Confidentiality Breaches & Informed Consent when Testing New Drugs Essay

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Confidentiality Breaches in Clinical Practice



The confidentiality and privacy of patients are considered as one of the fundamental freedoms that they should enjoy and are safeguarded under Health Insurance Portability and Accountability Act of 1996 (HIPPA). It is also a precept of the American Medical Association’s Code of Ethics and the Hippocratic Oath. The breach of confidentiality is unethical and illegal.

Medical professionals are under the obligation of protecting the patient’s confidentiality. Confidentiality and privacy prohibit medical providers from unlawful disclosure of the patient’s information. Some of the inappropriate disclosures include discussing a patient’s case in the elevators or corridors, giving out extra copies of handouts from conferences while they contain identifiable patients’ details and any other possible leakage of information to unauthorized individuals (Beltran-Aroca et al. 52). In clinical practice, the patients’ confidentiality can be breached due to indiscretion, carelessness, and sometimes malice. Medical practitioners are obligated legally and morally to maintain the patient’s privacy and guard secrecy. When they respect confidentiality, it safeguards doctor-patient relationship and ensures the well-being of the patient. Furthermore, failure to safeguard the patient’s private information may result in social implications and the subsequent loss of confidence in the healthcare system.



Tarasoff vs. Regents of the University of California presents a solid case on confidentiality. In this case, a psychiatric patient, Mr. Podder shared about his desire to kill his girlfriend and went ahead to do it (Bozzo 2). During the court proceedings, the doctors refused to provide evidence to the court citing the Hippocratic Oath. However, the courts maintained that the public interest to know outweighed the need of protecting the privacy of the patient. Not all judges agree with the opinion of the majority, but this case shades more light on the exception to the rule of confidentiality and when privacy or confidentiality can be breached. Some of such instances include concern for other person’s safety. Medical professionals should protect any third party who feels that the patient is threatening them (Elger, Handtke and Wangmo 51). It may also include instances of collaborative research, the concerns on public welfare, and government’s need to protect the public health. While the medical fraternity believes that this landmark case took a toll on the mental health profession, it is important to acknowledge the nature of the current society and the essentiality of re-evaluating laws to ensure they remain relevant.



People who are living with HIV/AIDS struggle in the current society marred with stigmatization. They mostly fight to psychological battles including fighting against friends and families discovering their HIV status and fighting against medical professionals who they entrust their confidential information regarding their health (Dapaah and Senah 42). These patients are wary of the probability of confidentiality breach regarding their status and the implications that would likely ensue. While the healthcare sector is scaling up the uptake of HIV/AIDS services, it outcomes might not be as expected if the victims are not convinced of their privacy. Healthcare providers face difficulties in concealing the HIV/AIDS status of their clients especially to their partners who need information on the patient’s status to support and care for them. Such a state presents a dilemma to healthcare practitioners who would easily resort to informing the client’s next of kin without seeking his or her consent. (Dapaah and Senah 44). For instance, while explaining to the family the reason a mother who is lactating is not breastfeeding, it is almost impossible not to disclose her status to her significant others.



Mark Siegler, Chicago physician-ethicists wrote an essay ‘Confidentiality in medicine-a decrepit concept” highlighting that patient confidentiality that has been taught from the Hippocrates era is dead. The battle is significantly between providing quality care and ensuring the patient’s confidentiality. In the current medical scene, the best care is provided in teaching highly staffed hospitals and necessitates role-playing by a significant number of nonmedical hospital desire. While the patient care advances, it mostly at the expense of the patient’s privacy (Beltran-Aroca et al. 60). Siegler underscores the significant changes that the healthcare system has experienced in the past few decades.

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However, it would be inappropriate to disregard the patient confidentiality rule entirely because it would cause total insanity and loss of confidentiality in the healthcare sector (Beltran-Aroca et al. 64). Confidentiality should be maintained in the healthcare sector by safeguarding the patient’s private information from those who should not know while protecting it against abuses. Therefore, incorporating medical law and ethics in the medical student’s curriculum is important to ensure that awareness is created regarding handling and managing clinical information.

