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Subpart C Certification Forms
An institution that intends to conduct HHS-supported research involving prisoners as subjects must certify that an IRB has made the seven (7) findings required under 45 CFR 46.305(a), including the finding that the proposed research represents one of the permissible...
Exempt Data Usage in Research
When an IRB reviews studies regarding data usage, risk is the primary consideration. When discussing exempt category reviews, issues surrounding the use of the DATA are key. The first issue often considered is what data are being used? What are the particulars of...
OHRP Issues Decision Charts for Current (2018) Requirements
On June 30, 2020, OHRP posted new decision charts for the revised Common Rule (2018 Requirements) on their website. These charts are intended to help decision-makers determine if research is considered human subjects research, if exemption categories apply, if...
Levels of risk in human subjects research
Investigators may have noticed that there seems to be a high degree of variability in Institutional review board (IRB) reviews, both in review type and approval requirements.Several regulations must be considered when reviewing a study. IRBs are given discretion to...
Emergency Use of a Test Article: Types and Regulations
The COVID-19 pandemic has brought up questions regarding the emergency use of drugs, devices, and/or biologics. What issues must investigators understand prior to submission of a study to the Institutional Review Board (IRB) for review? Below is a brief...