and related actions for the following periods:
All records will be made available to NIH or its authorized representatives upon request.
Investigators who fail to comply with this policy may be subject to:
Non-compliance that results in bias in PHS-funded research will trigger a Retrospective Review and may require a Mitigation Report to NIH as described in Section 5b.
a. Research Compliance Officer
The Research Compliance Officer (RCO) is responsible for the day-to-day administration of this policy, including maintaining disclosure systems, conducting FCOI reviews, developing Management Plans, and submitting required reports to NIH.
Contact: Research Compliance Officer | info@andsonbiotech.com | 1-470-945-0199
b. Policy Review
This policy will be reviewed at least annually and updated as necessary to reflect changes in federal regulations, NIH guidance, or Company practices. Updates will be communicated to all Investigators and key personnel within 30 days of adoption.
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