Investigators conducted a trial to determine whether Coumadin, an anticoagulant, would reduce future risk of blood clot formation in patients post open sternotomy for aortic valve replacement with a mechanical valve. The investigators used a double blind, placebo controlled trial design. Participants were randomly assigned to either the experimental group or control group in the study. Participants were evaluated at regularly scheduled intervals for coagulation times, blood clot formation, and risk for blood clot formation based on a detailed questionnaire utilizing a Likert scale for measurement.
A) Analyze and discuss the risks and potential benefits of the research study based on the content criteria listed below in the grading criteria.
1) What level of IRB review is needed? Why? Discuss your rationale.
2) Analyze risks and benefit of the study to the researcher, participant, and society as applicable
3) Discusses the level of IRB approval needed and delineates the rationale