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What Are the Legal and Ethical Framework

In this discussion, students will critically reflect on the differences and similarities between legal and ethical norms. Use these questions to stimulate in-depth discussion and reflection on these concepts. The following framework for ethical decision-making is intended to serve as a practical tool for exploring ethical dilemmas and identifying ethical options for action. Some ethicists begin by asking, “How will this action affect everyone involved?” – emphasizing the consequences of our actions. Utilitarianism, a results-oriented approach, holds that ethical action is that which strikes the best balance between right and wrong for as many stakeholders as possible. It requires a precise determination of the probability of a particular outcome and its effects. For example, ethical business conduct produces the greatest good and harms all those least affected – customers, employees, shareholders, the community and the environment. Cost-benefit analysis is another consequentialist approach. Unacceptable: The opposite of an ethically binding act is one that is ethically unacceptable, that is, it is wrong to do so and right not to do it. For example, we would say that murder is ethically unacceptable. Ethical frameworks are useful perspectives in determining which course of action can produce the most moral outcome.

In many cases, a person may not use an argumentation process, but rather do what they think is best at that time. Others may reflexively apply a principle they have learned from family, peers, religious teachings, or personal experiences. The study of ethics has produced many principles that can help in ethical decision-making. Some of the most common are considered in the following 5 ethical frameworks: Mandatory: When we say that something is ethically “mandatory”, we mean that it is not only right to do it, but that it is wrong not to do it. In other words, we have an ethical obligation to carry out the action. Sometimes the easiest way to see if an action is ethically binding is to look at what it would mean NOT to perform the action. For example, we could say that it is ethically obligatory for parents to take care of their children, not only because it is right for them to do so, but also because it is wrong for them not to do so. Children would suffer and die if parents did not take care of them. Parents are therefore ethically “obliged” to take care of their children. In Uganda, Switzerland and the United Kingdom, waiver of informed consent by the ethics committee and the relevant regulatory authority is permitted in situations where it is problematic or difficult to obtain consent, or where the public interest in the research outweighs the interests of the subjects [21, 37, 44, 45]. In the United Kingdom, additional authorisation from a health authority is required in these cases [44]. In Sweden, research can be conducted without informed consent if a weakened health condition prevents the subject from expressing an opinion.

The consultation should be given with the patient`s closest relatives and a guardian or other legal representative. However, consent by proxy is not required, since in this country, only the researcher (if > is 18 years old) can give consent [46]. The most universal requirement for the transfer of data or samples across the national borders identified in this work is ethical approval, while approval from national health authorities is only required in certain situations. Informed consent is not required in all release situations. However, waiver of informed consent is only permitted in certain countries/regions and under certain conditions. The framework of virtue Within the framework of virtue, we try to identify the character traits (positive or negative) that might motivate us in a particular situation. We deal with the kind of person we should be and what our actions say about our character. We define ethical behavior as everything a virtuous person would do in the situation, and we try to develop similar virtues. The heterogeneity and complexity of several diseases and the deep characterization of individuals have led to the rapid development of personalized medicine. Access to large amounts of health data is the next challenge for this medical model [49]. When the data available in a country may not be sufficient to effectively develop new pharmacogenetic treatment strategies and algorithms to diagnose patients, EHR represents a formidable resource for achieving the validity of results and increasing the impact of research. However, the lack of a uniform ethical and legal environment is an obstacle for the scientific community [2, 12].

This study shows that researchers are currently working in a very complex legal and ethical landscape. Regulations vary from country to country or region and are often incomplete, leading to uncertainty. There are also differences between regulations within a country. In Turkey, for example, while data protection law allows the use of unencrypted data with subjects` consent, sub-regulations restrict the use of unencrypted health data. In addition, rapid regulatory change over time makes it difficult for researchers to keep abreast of the latest regulations in all jurisdictions. There is an unmet need for an accessible resource that provides information on country-specific ESN requirements. Nevertheless, the complexity of this field means that, in many cases, researchers still need the advice of experienced professionals [12].

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