Legal and Ethical Impacts - Research Proposal Example

Legal and Ethical Impacts Legal and Ethical Impacts Introduction Nowadays, most of the health-care delivery systems in the world are“wired” in the country; they have electronic patient records that are transferred digitally. The heavy involvements in electronic patient records lead to paralleled and deep commitment towards protecting the privacy of the patients found in electronic databases. The health facilities are required to have Information Security Committee that report to the facilities senior management or Board of Trustees in order to generate and refine organizational policy that protect or secure patient privacy and confidentiality. As a result, most of the health facilities have long detected controls experience; detect controls are helpful when working with very high volumes of data, this controls associated with delays in the patient care delivery and could lead to patient harm. Advanced healthcare facilities use different modalities in detecting ethical violations of patient confidentiality. Advanced and well-managed health facilities have the following characteristics in terms of patience privacy: identifying controls first using a Compliance Department to investigate potential ethical violations and act on them within a month; check on areas susceptible to ethical violations, for example they occur primarily in routine-care-delivery areas at high volume, and some privacy violation experienced are associated with the quality improvement; and detection controls are meant for effective management system. Statement the Problem Despite most of the health care facilities leading corrective action in particular cases, there are patterns of patients’ privacy violations that are evident with time; these demonstrate more effective oversight and training required reflecting the high rates of privacy violation. Literature Review Most of the advanced or well-managed health facilities (AWHF) explore the Clinical Quality Improvement (QI) before confirming any patient documentation project; a well-described gap in between what the health facility should achieve when patients are seeking care and the actual results, an AWHF mostly implement data systems that track medical cost or service outcomes from primary clinical-care-delivery processes. When correctly combined with clinical management structures, result in quality control and improved system that achieve significant system improvements widely in clinical results accompanied by reduced care delivery costs; in the modern health care systems, performance improvement has moved from being optional to being a requirement for good practice (Boylan, 2004). Since some health care-delivery settings consist of information subsystems and internal governance structures that are relatively parallel to those found at AWHFs, these systems find AWHF’s ethical oversight structures perfect fit. By utilizing or implementing internal structures that are adhered to by AWHFs, can improve and manage ethical performance in every aspect of health care professionals’ interactions with their patients (Holland, 2007). At AWHFs, they honor all the four ethical principles that are observed in all patient interactions: beneficence, autonomy, justice, and non-maleficence; There are two main classes or sets of risk are attached: the risks to physical or mental health; and the risks to autonomy, privacy, or confidentiality, and related risks to reputation or respect. Ethical performance is evaluated in terms of the potential conflicts of interest that might have led a health-care professional to consider or make a patient’s health needs or process anything less than the top, first, priority. "Generalizable knowledge" is precisely defined as it is utilized in the Federal Regulation or Authority that governs ethical oversight of researchers, the Common Rule or Law, in the relevant circumstances of potential conflicts of interests. It is totally not possible to make research definable in intent to publish or even in terms of publication of the measurement of methods utilized; whether measured assessments are used or are not utilized at all. United States Health Insurance Portability and Accountability Act, the HIPAA, outlines clearly that any activity that has a primary purpose of care-delivery performance such as the "health-care operations" in particular contradistinctions to research activities. There are two core instruments that are used in implementation of ethical oversight; prevent and detect controls. Detect controls are also known as the enforceable policies or the retrospective reviews. They set policies, train all stakeholders in it, commit all health care providers to follow it to the letter, for example, requirement in signing in order to access confidential agreements, they monitor any potential violations, investigating potential violations, taking appropriate action in relation to the results of investigations (AWHFs Sanctions Grid). Prevent controls are also known as the prospective reviews. They pre-review or approve any activities before proceeding further; hence providing any on-going oversight by a privacy board or the Institutional Review Board, the IRB (Fairchild, 2004). Prevent controls entail much exorbitant cost in their operations, in terms of staffing, effort, and time needed for the organization and effort and time required of those subjected to review. For that reason, prevent controls are typically reserved for departments or areas with comparatively low volume and potentially high risk of ethical conflict of interest. The detect controls are often applied under the conditions of high volume and comparably low risk (Kass, 2001). Generally, hospitals put into effect the ethical principles of autonomy through patients informed consents, during the admission to the hospital, health care facility, to generally acquire health-care services, and via specified and informed consent documentation completed prior crucial surgical procedures or dangerous medical treatments or procedures. Even though chances of inappropriate conflicts of interest might be high, for instance a surgeon can stand to obtain significant payment or income for performing some operational procedure, which might distort their presentation of risks and benefits to the patient; the volume exclusively rules out any external ethical review prior to each procedure is carried out, prevent controls. For this reason, hospitals depended on the detect controls, which is hospital staffs or the surgeon are instructed to acquire signed and duly witnessed informed consent documentation; consent documentation is reviewed via the hospitals or health facilitys internal quality-assurance standards; the external accrediting agencies, for example, the Joint Commission on Accreditation of Healthcare Organizations constantly reviews the hospitals oversight procedures and practices; and the courts and legal system reviews allegations and accusations of the violations of individual rights via malpractice tort actions (Holland, 2007). Analysis Patient interactions entail a number of activities, described in figure one. The approach encompasses the four possible ethical principles to any patient-related activities or operations, well beyond the scope or areas habitually addressed by the policies meant to govern research only. Figure 1 Patient Interaction Activities The expression randomized treatments is used in the figure one in order to help in defining experimental research and is designated to those scenarios where randomization is an essential part of a study design when comparing competing treatments. The act of randomization, in some rare circumstances, does not dependably describe experimental research. These circumstances include when randomization utilized for the purposes of equity, especially when allocating scarce