79C3C34C52B45572883A05D425EB0F82
The Belmont Report
https://www.hhs.gov/ohrp/sites/default/files/the-belmont-report-508c_FINAL.pdf
http://leaux.net/URLS/ConvertAPI Text Files/DEC699AF1172688E4A064F8925FFA149.en.txt
Examining the file media/Synopses/DEC699AF1172688E4A064F8925FFA149.html:
This file was generated: 2020-12-01 05:00:59
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Criminal Convictions
Searching for indicator prisoners:
(return to top)
p.(None): *** David W. Louisell, J.D., Professor of Law, University of California at Berkeley.
p.(None): Donald W. Seldin, M.D., Professor and Chairman, Department of Internal Medicine, University of Texas at Dallas.
p.(None): *** Eliot Stellar, Ph.D., Provost of the University and Professor of Physiological Psychology, University of
p.(None): Pennsylvania.
p.(None): *** Robert H. Turtle, LL.B., Attorney, VomBaur, Coburn, Simmons & Turtle, Washington, D.C.
p.(None): *** Deceased.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Table of Contents
p.(None): Ethical Principles and Guidelines for Research Involving Human Subjects
p.(None): A. Boundaries Between Practice and Research
p.(None): B. Basic Ethical Principles
p.(None): 1. Respect for Persons
p.(None): 2. Beneficence
p.(None): 3. Justice
p.(None): C. Applications
p.(None): 1. Informed Consent
p.(None): 2. Assessment of Risk and Benefits
p.(None): 3. Selection of Subjects
p.(None):
p.(None):
p.(None):
p.(None): Ethical Principles & Guidelines for Research Involving Human Subjects
p.(None): Scientific research has produced substantial social benefits. It has also posed some troubling ethical questions.
p.(None): Public attention was drawn to these questions by reported abuses of human subjects in biomedical experiments,
p.(None): especially during the Second World War. During the Nuremberg War Crime Trials, the Nuremberg code was drafted as a set
p.(None): of standards for judging physicians and scientists who had conducted biomedical experiments on concentration camp
p.(None): prisoners. This code became the prototype of many later codes [1] intended to assure that research involving human
p.(None): subjects would be carried out in an ethical manner.
p.(None):
p.(None): The codes consist of rules, some general, others specific, that guide the investigators or the reviewers of research in
p.(None): their work. Such rules often are inadequate to cover complex situations; at times they come into conflict, and they are
p.(None): frequently difficult to interpret or apply. Broader ethical principles will provide a basis on which specific rules may
p.(None): be formulated, criticized and interpreted.
p.(None):
p.(None): Three principles, or general prescriptive judgments, that are relevant to research involving human subjects are
p.(None): identified in this statement. Other principles may also be relevant. These three are comprehensive, however, and are
p.(None): stated at a level of generalization that should assist scientists, subjects, reviewers and interested citizens to
p.(None): understand the ethical issues inherent in research involving human subjects. These principles cannot always be applied
p.(None): so as to resolve beyond dispute particular ethical problems. The objective is to provide an analytical framework that
p.(None): will guide the resolution of ethical problems arising from research involving human subjects.
p.(None):
p.(None): This statement consists of a distinction between research and practice, a discussion of the three basic ethical
p.(None): principles, and remarks about the application of these principles.
p.(None):
p.(None):
p.(None):
p.(None): Part A: Boundaries Between Practice & Research
p.(None): A. Boundaries Between Practice and Research
p.(None):
p.(None): It is important to distinguish between biomedical and behavioral research, on the one hand, and the practice of
...
p.(None): individual's life, and some individuals lose this capacity wholly or in part because of illness, mental disability, or
p.(None): circumstances that severely restrict liberty. Respect for the immature and the incapacitated may require protecting
p.(None): them as they mature or while they are incapacitated.
p.(None):
p.(None): Some persons are in need of extensive protection, even to the point of excluding them from activities which may harm
p.(None): them; other persons require little protection beyond making sure they undertake activities freely and with awareness of
p.(None): possible adverse consequence. The extent of protection afforded should depend upon the risk of harm and the likelihood
p.(None): of benefit. The judgment that any individual lacks autonomy should be periodically reevaluated and will vary in
p.(None): different situations.
p.(None):
p.(None): In most cases of research involving human subjects, respect for persons demands that subjects enter into the research
p.(None): voluntarily and with adequate information. In some situations, however, application of the principle is not obvious.
p.(None): The involvement of prisoners as subjects of research provides an instructive example. On the one hand, it would seem
p.(None): that the principle of respect for persons requires that prisoners not be deprived of the opportunity to volunteer for
p.(None): research. On the other hand, under prison conditions they may be subtly coerced or unduly influenced to engage in
p.(None): research activities for which they would not otherwise volunteer. Respect for persons would then dictate that prisoners
p.(None): be protected. Whether to allow
p.(None):
p.(None): prisoners to "volunteer" or to "protect" them presents a dilemma. Respecting persons, in most hard cases, is often a
p.(None): matter of balancing competing claims urged by the principle of respect itself.
p.(None):
p.(None): 2. Beneficence. — Persons are treated in an ethical manner not only by respecting their decisions and protecting them
p.(None): from harm, but also by making efforts to secure their well-being. Such treatment falls under the principle of
p.(None): beneficence. The term "beneficence" is often understood to cover acts of kindness or charity that go beyond strict
p.(None): obligation. In this document, beneficence is understood in a stronger sense, as an obligation. Two general rules have
p.(None): been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize
p.(None): possible benefits and minimize possible harms.
p.(None):
p.(None): The Hippocratic maxim "do no harm" has long been a fundamental principle of medical ethics. Claude Bernard extended it
p.(None): to the realm of research, saying that one should not injure one person regardless of the benefits that might come to
p.(None): others. However, even avoiding harm requires learning what is harmful; and, in the process of obtaining this
p.(None): information, persons may be exposed to risk of harm. Further, the Hippocratic Oath requires physicians to benefit their
...
p.(None): distinctions based on experience, age, deprivation, competence, merit and position do sometimes constitute criteria
p.(None): justifying differential treatment for certain purposes. It is necessary, then, to explain in what respects people
p.(None): should be treated equally. There are several widely accepted formulations of just ways to distribute burdens and
p.(None): benefits. Each formulation mentions some relevant property on the basis of which burdens and benefits should be
p.(None): distributed. These formulations are (1) to each person an equal share, (2) to each person according to individual need,
p.(None): (3) to each person according to individual effort, (4) to each person according to societal contribution, and (5) to
p.(None): each person according to merit.
p.(None):
p.(None): Questions of justice have long been associated with social practices such as punishment, taxation and political
p.(None): representation. Until recently these questions have not generally been associated with scientific research. However,
p.(None): they are foreshadowed even in the earliest reflections on the ethics of research involving human subjects. For
p.(None): example, during the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor
p.(None): ward patients, while the benefits of improved medical care flowed primarily to private patients. Subsequently, the
p.(None): exploitation of unwilling prisoners as research subjects in Nazi concentration camps was condemned as a particularly
p.(None): flagrant injustice. In this country, in the 1940's, the Tuskegee syphilis study used disadvantaged, rural black men to
p.(None): study the untreated course of a disease that is by no means confined to that population. These subjects were deprived
p.(None): of demonstrably effective treatment in order not to interrupt the project, long after such treatment became generally
p.(None): available.
p.(None):
p.(None): Against this historical background, it can be seen how conceptions of justice are relevant to research involving human
p.(None): subjects. For example, the selection of research subjects needs to be scrutinized in order to determine whether some
p.(None): classes (e.g., welfare patients, particular racial and ethnic minorities, or persons confined to institutions) are
p.(None): being systematically selected simply because of their easy availability, their compromised position, or their
p.(None): manipulability, rather than for reasons directly related to the problem being studied. Finally, whenever research
p.(None): supported by public funds leads to the development of therapeutic devices and procedures, justice demands both that
p.(None): these not provide advantages only to those who can afford them and that such research should not unduly involve persons
p.(None): from groups unlikely to be among the beneficiaries of subsequent applications of the research.
p.(None):
p.(None):
p.(None):
p.(None): Part C: Applications
...
p.(None): consent, and the principle of beneficence in risk/benefit assessment, the principle of justice gives rise to moral
p.(None): requirements that there be fair procedures and outcomes in the selection of research subjects.
