PPA 691 – Seminar in Public Policy Analysis Lecture 1d – The Belmont Report

Boundaries between Research and Practice “Practice” refers to interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success.

Boundaries between Research and Practice “Research” designates an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to contribute to generalizable knowledge.

Basic Ethical Principles Respect for persons. –Individuals should be treated as autonomous agents. –Persons with diminished capacity are entitled to protection. Respect for persons. –Individuals should be treated as autonomous agents. –Persons with diminished capacity are entitled to protection.

Basic Ethical Principles Beneficence (making efforts to secure their well-being). –Do not harm. –Maximize possible benefits and minimize possible harms. Beneficence (making efforts to secure their well-being). –Do not harm. –Maximize possible benefits and minimize possible harms.

Basic Ethical Principles Justice (who ought to receive the benefits of research and bear its burdens). –Possible criteria (equal share, individual need, individual effort, societal contribution, merit). –Avoid systematic subject selection because of availability, compromised position, or manipulability. –Avoid research results that may only go to those who can afford them or involve subjects unlikely to receive the benefits of subsequent applications. Justice (who ought to receive the benefits of research and bear its burdens). –Possible criteria (equal share, individual need, individual effort, societal contribution, merit). –Avoid systematic subject selection because of availability, compromised position, or manipulability. –Avoid research results that may only go to those who can afford them or involve subjects unlikely to receive the benefits of subsequent applications.

Applications Informed consent (Respect for persons). –Information. –Comprehension. –Voluntariness. Informed consent (Respect for persons). –Information. –Comprehension. –Voluntariness.

Applications Risk/benefit assessment (Beneficence). –The nature and scope of risks and benefits. The probabilities and magnitudes of potential risks and benefits. –The systematic assessment of risks and benefits. Determination of the validity of the presuppositions of the research Nature, probability, and magnitude of risk should be distinguished with clarity. Reasonableness of risk and benefit probabilities. Risk/benefit assessment (Beneficence). –The nature and scope of risks and benefits. The probabilities and magnitudes of potential risks and benefits. –The systematic assessment of risks and benefits. Determination of the validity of the presuppositions of the research Nature, probability, and magnitude of risk should be distinguished with clarity. Reasonableness of risk and benefit probabilities.

Applications Risk/benefit assessment (Beneficence). –Application of several principles. Brutal or inhumane treatment of human subjects is never morally justified. Risk should be reduced to those necessary to achieve the research objective. When research involves serious risk, review committees must be insistent on justification for the risk. When vulnerable populations are involved, the appropriateness of involving them should itself be demonstrate. Relevant risks and benefits must be thoroughly arrayed in documents and procedures used in the informed consent process. Risk/benefit assessment (Beneficence). –Application of several principles. Brutal or inhumane treatment of human subjects is never morally justified. Risk should be reduced to those necessary to achieve the research objective. When research involves serious risk, review committees must be insistent on justification for the risk. When vulnerable populations are involved, the appropriateness of involving them should itself be demonstrate. Relevant risks and benefits must be thoroughly arrayed in documents and procedures used in the informed consent process.

Applications Selection of subjects (justice). –Fair procedures for the selection of research subjects. Individual justice in the selection of subjects would require that researchers exhibit fairness. Social justice requires that distinction be drawn between classes of subjects that ought, and ought not, to participate in any particular kind of research, based on the ability of members of that class to bear burdens and on the appropriateness of placing further burdens on already burdened persons. Selection of subjects (justice). –Fair procedures for the selection of research subjects. Individual justice in the selection of subjects would require that researchers exhibit fairness. Social justice requires that distinction be drawn between classes of subjects that ought, and ought not, to participate in any particular kind of research, based on the ability of members of that class to bear burdens and on the appropriateness of placing further burdens on already burdened persons.