resource; or when randomized implementation is introduced in a new service or treatment to check if claims for its utilization, generating in research set up, hold up in practical world. In other world, AWHFs might permit new treatment or procedure on a pilot basis on randomly chosen subset of the system in a short period time to check whether it results in gains as outlined in a published literature (Bayer & Jennings, 2007). Quality improvements (QI) are part of the health-care operations and activities that are primarily meant for better health-care-delivery performances, and directly beneficial to the every patient involved; any attempt in implementing established desirable practice, contrary to scientifically determining desirable practice - outlined in terms of Level I, that is randomized control trial, Level II or the observational designs, and Level III or the consensus expert evidence or opinion; utilizes open loops or shared baselines methodology that motivates health professionals to take different courses from the treatment guidelines in order meet a particular patients need, that is, QI activities or procedures do not hinder health professionals and derail their ethical obligations to patients. Functions at different system levels, instead of the patient level supports and advises clinicians treating patients instead of directly allocating treatments at the patients’ level; this entail additional sophisticated analytic and measurement methods aimed at the management process and performance assessment; and might produce experiential information that is vital to other officers or groups trying to implement ideal practices. Solutions Various health facilities should use prevent controls in overseeing the ethical conduct of clinical research procedure or activities. A health professional in case of an ethical conflict of interest should put clinical research in place. A nurse, physician, or other health professionals may unconsciously or consciously place professional desires to yield shared biomedical information above their primary ethical obligation to the patients well-being and health-care needs. Just like any other patients interactions, clinical researchers require ethical oversight. An environment with a comparably low volumes of researchers activities with high exposure of ethical failures, the health facilities should use prevent controls, the policy boards and the IRBs, in overseeing appropriate ethical behaviors in the clinical researches activities. The health facilities should use detects controls in order to ensure ethical patients interactions when carrying out QI scheme: detect controls are suitable because, as they are ethically mandated actively to encourage results improvement in the entire care-provision settings; there are high volumes of performance-improvement projects or activities within the given system therefore making prevent controls difficult to implement; and the perils of QI activities towards the patients are reduced as compared with the well-documented perils of regularly poor-performing care. Quality betterment projects should gain perspective oversight, that is prevent controls, in scenario where someone considers sharing care-delivery-improvement activity with the healing professions, a scenario where a project transforms into a research setting hence raising the raising of potential conflicts of interest: this methodology parallels the case-series reports when it comes to studying models for a good oversight and risks to patients. Special ethical oversights normally include expedited review estimating the release of summary patient data or information extracted from routine or regular health-care operations. Administrative oversight are distinguished from ethical reviews; accountability, specifically, and authority for the ethical oversight lies with the side of administration only; proper administrative officers look for independent ethical reviews for particular projects, then work upon IRB advice in compliance with the health facilities internal policies; this is vital in terms of how the health facilities manage large or multicenter trials with other researchers collaborations. The health facilities associated people, which are the employees, are legally or morally required to meet ethical considerations in their patient-related activities, this includes the direct care delivery; performance-improvement activities ; other health-care operations; and research. QI requires measurement projects that primarily focus on the local patient-care-delivery performance instead of the suggestion of new scientific idea or knowledge; try to constantly accomplish established recommended practices based on existing Level I to Level III evidences; and also involving open-loop systems that clinicians are recommended to modify implementation terms based on patients’ need, that is QI protocol delivery does not bring any conflicts when the clinician’s principle ethical obligations to the patients’ well-being (Bayer & Jennings, 2007). QI will never include activities that involve unproven or experimental therapies, treatment that is not evidence-based best; whereby patients are treated randomly with competing treatments, which are potentially conflicting with the clinician’s principle ethical obligation to the patient’s well-being). This enforces additional testing expenses that represent perils to a patient, while not transferring any potential benefits to the same patients; or which is provided funds by awards or external grants with secondary or primary ambitions of knowledge generation, for example those managing the project have some conflicts of interest that might place the patients’ interest or well-being secondary to other goals. Conclusion All health facilities should use detects controls to manage all the QI activities or projects: All the health facilities’-related health professionals should regularly be trained on their ethical commitments towards all aspects of patient care delivery, and these should include the QI activities. The health facilities should routinely monitor for any violations, for example, the experimental research activities that masquerade as the QI; in case any breach is observed, the health facilities Sanctions Grid should be applied in order to correct the circumstance and deliver appropriate punishment if necessary. The health facilities should also utilize information received from the oversight procedures for improving training and other oversight activities, the detect controls functions as the management system but not as a punishment system. The health facilities should use prevent controls, the privacy boards and the IRBs, in reviewing all their research activities or projects prior to their initiation and also monitoring the on-going research activities and projects. If QI efforts achieve exemplary performance outcome and the clinical leadership teams associated would like to share their experiences through publications, established external ethical oversight should be applied at that scenario, most the activities might engage public release of the available no identifiable clinical information and data, and it should be overseen via an expedited review through privacy boards. This is how the health facilities should case-series reports. References Bayer, S., & Jennings, M. (2007). Public Health Ethics. New York: The Oxford University Press. Boylan, M. (Ed.). (2004). Public Health Policy and Ethics. Dordrecht: Kluwer Publishers. Fairchild, L. (2004). Public Health Ethics. Bioethics, 472-493. Holland, s. (2007). Public Health Ethics. Cambridge: Polity Press. Kass, E. (2001). Ethics Framework for the Public Health. The American Journal of Public Health, 91, 1775-17783. Philpot, M., Balint, E., Strosberg, K., & Baker, T. (Eds.). (2006). Advance in Bioethics (Vol. IX). London: Elsevier. Read More