Project ideas and programs evolve and develop from within the Foundation and as a result of input received from outside partners. All projects are subject to a rigorous review process to ensure they both align with and support the mission of the RUF as well as the mission of the FDA. All of RUF’s work must be approved by the RUF Board of Directors and the FDA Commissioner, who serves as an ex-officio member of the RUF Board. Additionally, some large and complex projects may also be subject to an outside review. When necessary, subject matter experts will be brought together for this outside review.
Review of Reagan-Udall Foundation Projects
Goal: Strictly guard against conflicts of interest and undue influence while raising funds for worthwhile Foundation projects.
Prior to initiation, all specific projects must be reviewed and approved:
(1) By the Reagan-Udall Board of Directors.
Before granting its final approval to a project, the Board shall submit the project to independent review. In selecting reviewers, the Board shall insure that:
• Reviewers are qualified experts on the relevant topics.
• Each reviewer has certified that he or she meets the conflict of interest standard in Article VII.
In the unusual case where a waiver of this requirement is necessary because there is no other practical means of ensuring the necessary expertise, the name of the reviewer and the justification for the waiver will be made public and the Board must determine that the financial interest is not so substantial as to be likely to affect the integrity of the review.
Before granting its final approval to a project, the Board shall also determine that:
• Independent review was sufficient to ensure the objectivity, scientific validity, and feasibility of the proposal.
• The project is likely to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, or cosmetic product development, accelerate innovation, or enhance product safety.
(2) By a meaningful independent review.
• For projects with a total budget over $250,000 (“large projects”), the Board may (i) use an existing independent review process (for example, if one of the project collaborators is an academic institution or foundation with an appropriate independent review mechanism); or (ii) utilize an ad hoc, independent panel to review the project.
• For small projects with a total budget of $250,000 or less (“small projects”), the Board may use an abbreviated independent review process.
• A majority of reviewers must determine that the project design is objective, scientifically valid, and feasible, and that the project is likely to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, or cosmetic product development, accelerate innovation, or enhance product safety.