p.(None):
p.(None): Justice is relevant to the selection of subjects of research at two levels: the social and the individual. Individual
p.(None): justice in the selection of subjects would require that researchers exhibit fairness: thus, they should not offer
p.(None): potentially beneficial research only to some patients who are in their favor or select only "undesirable" persons for
p.(None): risky research. Social justice requires that distinction be drawn between classes of subjects that ought, and ought
p.(None): not, to participate in any particular kind of research, based on the ability of members of that class to bear burdens
p.(None): and on the appropriateness of placing further burdens on already burdened persons. Thus, it can be considered a matter
p.(None): of social justice that there is an order of preference in the selection of classes of subjects (e.g., adults before
p.(None): children) and that some classes of potential subjects (e.g., the institutionalized mentally infirm or prisoners) may be
p.(None): involved as research subjects, if at all, only on certain conditions.
p.(None):
p.(None): Injustice may appear in the selection of subjects, even if individual subjects are selected fairly by investigators and
p.(None): treated fairly in the course of research. Thus injustice arises from social, racial, sexual and cultural biases
p.(None): institutionalized in society. Thus, even if individual researchers are treating their research subjects fairly, and
p.(None): even if IRBs are taking care to assure that subjects are selected fairly within a particular institution, unjust social
p.(None): patterns may nevertheless appear in the overall distribution of the burdens and benefits of research. Although
p.(None): individual institutions or investigators may not be able to resolve a problem that is pervasive in their social
p.(None): setting, they can consider distributive justice in selecting research subjects.
p.(None):
p.(None): Some populations, especially institutionalized ones, are already burdened in many ways by their infirmities and
p.(None): environments. When research is proposed that involves risks and does not include a therapeutic component, other less
p.(None): burdened classes of persons should be called upon first to accept these risks of research, except where the research is
p.(None): directly related to the specific conditions of the class involved. Also, even though public funds for research may
p.(None): often flow in the same directions as public funds for health care, it seems unfair that populations dependent on public
...
Political / Illegal Activity
Searching for indicator crime:
(return to top)
p.(None): J.D., Associate Professor of Law, Georgetown University Law Center.
p.(None): Karen Lebacqz, Ph.D., Associate Professor of Christian Ethics, Pacific School of Religion.
p.(None): *** David W. Louisell, J.D., Professor of Law, University of California at Berkeley.
p.(None): Donald W. Seldin, M.D., Professor and Chairman, Department of Internal Medicine, University of Texas at Dallas.
p.(None): *** Eliot Stellar, Ph.D., Provost of the University and Professor of Physiological Psychology, University of
p.(None): Pennsylvania.
p.(None): *** Robert H. Turtle, LL.B., Attorney, VomBaur, Coburn, Simmons & Turtle, Washington, D.C.
p.(None): *** Deceased.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Table of Contents
p.(None): Ethical Principles and Guidelines for Research Involving Human Subjects
p.(None): A. Boundaries Between Practice and Research
p.(None): B. Basic Ethical Principles
p.(None): 1. Respect for Persons
p.(None): 2. Beneficence
p.(None): 3. Justice
p.(None): C. Applications
p.(None): 1. Informed Consent
p.(None): 2. Assessment of Risk and Benefits
p.(None): 3. Selection of Subjects
p.(None):
p.(None):
p.(None):
p.(None): Ethical Principles & Guidelines for Research Involving Human Subjects
p.(None): Scientific research has produced substantial social benefits. It has also posed some troubling ethical questions.
p.(None): Public attention was drawn to these questions by reported abuses of human subjects in biomedical experiments,
p.(None): especially during the Second World War. During the Nuremberg War Crime Trials, the Nuremberg code was drafted as a set
p.(None): of standards for judging physicians and scientists who had conducted biomedical experiments on concentration camp
p.(None): prisoners. This code became the prototype of many later codes [1] intended to assure that research involving human
p.(None): subjects would be carried out in an ethical manner.
p.(None):
p.(None): The codes consist of rules, some general, others specific, that guide the investigators or the reviewers of research in
p.(None): their work. Such rules often are inadequate to cover complex situations; at times they come into conflict, and they are
p.(None): frequently difficult to interpret or apply. Broader ethical principles will provide a basis on which specific rules may
p.(None): be formulated, criticized and interpreted.
p.(None):
p.(None): Three principles, or general prescriptive judgments, that are relevant to research involving human subjects are
p.(None): identified in this statement. Other principles may also be relevant. These three are comprehensive, however, and are
p.(None): stated at a level of generalization that should assist scientists, subjects, reviewers and interested citizens to
p.(None): understand the ethical issues inherent in research involving human subjects. These principles cannot always be applied
p.(None): so as to resolve beyond dispute particular ethical problems. The objective is to provide an analytical framework that
p.(None): will guide the resolution of ethical problems arising from research involving human subjects.
p.(None):
p.(None): This statement consists of a distinction between research and practice, a discussion of the three basic ethical
p.(None): principles, and remarks about the application of these principles.
p.(None):
p.(None):
p.(None):
p.(None): Part A: Boundaries Between Practice & Research
...
Political / political affiliation
Searching for indicator political:
(return to top)
p.(None): 3. Justice. — Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the
p.(None): sense of "fairness in distribution" or "what is deserved." An injustice occurs when some benefit to which a person is
p.(None): entitled is denied without good reason or when some burden is imposed unduly. Another way of conceiving the principle
p.(None): of justice is that equals ought to be treated equally. However, this statement requires explication. Who is equal and
p.(None): who is unequal? What considerations justify departure from equal distribution? Almost all commentators allow that
p.(None): distinctions based on experience, age, deprivation, competence, merit and position do sometimes constitute criteria
p.(None): justifying differential treatment for certain purposes. It is necessary, then, to explain in what respects people
p.(None): should be treated equally. There are several widely accepted formulations of just ways to distribute burdens and
p.(None): benefits. Each formulation mentions some relevant property on the basis of which burdens and benefits should be
p.(None): distributed. These formulations are (1) to each person an equal share, (2) to each person according to individual need,
p.(None): (3) to each person according to individual effort, (4) to each person according to societal contribution, and (5) to
p.(None): each person according to merit.
p.(None):
p.(None): Questions of justice have long been associated with social practices such as punishment, taxation and political
p.(None): representation. Until recently these questions have not generally been associated with scientific research. However,
p.(None): they are foreshadowed even in the earliest reflections on the ethics of research involving human subjects. For
p.(None): example, during the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor
p.(None): ward patients, while the benefits of improved medical care flowed primarily to private patients. Subsequently, the
p.(None): exploitation of unwilling prisoners as research subjects in Nazi concentration camps was condemned as a particularly
p.(None): flagrant injustice. In this country, in the 1940's, the Tuskegee syphilis study used disadvantaged, rural black men to
p.(None): study the untreated course of a disease that is by no means confined to that population. These subjects were deprived
p.(None): of demonstrably effective treatment in order not to interrupt the project, long after such treatment became generally
p.(None): available.
p.(None):
p.(None): Against this historical background, it can be seen how conceptions of justice are relevant to research involving human
p.(None): subjects. For example, the selection of research subjects needs to be scrutinized in order to determine whether some
p.(None): classes (e.g., welfare patients, particular racial and ethnic minorities, or persons confined to institutions) are
...
