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03 Apr 12
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World War. During the Nuremberg War Crime Trials, the Nuremberg code was drafted as a set of standards for judging physicians and scientists who had conducted biomedical experiments on concentration camp prisoners.
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the term ”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. The purpose of medical or behavioral practice is to provide diagnosis, preventive treatment or therapy to particular individuals. (2) By contrast, the term ”research' 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). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.
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w; 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.
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B. Basic Ethical Principles
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1. Respect for Persons.
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st two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.
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r, not every human being is capable of self-determination
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In most cases of research involving human subjects, respect for persons demands that subjects enter into the research voluntarily and with adequate information
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-- 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.
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2. Beneficence.
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ligation. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms.
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The Hippocratic maxim ”do no harm”
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t one should not injure one person regardless of the benefits that might come to others.
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3. Justice.
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” An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly
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ons some relevant property on the basis of which burdens and benefits should be distributed. 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.
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bjects in Nazi concentration camps was condemned as a particularly flagrant injustice. In this country, in the 1940's, the Tuskegee syphilis study used disadvantaged, rural black men to study the untreated course of a disease that is by no means confined to that population.
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s, justice demands both that these not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research.
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C. Applications
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1. Informed Consent
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given the opportunity to choose what shall or shall not happen to them.
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Information
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of research establish specific items for disclosure intended to assure that subjects are given sufficient 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
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In many cases, it is sufficient to indicate to subjects that they are being invited to participate in research of which some features will not be revealed until the research is concluded.
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(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. Information about risks should never be withheld for the purpose of eliciting the cooperation of subjects, and truthful answers should always be given to direct questions about the research.
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Comprehension.
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Because the subject's ability to understand is a function of intelligence, rationality, maturity and language, it is necessary to adapt the presentation of the information to the subject's capacities
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Special provision may need to be made when comprehension is severely limited -- for example, by conditions of immaturity or mental disability.
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. The person authorized to act on behalf of the subject should be given an opportunity to observe the research as it proceeds in order to be able to withdraw the subject from the research, if such action appears in the subject's best interest.
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An agreement to participate in research constitutes a valid consent only if voluntarily given.
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Voluntariness.
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But undue influence would include actions such as manipulating a person's choice through the controlling influence of a close relative and threatening to withdraw health services to which an individual would otherwise be entitled.
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- 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.
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2. Assessment of Risks and Benefits.
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. 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.
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The Nature and Scope of Risks and Benefits
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s. The term ”risk” refers to a possibility that harm may occur.
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The term ”benefit” is used in the research context to refer to something of positive value related to health or welfare.
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The Systematic Assessment of Risks and Benefit
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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.
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: (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.
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(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.
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. (v) Relevant risks and benefits must be thoroughly arrayed in documents and procedures used in the informed consent process.
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3. Selection of Subjects. -
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. 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.
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04 Mar 12
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09 Jan 12
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ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects
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Three principles,
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the term ”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.
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”research' 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).
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Research and practice may be carried on together when research is designed to evaluate the safety and efficacy of a therapy.
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as autonomous agents,
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persons with diminished autonomy are entitled to protection
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autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of such deliberation.
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unless they are clearly detrimental to others.
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by making efforts to secure their well-being
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maximize possible benefits and minimize possible harms
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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.
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nature and possibility of an informed consent.
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pecific items for disclosure
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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
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it is sufficient to indicate to subjects that they are being invited to participate in research of which some features will not be revealed until the research is concluded.
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necessary to adapt the presentation of the information to the subject's capacities
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Previous codes and Federal regulations have required that 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.
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20 Oct 11
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26 Sep 11
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11 Sep 11
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13 Jun 11
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dual patient or client and that have a reasonabl
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the term ”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.
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”research' designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge
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Research and practice may be carried on together when research is designed to evaluate the safety and efficacy of a therapy.
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first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection
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An autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of such deliberation.
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Some persons are in need of extensive protection, even to the point of excluding them from activities which may harm them; other persons require little protection beyond making sure they undertake activities freely and with awareness of possible adverse consequence.
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”beneficence” is often understood to cover acts of kindness or charity that go beyond strict obligatio
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obligation. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms.
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In the case of scientific research in general, members of the larger society are obliged to recognize the longer term benefits and risks that may result fro
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m the improvement of knowledge and from the development of novel medical, psychotherapeutic, and social procedures.
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3. Justice. -- Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the sense of ”fairness in distribution” or ”what is deserved.”
