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Good Clinical PracticeWhich of the following are the three principles included in the Belmont Report? - correct answer • Respect for Persons • Beneficence • Justice Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subject...

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  • November 30, 2023
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  • 2023/2024
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Good Clinical Practice
Which of the following are the three principles included in the Belmont Report? - correct answer • Respect for Persons
• Beneficence • Justice
Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? - correct answer • Determining that the study has maximized benefits and minimized risks.
* The Belmont Report's principle of beneficence includes the two general rules as complementary expressions of beneficent actions (1) do not harm and (2) maximize possible benefits and minimize possible harms. Providing detailed information about the study and obtaining the subject's consent to participate would be an example of the principle of respect for persons. Ensuring that the selection of subjects includes people from all segments of the population would be an example of the principle of justice. Finally, ensuring that confidentiality is maintained is a regulatory requirement per HHS regulations 45 CFR 46. Ensuring confidentiality could be supported by respect for persons (extending the idea that the subject's right to autonomy could include their right to privacy and confidentiality) and beneficence (that maintaining privacy and confidentiality helps to protect subjects from potential harms of a breach of confidentiality with sensitive information), but it is not the best response for this question since it is not directly an example of the principle of beneficence in human subjects research.
Which of the following best describes the principle of Respect for Persons as described in the Belmont Report? - correct answer • Information
• Comprehension
• Voluntariness * Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied. While the importance of informed consent is unquestioned, controversy prevails over the nature and possibility of an informed consent. Nonetheless, there is widespread agreement that the consent process can be analyzed as containing three elements: information, comprehension and voluntariness. In terms of explaining the probability of assignment to trial arms in consent forms, which is true? - correct answer • ICH notes that it should be included, but does not specify how the information should be presented.
* ICH (2016) E6 Section 4.8.10(c) states that "Both the informed consent discussion and the written informed consent form and any other written information to be provided to subjects should include the probability for random assignment to each treatment;" however, it does not specify how the information
should be presented. The FDA has no such requirement about including probability for random assignment to each treatment, but does require an identification of any procedures which are experimental. This difference can be addressed by including a description of each arm of the study in the
consent form, and including a statement about the likelihood of receiving each of the study arms.
The new ICH E6(R2) integrated addendum requires sponsors to implement systems to manage quality throughout all stages of the trial process. The system should use a risk-based approach including which of the following? - correct answer • Identification of study risks to determine which may safely be omitted from continual monitoring.
* ICH (2016) E6 Section 5.0.4 states that the sponsor should decide which risks to reduce and/or which risks to accept. The approach used to reduce risk to an acceptable level should be proportionate to the significance of the risk. Risk reduction activities may be incorporated in protocol design and implementation, monitoring plans, and agreements. Routine scheduled audits of study documentation whether on-site or remote are not considered fully responsive to the need for continuous monitoring of data under a proactive risk-based approach. While data from Case Report Forms may be selected for ongoing monitoring, there is no ICH template and a "one-size-fits-all" approach is not appropriate for study-specific monitoring. The use of any specific method of analysis quality improvement is not required and routine annual review may not be sufficient for monitoring the study-specific risks that have been identified.
What is the status of ICH in U.S.? - correct answer • It is a FDA guidance * After the ICH E6 guideline was finalized, several countries adopted it as law. In the United States, however, the FDA adopted the ICH E6 only as guidance. Therefore, the ICH E6 guideline does not have the force of law in the United States and is not a regulation. In the Federal Register notice, FDA stated that the ICH E6 guideline "does not create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes, regulations, or both" (HHS and FDA 1997, 25692). Therefore,

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