Political / vulnerable
Searching for indicator vulnerable:
(return to top)
p.(None): acknowledging their own wishes and by the use of third parties to protect them from harm.
p.(None):
p.(None): The third parties chosen should be those who are most likely to understand the incompetent subject's situation and to
p.(None): act in that person's best interest. The person authorized to act on behalf of the subject should be given an
p.(None): opportunity to observe the research as it proceeds in order to be able to withdraw the subject from the research, if
p.(None): such action appears in the subject's best interest.
p.(None):
p.(None): Voluntariness. An agreement to participate in research constitutes a valid consent only if voluntarily given. This
p.(None): element of informed consent requires conditions free of coercion and undue influence. Coercion occurs when an overt
p.(None): threat of harm is intentionally presented by one person to another in order to obtain compliance. Undue influence, by
p.(None): contrast, occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in
p.(None): order to obtain compliance. Also, inducements that would ordinarily be acceptable may become undue influences if the
p.(None): subject is especially vulnerable.
p.(None):
p.(None): Unjustifiable pressures usually occur when persons in positions of authority or commanding influence -- especially
p.(None): where possible sanctions are involved -- urge a course of action for a subject. A continuum of
p.(None):
p.(None): such influencing factors exists, however, and it is impossible to state precisely where justifiable persuasion ends and
p.(None): undue influence begins. But undue influence would include actions such as manipulating a person's choice through the
p.(None): controlling influence of a close relative and threatening to withdraw health services to which an individual would
p.(None): otherwise be entitled.
p.(None):
p.(None): 2. Assessment of Risks and Benefits. — The assessment of risks and benefits requires a careful arrayal of relevant
p.(None): data, including, in some cases, alternative ways of obtaining the benefits sought in the research. Thus, the assessment
p.(None): presents both an opportunity and a responsibility to gather systematic and comprehensive information about proposed
p.(None): research. For the investigator, it is a means to examine whether the proposed research is properly designed. For a
p.(None): review committee, it is a method for determining whether the risks that will be presented to subjects are justified.
p.(None): For prospective subjects, the assessment will assist the determination whether or not to participate.
p.(None):
p.(None): The Nature and Scope of Risks and Benefits. The requirement that research be justified on the basis of a favorable
...
p.(None): judgments. Thus, there should first be a determination of the validity of the presuppositions of the research; then the
p.(None): nature, probability and magnitude of risk should be distinguished with as much clarity as possible. The method of
p.(None): ascertaining risks should be explicit, especially where there is no alternative to the use of such vague categories as
p.(None): small or slight risk. It should also be determined whether an investigator's estimates of the probability of harm or
p.(None): benefits are reasonable, as judged by known facts or other available studies.
p.(None):
p.(None): Finally, assessment of the justifiability of research should reflect at least the following
p.(None): considerations: (i)Brutal or inhumane treatment of human subjects is never morally justified. (ii) Risks should be
p.(None): reduced to those necessary to achieve the research objective. It should be determined whether it is in fact necessary
p.(None): to use human subjects at all. Risk can perhaps never be entirely eliminated, but it can often be reduced by careful
p.(None): attention to alternative procedures. (iii) When research involves significant risk of serious impairment, review
p.(None): committees should be extraordinarily insistent on the justification of the risk (looking usually to the likelihood of
p.(None): benefit to the subject -- or, in some rare cases, to the manifest voluntariness of the participation). (iv) When
p.(None): vulnerable populations are involved in research, the appropriateness of involving them should itself be demonstrated. A
p.(None): number of variables go into such judgments, including the nature and degree of risk, the condition of the particular
p.(None): population involved, and the nature and level of the anticipated benefits. (v) Relevant risks and benefits must be
p.(None): thoroughly arrayed in documents and procedures used in the informed consent process.
p.(None):
p.(None): 3. Selection of Subjects. — Just as the principle of respect for persons finds expression in the requirements for
p.(None): consent, and the principle of beneficence in risk/benefit assessment, the principle of justice gives rise to moral
p.(None): requirements that there be fair procedures and outcomes in the selection of research subjects.
p.(None):
p.(None): Justice is relevant to the selection of subjects of research at two levels: the social and the individual. Individual
p.(None): justice in the selection of subjects would require that researchers exhibit fairness: thus, they should not offer
p.(None): potentially beneficial research only to some patients who are in their favor or select only "undesirable" persons for
p.(None): risky research. Social justice requires that distinction be drawn between classes of subjects that ought, and ought
p.(None): not, to participate in any particular kind of research, based on the ability of members of that class to bear burdens
...
p.(None): institutionalized in society. Thus, even if individual researchers are treating their research subjects fairly, and
p.(None): even if IRBs are taking care to assure that subjects are selected fairly within a particular institution, unjust social
p.(None): patterns may nevertheless appear in the overall distribution of the burdens and benefits of research. Although
p.(None): individual institutions or investigators may not be able to resolve a problem that is pervasive in their social
p.(None): setting, they can consider distributive justice in selecting research subjects.
p.(None):
p.(None): Some populations, especially institutionalized ones, are already burdened in many ways by their infirmities and
p.(None): environments. When research is proposed that involves risks and does not include a therapeutic component, other less
p.(None): burdened classes of persons should be called upon first to accept these risks of research, except where the research is
p.(None): directly related to the specific conditions of the class involved. Also, even though public funds for research may
p.(None): often flow in the same directions as public funds for health care, it seems unfair that populations dependent on public
p.(None): health care constitute a pool of preferred research subjects if more advantaged populations are likely to be the
p.(None): recipients of the benefits.
p.(None):
p.(None): One special instance of injustice results from the involvement of vulnerable subjects. Certain groups, such as racial
p.(None): minorities, the economically disadvantaged, the very sick, and the institutionalized may continually be sought as
p.(None): research subjects, owing to their ready availability in settings where research is conducted.
p.(None): Given their dependent status and their frequently compromised capacity for free consent, they should be protected
p.(None): against the danger of being involved in research solely for administrative convenience, or because they are easy to
p.(None): manipulate as a result of their illness or socioeconomic condition.
p.(None):
p.(None):
p.(None): [1] Since 1945, various codes for the proper and responsible conduct of human experimentation in medical research have
p.(None): been adopted by different organizations. The best known of these codes are the Nuremberg Code of 1947, the Helsinki
p.(None): Declaration of 1964 (revised in 1975), and the 1971 Guidelines (codified into Federal Regulations in 1974) issued by
p.(None): the U.S. Department of Health, Education, and Welfare Codes for the conduct of social and behavioral research have also
p.(None): been adopted, the best known being that of the American Psychological Association, published in 1973.
p.(None):
...
Health / Cognitive Impairment
Searching for indicator impairment:
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p.(None): accumulation and assessment of information about all aspects of the research, and to consider alternatives
p.(None): systematically. This procedure renders the assessment of research more rigorous and precise, while making communication
p.(None): between review board members and investigators less subject to misinterpretation, misinformation and conflicting
p.(None): judgments. Thus, there should first be a determination of the validity of the presuppositions of the research; then the
p.(None): nature, probability and magnitude of risk should be distinguished with as much clarity as possible. The method of
p.(None): ascertaining risks should be explicit, especially where there is no alternative to the use of such vague categories as
p.(None): small or slight risk. It should also be determined whether an investigator's estimates of the probability of harm or
p.(None): benefits are reasonable, as judged by known facts or other available studies.
p.(None):
p.(None): Finally, assessment of the justifiability of research should reflect at least the following
p.(None): considerations: (i)Brutal or inhumane treatment of human subjects is never morally justified. (ii) Risks should be
p.(None): reduced to those necessary to achieve the research objective. It should be determined whether it is in fact necessary
p.(None): to use human subjects at all. Risk can perhaps never be entirely eliminated, but it can often be reduced by careful
p.(None): attention to alternative procedures. (iii) When research involves significant risk of serious impairment, review
p.(None): committees should be extraordinarily insistent on the justification of the risk (looking usually to the likelihood of
p.(None): benefit to the subject -- or, in some rare cases, to the manifest voluntariness of the participation). (iv) When
p.(None): vulnerable populations are involved in research, the appropriateness of involving them should itself be demonstrated. A
p.(None): number of variables go into such judgments, including the nature and degree of risk, the condition of the particular
p.(None): population involved, and the nature and level of the anticipated benefits. (v) Relevant risks and benefits must be
p.(None): thoroughly arrayed in documents and procedures used in the informed consent process.
p.(None):
p.(None): 3. Selection of Subjects. — Just as the principle of respect for persons finds expression in the requirements for
p.(None): consent, and the principle of beneficence in risk/benefit assessment, the principle of justice gives rise to moral
p.(None): requirements that there be fair procedures and outcomes in the selection of research subjects.
p.(None):
p.(None): Justice is relevant to the selection of subjects of research at two levels: the social and the individual. Individual
p.(None): justice in the selection of subjects would require that researchers exhibit fairness: thus, they should not offer
...
