CITI Training: Belmont report

CITI Training: Belmont report What are the three principles discussed in the Belmont Report? Ans- respect of persons, beneficence, and justice What does respect for persons mean? Ans- the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy. What does beneficence mean? Ans- do not harm and maximize possible benefits and minimize possible harms What does justice mean? Ans- 1. to each person an equal share, 2. to each person according to individual need, 3. to each person according to individual effort, 4. to each person according to societal contribution, 5. to each person according to merit. What are applications for Belmont report? Ans- 1. Informed Consent 2. Assessment of Risk and Benefits 3. Selection of Subjects What does informed consent mean? Ans- 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. What does Information mean? Ans- Most codes of research establish specific items for disclosure intended to assure that subjects are given sufficient information. What does comprehension mean? Ans- The manner and context in which information is conveyed is as important as the information itself. What does voluntariness mean? Ans- An agreement to participate in research constitutes a valid consent only if voluntarily given. What is the Assessment of Risks and Benefits? Ans- The assessment of risks and benefits requires a careful arrayal of relevant data, including, in some cases, alternative ways of obtaining the benefits sought in the research. What is the Nature and Scope of Risks and Benefits? Ans- The requirement that research be justified on the basis of a favorable risk/benefit assessment bears a close relation to the principle of beneficence, just as the moral requirement that informed consent be obtained is derived primarily from the principle of respect for persons. What is the Systematic Assessment of Risks and Benefits? Ans- 1. Brutal or inhumane treatment of human subjects is never morally justified. 2. Risks should be reduced to those necessary to achieve the research objective. 3. When research involves a significant risk of serious impairment, review committees should be extraordinarily insistent on the justification of the risk (looking usually to the likelihood of benefit to the subject -- or, in some rare cases, to the manifest voluntariness of the participation). 4. When vulnerable populations are involved in research, the appropriateness of involving them should itself be demonstrated. 5. Relevant risks and benefits must be thoroughly arrayed in documents and procedures used in the informed consent process. What is the Selection of Subjects? Ans- gives rise to moral requirements that there be fair procedures and outcomes in the selection of research subjects