This group review serves an important role in the protection of the rights and welfare of human research subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. What is an Institutional Review Board (IRB)? These questions and answers are organized as follows.ฤก. For ease of reference, the numbers assigned to the questions are consecutive throughout this section. The following is a compilation of answers to questions asked of FDA regarding the protection of human subjects of research. Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |