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Skloot, R. (2010). The immortal life of Henrietta Lacks. New York, NY: Crown Publishing Group.

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INITIAL POST

            Research drives innovation in health care and establishes evidence-based practice. The medical community relies on research to promote better practice, develop new technology, work more efficiently, and to develop life-saving medicines and treatments. The standards that guide research are of paramount importance. Research must be carefully planned, rigorously executed, replicable, and above all else, it must be ethical. Fouka and Mantzorou (2011) contend that within the context of research, ethics must be applied to the daily work of the study, the protection and dignity of research subjects, and to the publication of research. The primary ethical issues involving research are informed consent, beneficence, non-maleficence, respect for anonymity and confidentiality, and respect for privacy (Fouka & Mantzorou, 2011).

Lenzer (2016) reports that The Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE) was a study that aimed to analyze the effects of extending work hours for first-year internal medicine residents on patient mortality and negative outcomes at a 30-day interval (Lenzer, 2016). Shea et al. (2018) maintain that the study analyzed several patient safety issues including readmission rates, prolonged length of stay, various medical complications, and overall costs associated with care. The iCompare research study was a randomized control trial conducted in the 2015-2016 academic year. It was funded by the National Institute of Health and included resident-subjects from 40 medical programs that agreed to sign an Institutional Affiliation Agreement. The University of Pennsylvania served as the institutional review board for all the participating medical programs. The researchers randomly assigned residents to work in one of two groups. Residents belonging to the first group worked a maximum 16 consecutive hours, which is the maximum number of hours allowed by the Accreditation Council for Graduate Medical Education, while residents belonging to the second group worked as many as 30 hours consecutively (Shea et al., 2018).  

Ethical Breaches in the iCOMPARE Study

Informed Consent

While it is true that the various academic institutions agreed to participate in the iCOMPARE study, and even assisted in facilitating the research, the residents nor the patients were informed that they were active participants in the iCOMPARE study (Lenzer, 2016). Informed consent is arguably the primary ethical issue for research that involves human participants. Informed consent requires that “a person knowingly, voluntarily, and intelligently and in a clear and manifest way, gives his consent” (Fouka & Mantzorou, para. 8, 2011). In order for informed consent to occur, research participants must be provided with an introduction of the study as well as the risks and benefits. Moreover, in denying informed consent the residents and patients were also denied autonomy and self-determination (Fouka &Mantzorou, 2011).

Matthew Alvin (2017) was a resident participant in the iCOMPARE research study. While he admits he did not give informed consent, he asserts that he gave implied consent to participate in the study. Alvin bases his assertion on the fact that prospective medical students were sent information about the iCOMPARE research study via email during the months in which they interviewed for residency assignments. And, that by participating in the residency program itself, he consented implicitly to any and all integral components of the academic program (Alvin, 2017). I respectfully disagree with Dr. Alvin’s assessment of implied consent, and would argue that information about a potential research study sent via email is informal and does not meet the legal or ethical litmus test for implied consent. Furthermore, the patient participants received no such informal email communication. They were not provided any information about the research, nor were the risks and benefits explained to them. The iCOMPARE study exposed both residents and patients to unnecessary risks and denied both groups the option of opting out of the study. The gross disregard for informed consent in the iCOMPARE study violated the very foundation for which reliable research is based.

Beneficence and Non-Maleficence 

Beneficence and non-maleficence are ethical principles which require researchers to have good intentions for the welfare of participants when conducting research. These principles require researchers to above all else, do no harm (Fouka &Mantzorou, 2011). The researchers in the iCOMPARE study showed blatant disregard for the ethical principles of beneficence and non-maleficence. Inexperienced first-year residents were pushed to the physical limits of exhaustion, working more than double the hours allowed by the Accreditation Council for Graduate Medical Education. This undoubtedly had both physical and psychological implications. Errors made by residents during this research could have potentially impacted the perceived quality of their residency experience, and contributed to internalized feelings of self-doubt. Moreover, Patients’ lives were put in the hands of residents who were purposely overworked simply to find out if fatigue contributes to medical errors. I did not find any data which corroborated or eliminated any undue harm incurred by either residents or patients during the iCOMPARE research study.

Suggestions for the iCOMPARE Study

Because ethical standards were not upheld during this research, the validity of the study is questionable. The designers of this research should have facilitated informed consent with the resident-participants, since some of them were working more hours than recommended by the Accreditation Council for Graduate Medical Education. Obtaining informed consent from the patient-participants is more of a gray area, because technically, medical residents are supervised by attending physicians who are ultimately responsible for the care provided. However, since the aim of the research was to determine if fatigue played a significant role in patient mortality and medical errors, I believe that patients had a right to be informed of the study.

It is likely that the researchers did not provide informed consent to the participants because they believed the participants, especially the residents would have behaved differently had they known they were part of a study, this phenomenon is known as the Hawthorne Effect (Poilt & Beck, 2015). Had the residents been provided with informed consent, they would have known which experimental group they were based upon the hours they were assigned, essentially negating any attempt at randomization. Nonetheless, these reasons are not significant enough to violate research ethics. The researchers should have chosen a quasi-experimental design for this study because it lacks randomization, and would have facilitated informed consent (Polit & Beck, 2017). When research is being conducted on sensitive issues, researchers should choose a design that maintains ethical standards, even if that design ranks lower on the evidentiary pyramid.

The researchers of iCOMPARE, leaders of 40 graduate medical programs including John Hopkins, The National Institute of Health, and an institutional review board at the University of Pennsylvania were all complicit in violating the ethical principles of informed consent, beneficence, and non-maleficence. The iCOMPARE study not only violated ethical principles and exposed medical residents and patients to potential dangers; it also compromised the value of any conclusions or statistical information deduced from the results of the study. Ethically flawed research negatively impacts the medical profession. The iCOMPARE study violated the relationship of trust which must be maintained between patients and medical providers. And, although Dr. Alvin believes implied consent is applicable to the participating residents in this case, he cannot speak for the countless other residents, nor the patients who unwillingly participated in this research study.  

 

References

Alvin, M. D. (2017). ICOMPARE: An interns perspective. Journal of Graduate Medical Education,9(2), 261-262. doi:10.4300/jgme-d-16-00711.1

Fouka, G., & Mantzorou, M. (2011). What are the major ethical issues in conducting research? Is there a conflict between the research ethics and the nature of nursing. Health Science Journal. Retrieved from http://www.hsj.gr/medicine/what-are-the-major-ethical-issues-in-conducting-research-is-there-a-conflict-between-the-research-ethics-and-the-nature-of-nursing.php?aid=3485

Lenzer, J. (2016). Groups call for “dangerous” trial of doctors’ working hours to stop. Bmj,I1070. doi:10.1136/bmj.i1070

Shea, J. A., Silber, J. H., Desai, S. V., Dinges, D. F., Bellini, L. M., Tonascia, J., . . . Asch, D. A. (2018). Development of the individualised Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE) trial: A protocol summary of a national cluster-randomised trial of resident duty hour policies in internal medicine. BMJ Open,8(9). doi:10.1136/bmjopen-2018-021711

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