Case Study 3
Investigators conducted a trial to determine whether Coumadin, an anti-coagulant, 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.
Case Study 3
As a researcher knowing the risks and benefits of using coumadin as an anticoagulant for patients with open sternotomy for aortic valve replacement with a mechanical valve will allow the practitioner to provide better patient care thus ensuring best patient outcomes. A benefit for the researcher would be to find the scientific support for the desired outcome. The researcher has legal risks of following all the rules and regulations put forth for a research trail. Most important is following the ethical principles of the Belmont Report that includes respect for persons, beneficence, and justice (National Academics of Sciences, 2018).
As a participant in the study, the results may or may not provide immediate benefits of decreased clot formation using coumadin for patients with open sternotomy for aortic valve replacement with mechanical valve. The results may or may not be a benefit for their future care. The risk to the participants could be life threatening as blood clots can be fatal. Invasive blood tests put the participant at risk for infection and discomfort and a questionnaire is being utilized in this study increasing the risk of patient confidentiality being compromised (National Academics of Sciences, 2018).
The benefit for society in this study is having the best anticoagulants for future patients with post open sternotomy for aortic valve replacement with mechanical valve. Knowing the top treatment option will decrease hospitalization, decrease cost for health care and provide better patient care with improved outcomes. Societal risks are placed upon the family members who can experience emotional distress from potential adverse effects that the anticoagulant may or may not have on their loved ones (National Academics of Sciences, 2018).
A double-blind, placebo-controlled study design will be used to answer the research question; will coumadin reduce the risk of blood clots in patients with post open sternotomy for aortic valve replacement with mechanical valve. The two processes are designed to: 1) “answer the research question” and 2) determine if the risks are “reasonable” for the anticipated benefit (National Academics of Sciences, 2018). The research trial is designed to test safety and the effects of a drug measured in humans. There will be a control group which will receive standard treatment and an experimental group that will receive the “experiment treatment for blood clot formation in patients post open sternotomy for aortic valve replacement with a mechanical valve (University of Washington, 2018). At the end of the study the results from both groups will be compared to determine how effective the experimental treatment is.
A full board IRB review is needed due to the increased risks of physical harm to the participants. The IRB will factor in multiple components: 1) the current “standard medical care” 2) the trial “components to determine their ethical acceptability” 3) the “prospect of direct benefits” and 4) determine if the risks will “yield potentially useful societal knowledge” (National Academics of Sciences, 2018).
References:
John Carroll University. (n.d.). (2013). Types of IRB review. Retrieved June 12, 2018 from: http://sites.jcu.edu/research/pages/irb/review/review-types/
National Academics of Sciences. (n.d.). (2018). Chapter 4: Assessing risks and potential benefits and evaluating vulnerability (research involving human participants V1). Retrieved on June 13, 2018 from: http://www.onlineethics.org/cms/8033.aspx
University of Washington (UW) Medicine. (n.d.). (2018). Definitions of some commonly used terms. Retrieved on June 13, 2018 from: https://www.uwmedicine.org/research/research-trials/terms