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mentions some relevant property on the basis of which burdens and benefits should be distributed. 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.
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ed. Finally, whenever research supported by public funds leads to the development of therapeutic devices and procedures, justice demands both that these not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research.
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Most codes of research establish specific items for disclosure intended to assure that subjects are given sufficient 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.
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t (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
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Comprehension.
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ons are thus respected both by acknowledging their own wishes and by the use of third parties to protect them from harm.
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Voluntarines
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2. Assessment of Risks and Benefits.
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The Nature and Scope of Risks and Benefits
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Previous codes and Federal regulations have required that risks to subjects be outweighed by the sum of both the anticipated be
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nefit to the subject, if any, and the anticipated benefit to society in the form of knowledge to be gained from the research.
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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 i
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nstitutionalized mentally infirm or prisoners) may be involved as research subjects, if at all, only on certain conditions.
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e Nuremberg Code of 1947, the Helsinki Declaration of 1964 (revised in 1975), and the 1971 Guidelines (codified into Federal Regulations in 1974) issued by the U.S. Department of Health, Education, and Welfare Codes for the conduct of social and behavioral research have also been adopted, the best known being that of the American Psychological Association, published in 1973.
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Even when a procedure applied in practice may benefit some other person, it remains an intervention designed to enhance the well-being of a particular individual or groups of individuals; thus, it is practice and need not be reviewed as research.
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(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.
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For example, the selection of research subjects needs to be scrutinized in order to determine whether some classes (e.g., welfare patients, particular racial and ethnic minorities, or persons confined to institutions) are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied. Finally, whenever research supported by public funds leads to the development of therapeutic devices and procedures, justice demands both that these not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research.
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the consent process can be analyzed as containing three elements: information, comprehension and voluntariness.
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In all cases of research involving incomplete disclosure, such research is justified only if it is clear that (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.
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nformation about risks should never be withheld for the purpose of eliciting the cooperation of subjects, and truthful answers should always be given to direct questions about the research. Care should be taken to distinguish cases in which disclosure would destroy or invalidate the research from cases in which disclosure would simply inconvenience the investigator.
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This element of informed consent requires conditions free of coercion and undue influence. Coercion occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance. Undue influence, by contrast, occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance. Also, inducements that would ordinarily be acceptable may become undue influences if the subject is especially vulnerable.
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It is commonly said that benefits and risks must be ”balanced” and shown to be ”in a favorable ratio.” The metaphorical character of these terms draws attention to the difficulty of making precise judgments.
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(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. It should be determined whether it is in fact necessary to use human subjects at all. Risk can perhaps never be entirely eliminated, but it can often be reduced by careful attention to alternative procedures. (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. A number of variables go into such judgments, including the nature and degree of risk, the condition of the particular population involved, and the nature and level of the anticipated benefits. (v) Relevant risks and benefits must be thoroughly arrayed in documents and procedures used in the informed consent process.
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Justice is relevant to the selection of subjects of research at two levels: the social and the individual. 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.
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05 Feb 11
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11 Sep 10
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On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
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One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed
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Commission was directed to consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in such research and (iv) the nature and definition of informed consent in various research settings.
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The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations.
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It is a statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects.
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Ethical Principles & Guidelines for Research Involving Human Subjects
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Three principles, or general prescriptive judgments, that are relevant to research involving human subjects are identified in this statement.
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These principles cannot always be applied so as to resolve beyond dispute particular ethical problems. The objective is to provide an analytical framework that will guide the resolution of ethical problems arising from research involving human subjects.
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A. Boundaries Between Practice and Research
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It is important to distinguish between biomedical and behavioral research
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The distinction between research and practice is blurred partly because both often occur together (as in research designed to evaluate a therapy) and partly because notable departures from standard practice are often called ”experimental” when the terms ”experimental” and ”research” are not carefully defined.
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the term ”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. The purpose of medical or behavioral practice is to provide diagnosis, preventive treatment or therapy to particular individuals
-
the term ”research' 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). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.
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he fact that a procedure is ”experimental,” in the sense of new, untested or different, does not automatically place it in the category of research
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Research and practice may be carried on together when research is designed to evaluate the safety and efficacy of a therapy
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B. Basic Ethical Principles
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The expression ”basic ethical principles” refers to those general judgments that serve as a basic justification for the many particular ethical prescriptions and evaluations of human actions.
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Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice.
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1. Respect for Persons
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The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.
-
2. Beneficence.
-
In this document, beneficence is understood in a stronger sense, as an obligation. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms.
