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Conflict of Interest and Fair Access Statement
Guidance

The following describes the responsibilities of the Principal Investigator, the Center Director, the Agency's Ethics Official, and the FDA CRADA Review Board regarding situations which may raise conflict of interest and fair access questions. It also explains the purpose of the "CRADA Conflict of Interest and Fair Access Statement" which becomes part of the CRADA. This Statement has been developed to:

1. identify any real or apparent conflict of interest at the beginning of the CRADA review process and,
2. provide information regarding how the proposed CRADA partner was selected.

This information will be used by the Center Management, the Agency's Ethics Official, and the CRADA Review Board during the Agency's review process to address and resolve any issues that are raised.

1. An FDA employee who may become the Principal Investigator in a collaboration must:
   1. complete the entire Statement and include it as part of the proposed CRADA for review by the Center Director, the Ethics and Personnel Security Branch and the CRADA Review Board.
   2. items I and II of the Statement are self-explanatory
   3. under Item III, address his/her regulatory review responsibilities regarding the proposed collaborator's products and those of any known competitors' products.
   4. assure that this information accompanies the CRADA submitted to the Center Director for review, approval, and transmission to the Ethics and Personnel Security Branch and the CRADA Review Board

Note: The proposed CRADA goes to his/her Center Director for forwarding to other FDA reviewing officials. The Conflict of Interest and Fair Access Statement goes only to the Ethics and Personnel Security Branch and the Executive Secretary of the CRADA Review Board.

2. The Center Director proposing the CRADA may discuss his/her recommended action(s) to resolve any apparent conflicts of interest that the Principal Investigator has raised and then:
   1. transmit it to other FDA organizations for their review; and
   2. transmit the CRADA along with other organizational comments, through the Executive Secretary, to the CRADA Review Board for their review and determination.

NOTE: Other FDA Centers and ORA review CRADAs for any potential organizational conflict of interest problems which may need resolving.

3. The Agency's Ethics Official, as part of the CRADA review process, will:
   1. review the CRADA and the "Conflict of Interest and Fair Access Statement" and
   2. determine whether any real or apparent conflict(s) of interest or other appearances of impropriety have been sufficiently addressed by:
      1. the Principal Investigator and
      2. the Center Director's planned management of the project.

Based on this review and any other pertinent information, the Agency's Ethics Official comments on the CRADA proposal and the FDA scientist's proposed participation. Their memorandum will become part of the CRADA file and will be reviewed by the CRADA Review Board.

Specifically, the Ethics and Personnel Security Branch will address whether the proposed CRADA:

1. is acceptable in terms of individual conflict of interest (Item II of the Statement), and the scientist
2. does not otherwise have a conflict of interest that would preclude
3. his or her participation in the collaboration (Items III and IV of the Statement).

All CRADAs in their entirety are reviewed by the FDA CRADA Review Board and the Commissioner before they are executed. To the extent possible, steps should be taken to resolve any conflict of interest matters (individual, appearance, or organizational) posed by the CRADA prior to its presentation to the CRADA Review Board.

Additional Guidance for FDA Employees

For further guidance on ethical matters regarding collaborations which are accomplished under CRADAs, FDA employee-collaborators may contact the Ethics and Personnel Security Branch in FDA's Office of Human Resources and Management Services.

For questions regarding other CRADA-related matters, FDA employee-inventors/collaborators should contact their Center FTTA Liaison or Technology Transfer staff listed on this Web site.

FDA Technology Transfer

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