Belmont Report

complementary expressions of beneficent actions

(1) do not harm and (2) maximize possible benefits and minimize possible harms.

Respect for persons

incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection.

3. Selection of Subjects.

it can be considered a matter of social justice that there is an order of preference in the selection of classes of subjects (e.g., adults before children) and that some classes of potential subjects (e.g., the institutionalized mentally infirm or prisoners) may be involved as research subjects, if at all, only on certain conditions.

Information.

These items generally include: the research procedure, their purposes, risks and anticipated benefits, alternative procedures (where therapy is involved), and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the research. Additional items have been proposed, including how subjects are selected, the person responsible for the research, etc.

The Nature and Scope of Risks and Benefits.

Accordingly, so-called risk/benefit assessments are concerned with the probabilities and magnitudes of possible harm and anticipated benefits.

Voluntariness.

An agreement to participate in research constitutes a valid consent only if voluntarily given. This element of informed consent requires conditions free of coercion and undue influence.

Comprehension.

Making sure the the manner and context in which information is presented is easily understandable to the research subjects.

Respect for Persons, Beneficence, Justice.

Which of the following are the three principles discussed in the Belmont Report?

Examples of Justified incomplete information.

(1) incomplete disclosure is truly necessary to accomplish the goals of the research, (2) there are no undisclosed risks to subjects that are more than minimal, and (3) there is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them.

The Systematic Assessment of Risks and Benefits.

It is commonly said that benefits and risks must be "balanced" and shown to be "in a favorable ratio." (i) Brutal or inhumane treatment of human subjects is never morally justified. (ii) Risks should be reduced to those necessary to achieve the research objective. (iii) When research involves 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).(iv) When vulnerable populations are involved in research, the appropriateness of involving them should itself be demonstrated.v) Relevant risks and benefits must be thoroughly arrayed in documents and procedures used in the informed consent process.

Beneficence

Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being.

Informed Consent.

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.

Justice

Who ought to receive the benefits of research and bear its burdens? These formulations are (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, and (5) to each person according to merit.

maximization of benefits and a minimization of risks

an example of how the Principle of Beneficence can be applied to a study employing human subjects

autonomous person

an individual capable of deliberation about personal goals and of acting under the direction of such deliberation.

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. Thus, the assessment presents both an opportunity and a responsibility to gather systematic and comprehensive information about proposed research.