Health / Comatose
Searching for indicator comatose:
(return to top)
p.(None): cases in which disclosure would simply inconvenience the investigator.
p.(None):
p.(None): Comprehension. The manner and context in which information is conveyed is as important as the information itself. For
p.(None): example, presenting information in a disorganized and rapid fashion, allowing too little time for consideration or
p.(None): curtailing opportunities for questioning, all may adversely affect a subject's ability to make an informed choice.
p.(None):
p.(None): Because the subject's ability to understand is a function of intelligence, rationality, maturity and language, it is
p.(None): necessary to adapt the presentation of the information to the subject's capacities. Investigators are responsible for
p.(None): ascertaining that the subject has comprehended the information. While there is always an obligation to ascertain that
p.(None): the information about risk to subjects is complete and adequately comprehended, when the risks are more serious, that
p.(None): obligation increases. On occasion, it may be suitable to give some oral or written tests of comprehension.
p.(None):
p.(None): Special provision may need to be made when comprehension is severely limited -- for example, by conditions of
p.(None): immaturity or mental disability. Each class of subjects that one might consider as incompetent (e.g., infants and young
p.(None): children, mentally disable patients, the terminally ill and the comatose) should be considered on its own terms. Even
p.(None): for these persons, however, respect requires giving them the opportunity to choose to the extent they are able, whether
p.(None): or not to participate in research. The objections of these subjects to involvement should be honored, unless the
p.(None): research entails providing them a therapy unavailable elsewhere. Respect for persons also requires seeking the
p.(None): permission of other parties in order to protect the subjects from harm. Such persons are thus respected both by
p.(None): acknowledging their own wishes and by the use of third parties to protect them from harm.
p.(None):
p.(None): The third parties chosen should be those who are most likely to understand the incompetent subject's situation and to
p.(None): act in that person's best interest. The person authorized to act on behalf of the subject should be given an
p.(None): opportunity to observe the research as it proceeds in order to be able to withdraw the subject from the research, if
p.(None): such action appears in the subject's best interest.
p.(None):
p.(None): Voluntariness. An agreement to participate in research constitutes a valid consent only if voluntarily given. This
p.(None): element of informed consent requires conditions free of coercion and undue influence. Coercion occurs when an overt
...
Health / Drug Usage
Searching for indicator influence:
(return to top)
p.(None):
p.(None): The third parties chosen should be those who are most likely to understand the incompetent subject's situation and to
p.(None): act in that person's best interest. The person authorized to act on behalf of the subject should be given an
p.(None): opportunity to observe the research as it proceeds in order to be able to withdraw the subject from the research, if
p.(None): such action appears in the subject's best interest.
p.(None):
p.(None): Voluntariness. An agreement to participate in research constitutes a valid consent only if voluntarily given. This
p.(None): element of informed consent requires conditions free of coercion and undue influence. Coercion occurs when an overt
p.(None): threat of harm is intentionally presented by one person to another in order to obtain compliance. Undue influence, by
p.(None): contrast, occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in
p.(None): order to obtain compliance. Also, inducements that would ordinarily be acceptable may become undue influences if the
p.(None): subject is especially vulnerable.
p.(None):
p.(None): Unjustifiable pressures usually occur when persons in positions of authority or commanding influence -- especially
p.(None): where possible sanctions are involved -- urge a course of action for a subject. A continuum of
p.(None):
p.(None): such influencing factors exists, however, and it is impossible to state precisely where justifiable persuasion ends and
p.(None): undue influence begins. But undue influence would include actions such as manipulating a person's choice through the
p.(None): controlling influence of a close relative and threatening to withdraw health services to which an individual would
p.(None): otherwise be entitled.
p.(None):
p.(None): 2. Assessment of Risks and Benefits. — The assessment of risks and benefits requires a careful arrayal of relevant
p.(None): data, including, in some cases, alternative ways of obtaining the benefits sought in the research. Thus, the assessment
p.(None): presents both an opportunity and a responsibility to gather systematic and comprehensive information about proposed
p.(None): research. For the investigator, it is a means to examine whether the proposed research is properly designed. For a
p.(None): review committee, it is a method for determining whether the risks that will be presented to subjects are justified.
p.(None): For prospective subjects, the assessment will assist the determination whether or not to participate.
p.(None):
p.(None): The Nature and Scope of Risks and Benefits. The requirement that research be justified on the basis of a favorable
p.(None): risk/benefit assessment bears a close relation to the principle of beneficence, just as the moral requirement that
p.(None): informed consent be obtained is derived primarily from the principle of respect for persons. The term "risk" refers to
p.(None): a possibility that harm may occur. However, when expressions such as "small risk" or "high risk" are used, they usually
p.(None): refer (often ambiguously) both to the chance (probability) of experiencing a harm and the severity (magnitude) of the
...
Health / Mentally Disabled
Searching for indicator mentally:
(return to top)
p.(None): research. Care should be taken to distinguish cases in which disclosure would destroy or invalidate the research from
p.(None): cases in which disclosure would simply inconvenience the investigator.
p.(None):
p.(None): Comprehension. The manner and context in which information is conveyed is as important as the information itself. For
p.(None): example, presenting information in a disorganized and rapid fashion, allowing too little time for consideration or
p.(None): curtailing opportunities for questioning, all may adversely affect a subject's ability to make an informed choice.
p.(None):
p.(None): Because the subject's ability to understand is a function of intelligence, rationality, maturity and language, it is
p.(None): necessary to adapt the presentation of the information to the subject's capacities. Investigators are responsible for
p.(None): ascertaining that the subject has comprehended the information. While there is always an obligation to ascertain that
p.(None): the information about risk to subjects is complete and adequately comprehended, when the risks are more serious, that
p.(None): obligation increases. On occasion, it may be suitable to give some oral or written tests of comprehension.
p.(None):
p.(None): Special provision may need to be made when comprehension is severely limited -- for example, by conditions of
p.(None): immaturity or mental disability. Each class of subjects that one might consider as incompetent (e.g., infants and young
p.(None): children, mentally disable patients, the terminally ill and the comatose) should be considered on its own terms. Even
p.(None): for these persons, however, respect requires giving them the opportunity to choose to the extent they are able, whether
p.(None): or not to participate in research. The objections of these subjects to involvement should be honored, unless the
p.(None): research entails providing them a therapy unavailable elsewhere. Respect for persons also requires seeking the
p.(None): permission of other parties in order to protect the subjects from harm. Such persons are thus respected both by
p.(None): acknowledging their own wishes and by the use of third parties to protect them from harm.
p.(None):
p.(None): The third parties chosen should be those who are most likely to understand the incompetent subject's situation and to
p.(None): act in that person's best interest. The person authorized to act on behalf of the subject should be given an
p.(None): opportunity to observe the research as it proceeds in order to be able to withdraw the subject from the research, if
p.(None): such action appears in the subject's best interest.
p.(None):
p.(None): Voluntariness. An agreement to participate in research constitutes a valid consent only if voluntarily given. This
...
p.(None):
p.(None): 3. Selection of Subjects. — Just as the principle of respect for persons finds expression in the requirements for
p.(None): consent, and the principle of beneficence in risk/benefit assessment, the principle of justice gives rise to moral
p.(None): requirements that there be fair procedures and outcomes in the selection of research subjects.
p.(None):
p.(None): Justice is relevant to the selection of subjects of research at two levels: the social and the individual. Individual
p.(None): justice in the selection of subjects would require that researchers exhibit fairness: thus, they should not offer
p.(None): potentially beneficial research only to some patients who are in their favor or select only "undesirable" persons for
p.(None): risky research. Social justice requires that distinction be drawn between classes of subjects that ought, and ought
p.(None): not, to participate in any particular kind of research, based on the ability of members of that class to bear burdens
p.(None): and on the appropriateness of placing further burdens on already burdened persons. Thus, it can be considered a matter
p.(None): of social justice that there is an order of preference in the selection of classes of subjects (e.g., adults before
p.(None): children) and that some classes of potential subjects (e.g., the institutionalized mentally infirm or prisoners) may be
p.(None): involved as research subjects, if at all, only on certain conditions.
p.(None):
p.(None): Injustice may appear in the selection of subjects, even if individual subjects are selected fairly by investigators and
p.(None): treated fairly in the course of research. Thus injustice arises from social, racial, sexual and cultural biases
p.(None): institutionalized in society. Thus, even if individual researchers are treating their research subjects fairly, and
p.(None): even if IRBs are taking care to assure that subjects are selected fairly within a particular institution, unjust social
p.(None): patterns may nevertheless appear in the overall distribution of the burdens and benefits of research. Although
p.(None): individual institutions or investigators may not be able to resolve a problem that is pervasive in their social
p.(None): setting, they can consider distributive justice in selecting research subjects.
p.(None):
p.(None): Some populations, especially institutionalized ones, are already burdened in many ways by their infirmities and
p.(None): environments. When research is proposed that involves risks and does not include a therapeutic component, other less
p.(None): burdened classes of persons should be called upon first to accept these risks of research, except where the research is
p.(None): directly related to the specific conditions of the class involved. Also, even though public funds for research may
...
