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.
Analyze and discuss the risks and potential benefits of the research study based on the content criteria listed below in the grading criteria:
The trial consists of determining the risk for blood-clots postoperatively after mechanical valve replacement of the aortic valve. Patients were randomly assigned anticoagulant therapy or a placebo in a double-blind study. The study involved following up with interview Likert scale questionnaires regarding risk for clot formation, testing patient coagulation times, and monitoring blood clot formation. There is no alternate anti-coagulation therapy given, which poses a very high risk for injury or death to the patients who will receive the placebo instead of anticoagulant therapy. Post-op patients are at increased risk for the formation of blood clots, and patients who have had valve replacement are also at higher risk for forming blood clots. To not administer anticoagulant therapy to post-open-heart surgery patients could be deemed as negligence on the part of the researchers.
According to the Belmont Report, beneficence, or the “do no harm” principal, is not being used in this study as there is definite risk of actual harm being done to patients related to formation of blood clots, as well as potential risk for psychological harm related to increased anxiety related to fear of development of blood clots. To assess the risk vs benefit, the IRB would need to see if there is any alternative way to obtain the benefits, particularly as the participants would most likely be people who are considered vulnerable due to age or terminal illness.
For the researchers, there is the risk of having funding pulled, for being disallowed to perform other studies, and there is the risk for litigation participants who may be harmed. Specific vulnerable demographics may also be affected and potentially harmed through this study.
The potential benefits from this study would be recognition for the researchers and institute facilitating this study should new therapy guidelines be developed related to the information gleaned. For the participants, the benefit of having potentially helped change how valve replacement surgery patients are cared for may boost self-esteem. For society, the study could show a need for fine-tuning the use of Coumadin therapy to specific patient demographics based on more focused risk factors. This could eliminate the need for on-going monthly lab draws, especially for those who have increased anxiety related to lab procedures.
What level of IRB review is needed? Why? Discuss your rationale:
This study would require a full board review since the risk to participants is not considered minimal. The data is also gathered in a manner that is not considered “minimal risk.” Because there is actual risk for death, physical, or psychological injury related to blood clot formation or the fear of blood clot formation, this study would not be considered as one of the six types of “exempt studies,” nor would it qualify for an expedited review. The IRB would need to fully investigate, assess, and weigh and consider risk versus benefit before approving this study.
References:
Cedars-Sinai Medical Center. (2015, October 5). Blood clots may complicate aortic valve replacements: Anti-coagulation medicine successful, fast in resolving clots that could impair valve motion. ScienceDaily. Retrieved June 14, 2018 from www.sciencedaily.com/releases/2015/10/151005151210.htm
Chapter 4: Assessing Risks and Potential Benefits and Evaluating Vulnerability (Research Involving Human Participants V1). (n.d.). Retrieved November 14, 2017, from http://www.onlineethics.org/cms/8033.aspx
The Belmont Report (Rep.). (1979, April 9). Retrieved https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
I agree. There needs to be a full IRB Review and I also believe that there should be a more concrete plan for the study. They did not discuss whether or not they discussed the risk vs. benefits to the patients. As you stated, this medication has enough risks to NOT fall under the minimal risk category and, therefore, should have a considerately specific IRB Review as well as a better plan of study. They need to incorporate the PT/INR testing as well as protocols for bleeding and possible blood clots.
Thank you for pointing out something that I neglected to include in my original post: There was no mention of discussing risks vs benefits with the potential subjects.
If they did omit that discussion, then the test subjects would not be able to fully consent, as they would not be fully informed regarding risks and benefits related to the study. That is not protecting the patient from harm and it is not allowing full autonomy regarding directing their healthcare choices.
I think we are in definite agreement regarding the viewpoint that this study does not seem well thought out, and could be improved to promote safety and reduce risk for harm for the test subjects.