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Research Ethics: The Protection of Human Subjects The Regulations and the Roles of the Researcher and the IRB. Presented by Sinclair Community College Institutional Review Board Adapted from materials provided by Frances Jeffries, Ph.D., Consultant, Bridgewater, MA.
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Sinclair Community College
Institutional Review Board
Adapted from materials provided by Frances Jeffries, Ph.D., Consultant, Bridgewater, MA
A Historical Perspective
(unless justified by study objectives)
(For new drugs and devices)
21 CFR 50 and 21 CFR 56
(45 CFR 46)
Human in vitro Fertilization
The Institutional Review Board
The IRB’s decision to deny approval of a protocol (or to deny permission to recruit subjects on-campus)cannot be overridden.
The IRB’s decision is FINAL.
which is intended to develop or contribute to generalizable knowledge
…when the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during performance of routine physical or psychological examinations or tests
(Written statement regarding the research may be required to be given to subjects)
unless required by
Exemption from IRB Review
that is not exempt under Category 2 if
by the FDA or approved by the EPA or the USDA
(IRB Chair may expedite in emergency)
(Note: Where medical devices are employed, they must be cleared/approved for marketing.)
that have been collected--or will be collected--solely for non-research purposes, such as
made for research purposes
(Assuming complete application)
(10 calendar days before meeting)
The IRB has the authority to suspend or terminate approval of research and destroy data that is not being conducted in accordance with IRB requirements or that has been associated with unexpected serious harm to subjects.
Failure to follow the rules may result in charges of scientific misconduct!
Go to <http://www.sinclair.edu/departments/grants/?????????>