The Ethical Issues Raised in New England Journal of Medicine by Henry Beecher - Assignment Example

Ethical Considerations Name Course Name and Code Instructor’s Name Date Introduction Using human subjects in clinical research has received vast attention for the last couple of decades. The Institute for the Protection of Human Subjects (IRB’s) was particularly established in various institutions undertaking human research. Various ethical issues have been identified in human projects research including safety, informed consent, privacy and confidentiality, and handling of adverse events. In the same line of argument, there are also three primary principles that must be adhered to when conducting a clinical research using human subjects and these include autonomy, beneficence, and justice. Several advances have been made to try to make clinical research involving human subjects more ethical. For example, Emanuel, Wendler, and Grady came up with seven principles that make clinical studies that involve human subjects ethical. The case described in the New England Journal of Medicine by Henry Beecher, exhibits various ethical issues. This paper discus the ethical issues raised in the mentioned case. Accordingly, with regard to the principles articulated by Emanuel, Wendler and Grady; What Makes Clinical Research Ethical? The paper will discuss whether the application of these principles to the case would have made it ethically acceptable. Ethical Concerns The use of human subjects in clinical research has several ethical implications, about this; there three traditionally recognized principles that must be adhered to by the researcher to ensure that ethical concerns are not violated. As cited form the introduction above, the three principles are autonomy, beneficence, and justice (Callahan, 1998). Autonomy in this perspective requires the investigator to respect each participant as a person with capacity to make an informed decision with respect to participating in the research study. The research for this matter must ensure that each participant in the research is aware of all the aims and objectives of the study; there is full disclosure of the nature of the study, benefits, dangers, and alternatives together with an extended opportunity to ask questions (Callahan, 1998). Most of the autonomy requirements are included in the informed consent document. Beneficence is the researcher’s obligation to maximize the benefits of the individuals participating in the research and/or the society as well as minimizing risk of harm to the individual. Given this principle, it is extremely important for the researcher to conduct an honest and thorough risk and benefit investigation before pursuing the intended clinical investigation. Accordingly, the justice principle demands for equitable selection of participants, for instance, avoiding coercion of individuals into participating in a research study that they may not want to; the use of prisoners, and institutionalized children (Callahan, 1998). Further, this principle dictates that the benefits and burdens of the research must be equitably distributed among the population that is likely to benefit from the research. When these principles are violated when designing or conducting a scientific research then, ethical issues are likely to arise. There are a myriad of ethical issues that must be considered when designing research projects that utilize human beings as participants (Faden & Beauchamp, 1986). In this regard, the researcher must primarily consider the safety of the participants. This can be accomplished through careful determination of the risk/benefit ratio by using all the available relevant information to make a suitable assessment as well as monitoring the research continually as it proceeds (Callahan, 1998). The case of Willowbrook State School, there is nowhere that we are told that the risk/benefit assessment was undertaken prior to the administration of mild form hepatitis to the mentally ill children. The safety of these children was not taken onto consideration prior to the study (Gibbs, 2004). This was a grave violation of the rights of these children. Critically important to mention, the researcher must obtain an informed consent from the participants before conducting a clinical investigation that involve the use of human beings as subjects (Faden & Beauchamp, 1986). This informed consent should be obtained in writing after the participant has received a full disclosure of benefits, and risks with regard to the study. Similarly, the subject must have been given an opportunity to evaluate the risks and benefits associated with the research by asking extended questions (Callahan, 1998). Accordingly, the informed consent should be an ongoing process and not just a formality process. An informed consent can also be given by the custodian of the participant if the participant is incompetent due to his/her mental status. The case of Willowbrook State School, although the informed consent was given by parents of the participants, the participants were not given a fair opportunity. They were treated unjustly, for instance, these children were institutionalized thus going against the justice ethical principle. Privacy and confidentiality of the participants is another vital issue that the researcher must observe when conducting a clinical research involving human subjects (Gibbs, 2004). For example, the investigator is obliged not to release participant’s information to unauthorized personnel and also how the subject is to be notified of any unforeseen findings from the study that he/she may or may not want to know (Callahan, 1998). Accordingly, if need be to release this confidential information, the subject must be informed. The Willowbrook State School case displays a situation where the findings from the research can be easily be released to the public since there are no regulations as to how the results will be treated. Similarly, there is no any communication with regard to the implications the study might have on the participants. This undermines privacy and confidentiality ethical concerns. The way adverse events will be handled due to the clinical research study must be comprehensively stated. The investigator undertaking the study must clearly state and have a clear procedure for handling adverse events should they occur; for example, the person that will provide care for the injured participant and the person that will pay for the care must be present (Callahan, 1998). The Willowbrook State School case study has no explanation with regard to will take care and for the care for the participants in case; they were injured in course of the study. The case has compromised this ethical concern in the event of a clinical research study involving human subjects. Furthermore, when enrolling participants for a clinical research of human subjects it is significantly important for the researcher to be in a state of equipoise; for instance, if a new intervention is being investigated against the currently accepted treatment, the researcher must be genuinely uncertain as to which method is better (Callahan, 1998). An informed consent that is ethically valid when conducting a clinical research study involving human subjects must have the components including