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
Considering the case study above, risks of the study to the researcher would include legal liability for appropriate conduct and possible errors during the trial. Risks to the participant may include potential physical discomfort or harm due to development of blood clot formation which may lead to psychological, emotional, or economical harm as well (National Academics of Sciences, 2018). Communities associated with trial participants may also be affected socially, emotionally and economically.
Researchers would benefit from a trial to determine whether Coumadin would reduce future risk of blood clot formation in patients post open sternotomy for aortic valve replacement with a mechanical valve by possibly producing evidence to support a hypothesized new therapeutic practice. Participants may benefit in this trial by receiving Coumadin and having a possible decreased risk of blood clot formation. Society may benefit from this trial by possible improved pharmacological therapy to decrease risk for post operative blood clot formation in patients who have received an open aortic valve replacement with a mechanical valve. Improved methods of blood clot prevention also may lead to decreased risk for post operative complications and reduction in health care associated costs.
The above trial would have to undergo a full IRB review due to a greater incidence and magnitude of risk than minimal risk for participants. Minimal risk is defined as “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 the performance of routine physical or psychological examinations or tests (John Carroll University, 2013).” Risks of the trial may cause harm or injury and could possibly be fatal which is considered higher than minimal risk. A full IRB review increases monitoring for ethical practices within trials to ensure accountability for managing risks and benefits.
References:
John Carroll University. (2013). Types of IRB review. Retrieved June 12, 2018 from: http://sites.jcu.edu/research/pages/irb/review/review-types/
National Academics of Sciences. (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
I agree with your analysis that this research would need a full review by the IRB due to evaluate the risks vs. benefits the research might have on the participants. Emmanuel,Wendler and Grady (2010) propose 7 things to consider when deciding if a study os ethical. One of the proposals is that there is “favorable risk-benefit ratio-within the context of standard clinical practice and the research protocol, risks must be minimized, potential benefits enhanced, and the potential benefits to individuals and knowledge gained for society must outweigh the risks”.
The study would benefit from strict and clear inclusion/ exclusion criteria the research coordinators can follow.
Reference:
Emmanuel, Wendler and Grady. (2010). What makes clinical research ethical? JAMA. 2000;283:2701-2711. Retrieved from: https://www.ncbi.nlm.nih.gov/pubmed/10819955
I agree strict inclusion and exclusion criteria would benefit the trial to minimize variables which could influence outcomes. Reduced variances would allow researchers to more accurately determine the effectiveness and clinical significance of Coumadin use postoperatively for blood clot prevention.
I, also, agree with your analysis. When the risks are so great that there is the chance for a medical catastrophe or even death, then there needs to be some specific protocols in place. The pts also need to be made aware of the risks vs. benefits prior to the study as well as pre-testing and post-testing. There was no mention of PT/INR testing which is very important when taking Coumadin. I also feel that the risks associated with NOT receiving the Coumadin are just as great. I think you said it best in your last sentence: “The study would benefit from strict and clear inclusion/ exclusion criteria the research coordinators can follow.” Great post! Thanks!
The case study reported that patients would regularly be monitored for “coagulation times, blood clot formation, and risk for blood clot formation”. Frequent evaluation and observation is critical to ensure patients receive proper care in a timely manner if clots develop to prevent further harm or injury.