Home Page | Search FDA Site |
FDA A-Z Index | Contact FDA
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:
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.
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.
NOTE: Other FDA Centers and ORA review CRADAs for any potential organizational conflict of interest problems which may need resolving.
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:
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.
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.