HUMAN NUTRITION

Detailed explanation-1: -The documents reviewed should include the complete documents received from the clinical investigator, such as the protocol, the investigator’s brochure, a sample consent document and any advertising intended to be seen or heard by prospective study subjects.

Detailed explanation-2: -The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research.

Detailed explanation-3: -Rules for Measurement Books It is the basis of all accounts of quantities of work done, purchase made and it must contain such a complete record of facts as to be conclusive evidence in court of law. The description of the work/materials must be lucid, and such as to admit of easy identification and check.

Detailed explanation-4: -Criteria for IRB Approval of a Human Research Study Risks to subjects are minimized. Procedures are consistent with sound research design and do not unnecessarily expose subjects to risk. Study utilizes procedures already performed for diagnosis/treatment–when appropriate.