Searching for indicator disability:
(return to top)
p.(None): The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge
p.(None): autonomy and the requirement to protect those with diminished autonomy.
p.(None):
p.(None): An autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of
p.(None): such deliberation. To respect autonomy is to give weight to autonomous persons' considered opinions and choices while
p.(None): refraining from obstructing their actions unless they are clearly detrimental to others. To show lack of respect for an
p.(None): autonomous agent is to repudiate that person's considered judgments, to deny an individual the freedom to act on those
p.(None): considered judgments, or to withhold information necessary to make a considered judgment, when there are no compelling
p.(None): reasons to do so.
p.(None):
p.(None): However, not every human being is capable of self-determination. The capacity for self-determination matures during an
p.(None): individual's life, and some individuals lose this capacity wholly or in part because of illness, mental disability, or
p.(None): circumstances that severely restrict liberty. Respect for the immature and the incapacitated may require protecting
p.(None): them as they mature or while they are incapacitated.
p.(None):
p.(None): Some persons are in need of extensive protection, even to the point of excluding them from activities which may harm
p.(None): them; other persons require little protection beyond making sure they undertake activities freely and with awareness of
p.(None): possible adverse consequence. The extent of protection afforded should depend upon the risk of harm and the likelihood
p.(None): of benefit. The judgment that any individual lacks autonomy should be periodically reevaluated and will vary in
p.(None): different situations.
p.(None):
p.(None): In most cases of research involving human subjects, respect for persons demands that subjects enter into the research
p.(None): voluntarily and with adequate information. In some situations, however, application of the principle is not obvious.
p.(None): The involvement of prisoners as subjects of research provides an instructive example. On the one hand, it would seem
...
p.(None): that are more than minimal, and (3) there is an adequate plan for debriefing subjects, when appropriate, and for
p.(None): dissemination of research results to them. Information about risks should never be withheld for the purpose of
p.(None): eliciting the cooperation of subjects, and truthful answers should always be given to direct questions about the
p.(None): research. Care should be taken to distinguish cases in which disclosure would destroy or invalidate the research from
p.(None): cases in which disclosure would simply inconvenience the investigator.
p.(None):
p.(None): Comprehension. The manner and context in which information is conveyed is as important as the information itself. For
p.(None): example, presenting information in a disorganized and rapid fashion, allowing too little time for consideration or
p.(None): curtailing opportunities for questioning, all may adversely affect a subject's ability to make an informed choice.
p.(None):
p.(None): Because the subject's ability to understand is a function of intelligence, rationality, maturity and language, it is
p.(None): necessary to adapt the presentation of the information to the subject's capacities. Investigators are responsible for
p.(None): ascertaining that the subject has comprehended the information. While there is always an obligation to ascertain that
p.(None): the information about risk to subjects is complete and adequately comprehended, when the risks are more serious, that
p.(None): obligation increases. On occasion, it may be suitable to give some oral or written tests of comprehension.
p.(None):
p.(None): Special provision may need to be made when comprehension is severely limited -- for example, by conditions of
p.(None): immaturity or mental disability. Each class of subjects that one might consider as incompetent (e.g., infants and young
p.(None): children, mentally disable patients, the terminally ill and the comatose) should be considered on its own terms. Even
p.(None): for these persons, however, respect requires giving them the opportunity to choose to the extent they are able, whether
p.(None): or not to participate in research. The objections of these subjects to involvement should be honored, unless the
p.(None): research entails providing them a therapy unavailable elsewhere. Respect for persons also requires seeking the
p.(None): permission of other parties in order to protect the subjects from harm. Such persons are thus respected both by
p.(None): acknowledging their own wishes and by the use of third parties to protect them from harm.
p.(None):
p.(None): The third parties chosen should be those who are most likely to understand the incompetent subject's situation and to
p.(None): act in that person's best interest. The person authorized to act on behalf of the subject should be given an
p.(None): opportunity to observe the research as it proceeds in order to be able to withdraw the subject from the research, if
p.(None): such action appears in the subject's best interest.
p.(None):
...
Health / Physically Disabled
Searching for indicator illness:
(return to top)
p.(None): The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge
p.(None): autonomy and the requirement to protect those with diminished autonomy.
p.(None):
p.(None): An autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of
p.(None): such deliberation. To respect autonomy is to give weight to autonomous persons' considered opinions and choices while
p.(None): refraining from obstructing their actions unless they are clearly detrimental to others. To show lack of respect for an
p.(None): autonomous agent is to repudiate that person's considered judgments, to deny an individual the freedom to act on those
p.(None): considered judgments, or to withhold information necessary to make a considered judgment, when there are no compelling
p.(None): reasons to do so.
p.(None):
p.(None): However, not every human being is capable of self-determination. The capacity for self-determination matures during an
p.(None): individual's life, and some individuals lose this capacity wholly or in part because of illness, mental disability, or
p.(None): circumstances that severely restrict liberty. Respect for the immature and the incapacitated may require protecting
p.(None): them as they mature or while they are incapacitated.
p.(None):
p.(None): Some persons are in need of extensive protection, even to the point of excluding them from activities which may harm
p.(None): them; other persons require little protection beyond making sure they undertake activities freely and with awareness of
p.(None): possible adverse consequence. The extent of protection afforded should depend upon the risk of harm and the likelihood
p.(None): of benefit. The judgment that any individual lacks autonomy should be periodically reevaluated and will vary in
p.(None): different situations.
p.(None):
p.(None): In most cases of research involving human subjects, respect for persons demands that subjects enter into the research
p.(None): voluntarily and with adequate information. In some situations, however, application of the principle is not obvious.
p.(None): The involvement of prisoners as subjects of research provides an instructive example. On the one hand, it would seem
...
p.(None): environments. When research is proposed that involves risks and does not include a therapeutic component, other less
p.(None): burdened classes of persons should be called upon first to accept these risks of research, except where the research is
p.(None): directly related to the specific conditions of the class involved. Also, even though public funds for research may
p.(None): often flow in the same directions as public funds for health care, it seems unfair that populations dependent on public
p.(None): health care constitute a pool of preferred research subjects if more advantaged populations are likely to be the
p.(None): recipients of the benefits.
p.(None):
p.(None): One special instance of injustice results from the involvement of vulnerable subjects. Certain groups, such as racial
p.(None): minorities, the economically disadvantaged, the very sick, and the institutionalized may continually be sought as
p.(None): research subjects, owing to their ready availability in settings where research is conducted.
p.(None): Given their dependent status and their frequently compromised capacity for free consent, they should be protected
p.(None): against the danger of being involved in research solely for administrative convenience, or because they are easy to
p.(None): manipulate as a result of their illness or socioeconomic condition.
p.(None):
p.(None):
p.(None): [1] Since 1945, various codes for the proper and responsible conduct of human experimentation in medical research have
p.(None): been adopted by different organizations. The best known of these codes are the Nuremberg Code of 1947, the Helsinki
p.(None): Declaration of 1964 (revised in 1975), and the 1971 Guidelines (codified into Federal Regulations in 1974) issued by
p.(None): the U.S. Department of Health, Education, and Welfare Codes for the conduct of social and behavioral research have also
p.(None): been adopted, the best known being that of the American Psychological Association, published in 1973.
p.(None):
p.(None): [2] Although practice usually involves interventions designed solely to enhance the well-being of a particular
p.(None): individual, interventions are sometimes applied to one individual for the enhancement of the well-being of another
p.(None): (e.g., blood donation, skin grafts, organ transplants) or an intervention may have the dual purpose of enhancing the
p.(None): well-being of a particular individual, and, at the same time, providing some benefit to others (e.g., vaccination,
p.(None): which protects both the person who is vaccinated and society generally). The fact that some forms of practice have
p.(None): elements other than immediate benefit to the individual receiving an intervention, however, should not confuse the
p.(None): general distinction between research and practice. Even when a procedure applied in practice may benefit some other
p.(None): person, it remains an intervention designed to enhance the well-being of a particular individual or groups of
p.(None): individuals; thus, it is practice and need not be reviewed as research.
p.(None):
...