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The Hippocratic maxim ”do no harm” has long been a fundamental principle of medical ethics.
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Claude Bernard extended it to the realm of research, saying that one should not injure one person regardless of the benefits that might come to others.
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Learning what will in fact benefit may require exposing persons to risk
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An example is found in research involving children.
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3. Justice.
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Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the sense of ”fairness in distribution” or ”what is deserved.” An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly.
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It is necessary, then, to explain in what respects people should be treated equally. There are several widely accepted formulations of just ways to distribute burdens and benefits. Each formulation mentions some relevant property on the basis of which burdens and benefits should be distributed. 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.
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n this country, in the 1940's, the Tuskegee syphilis study
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the selection of research subjects needs to be scrutinized in order to determine whether some classes (e.g., welfare patients, particular racial and ethnic minorities, or persons confined to institutions) are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied.
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C. Applications
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Applications of the general principles to the conduct of research leads to consideration of the following requirements: informed consent, risk/benefit assessment, and the selection of subjects of research.
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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.
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1. Informed Consen
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he consent process can be analyzed as containing three elements: information, comprehension and voluntariness.
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ost codes of research establish specific items for disclosure intended to assure that subjects are given sufficient 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.
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Information
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It may be that a standard of ”the reasonable volunteer” should be proposed: the extent and nature of information should be such that persons, knowing that the procedure is neither necessary for their care nor perhaps fully understood, can decide whether they wish to participate in the furthering of knowledge. Even when some direct benefit to them is anticipated, the subjects should understand clearly the range of risk and the voluntary nature of participation.
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A special problem of consent arises where informing subjects of some pertinent aspect of the research is likely to impair the validity of the research.
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In all cases of research involving incomplete disclosure, such research is justified only if it is clear that (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.
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Comprehension.
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The manner and context in which information is conveyed is as important as the information itself.
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Because the subject's ability to understand is a function of intelligence, rationality, maturity and language, it is necessary to adapt the presentation of the information to the subject's capacities.
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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.
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Voluntariness.
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Coercion occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance. Undue influence, by contrast, occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance.
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2. Assessment of Risks and Benefits
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the assessment presents both an opportunity and a responsibility to gather systematic and comprehensive information about proposed research. 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.
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The Nature and Scope of Risks and Benefits.
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term ”risk” refers to a possibility that harm may occur. However, when expressions such as ”small risk” or ”high risk” are used, they usually refer (often ambiguously) both to the chance (probability) of experiencing a harm and the severity (magnitude) of the envisioned harm.
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The term ”benefit” is used in the research context to refer to something of positive value related to health or welfare. Unlike, ”risk,” ”benefit” is not a term that expresses probabilities. Risk is properly contrasted to probability of benefits, and benefits are properly contrasted with harms rather than risks of harm.
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risk/benefit assessments are concerned with the probabilities and magnitudes of possible harm and anticipated benefits.
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sychological harm, physical harm, legal harm, social harm and economic harm and the corresponding benefits.
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The Systematic Assessment of Risks and Benefits
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t is commonly said that benefits and risks must be ”balanced” and shown to be ”in a favorable ratio.”
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assessment of the justifiability of research should reflect at least the following considerations: (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. It should be determined whether it is in fact necessary to use human subjects at all.
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(iii) When research involves significant risk of serious impairment, review committees should be extraordinarily insistent on the justification of the risk
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(iv) When vulnerable populations are involved in research, the appropriateness of involving them should itself be demonstrated
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(v) Relevant risks and benefits must be thoroughly arrayed in documents and procedures used in the informed consent process.
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3. Selection of Subjects.
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the principle of justice gives rise to moral requirements that there be fair procedures and outcomes in the selection of research subjects.
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Justice is relevant to the selection of subjects of research at two levels: the social and the individual. 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.
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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
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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.
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12 Aug 10
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09 Jun 10
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23 Apr 10
Arif ShaonOn July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles. In carrying out the above, the Commission was directed to consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in such research and (iv) the nature and definition of informed consent in various research settings.
The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations. -
15 Jan 10
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13 Jan 10
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Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice.
-
An autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of such deliberation.
-
Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms.
-
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09 Jan 10
Chris WillmottOffice of Human Subjects Research: The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations. It is the outgrowth of an intensive four-day period of discussions that were held in
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05 Sep 08
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31 Aug 08
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15 Mar 07
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23 Feb 07
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10 Jan 07
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