Conflict Between Research and Ethics, Essay Example

Abstract

The paper discusses conflicts between research and ethics. The example of the Hepatitis Study at Willowbrook State School for mentally retarded children is used to illustrate the case. The paper discusses the role of informed consent in clinical human research and the potential benefits of clinical trials. Institutional compliance and the existing ethical inconsistencies in medical research are discussed. The paper proposes that the existing ethical frameworks be reviewed and reconsidered. Ethics committees should stop promoting blind compliance with ethical requirements and rules. New advisory networks should be created, to monitor the course and the outcomes of each medical research and provide clinical trial managers with support and ethical assistance from the very beginning to the very end of the trial.

Keywords: ethics, research, clinical trial, hepatitis, compliance.

Conflict between Research and Ethics

Medicine is as an art and science of healing, encompassing numerous care practices and approaches designed to restore and maintain health. In distinction from exact sciences, medicine is inherently experimental. Experimentation is used to monitor the effects of the existing treatments on patient health. Experimentation is critical for the development of new, more effective treatments. Medicine is impossible without experimentation; likewise, human health is impossible without medicine. Unfortunately, clinical trials are the sources of numerous ethical issues, and even the multitude of ethical requirements and guidelines does not alleviate the burden of ethical conflicts in medical research. The reasons of ethical failures in medical research are so numerous, that it is virtually impossible to list them all. What we need is to reconsider and review the existing ethical frameworks, to avoid blind ethical compliance, to monitor the course and outcomes of each clinical trial, and to provide clinical trial managers with effective advisory support from the very beginning to the very end of each medical research.

Ethics and Research: Hepatitis in Children with Mental Retardation

That researchers often violate the basic principles of ethical conduct in medical research is a well-known fact. History witnessed dozens of medical and ethical scandals in clinical trials. Hepatitis studies at the Willowbrook State School for children with mental retardation are the brightest example of ethical misconduct in medical research. Between 1956 and 1971, the Willowbrook State School for children with mental retardation became a new arena of medical research (EHMR, 2001). Due to the unsanitary conditions, hepatitis had been the major health problem at Willowbrook, and it was virtually inevitable that all children would contract hepatitis (EHMR, 2001). Hepatitis added to the subsequent stigmatization of mentally retarded children, because many of them later became Hepatitis carriers (EHMR, 2001). Dr. Krugman proposed that a research be conducted, to distinguish between strains of Hepatitis and to develop a vaccine (EHMR, 2001). To meet the goals of the study, Krugman had to feed local children with the strains of Hepatitis – in other words, children had to be infected (EHMR, 2001).

Krugman reassured the public that the benefits of his research would overweigh potential harms (EHMR, 2001). He claimed that sooner or later, children would inevitably become infected (EHMR, 2001). Krugman argued that children participating in the research would be admitted to a special well-staffed unit, and only children with parents who gave informed consent would participate in the study (EHMR, 2001). In reality, the school was overcrowded, and long waiting lists made admission to the school virtually impossible (EHMR, 2001). Most of rooms available for children at that time were on the experimental wing, and parents who did not have resources to support their mentally retarded children had but to give their written consent to turn their children into research subjects (EHMR, 2001). Today, despite the development of numerous regulations and ethical requirements, patient consent remains the issue of the major ethical concern. Researchers are not always willing to disclose the fullest information about the research. Meanwhile, research participants suffer the lack of full information about the study and are not aware of the health and life risks of their participation in the clinical trial.

Medical Research, Informed Consent, and Benefits of Medical Research

Informed consent is one of the most controversial issues in medical research and poses a threat to the future of medical human research as such. Medical researchers and clinical trial managers use a variety of techniques to enroll human subjects. More often than not, researchers either refuse to provide the fullest information about the study and its potential effects on human health, or consciously distort this information to enroll as many subjects as possible. The case of the Hepatitis study at Willowbrook School is very demonstrative: Dr. Krugman manipulated the parents of mentally retarded children and reassured them that the benefits of the study would overweigh its risks for children. However, Krugman was not alone in his manipulations: Menikoff (2006) writes that medical researchers consciously avoid telling their participants that the research study is not in their best interests, because the treatment had already been approved by all regulatory bodies. Researchers may persuade participants that there is no way for them to obtain treatment other than to enroll in the trial (Menikoff, 2006). Clinical trial managers make participants believe that the goal of the clinical study is to improve their health (Menikoff, 2006). The situation is particularly difficult with critically ill patients who, due to their health condition, are not able to provide informed consent prior to their participation in the study (Harvey et al., 2006). As a result, “much of our current system has contained the remnant of a disturbing notion: that to have the appropriate amount of research, we need to deceive many patients when they are being asked to participate in clinical trials” (Menikoff, 2006). Does that mean that medical research is potentially dangerous to research participants and should be banned?

No, there is no need to put a ban on medical research, because successful medicine is impossible without experimentation. Clinical trials can benefit participants and society in several ways. Clinical trials help participants to play more active role in their own health care, to gain access to new research treatments before they become widely available, to obtain expert medical care during the trial, and to help society improve its medicine and health care by contributing to medical research (Clinical Trials, 2007). Unfortunately, all these benefits lose their meaning, unless individuals have the fullest information about the goals and risks of their participation in the clinical trial. In case of the Willowbrook study, participants did not have a single opportunity to obtain expert medical care and could not play an active role in their own health care, as long as they did not have the full information about the goals and risks of their participation in the study. They could not evaluate the risks of adverse health effects and had no other choice but to agree to participate in the study. Here, institutions and ethics committees can contribute to the development of sound ethical attitudes and frameworks in medical research.