Health / Physically Ill
Searching for indicator sick:
(return to top)
p.(None): even if IRBs are taking care to assure that subjects are selected fairly within a particular institution, unjust social
p.(None): patterns may nevertheless appear in the overall distribution of the burdens and benefits of research. Although
p.(None): individual institutions or investigators may not be able to resolve a problem that is pervasive in their social
p.(None): setting, they can consider distributive justice in selecting research subjects.
p.(None):
p.(None): Some populations, especially institutionalized ones, are already burdened in many ways by their infirmities and
p.(None): environments. When research is proposed that involves risks and does not include a therapeutic component, other less
p.(None): burdened classes of persons should be called upon first to accept these risks of research, except where the research is
p.(None): directly related to the specific conditions of the class involved. Also, even though public funds for research may
p.(None): often flow in the same directions as public funds for health care, it seems unfair that populations dependent on public
p.(None): health care constitute a pool of preferred research subjects if more advantaged populations are likely to be the
p.(None): recipients of the benefits.
p.(None):
p.(None): One special instance of injustice results from the involvement of vulnerable subjects. Certain groups, such as racial
p.(None): minorities, the economically disadvantaged, the very sick, and the institutionalized may continually be sought as
p.(None): research subjects, owing to their ready availability in settings where research is conducted.
p.(None): Given their dependent status and their frequently compromised capacity for free consent, they should be protected
p.(None): against the danger of being involved in research solely for administrative convenience, or because they are easy to
p.(None): manipulate as a result of their illness or socioeconomic condition.
p.(None):
p.(None):
p.(None): [1] Since 1945, various codes for the proper and responsible conduct of human experimentation in medical research have
p.(None): been adopted by different organizations. The best known of these codes are the Nuremberg Code of 1947, the Helsinki
p.(None): Declaration of 1964 (revised in 1975), and the 1971 Guidelines (codified into Federal Regulations in 1974) issued by
p.(None): the U.S. Department of Health, Education, and Welfare Codes for the conduct of social and behavioral research have also
p.(None): been adopted, the best known being that of the American Psychological Association, published in 1973.
p.(None):
p.(None): [2] Although practice usually involves interventions designed solely to enhance the well-being of a particular
p.(None): individual, interventions are sometimes applied to one individual for the enhancement of the well-being of another
...
Health / Terminally Ill
Searching for indicator terminally:
(return to top)
p.(None): research. Care should be taken to distinguish cases in which disclosure would destroy or invalidate the research from
p.(None): cases in which disclosure would simply inconvenience the investigator.
p.(None):
p.(None): Comprehension. The manner and context in which information is conveyed is as important as the information itself. For
p.(None): example, presenting information in a disorganized and rapid fashion, allowing too little time for consideration or
p.(None): curtailing opportunities for questioning, all may adversely affect a subject's ability to make an informed choice.
p.(None):
p.(None): Because the subject's ability to understand is a function of intelligence, rationality, maturity and language, it is
p.(None): necessary to adapt the presentation of the information to the subject's capacities. Investigators are responsible for
p.(None): ascertaining that the subject has comprehended the information. While there is always an obligation to ascertain that
p.(None): the information about risk to subjects is complete and adequately comprehended, when the risks are more serious, that
p.(None): obligation increases. On occasion, it may be suitable to give some oral or written tests of comprehension.
p.(None):
p.(None): Special provision may need to be made when comprehension is severely limited -- for example, by conditions of
p.(None): immaturity or mental disability. Each class of subjects that one might consider as incompetent (e.g., infants and young
p.(None): children, mentally disable patients, the terminally ill and the comatose) should be considered on its own terms. Even
p.(None): for these persons, however, respect requires giving them the opportunity to choose to the extent they are able, whether
p.(None): or not to participate in research. The objections of these subjects to involvement should be honored, unless the
p.(None): research entails providing them a therapy unavailable elsewhere. Respect for persons also requires seeking the
p.(None): permission of other parties in order to protect the subjects from harm. Such persons are thus respected both by
p.(None): acknowledging their own wishes and by the use of third parties to protect them from harm.
p.(None):
p.(None): The third parties chosen should be those who are most likely to understand the incompetent subject's situation and to
p.(None): act in that person's best interest. The person authorized to act on behalf of the subject should be given an
p.(None): opportunity to observe the research as it proceeds in order to be able to withdraw the subject from the research, if
p.(None): such action appears in the subject's best interest.
p.(None):
p.(None): Voluntariness. An agreement to participate in research constitutes a valid consent only if voluntarily given. This
...
Health / ill
Searching for indicator ill:
(return to top)
p.(None): cases in which disclosure would simply inconvenience the investigator.
p.(None):
p.(None): Comprehension. The manner and context in which information is conveyed is as important as the information itself. For
p.(None): example, presenting information in a disorganized and rapid fashion, allowing too little time for consideration or
p.(None): curtailing opportunities for questioning, all may adversely affect a subject's ability to make an informed choice.
p.(None):
p.(None): Because the subject's ability to understand is a function of intelligence, rationality, maturity and language, it is
p.(None): necessary to adapt the presentation of the information to the subject's capacities. Investigators are responsible for
p.(None): ascertaining that the subject has comprehended the information. While there is always an obligation to ascertain that
p.(None): the information about risk to subjects is complete and adequately comprehended, when the risks are more serious, that
p.(None): obligation increases. On occasion, it may be suitable to give some oral or written tests of comprehension.
p.(None):
p.(None): Special provision may need to be made when comprehension is severely limited -- for example, by conditions of
p.(None): immaturity or mental disability. Each class of subjects that one might consider as incompetent (e.g., infants and young
p.(None): children, mentally disable patients, the terminally ill and the comatose) should be considered on its own terms. Even
p.(None): for these persons, however, respect requires giving them the opportunity to choose to the extent they are able, whether
p.(None): or not to participate in research. The objections of these subjects to involvement should be honored, unless the
p.(None): research entails providing them a therapy unavailable elsewhere. Respect for persons also requires seeking the
p.(None): permission of other parties in order to protect the subjects from harm. Such persons are thus respected both by
p.(None): acknowledging their own wishes and by the use of third parties to protect them from harm.
p.(None):
p.(None): The third parties chosen should be those who are most likely to understand the incompetent subject's situation and to
p.(None): act in that person's best interest. The person authorized to act on behalf of the subject should be given an
p.(None): opportunity to observe the research as it proceeds in order to be able to withdraw the subject from the research, if
p.(None): such action appears in the subject's best interest.
p.(None):
p.(None): Voluntariness. An agreement to participate in research constitutes a valid consent only if voluntarily given. This
p.(None): element of informed consent requires conditions free of coercion and undue influence. Coercion occurs when an overt
...
Social / Age
Searching for indicator age:
(return to top)
p.(None): the application of previously accepted routine practices that on closer investigation turn out to be dangerous. But the
p.(None): role of the principle of beneficence is not always so unambiguous. A difficult ethical problem remains, for example,
p.(None): about research that presents more than minimal risk without immediate prospect of direct benefit to the children
p.(None): involved. Some have argued that such research is inadmissible, while others have pointed out that this limit would rule
p.(None): out much research promising great benefit to children in the future. Here again, as with all hard cases, the different
p.(None): claims covered by the principle of beneficence may come into conflict and force difficult choices.
p.(None):
p.(None): 3. Justice. — Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the
p.(None): sense of "fairness in distribution" or "what is deserved." An injustice occurs when some benefit to which a person is
p.(None): entitled is denied without good reason or when some burden is imposed unduly. Another way of conceiving the principle
p.(None): of justice is that equals ought to be treated equally. However, this statement requires explication. Who is equal and
p.(None): who is unequal? What considerations justify departure from equal distribution? Almost all commentators allow that
p.(None): distinctions based on experience, age, deprivation, competence, merit and position do sometimes constitute criteria
p.(None): justifying differential treatment for certain purposes. It is necessary, then, to explain in what respects people
p.(None): should be treated equally. There are several widely accepted formulations of just ways to distribute burdens and
p.(None): benefits. Each formulation mentions some relevant property on the basis of which burdens and benefits should be
p.(None): distributed. These formulations are (1) to each person an equal share, (2) to each person according to individual need,
p.(None): (3) to each person according to individual effort, (4) to each person according to societal contribution, and (5) to
p.(None): each person according to merit.
p.(None):
p.(None): Questions of justice have long been associated with social practices such as punishment, taxation and political
p.(None): representation. Until recently these questions have not generally been associated with scientific research. However,
p.(None): they are foreshadowed even in the earliest reflections on the ethics of research involving human subjects. For
p.(None): example, during the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor
p.(None): ward patients, while the benefits of improved medical care flowed primarily to private patients. Subsequently, the
p.(None): exploitation of unwilling prisoners as research subjects in Nazi concentration camps was condemned as a particularly
...
