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.
My first pause was when I realized that it was a double-blind placebo-controlled trial looking at the risk of blood clot formation. Those two pieces of information in one sentence elicited from me somewhat of a visceral reaction. The potential risk of this study to the participants could be significant. As a participant, you would have no idea if you were receiving treatment or the placebo, and neither would the researchers. What if my labs indicated clot formation? What if I develop a clot? Will I be taken out of the study to receive treatment? Participants should consider all these possibilities when considering signing up for this study. With the mortality rate of blood clots and considering that Coumadin is one of the more common treatments/preventions for blood clot formation, the risk of loss of human life is real and at high risk.
The benefit to the participants in the trial receiving the treatment and to future patients if the study proved the efficacy of Coumadin in reducing the risk of clot formation and could, therefore, become an evidence-based treatment protocol for prevention of clot formation post valve replacement. The benefit to the researchers is identical as it would be for the society as a whole. If the study proved the efficacy of Coumadin as prevention of these clots, everyone benefits.
As a researcher, I would first have to out myself as an empathetic soul and think “what if one of my participants died in the placebo group that could have been saved if they were in the treatment group?” I’m not sure I could live with the implications of that guilt and my obligation to “do no harm.” The brief case study doesn’t indicate if a participant would be removed from the study if their periodic labs were to indicate clot formation. Would alternative therapy be offered if their labs did indicate clot formation? Would the death of a participant during the study spur any additional investigation such as an autopsy to determine if the cause of death was related to the study?
Being unfamiliar with the research world, but in tune with risk management, that would be a huge concern. I understand that research trials of this nature usually indemnify against liability during the study, but my conscience would not be able to get past the possibility.
This study would require a full IRB review because the risk is greater than minimal and could include death. In a survey of IRB members, many of the IRB members surveyed are researchers, as well, and admitted to being concerned about the consequences, both personal and professional, of their decisions on the board (Cook, 2011). IRBs are tasked with protecting the participants but must feel obligated, as well, to facilitate further research because only through research and trials do we find the evidence on which to base our practice.
Cook, A., & Hoas, H. (2011). Protecting research subjects: IRBs in a changing research
landscape. IRB Ethics & Human Research, 33(2), 14-9. Accessed on June 15, 2018.
The ethics involved in a study such as this is extensive. According to Dr. Christine Grady, chief of the NIH Clinical Center Department of Bioethics believes that “when people are invited to participate in research, there is a strong belief that it should be their choice based on their understanding of what the study is about, and what the risks and benefits of the study are (2016).” According to the NIH Clinical Center, there are seven principles that are used to guide the conduct of ethical research.
I agree with your thought process, because as nurses we are hardwired to help people. The thought of someone receiving a placebo when the medication could save them is hard to understand. I thought that the fact that you mentioned that several IRB members admitted to being concerned about the consequences of their actions was an important detail. It seems as though it has to be combed through very delicately.
Resources:
Guiding Principles for Ethical Research. (2016, March 16). Retrieved from https://www.nih.gov/health-information/nih-clinical-research-trials-you/guiding-principles-ethical-research
As I was researching IRB’s, I also found that compensation for participants is a big area of review, as well, due to the risk/benefit and coercing participants to join. I would also think informed consent would be a sticky area, as well. I would hate to be an attorney in charge of writing these documents and ensuring risks are disclosed and enough information is given about the study for the participant to make an informed decision. Personally, most studies I read about, I’m not sure I would’ve volunteered to be a participant. My instinct is to disclose and fix what I can!
I, too, was concerned over the risk vs. benefits of the study. There are risks to both sides and if the study is not conducted properly then there is the chance of injury to either side. The risk to those receiving a placebo, is that there is possible clot formation, as you said. Should we be risking that pts life to be the control? I’m not convinced. Then there is the chance of bleeding to those receiving the Coumadin. If they are not properly monitoring the dosage and testing the PT/INR then they will not be able to tell if the Coumadin is doing what it is supposed to or if the study will even be accurate.
The other thing that bothered me was the fact that they were using questionnaires to get information. There should be more physical, medical testing to get information, other than questionnaires.
As a healthcare provider, we are taught to “do no harm”. I cannot consider doing this sort of study without a more solid way of following through with the study and providing a detailed and informative conversation with the pts that are considered for the study.
I was under the impression they were conducting lab studies to obtain the coagulation times as well as questionnaires for risk factors. Its standard of practice to monitor Coumadin with PT/INR studies regularly. I’m not certain a study that poses this kind of risk could receive approval without a more objective measure of coagulation times and clot studies. Either way, I agree, this study made me uncomfortable.