Jewish Chronic Disease Hospital - Research Paper Example

?Jewish Chronic Disease Hospital Introduction In 1963 at Jewish Chronic Disease Hospital, 22 chronically-ill indigent patients were injected with live cancer cells, but they were not told about it, instead they were informed of a skin test which ended up to having no signed or documented consent about the procedure (Esposito & Podell, 2010). Investigators pointed out that there was an oral consent, but no documentation made because it would not be necessary due to custom of performing dangerous medical procedures without consent and if patients were to be informed, the procedure might just frightened them (Johnmueller.org, 2010). Believing that the procedure would succeed, the researchers strongly stand on their ground that no consent from patients was necessary (Johnmueller.org, 2010). Three years after the incident and after a year of probation of the researchers involved in the incident, one of them was elected president of the American Association for Cancer Research (Johnmueller.org, 2010). The proponent of this paper tries to assess the issues involved in the above case, how they were handled and might have been handled differently. Below are some of the ethical issues involved in the above case. Oral consent but no documentation The researchers were able to point out that oral consents were made but there was no documentation involved due to some certain reasons. This made it clear that the entire research was a one-sided approach which strongly emphasized only the main objectives of the researchers, without taking into account the rights of the respondents. Rules or guidelines on what is right and appropriate conduct are all incorporated in ethics (Rumrill, Cook, & Wiley, 2011). Thus, there should be appropriate way to conduct research among the chosen respondents especially in medical research. Research involving human subjects includes legal and ethical considerations which primarily include human subjects’ protection, protection of privacy and the disclosure of risks involved (Kulynych, 2002). Furthermore, since 1980s epidemiologists and physicians adhered to the importance of informed consent in certain investigations (Regidor, 2004). In the case of Jewish Chronic Disease Hospital, researchers strongly argued that they were able to inform the respondents through oral consent due to certain reasons. One reason is that the respondents were indigent, which means it would be appropriate to explain everything to them in an oral approach. However, the case of Jewish Chronic Disease Hospital did not only include ethical considerations, but tied in it was legal accountability of the researchers. These two seemed to be integrated in the case of Jewish Chronic Disease Hospital and the researchers involved. Citing the significance of informed consent, the researchers were able to do at least somewhere in the right thing, but the problem in this approach is the lack of showing some documents to prove that indeed there were oral consents made on the part between the respondents and the researchers. Oral consent was appropriate at some point knowing that it still belongs to the category of informed consent. However, there still something lacking in it in the case of therapeutic research where there seems to some remarkable risks involved. Consent should be highly documented in this case so whatever may happen, there would be some legal basis that will point out to adherence to the ethical standards. Custom to perform dangerous medical procedures without consent As stated earlier, in medical research, the respondents have the right to express their consent in certain research investigations. This is considered to be sound and ethical especially if it has to be applied in the case of Jewish Chronic Disease Hospital. However, the said hospital had certain customary procedure that in the event of performing dangerous medical procedures, consent from patients or respondents will not be necessary because it can be waved. In fact, this is supported by some legal and ethical standard that at some point, the risks associated with therapeutic research may not necessarily be disclosed as stipulated in the federal medical privacy regulation (Kulynych, 2002). Indeed, the Jewish Chronic Disease Hospital had customary process of performing medical procedures without consent. However, this may apply positively in cases of emergency in which the situation is a matter of life and death. In this case, an individual does not have any choice but rely on the decision of a medical expert prior to saving his or her life. It was a different case when it comes to therapeutic research and when an individual is conscious and has the ability to understand things and give consent. Taking a closer look at the case, when people involved in the research study are indigent, it does automatically mean they are unable to understand things and incapable to give consent. They have the right to be informed and to give consent as long as they are capable and able to “understand information, process information, has the ability to appreciate situation and its consequences, ability to weigh benefits, risks and alternatives, ability to make and communicate a decision” (Meulenbroek et al., 2010, p. 56). Indeed, the researchers were not able to document in detail whether the respondents even though were indigents were able to understand information and process it, has the ability to appreciate situation and its consequences and so on. Another thing that was overlooked in the research was the capacity of the respondents to exercise their right to give consent knowing the fact that they would have been able to meet the criteria involved in giving consent. They might have been competent enough to consent. Patients were not told that they would receive cancer cells In the United States, there are sets of requirements that investigators or researchers need to use in a particular study involving human participants and they can be based on international standard or the US regulations (Chanaud, 2008). It is in this reason that there could be varying approach that will be used especially in cases that involved potential risks. In the case of Jewish Chronic Disease Hospital, researchers were not able to inform their human subjects about the cancer cells, rather they were inform about the whole thing as simple skin test operation. It is clear in this case that the respondents were totally deceived and completely suppressed from their right to know the whole situation. They