Social / Child
Searching for indicator children:
(return to top)
p.(None): others. However, even avoiding harm requires learning what is harmful; and, in the process of obtaining this
p.(None): information, persons may be exposed to risk of harm. Further, the Hippocratic Oath requires physicians to benefit their
p.(None): patients "according to their best judgment." Learning what will in fact benefit may require exposing persons to risk.
p.(None): The problem posed by these imperatives is to decide when it is justifiable to seek certain benefits despite the risks
p.(None): involved, and when the benefits should be foregone because of the risks.
p.(None):
p.(None): The obligations of beneficence affect both individual investigators and society at large, because they extend both to
p.(None): particular research projects and to the entire enterprise of research. In the case of particular projects,
p.(None): investigators and members of their institutions are obliged to give forethought to the maximization of benefits and the
p.(None): reduction of risk that might occur from the research investigation. In the case of scientific research in general,
p.(None): members of the larger society are obliged to recognize the longer term benefits and risks that may result from the
p.(None): improvement of knowledge and from the development of novel medical, psychotherapeutic, and social procedures.
p.(None):
p.(None): The principle of beneficence often occupies a well-defined justifying role in many areas of research involving human
p.(None): subjects. An example is found in research involving children. Effective ways of treating childhood diseases and
p.(None): fostering healthy development are benefits that serve to justify research involving children -- even when individual
p.(None): research subjects are not direct beneficiaries. Research also makes it possible to avoid the harm that may result from
p.(None): the application of previously accepted routine practices that on closer investigation turn out to be dangerous. But the
p.(None): role of the principle of beneficence is not always so unambiguous. A difficult ethical problem remains, for example,
p.(None): about research that presents more than minimal risk without immediate prospect of direct benefit to the children
p.(None): involved. Some have argued that such research is inadmissible, while others have pointed out that this limit would rule
p.(None): out much research promising great benefit to children in the future. Here again, as with all hard cases, the different
p.(None): claims covered by the principle of beneficence may come into conflict and force difficult choices.
p.(None):
p.(None): 3. Justice. — Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the
p.(None): sense of "fairness in distribution" or "what is deserved." An injustice occurs when some benefit to which a person is
p.(None): entitled is denied without good reason or when some burden is imposed unduly. Another way of conceiving the principle
p.(None): of justice is that equals ought to be treated equally. However, this statement requires explication. Who is equal and
p.(None): who is unequal? What considerations justify departure from equal distribution? Almost all commentators allow that
p.(None): distinctions based on experience, age, deprivation, competence, merit and position do sometimes constitute criteria
p.(None): justifying differential treatment for certain purposes. It is necessary, then, to explain in what respects people
p.(None): should be treated equally. There are several widely accepted formulations of just ways to distribute burdens and
p.(None): benefits. Each formulation mentions some relevant property on the basis of which burdens and benefits should be
p.(None): distributed. These formulations are (1) to each person an equal share, (2) to each person according to individual need,
p.(None): (3) to each person according to individual effort, (4) to each person according to societal contribution, and (5) to
p.(None): each person according to merit.
p.(None):
...
p.(None): eliciting the cooperation of subjects, and truthful answers should always be given to direct questions about the
p.(None): research. Care should be taken to distinguish cases in which disclosure would destroy or invalidate the research from
p.(None): cases in which disclosure would simply inconvenience the investigator.
p.(None):
p.(None): Comprehension. The manner and context in which information is conveyed is as important as the information itself. For
p.(None): example, presenting information in a disorganized and rapid fashion, allowing too little time for consideration or
p.(None): curtailing opportunities for questioning, all may adversely affect a subject's ability to make an informed choice.
p.(None):
p.(None): Because the subject's ability to understand is a function of intelligence, rationality, maturity and language, it is
p.(None): necessary to adapt the presentation of the information to the subject's capacities. Investigators are responsible for
p.(None): ascertaining that the subject has comprehended the information. While there is always an obligation to ascertain that
p.(None): the information about risk to subjects is complete and adequately comprehended, when the risks are more serious, that
p.(None): obligation increases. On occasion, it may be suitable to give some oral or written tests of comprehension.
p.(None):
p.(None): Special provision may need to be made when comprehension is severely limited -- for example, by conditions of
p.(None): immaturity or mental disability. Each class of subjects that one might consider as incompetent (e.g., infants and young
p.(None): children, mentally disable patients, the terminally ill and the comatose) should be considered on its own terms. Even
p.(None): for these persons, however, respect requires giving them the opportunity to choose to the extent they are able, whether
p.(None): or not to participate in research. The objections of these subjects to involvement should be honored, unless the
p.(None): research entails providing them a therapy unavailable elsewhere. Respect for persons also requires seeking the
p.(None): permission of other parties in order to protect the subjects from harm. Such persons are thus respected both by
p.(None): acknowledging their own wishes and by the use of third parties to protect them from harm.
p.(None):
p.(None): The third parties chosen should be those who are most likely to understand the incompetent subject's situation and to
p.(None): act in that person's best interest. The person authorized to act on behalf of the subject should be given an
p.(None): opportunity to observe the research as it proceeds in order to be able to withdraw the subject from the research, if
p.(None): such action appears in the subject's best interest.
p.(None):
p.(None): Voluntariness. An agreement to participate in research constitutes a valid consent only if voluntarily given. This
...
p.(None): thoroughly arrayed in documents and procedures used in the informed consent process.
p.(None):
p.(None): 3. Selection of Subjects. — Just as the principle of respect for persons finds expression in the requirements for
p.(None): consent, and the principle of beneficence in risk/benefit assessment, the principle of justice gives rise to moral
p.(None): requirements that there be fair procedures and outcomes in the selection of research subjects.
p.(None):
p.(None): Justice is relevant to the selection of subjects of research at two levels: the social and the individual. Individual
p.(None): justice in the selection of subjects would require that researchers exhibit fairness: thus, they should not offer
p.(None): potentially beneficial research only to some patients who are in their favor or select only "undesirable" persons for
p.(None): risky research. Social justice requires that distinction be drawn between classes of subjects that ought, and ought
p.(None): not, to participate in any particular kind of research, based on the ability of members of that class to bear burdens
p.(None): and on the appropriateness of placing further burdens on already burdened persons. Thus, it can be considered a matter
p.(None): of social justice that there is an order of preference in the selection of classes of subjects (e.g., adults before
p.(None): children) and that some classes of potential subjects (e.g., the institutionalized mentally infirm or prisoners) may be
p.(None): involved as research subjects, if at all, only on certain conditions.
p.(None):
p.(None): Injustice may appear in the selection of subjects, even if individual subjects are selected fairly by investigators and
p.(None): treated fairly in the course of research. Thus injustice arises from social, racial, sexual and cultural biases
p.(None): institutionalized in society. Thus, even if individual researchers are treating their research subjects fairly, and
p.(None): even if IRBs are taking care to assure that subjects are selected fairly within a particular institution, unjust social
p.(None): patterns may nevertheless appear in the overall distribution of the burdens and benefits of research. Although
p.(None): individual institutions or investigators may not be able to resolve a problem that is pervasive in their social
p.(None): setting, they can consider distributive justice in selecting research subjects.
p.(None):
p.(None): Some populations, especially institutionalized ones, are already burdened in many ways by their infirmities and
p.(None): environments. When research is proposed that involves risks and does not include a therapeutic component, other less
p.(None): burdened classes of persons should be called upon first to accept these risks of research, except where the research is
...
