GOOD CLINICAL PRACTICE QUESTIONS AND ANSWERS

Which of the following are the three principles included in the Belmont Report? - 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? - 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? - 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