Full disclosure policy

NEPA is a declaration of the nation s environmental policy and goals. It supplements FDA s authority under the FFDCA and other public health statutes but it does not supersede these statutes. It does not require substantive FDA decisions to favor environmental protection over other considerations mandated by other statutes the FDA administers. NEPA is a full disclosure statute that requires public involvement and it is a broad statute that considers all aspects of the human environment. In addition, NEPA applies abroad and requires Federal agencies to identify those actions that may have trans-boundary environmental effects. The FDA considers allowing an FCN to become effective... 

The board of directors endorsed a policy of full disclosure to families as part of the overall patient safety agenda. The policy states, Children s Hospitals and... 

There are additional requirements imposed in these policies, which are beyond the scope of this chapter. Additional elements include requirements such as voluntary disclosure or full cooperation with government officials. Whether or not to comply with these additional requirements is the type of Judgment which can only be made on a case-by-case basis, after consultation between management and legal counsel, and an analysis of all the consequences flowing from the particular situation. 

---