SUNY PP - Policies & Procedures

  

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Name Related Docs Doc# Type Category Code (Key)
Policy on Conflicts of Interest in Public Health Service Sponsored Programs
Appendices

Appendix A

FCOI Reports to PHS will consist of:  

  1. Grant number;
  2. PD/PI or contact PD/PI;
  3. Name of Investigator with the FCOI;
  4. Name of the entity with which the Investigator has an FCOI;
  5. Nature of FCOI (e.g., equity, consulting fees, travel reimbursement, honoraria);
  6. Value of the financial interest $0-4,999; $5K-9,999; $10K-19,999; amounts between $20K-100K by increments of $20K; amounts above $100K by increments of $50K or a statement that a value cannot be readily determined;
  7. A description how the Significant Financial Interest relates to PHS-funded research and the basis for the DIO’s determination that the Significant Financial Interest is a FCOI; and
  8. Key elements of the related management plan, including:
    1. Role and principal duties of the conflicted Investigator in the research project;
    2. Conditions of the management plan;
    3. How the management plan is designed to safeguard objectivity in the research project;
    4. Confirmation of the Investigator’s agreement to the management plan;
    5. How the management plan will be monitored to ensure Investigator compliance; and
    6. Other information as needed.

Appendix B

The following information regarding an SFI will be made publicly available prior to expenditure of any PHS Award funds if it is determined that an Investigator still holds the SFI and that the SFI is a FCOI and is related to the PHS Award. 

  1. Investigator’s name;
  2. Investigator’s title and role with respect to the research project;
  3. Name of the entity in which the SFI is held;
  4. Nature of the SFI; and
  5. Approximate dollar value of the SFI (dollar ranges will be provided, e.g., $0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through references to public prices or other reasonable measures of fair market value.

Appendix C

The following must be documented in the retrospective review:

  1. Project number;
  2. Project title;
  3. PD/PI or contact PD/PI if a multiple PD/PI model is used;
  4. Name of the Investigator with the FCOI;
  5. Name of the entity with which the Investigator has an FCOI;
  6. Reason(s) for the retrospective review;
  7. Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed);
  8. Findings and conclusions of the review.
  9. If results of the retrospective review warrant, update previously submitted FCOI report

Appendix D

The following will be documented in mitigation report:

  1.  Key elements documented in retrospective review;
  2. Description of the impact of the bias on the research project;
  3. Plan of action(s) to eliminate or mitigate the effect of the bias; and
  4. Extent of harm done including supporting data, if any.

PHS Significant Financial Interest Disclosure Form

Details 10000 Policy RS


Category Codes Key
GO = Governance
AA = Academic Affairs
CC = Community Colleges
ST = Student Affairs
HC = Hospitals / Clinical Services
FM = Facility Management / Safety
HR = HR / Labor Relations
LE = Legal and Compliance
FI = Financial
IA = Internal Audit
PH = Philanthropy
AP = Affiliated Programs
RE = Related Entities
RS = Research
PO = Police
AT = Athletics
AD = Audit
PM = Protection of Minors
IS = Information Security

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