Informed Consent when Testing New Drugs



Informed consent in a clinical trial has many facets to it and involves more than obtaining the research subjects written or verbal informed consent to take part in the trial. The informed consent concept is embedded in The Belmont Report, The Declaration of Helsinki, and the principles of Nuremberg Code (Nijhawan et al. 134). Informed consent entails providing a potential participant with sufficient information regarding the participation in the clinical investigation. The researcher should ensure the participants understand the information fully. The participants should be given ample time to ask questions and deliberate on the research protocol before deciding on whether to participate in it. After obtaining the participant’s voluntary agreement to participate in the study, the researcher should continue furnishing the subjects with more information as the clinical trial progresses.



During the development of new medical products, it is unclear whether they will work and the risks involved. Clinical trials are used to measure whether the new drug is safe enough to outweigh the related risks. It determines how the drug should be used including the best dose, frequency, precautions, and contraindication. It also measures the efficacy of the drug at curing or treating a condition or relieving pain. Clinical trials primarily purpose to study new medical products like AIDS drugs in people. It is imperative that those participating in a clinical trial are well acquainted with the role of a study subject and not as a patient (Nijhawan et al. 135). While the participants may get personal treatment from participating in a clinical trial that may be beneficial, they must be well-aware that they may be exposed to unknown risks, may not benefit from the clinical trial, and the study may be dissimilar from the standard medical protocols that they are well-conversant with currently.



Informed consent is crucial in any clinical trial and to ensure that the potential participants make an informed decision, the researcher should provide information on what will be done to them, the protocol of the research, discomforts or risk involved, and a reminder that participation is voluntary (Staunton 3). When obtaining consent from vulnerable groups or people such as individuals living with HIV/AIDS, appropriate strategies for communicating what the study entails should be employed. Disclosure of information about the study may not be a challenge, but comprehension of this information is not guaranteed. It is the responsibility of the principal investigator to simplify the information to the study subjects’ level of understanding.



As a vulnerable population, people living with HIV/AIDS are quite willing to try out cures that are unproven hoping to be free of the disease. Therefore, the population is willing to assume great risks in their pursuit of recovery. These individuals are more likely to enroll in the early stages of a trial on HIV/AIDS drugs regardless of being informed that it may not be beneficial to them (Staunton 6). Moreover, a therapeutic misconception is likely to occur because the participants would assume that the decisions made are based on their best clinical interest. In such situations, the participants are likely to overestimate the benefit and underestimate the risk. If the participants fail to recognize that the decisions made….....

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Work Cited

Beltran-Aroca, Cristina M., et al. "Confidentiality breaches in clinical practice: what happens in hospitals?." BMC medical ethics17.1 (2016): 52-64.

Bickenbach, Jerome. "WHO’s Definition of Health: Philosophical Analysis." Handbook of the Philosophy of Medicine (2015): 1-14.

Bozzo, Alexander. "A challenge to unqualified medical confidentiality." Journal of Medical Ethics (2017): medethics-2017.

Dapaah, Jonathan Mensah, and Kodjo A. Senah. "HIV/AIDS clients, privacy, and confidentiality; the case of two health centers in the Ashanti Region of Ghana." BMC medical ethics 17.1 (2016): 41-51.

Elger, Bernice S., Violet Handtke, and Tenzin Wangmo. "Informing patients about limits to confidentiality: A qualitative study in prisons." International Journal of Law and Psychiatry 41 (2015): 50-57.

Habersack, Marion, and Gero Luschin. "WHO-definition of health must be enforced by national law: a debate." BMC medical ethics 14.1 (2013): 24-26.

Hróbjartsson, Asbjørn, et al. "Observer bias in randomized clinical trials with measurement scale outcomes: a systematic review of trials with both blinded and nonblinded assessors." Canadian Medical Association Journal 185.1 (2013): 201-211

Hall, William, et al. "Priority Setting and Resource Allocation in Healthcare: Learning from Local Government." Journal of Health Care Finance 43.3 (2016): 1-23.

Nijhawan, Lokesh P., et al. "Informed consent: Issues and challenges." Journal of advanced pharmaceutical technology & research 4.3 (2013): 134-140

Kapstein, Ethan B., and Joshua W. Busby. AIDS drugs for all: social movements and market transformations. Cambridge University Press, 2013.

Preda, Adina, and Kristin Voigt. "The social determinants of health: Why should we care?." The American Journal of Bioethics 15.3 (2015): 25-36.

Staunton, Ciara. "Informed consent for HIV cure research in South Africa: issues to consider." BMC medical ethics 16.1 (2015): 3-10.
 

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