1. The Belmont Report
1.1. Ethical Principle and Guidelines for Research Involving Human Subjects
1.2. A. Boundaries Between Practice and Research
1.2.1. Practice
1.2.1.1. 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
1.2.1.2. The purpose of medical or behavioral practice is to provide diagnosis, preventive treatment or therapy to particular individuals.
1.2.2. Research =
1.2.2.1. designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships)
1.2.2.2. usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.
1.2.3. Research and practice may be carried on together when research is designed to evaluate the safety and efficacy of a therapy. This need not cause any confusion regarding whether or not the activity requires review; the general rule is that if there is any element of research in an activity, that activity should undergo review for the protection of human subjects.
1.3. B. Basic Ethical Prinicples
1.3.1. 1. Respect for Persons
1.3.1.1. individuals should be treated as autonomous agents
1.3.1.2. persons with diminished autonomy are entitled to protection
1.3.2. 2. Benificence
1.3.2.1. 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
1.3.2.2. Two Principles
1.3.2.2.1. do not harm
1.3.2.2.2. maximize possible benefits and minimize possible harms.
1.3.3. 3. Justice
1.3.3.1. An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly
1.3.3.2. equals ought to be treated equally
1.3.3.3. distinctions based on experience, age, deprivation, competence, merit and position do sometimes constitute criteria justifying differential treatment for certain purposes.
1.3.3.4. Five Formulations
1.3.3.4.1. 1. to each person an equal share
1.3.3.4.2. 2. to each person according to individual need
1.3.3.4.3. 3. to each person according to individual effort
1.3.3.4.4. 4. to each person according to societal contribution
1.3.3.4.5. to each person according to merit
1.4. C. Applications
1.4.1. 1. Informed Consent
1.4.1.1. Three Elements
1.4.1.1.1. 1. Information
1.4.1.1.2. 2. Comprehension
1.4.1.1.3. 3. Voluntariness
1.4.2. 2. Assessment of Risks and Benefits
1.4.2.1. For the investigator, it is a means to examine whether the proposed research is properly designed. For a review committee, it is a method for determining whether the risks that will be presented to subjects are justified. For prospective subjects, the assessment will assist the determination whether or not to participate.
1.4.2.2. The Nature and Scope of Risks and Benefits.
1.4.2.2.1. Relates to respect for persons
1.4.2.2.2. benefit means something of positive value related to health or welfare
1.4.2.2.3. risk means the probability of harm
1.4.2.2.4. Risks and benefits of research may affect the individual subjects, the families of the individual subjects, and society at large (or special groups of subjects in society)
1.4.2.2.5. Looking for balance -- risks to subjects be outweighed by the sum of both the anticipated benefit to the subject, if any, and the anticipated benefit to society in the form of knowledge to be gained from the research
1.4.2.3. Systematic assessment of risks and benefits
1.4.2.3.1. should first be a determination of the validity of the presuppositions of the research
1.4.2.3.2. then the nature, probability and magnitude of risk should be distinguished with as much clarity as possible.
1.4.2.3.3. The method of ascertaining risks should be explicit, especially where there is no alternative to the use of such vague categories as small or slight risk.
1.4.2.3.4. should also be determined whether an investigator's estimates of the probability of harm or benefits are reasonable, as judged by known facts or other available studies.
1.4.2.3.5. Five considerations
1.4.3. Selection of Subjects
1.4.3.1. the principle of justice gives rise to moral requirements that there be fair procedures and outcomes in the selection of research subjects.
1.4.3.2. Justice is relevant to the selection of subjects of research at two levels:
1.4.3.2.1. Individual justice in the selection of subjects would require that researchers exhibit fairness: thus, they should not offer potentially beneficial research only to some patients who are in their favor or select only "undesirable" persons for risky research.
1.4.3.2.2. 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. Thus, 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.
1.4.3.2.3. Thus injustice arises from social, racial, sexual and cultural biases institutionalized in society. Unjust social patterns may appear in the overall distribution of the burdens and benefits of research.
1.4.3.2.4. consider distributive justice in selecting research subjects.
1.4.3.2.5. One special instance of injustice results from the involvement of vulnerable subjects. Certain groups, such as racial minorities, the economically disadvantaged, the very sick, and the institutionalized may continually be sought as research subjects, owing to their ready availability in settings where research is conducted. Given their dependent status and their frequently compromised capacity for free consent, they should be protected against the danger of being involved in research solely for administrative convenience, or because they are easy to manipulate as a result of their illness or socioeconomic condition.