were completely regarded as merely simple subjects of the entire research process, and researchers were oblivious about the rights of their respondents in exchange of finding significant information about the entire study. Things like this continue to exist considering that patients or human subjects need to enhance further their understanding on informed consent process for surgery and clinical research (Falagas, Korbila, Giannopoulou, Kondilis, & Peppas, 2009). If they are equipped with this, clinical research will just substantially flow based on the underlying rules and guidelines emancipated within the international standard and or certain regulations. Thus, investigators will no longer be frightened of not getting the results they want to achieve because of same reasons discussed in the case of Jewish Chronic Disease Hospital. Investigators belief of frightening the patients One of the reasons why patients were not told that they would receive active cancer cells was due to researchers’ belief of frightening them. This alone proves the fact that researchers were not 100 percent certain that their study would come up with significant success. If they did, then they should have disclosed the real purpose of the study and the entire process of it to their respondents and assure them of a 100 percent success or even somewhere near it. Then there would no reason at all that patients will be frightened about the entire process. However, considering that the whole thing was a clinical study, potential risks were actually involved. These risks were what the researchers assumed to frighten their patients or chosen respondents. Nevertheless, considering that patients or respondents are totally enhanced when it comes to their understanding on inform consent, it would be evident that there should be some of them who would offer themselves for study or clinical trials. This is evident in the case of regenerative medicine, the stem cells which is first applied to a child in the hope of the parents that that alone would be the real source of healing. Indeed, it was. Prior to the actual treatment, the doctor made it clear with the patient’s parents that the entire process would come as sort of a clinical trial with some undocumented risks that may possibly arise. Investigators view that their procedures would succeed Another reason why investigators denied about the introduction of live cancer cells to their patients was the thought that it would not really harm them because of it would succeed. This was a basic form of assumption or in other way, a form of certainty. Whatever it may be, investigators still lack the ability to apply the appropriate clinical communication research. Within this area, there has to be much to learn about the patients’ cognition, dependence, emotion and value (Salmon & Young, 2005). The researchers in the case of Jewish Chronic Disease Hospital certainly lacked this consideration which made them performed the study under their control and outside the bound of their respondents’ real choice. One of the researchers was elected president of the American Association for Cancer Research Three years after the probation of those physicians responsible for the incident, one of them was elected president of the American Association for Cancer Research. Ongoing debate regarding this continues to exist whether the said approach was completely unethical or not. There is only one concern in here. Considering that legal approach might be consider integral part of the set of guidelines or rules underlying ethical standard, a year of probation may be considered the real process that had become applicable to those researchers involved in the incident. After that year of probation, they would be clear from their obligations regarding with paying the consequences of their actions. Thus, there would be no problem electing such researcher as president of the American Association for Cancer Research if that person was really qualified for that position. Conclusion There are various ethical issues mentioned in this paper and they are all based on the incident in Jewish Chronic Disease Hospital in 1963 involving ill patients and researchers. The real point of the case is the absence of a guiding principle that will substantially enhance the knowledge of the respondents especially in the field of clinical research. Informed consent is necessary because it is the fundamental component of exercising the right of individuals in clinical research. Furthermore, it would become the right guiding principle in order that ethical standard within clinical research will substantially be implemented in the universal setting. References Chanaud, C. M. (2008). Determination of required content of the informed consent process for human participants in biomedical research conducted in the U.S.: A practical tool to assist clinical investigators. Contemporary Clinical Trials. 29, 501-506. Esposito, M., & Podell, R. (2010). Jewish Chronic Disease Hospital Study Ethical Issues. Retrieved November 3, 2011, from http://www.mariaesposito.org/9816%20Group%20Jewish%20Chronic%20Disease.pdf Falagas, M. E., Korbila, I. P., Giannopoulou, K. P., Kondilis, B. K., & Peppas, G. (2009). Informed consent: how much and what do patients understand? The American Journal of Surgery. 198, 420-435. Johnmueller.org. (2010). They are dying anyhow? Retrieved November 3, 2011, from Johnmueller.org (2010) They are dying anyhow? http://johnmueller.org/Problems/Cancer.html Kulynych, J. (2002). Legal and ethical issues in neuroimaging research: human subjects protection, medical privacy, and the public communication of research results. Brain and Cognition. 50, 345-357. Meulenbroek, O., Dassen, M. V., Kessels, R. P. C., Graff, M. J. L., Sjogren, M. J. C., Schalk, B. M. W., Ossewaarde, M. E. H., Claassen, J. A. H. R., Melis, R. J. F., & Rikkert, M. G. M. O. (2010). Informed consent in dementia research. Legislation, theoretical concepts and how to assess capacity to consent. European Geriatric Medicine. 1, 58-63. Regidor, E. (2004). The use of personal data from medical records and biological materials: ethical perspectives and the basis for legal restrictions in health research. Social Science & Medicine. 59, 1975-1984. Rumrill, P. D. Jr., Cook, B. G., & Wiley, A. L. (2011). Research in Special Education (2nd ed.). Springfield, Illinois: Charles C. Thomas Publisher. Salmon, P., & Young, B. (2005). Core assumptions and research opportunities in clinical communication. Patient Education and Counseling. 58, 225-234. Read More