Ethical Issues on Confidentiality: Research and Medical Procedures A guiding principle followed by most administrators and health care providers is the concept that ethical principles must match the values of the whole organization. This belief should serve as a continuous teaching to all staff so that the organization’s goals may be uniformly achieved. Healthcare administrators must be fully competent in adhering to the ethical principles of patient and employee confidentiality in order to promote trust, respect, and the protection of individual’s rights concerning health information. This is one of the main objectives of the Privacy Rule or HIPAA, and a breach to this rule is one of the most common ethical issues. When administrators demonstrate capable ethical decisions in guiding the flow of services in the organization, there may only be a few disorders that will be encountered in the operations as a result of ethical perplexities.
In the article, Ethics of Stem Cell Research (Siegel, A., Stanford Encyclopedia of Philosophy, Spring2013), the ethical dilemma of confidentiality in research pales in comparison to the dilemma posed in destroying human embryonic cells. A great dispute is presented on the use of human embryos and whether researchers are dealing with a human being or not. The question on the permissibility or the impermissibility to destroy human embryos is fully explored without the full ethical answer being presented. Confidentiality, research, and medical procedures all impart ethical dilemmas that complicate organizational activities. Problems of the Affected Population: Patients and Participants In the procurement of embryotic cells for example, research subjects are not considered the same way as patients and regarded differently in terms of confidentiality and privacy issues.
According to the article, HIPAA, the Privacy Rule, and Its Application to Health Research (2009), “Health research is not the focus of HIPAA.” and, “Because a great deal of health research in the United States is also subject to the Common Rule- the federal rule that governs most federally funded research conducted on human beings and aims to ensure that the rights of human subjects are protected during the course of a research project, historically focusing on protection from physical and mental harm by stressing autonomy and consent.” (HIPAA and Research, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, 2009). Many research institutions are not considered covered entities and therefore the subjects are not covered by the Privacy law. Nevertheless, all subjects must submit personally identifiable health information and in the course of research or procedure, a subject may be harmed.
This is an uneven application of confidentiality and the Privacy law that gives more benefit to a patient than a research subject. Medical research in particular has a participant and some experimental procedures are accomplished with the patient as the subject in the belief that the experiment could bring positive results to the patient specially, when there is no definite answer to a needed treatment. According to Fremgen B.F. (2009), ethical issues arise when there is harmful effect to the patient from experimental procedures. Lack of understanding and communication remains a big barrier to ethical issues.
Somehow the creation of the Privacy Law did not consider the welfare of the research subject, yet they are likened to a patient who undergoes procedures, submits identifiable health information, and when procedures are not perfect, may also suffer harmful consequences. The other bothersome issue is when the bodily parts contributed by the participant are sold, reused or endorsed to other institutions for other purposes. Other issues pertain to the interest of the researcher placed above the interest of the patient (B.F.Fremgen2009). Informed and voluntary consent from participants are used as shield in order to further the research activities, but privacy and confidentiality are both compromised on research participants and must also be incorporated.
In California, where the biggest budget for stem cell research is allocated, the California Institute of Regenerative medicine (CIRM) in their objectives has encouraged institutions and researchers on the development of best practices in hSC projects. Institutional Review Boards (IRBs) at each research institution must be responsible for the proper review of projects involving human participants. The regulations of the CIRM implies that donor consent must be understood fully by the participant, maintain a clear record of every embryo, strict accounting of donated cells, and must always be consistent with existing laws. In fairness to the donor, any medical complication must be treated fully, and the donor must not bear any cost for any treatment (G.P Lomax, Z. Hall, B. Lo, Responsible Oversight of Human Stem Cell Research: The California Institute for Regenerative Medicine, 2007)
The foundation for all procurement of biological materials can be summed in informed consent. Authorizations and voluntary consent must be explicitly understood by the donor and must be presented with choices they can understand including the information regarding the destruction of the cells, commercial application and sharing (L. P Knowles, Issues in Procurement of Embryonic Stem Cells: Informed Consent and Conflict of Interest, n.d.) Information management system must be in place for protection of confidentiality. In most instances, the system must protect the anonymity of the donor to safeguard privacy. There will always be people who would donate biological materials for their own reasons beyond ones understanding.
These individuals must be informed fully of the consequences and possible risks. In some places, inducement of monetary consideration is prohibited. However, there are instances when the donor sincerely commits to help in exchange for some requirements like burial assistance when deemed terminally ill. Ethical issues and personal choice of the donor must be taken into consideration at all times and the option to donate must be free from pressure. In some parts of the globe, there are ads roaming related to procurement of organs from individuals who are impoverished and destitute. The government and the public must be vigilant in exposing this black market trade of organ trafficking so as to safeguard the dignity, confidentiality, and humanity in general. The mainstream media must be cooperative in relaying to the public not only the positive implications of medical research but also the contrary, so that that knowledge and understanding of present scientific advancement and problems may be learned.
The Administrator and Ethical Issues
An administrator who is engaged in a healthcare institution where research activities are occurring commits to a heavier burden of maintaining the place for it to be free of ethical issues. Aside from the issue of patient care, privacy, lack of resources, maintaining regulations, and promoting goodwill, the needed knowledge on the requirements or regulations on research must be understood. The administrator must be adept at ethical analysis and organizational policies. Many have not been through a lot of experience related to research institutions but according to Fremgen B. F. (2009), “Adherence to bioethical principles involves the entire healthcare team, not just the physicians” (pg. 251). The ethics of the institution must be in accord with the staff and conflicting values should not prevail. The administrator must know how to initiate educational sessions and communicate the ethical values even with the integration of research and experimental procedures.
Siegel, A. Ethics of Stem Cell Research, Stanford Encyclopedia of Philosophy, rev. Jan 28,2013 Retrieved from: http://plato.stanford.edu/entries/stemcells/#EthDesHumEmbForRes Knowles, L.P. Issues in Procurement of Embryonic Stem Cell: Informed Consent and Conflicts of Interest, Retrieved::http://www.stemcellnetwork.ca/uploads/File/whitepapers/Inf Consent-and-Conflicts-of-Interest.pdf
Institute of Medicine (US) Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule; Nass SJ, Levit LA, Gostin LO, editors. Washington (DC): National Academies Press (US); 2009.Retrieved from: http://www.ncbi.nlm.nih.gov/books/NBK9573/
Lomax GP, Hall ZW, Lo B (2007) Responsible Oversight of Human Stem Cell Research: The California Institute for Regenerative Medicine’s Medical and Ethical Standards.Retrieved http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.0040114 B.F. Fremgen, Medical Law and Ethics (Third Ed. 2009)
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