disclosure, understanding, voluntariness, competence, and consent (Morreim, 2004). Disclosure in this essence demands that the researcher fully informs the potential participants about the nature and purpose of the study, the procedure that will be used, the expected benefits to the participants and/or the society, the foreseeable dangers/risks, and discomforts together with the alternatives of taking part in the research. Consequently, the researcher must provide a statement that describes the procedure that be used in the study in order to ensure privacy, confidentiality or anonymity of the participant (Morreim, 2004). It is also important for the consent document to make it clear the person to contact with questions about the study, the rights of the participants and in case of injury (Gibbs, 2004). The case of Willowbrook State School, we are told that the parents of the participants are the ones who signed the informed consent document on behalf of their children. Although, these children have mental problems, the researcher ought to have provided the risks or dangers associated with administering mild hepatitis. By not stating the related risks with the study, the researcher gravely compromised the ethical concerns of the study. Understanding in clinical research that involves human subjects’ demands that the participants should and must have full understanding of what the research is all about, for this matter, they must be given an opportunity to ask questions that have to be answered by the researcher. Above all, the language used in the consent document should be simple and easy to understand; it should not be written in clinical jargon (IOM, 2001). According to the case of Willowbrook State School, the participants were not considered to have the capacity to understand and hence they were not involved in the signing of the informed consent document. Voluntariness in clinical research studies requires that the participant’s consent to participate in the research should and must be voluntary and free of any coercion. It should also be free of promises of benefits that are unlikely result from the study (IOM, 2001). The provided case exhibits a situation where participants were unknowingly forced into participating in the study. The mentally ill children were not aware of what they went through during the study. The informed consent tenets were extremely violated in this study. Competence on the other hand demands that the research subjects must be competent for them to give their consent (Greely, 1999). This component gives a provision for a designated surrogate to give the informed consent on behalf of the participant if the participant is mentally ill, suffering from a disease, and/or due to emergency issues; the given informed consent should be in the best interest of the participant. The administration of mild hepatitis to the mentally ill children was not ethical as it was based on illusion that these children were likely to contract hepatitis; the research was not in the best interest of the participants. What makes clinical research ethical? According to Emanuel, Wendler and Grady, informed consent is neither necessary nor sufficient for ethical clinical research. Based on fundamental philosophies underlying major codes, declarations together with other documents viable for clinical research with human subjects there are seven requirements that systematically elucidate a logical and comprehensive framework for evaluating the morality and ethics of clinical research studies (Emanuel, et al, 2000). These requirements include Value; this states that the clinical research should be able to provide the enhancement of health or relevant health knowledge should be derived from the study. The research must also have a scientific validity, for instance, the research should be methodologically rigorous (Emanuel, et al, 2000). Thirdly, there should be fair subject selection; the selection should be based on scientific objectives, no vulnerability or privileges, should be potential to distribute uniformly risks and benefits, should determine communities selected as study sites and the inclusion criteria for individual subjects. Accordingly, the research should determine the risk-benefit ratio within context of standard clinical practice and the research protocol, risks must be minimized while potential benefits enhanced to individuals and the knowledge gained by the society must outweigh the risks (Emanuel, et al, 2000). There must be an independent review; here unaffiliated individuals must review the research to determine its validity before approving it; they can amend or terminate it. Informed consent; research participants should be informed about the research and provide their voluntary consent. Lastly, there must be respect for the enrolled subjects; the confidentiality and privacy of the participants must be protected, there should be an opportunity for withdrawal, and their well-being must also be monitored (Emanuel, et al, 2000). The Willowbrook State School case could have been ethical if all these requirements were followed to the latter. Fulfilling the above requirements sufficiently regards any clinical research ethical. Conclusion The use of human subjects in clinical research is a critical issue as it is faced with numerous ethical concerns. Research ethics advocates have come up with various ethical concerns that are that must be taken into consideration in order to not violate the moral rights of the individual and the society at large. The concerns raised here include participant’s safety, privacy and confidentiality, and the handling of adverse events in case they occur in the course of the study. Similarly, there are three basic principles that the investigator must consider when conducting a clinical research that involves the use of human subject. These principles are participant autonomy, beneficence, and justice for the participants. In the case of Willowbrook State School, there was grave violation of ethics. The ethical concerns together with basic research principles were gravely compromised. The principles articulated by Emanuel, Wendler and Grady; What Makes Clinical Research Ethical? Provide a framework that must consistently be followed to ensure any research is ethical. Bibliography Beecher, K. H. (1966) ‘Ethics and Clinical research,’ 1354-60, New England Journal of Medicine 274: 24, p.1359 Callahan, T. (1998) University of Washington School of Medicine: Ethics in Medicine. Available at http://depts.washington.edu/bioethx/topics/resrch.html Emanuel J. E, Wendler D. and Grady, C. (2000) What Makes Clinical Research Ethical? JAMA 283 (20): 2701-2711 Faden, R.R., and T.L. Beauchamp. (1986). A History and Theory of Informed Consent. New York: Oxford University Press. Gibbs J N. (2004) State regulation of pharmaceutical clinical trials. Food Drug Law J 59265–285.285. Greely H T. (1999) Breaking the stalemate: a prospective regulatory framework for unforseen research uses of human tissue samples and health information. Wake Forest Law Rev. 34740 Institute of Medicine (IOM). (2001). Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, D.C.: National Academy Press. Morreim E H. (2004) Litigation in clinical research: malpractice doctrines versus research realities. J Law Med Ethics 32474–484.484. Read More