Research Ethics, Institutional Compliance, and the Role of Clinical Trial Manager

With the growing societal concerns about the ethical nature of clinical trials, institutions are bound to carry the burden of numerous ethical responsibilities (Allen, 2008). Medical institutions conducting research must operate within the boundaries of the existing ethical frameworks. A failure to meet the basic ethical responsibilities in medical research can attract serious penalties or cause a public scandal (Allen, 2008). History witnessed numerous examples of the whole medical institutions penalized for the actions of a single clinical trial team and systemic failures within the institution (Allen, 2008). Other cases turned out to be a major public scandal, including the Hepatitis Study at Willowbrook State School. Unfortunately, the current state of ethics in medical research is limited to a number of bureaucratic procedures. Ethical committees are exclusively focused on ethical compliance, whereas institutions hold a view of ethical conduct limited to a number of correctly completed forms and informed consent materials submitted for ethical review. Today, governments and institutions should reconsider and review the existing regulatory frameworks, to shift the emphasis from blind ethical compliance toward complex monitoring of clinical trials and the development of advisory and support systems in medical ethics.

The fact is in that the presence of the complex ethical governance frameworks in medical research institutions does not guarantee that these systems operate efficiently. Objectively, Dr. Krugman followed the basic ethical requirements in clinical trials: parents provided written consent and only children with parents who gave their consent participated in the study (EHMR, 2001). However, the very procedure of obtaining consent from parents was far from ethical. One of the possible reasons of ethical misconduct in medical research is that clinical trial managers misunderstand their role in medical research. Farrell, Kenyon and Shakur (2010) write that a clinical trial manager is expected to (a) plan, coordinate and monitor the completion of a project; (b) promote excellent communication and presentation of the results; (c) organize and motivate others; (d) display enthusiasm and innovation when faced with challenges; (e) manage budgets and promote better accountability; and (f) use strategic, operational, and tactical skills when planning and executing a project. However, I also believe that clinical trial managers are directly responsible for ethical compliance during clinical trials. As a manager, I would seek to monitor how medical researchers inform potential participants about the goals and potential risks of the study, whether potential research subjects are fully aware of other, officially approved treatments, whether they know everything about their disease and possible treatments, and whether their objective health condition allows them to participate in the study.

Managers do not have powers and capabilities needed to change the quality of the existing ethical frameworks; nor can managers refuse to follow ethical rules and regulations during ethical trials. Today, a broader shift is needed, to improve the coordination of efforts between medical research institutions and ethics committees. When society is trying to protect the basic human rights and to eliminate any form of human discrimination in science, ethical compliance should no longer be limited to the process of completing and submitting several written forms for ethical review. Blind ethical compliance should give way to the development of more supportive, advisory systems of ethics in research. Instead of relying exclusively on compliance, ethics committees should (a) monitor the course and outcomes of each clinical trial; and (b) provide clinical trial managers with support and advice from the very beginning to the very end of the research process. These steps will mark the beginning of a new stage in the development and progress of the medical science and a new shift in medical research consciousness toward making clinical trials more ethical and humane.

Conclusion

Despite the development of numerous ethical rules and guidelines, the gap between research and ethics in medicine continues to persist. Medical researchers and clinical trial managers use a variety of manipulative techniques, to enroll as many research participants as possible. More often than not, researchers either refuse to provide the fullest information about the clinical trial or distort the information about potential risks and adverse effects in ways that make participants provide their consent to participate in the study. The Hepatitis study at Willowbrook State School for mentally retarded children is the bright example of how medical researchers and clinical trial managers manipulate potential participants to get their consent. Ethical compliance should no longer be limited to completing forms and submitting them for ethical review. Ethics committees should monitor the course and outcomes of each particular research and provide clinical trial managers with support and advice. These changes will mark the beginning of the new, more ethical stage of progress in medical research.

References

Allen, G. (2008). Getting beyond form filling: The role of institutional governance in human research ethics. Journal of Academic Ethics, 6, 105-116.

Clinical Trials. (2007). Understanding clinical trials. Clinical Trials. Retrieved from http://clinicaltrials.gov/ct2/info/understand#Q06

EHMR. (2001). Hepatitis studies at the Willowbrook State School for children with mental retardation. Ethics in Mental Health Research. Retrieved from http://www.emhr.net/download.php?id=4

Farrell, B., Kenyon, S. & Shakur, H. (2010). Managing clinical trials. Trials, 11, 78. Retrieved from http://www.trialsjournal.com/content/11/1/78

Harvey, S.E., Elbourne, D., Ashcroft, J., Jones, C.M. & Rowan, K. (2006). Informed consent in clinical trials in critical care: Experience from the PAC-Man study. Intensive Care, 32, 2020-2025.

Menikoff, J. (2006). What the doctor didn’t say: The hidden truth about medical research. New York: Oxford University Press.