Review the DeGrazia et al., (2015) article (posted on Blackboard), looking for evidence of any ethical or legal issues that arose in the study and how the researchers dealt with the issues. Please answer all of the following questions in your reading of the article:
- Why are the subjects in this study considered ethically vulnerable? (15 points) Hint look at your textbook for the answer.
- Identify the possible physical risks authors listed to the subjects by participating in this study. (15 points)
- Which ethical protections should be put in place to protect these subjects from harm? (15 points) List three.
- What should specifically be included in the informed consent? Hint: look at the sample on BB (15 points)
- What evidence do the authors provide that the Institutional Review Board (IRB) reviewed the study and that appropriate informed consent was obtained? Tip: this information is found in the method/procedure section of a published study(15 points)
- How do the authors minimize the risks to the subjects? (10 points)
- In your opinion, do the potential benefits of this treatment outweigh the potential risks to the infant (subject)? Why or why not? ***For only this question there are no right or wrong opinions or positions as long as they are based on a basic understanding of the required material (15 points)
Sample Solution
e to harmonisation of the VAT system in the EU, there has been a significant increase in cross-border trade. The harmonisation included the creation of cross-border trade which would ensure a significant level of trade in goods and services, thereby lessening the possibility of VAT fraud and abuse of law. The Commission has constantly highlighted the vulnerability of the VAT system and due to the complexity of the 28 jurisdictions engaged in cross-border trade, the EU legislator is faced with a constant challenge of preventing VAT as an environment for abuse or VAT fraud. 4.1.2 Vulnerability 2: 4.2 The fundamental distinction between abuse of law and abuse of rights In the context of taxation, the CJEU has defined âabuseâ as a form of tax minimisation, which through misuse of legal forms achieves a result which is not in compliance with system principles. This means that though tax abuse and tax avoidance are related, they do not coincide. At this juncture, it is important to note that both abuse of rights and abuse of law are not necessarily the same. Generally speaking, abuse of law indicates abuse in Union law, whereas abuse of rights indicates abuse of Union law. The former may be defined as a situation where a person relies on a European legal right to circumvent or displace national law, while taking advantage of a right in European law, but in a manner running contrary to its spirit constitutes the latter. In 2006, the CJEU extended the abuse of law principle in the Halifax to apply to the field of VAT. The abstract distinction between both abuse of law and abuse of rights is based on a dictum from Centros, where it was provided that abuse of law involves avoiding national provisions through claiming fundamental freedoms, whereas abuse of rights involves abusing rights directly provided by EU law. According to this dictum, a Member State: âis entitled to take measures to prevent certain of its nationals from attempting, under cover of the rights created by the Treaty, improperly to circumvent their national legislation or to prevent individuals from improperly or fraudulently taking advantage of provisions of Community lawâ. Thus, abuse of law is illegitimate from the instrument point of view. Here, a person imprope>
e to harmonisation of the VAT system in the EU, there has been a significant increase in cross-border trade. The harmonisation included the creation of cross-border trade which would ensure a significant level of trade in goods and services, thereby lessening the possibility of VAT fraud and abuse of law. The Commission has constantly highlighted the vulnerability of the VAT system and due to the complexity of the 28 jurisdictions engaged in cross-border trade, the EU legislator is faced with a constant challenge of preventing VAT as an environment for abuse or VAT fraud. 4.1.2 Vulnerability 2: 4.2 The fundamental distinction between abuse of law and abuse of rights In the context of taxation, the CJEU has defined âabuseâ as a form of tax minimisation, which through misuse of legal forms achieves a result which is not in compliance with system principles. This means that though tax abuse and tax avoidance are related, they do not coincide. At this juncture, it is important to note that both abuse of rights and abuse of law are not necessarily the same. Generally speaking, abuse of law indicates abuse in Union law, whereas abuse of rights indicates abuse of Union law. The former may be defined as a situation where a person relies on a European legal right to circumvent or displace national law, while taking advantage of a right in European law, but in a manner running contrary to its spirit constitutes the latter. In 2006, the CJEU extended the abuse of law principle in the Halifax to apply to the field of VAT. The abstract distinction between both abuse of law and abuse of rights is based on a dictum from Centros, where it was provided that abuse of law involves avoiding national provisions through claiming fundamental freedoms, whereas abuse of rights involves abusing rights directly provided by EU law. According to this dictum, a Member State: âis entitled to take measures to prevent certain of its nationals from attempting, under cover of the rights created by the Treaty, improperly to circumvent their national legislation or to prevent individuals from improperly or fraudulently taking advantage of provisions of Community lawâ. Thus, abuse of law is illegitimate from the instrument point of view. Here, a person imprope>
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