The New York State Department of Health offers a free, downloadable adverse event reporting form for office-based surgery. The four-page form includes sections detailing accreditation, the nature of ...
Federal Regulations [45 CFR 46.103(b)(5) and 21 CFR 56.108(b)(1)] and UAB IRB policy (POL006) requires Principal Investigators of all human subject’s research (FDA-regulated or not), and their ...
When the HSRO approves human-subjects research, the approval is based upon the information about how the research will be conducted and the risks and anticipated benefits to subjects that are known at ...