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Introduction
The conduct of medical research in laboratories is subject to both ethical and legal provisions. The clinical laboratory operations within a given country are driven by a set of ethical conduct, which the researchers and laboratory technicians are expected to observe (Wiggins & Wilbanks, 2019). For instance, in biomedical research, the laboratory technicians have a mandate to monitor values, such as dignity, autonomy, and the subject’s privacy. The legal considerations, which the researchers need to observe in clinical laboratory activities, include issues such as informed consent, participant safety, and confidentiality. The laboratory management’s failure to follow these ethical and legal requirements is bound to undermine its operations, credibility, and reputation. This essay will examine the legal and ethical issues which underpin clinical laboratory activities.
Ethical Considerations
Ethics is a term that refers to habits or customs. Ethical considerations in the laboratory setting have evolved significantly over the years, considering the numerous unethical testing of research subjects in the past. For instance, the Tuskegee experiment saw an entirely black population become the test subjects in a clinical trial without their informed consent (Wiggins & Wilbanks, 2019). The evolution of laboratory ethics is geared towards ensuring similar incidents of malpractice do not take place. For instance, there is a need to inform the research participants about the study and make sure researchers act professionally. Therefore, the development of ethical standards through consensus with stakeholders in various settings has led to the formulation of the Nuremberg Code, the Belmont Report, and the Declaration of Geneva (Friesen et al., 2017). The provisions in these reports outline the steps which clinical technicians should observe when conducting healthcare research.
The core tenets of ethical healthcare research include justice, beneficence, and respect for persons. The researchers have a responsibility to acknowledge the independence of the study participants. For instance, the test subjects must get involved in the exercise out of their volition, and the laboratory stakeholders should not exercise undue influence over them (Friesen et al., 2017). Beneficence outlines the need for the researchers to act in the best interest of their research subjects at all times. In handling human participants, the clinical researchers must focus on maximizing benefits and minimizing the test harm. Justice is a component that outlines the laboratory experts’ responsibility to ensure they treat their patients equally and without prejudice. For instance, laboratory professionals have a mandate to treat their subjects fairly and give them a comprehensive report of the benefits, risks, and costs they have to endure.
The International Organization for Standardization (ISO) has developed multiple codes meant to guide laboratory operations activities. The standards set by ISO, such as ISO 15189:2012, highlight the requirements for competence and quality in laboratory activities (Biros, 2018). The clinical laboratory stakeholders need to observe the provisions in this standard since it summarizes the acceptable ethical conduct for each party. ISO 15189:2012 describes the need for laboratories to ensure they do not engage in activities that might diminish their competence and call to question their judgment or operational integrity. The standard informs healthcare researchers of the need to declare a conflict of interests and avoid pressure or influence which might affect their work (Friesen et al., 2017). Clinical laboratories, which meet the provisions of ISO 15189:2012, are bound to stand out in the industry since their conduct will be above reproach.
The ethical issues that clinical laboratories have to deal with in their routine activities include psychological risks to the subjects and preferential treatment. The laboratory staff faces different problems in their operations, which might be a source of ethical dilemmas, such as the test subjects’ lack of understanding of what is taking place. The researchers have a responsibility to understand each research subject’s capability and capacity and ensure they inform them about the initiative (Biros, 2018). For example, the laboratory staff must administer surveys and questionnaires to collect data about the study participants, determining whether they complete the exercise effectively. The research subjects should not encompass individuals who have mental illness since they cannot make decisions.
Laboratory staff should also consider ethical issues, such as collecting samples, retaining records, using remnants of the specimens, and sharing information assets with third parties. In their engagement with the research subjects, the researchers need to ensure they are fair and just by outlining how data and samples extracted from them will be used by the laboratory (Biros, 2018). For instance, there is a need for the researchers to develop a framework for the retention of medical records and sharing of information with external parties. The framework created on medical records and specimen management needs to be shared with the research participants, considering they should know what will happen with their information assets (Bracken-Roche et al., 2017). The disclosure of the patient’s data without their consent amounts to a breach of trust and privacy and can lead to the aggrieved party’s legal action.
Legal Issues in Clinical Laboratories
The legal considerations that the laboratory staff needs to know to include the regulations on research data, participant privacy, and the transmission of results. The researchers have a mandate to effectively manage the information assets, such as names, date of birth, and other identifiable details they collect from the study subjects. Data collected in a clinical study needs to be effectively managed, considering its quality can be quickly compromised by malicious actors and errors (Bracken-Roche et al., 2017). The clinical laboratories are accountable for their actions and have the mandate to ensure they do not act to compromise the study participants’ wellbeing.
The researchers have to ensure information assets, such as subject data, are held in confidence and are not disclosed to parties without sufficient authorization. For example, the laboratory staff must ensure they secure the specimens and participant data from unauthorized access by implementing security measures, such as access control and identity authentication. Observing measures, such as the federal Animal Welfare Act (WFA), ensures the researchers do not engage in unethical and illegal practices (Bracken-Roche et al., 2017). The Public Health Service Policy on Human Care outlines the steps laboratory staff need to meet to ensure their studies are legal and do not violate provisions, such as informed consent and privacy.
Conclusion
Clinical laboratories do not operate in a legal lacuna since there are set directives and legislation on their staff members’ conduct. In recent years, clinical research has become a critical component, considering it is synonymous with developing solutions to challenges afflicting society, such as diseases. Therefore, there is a need to ensure that the research activities carried out in laboratories are beyond reproach, and that all ethical or legal issues are mitigated. In managing the laboratory activities, there is a need to control the specimens and data collected effectively. For instance, laboratory staff members must ensure they do not disclose study participant data to third parties without the necessary approval.
References
Biros, M. (2018). Capacity, Vulnerability, and Informed Consent for Research. Journal of Law, Medicine & Ethics, 46(1), 72–78.
Bracken-Roche, D., Bell, E., Macdonald, M. E., & Racine, E. (2017). The concept of ‘vulnerability’ in research ethics: an in-depth analysis of policies and guidelines. Health research policy and systems, 15(1), 8.
Friesen, P., Kearns, L., Redman, B., & Caplan, A. L. (2017). Rethinking the Belmont Report?. The American journal of bioethics : AJOB, 17(7), 15–21.
Wiggins, A., & Wilbanks, J. (2019). The Rise of Citizen Science in Health and Biomedical Research.The American journal of bioethics : AJOB, 19(8), 3–14.
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