In addition or as a supplement to regulations already noted in this Handbook, listed below are important regulations or policies of Federal sponsors and the Health Science Center.
Human research is the use of any information about or obtained from living persons.
This broad definition encompasses a wide variety of activities such as in vivo and in vitro studies, review of medical records, collection of data through surveys or observation, performance of blood tests, examination of pathological specimens, discarded tissue or secretions, any use of investigational drugs or devices, and randomized trials. Research, in the context of human subjects use, is defined as a systematic investigation, including research development testing and evaluation, designed to develop or to contribute to generalizable knowledge. Because all human subjects research must be approved by the IRB, if there is any doubt as to whether IRB review is necessary, the IRB office should be contacted to make the determination. The Institutional Review Board and the Institutional Review Board Office share the common mission of facilitating the ethical conduct of human research. There are three general areas of concern for human research subjects that are assessed in the research review and approval process.