Social / Ethnicity
Searching for indicator ethnic:
(return to top)
p.(None): representation. Until recently these questions have not generally been associated with scientific research. However,
p.(None): they are foreshadowed even in the earliest reflections on the ethics of research involving human subjects. For
p.(None): example, during the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor
p.(None): ward patients, while the benefits of improved medical care flowed primarily to private patients. Subsequently, the
p.(None): exploitation of unwilling prisoners as research subjects in Nazi concentration camps was condemned as a particularly
p.(None): flagrant injustice. In this country, in the 1940's, the Tuskegee syphilis study used disadvantaged, rural black men to
p.(None): study the untreated course of a disease that is by no means confined to that population. These subjects were deprived
p.(None): of demonstrably effective treatment in order not to interrupt the project, long after such treatment became generally
p.(None): available.
p.(None):
p.(None): Against this historical background, it can be seen how conceptions of justice are relevant to research involving human
p.(None): subjects. For example, the selection of research subjects needs to be scrutinized in order to determine whether some
p.(None): classes (e.g., welfare patients, particular racial and ethnic minorities, or persons confined to institutions) are
p.(None): being systematically selected simply because of their easy availability, their compromised position, or their
p.(None): manipulability, rather than for reasons directly related to the problem being studied. Finally, whenever research
p.(None): supported by public funds leads to the development of therapeutic devices and procedures, justice demands both that
p.(None): these not provide advantages only to those who can afford them and that such research should not unduly involve persons
p.(None): from groups unlikely to be among the beneficiaries of subsequent applications of the research.
p.(None):
p.(None):
p.(None):
p.(None): Part C: Applications
p.(None): C. Applications
p.(None):
p.(None): Applications of the general principles to the conduct of research leads to consideration of the following requirements:
p.(None): informed consent, risk/benefit assessment, and the selection of subjects of research.
p.(None):
p.(None): 1. Informed Consent. — Respect for persons requires that subjects, to the degree that they are capable, be given the
p.(None): opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for
p.(None): informed consent are satisfied.
p.(None):
p.(None): While the importance of informed consent is unquestioned, controversy prevails over the nature and possibility of an
...
Social / Incarcerated
Searching for indicator liberty:
(return to top)
p.(None): The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge
p.(None): autonomy and the requirement to protect those with diminished autonomy.
p.(None):
p.(None): An autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of
p.(None): such deliberation. To respect autonomy is to give weight to autonomous persons' considered opinions and choices while
p.(None): refraining from obstructing their actions unless they are clearly detrimental to others. To show lack of respect for an
p.(None): autonomous agent is to repudiate that person's considered judgments, to deny an individual the freedom to act on those
p.(None): considered judgments, or to withhold information necessary to make a considered judgment, when there are no compelling
p.(None): reasons to do so.
p.(None):
p.(None): However, not every human being is capable of self-determination. The capacity for self-determination matures during an
p.(None): individual's life, and some individuals lose this capacity wholly or in part because of illness, mental disability, or
p.(None): circumstances that severely restrict liberty. Respect for the immature and the incapacitated may require protecting
p.(None): them as they mature or while they are incapacitated.
p.(None):
p.(None): Some persons are in need of extensive protection, even to the point of excluding them from activities which may harm
p.(None): them; other persons require little protection beyond making sure they undertake activities freely and with awareness of
p.(None): possible adverse consequence. The extent of protection afforded should depend upon the risk of harm and the likelihood
p.(None): of benefit. The judgment that any individual lacks autonomy should be periodically reevaluated and will vary in
p.(None): different situations.
p.(None):
p.(None): In most cases of research involving human subjects, respect for persons demands that subjects enter into the research
p.(None): voluntarily and with adequate information. In some situations, however, application of the principle is not obvious.
p.(None): The involvement of prisoners as subjects of research provides an instructive example. On the one hand, it would seem
p.(None): that the principle of respect for persons requires that prisoners not be deprived of the opportunity to volunteer for
...
Searching for indicator prison:
(return to top)
p.(None): them as they mature or while they are incapacitated.
p.(None):
p.(None): Some persons are in need of extensive protection, even to the point of excluding them from activities which may harm
p.(None): them; other persons require little protection beyond making sure they undertake activities freely and with awareness of
p.(None): possible adverse consequence. The extent of protection afforded should depend upon the risk of harm and the likelihood
p.(None): of benefit. The judgment that any individual lacks autonomy should be periodically reevaluated and will vary in
p.(None): different situations.
p.(None):
p.(None): In most cases of research involving human subjects, respect for persons demands that subjects enter into the research
p.(None): voluntarily and with adequate information. In some situations, however, application of the principle is not obvious.
p.(None): The involvement of prisoners as subjects of research provides an instructive example. On the one hand, it would seem
p.(None): that the principle of respect for persons requires that prisoners not be deprived of the opportunity to volunteer for
p.(None): research. On the other hand, under prison conditions they may be subtly coerced or unduly influenced to engage in
p.(None): research activities for which they would not otherwise volunteer. Respect for persons would then dictate that prisoners
p.(None): be protected. Whether to allow
p.(None):
p.(None): prisoners to "volunteer" or to "protect" them presents a dilemma. Respecting persons, in most hard cases, is often a
p.(None): matter of balancing competing claims urged by the principle of respect itself.
p.(None):
p.(None): 2. Beneficence. — Persons are treated in an ethical manner not only by respecting their decisions and protecting them
p.(None): from harm, but also by making efforts to secure their well-being. Such treatment falls under the principle of
p.(None): beneficence. The term "beneficence" is often understood to cover acts of kindness or charity that go beyond strict
p.(None): obligation. In this document, beneficence is understood in a stronger sense, as an obligation. Two general rules have
p.(None): been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize
p.(None): possible benefits and minimize possible harms.
p.(None):
p.(None): The Hippocratic maxim "do no harm" has long been a fundamental principle of medical ethics. Claude Bernard extended it
...
Social / Institutionalized
Searching for indicator institutionalized:
(return to top)
p.(None):
p.(None): 3. Selection of Subjects. — Just as the principle of respect for persons finds expression in the requirements for
p.(None): consent, and the principle of beneficence in risk/benefit assessment, the principle of justice gives rise to moral
p.(None): requirements that there be fair procedures and outcomes in the selection of research subjects.
p.(None):
p.(None): Justice is relevant to the selection of subjects of research at two levels: the social and the individual. Individual
p.(None): justice in the selection of subjects would require that researchers exhibit fairness: thus, they should not offer
p.(None): potentially beneficial research only to some patients who are in their favor or select only "undesirable" persons for
p.(None): risky research. Social justice requires that distinction be drawn between classes of subjects that ought, and ought
p.(None): not, to participate in any particular kind of research, based on the ability of members of that class to bear burdens
p.(None): and on the appropriateness of placing further burdens on already burdened persons. Thus, it can be considered a matter
p.(None): of social justice that there is an order of preference in the selection of classes of subjects (e.g., adults before
p.(None): children) and that some classes of potential subjects (e.g., the institutionalized mentally infirm or prisoners) may be
p.(None): involved as research subjects, if at all, only on certain conditions.
p.(None):
p.(None): Injustice may appear in the selection of subjects, even if individual subjects are selected fairly by investigators and
p.(None): treated fairly in the course of research. Thus injustice arises from social, racial, sexual and cultural biases
p.(None): institutionalized in society. Thus, even if individual researchers are treating their research subjects fairly, and
p.(None): even if IRBs are taking care to assure that subjects are selected fairly within a particular institution, unjust social
p.(None): patterns may nevertheless appear in the overall distribution of the burdens and benefits of research. Although
p.(None): individual institutions or investigators may not be able to resolve a problem that is pervasive in their social
p.(None): setting, they can consider distributive justice in selecting research subjects.
p.(None):
p.(None): Some populations, especially institutionalized ones, are already burdened in many ways by their infirmities and
p.(None): environments. When research is proposed that involves risks and does not include a therapeutic component, other less
p.(None): burdened classes of persons should be called upon first to accept these risks of research, except where the research is
p.(None): directly related to the specific conditions of the class involved. Also, even though public funds for research may
p.(None): often flow in the same directions as public funds for health care, it seems unfair that populations dependent on public
p.(None): health care constitute a pool of preferred research subjects if more advantaged populations are likely to be the
p.(None): recipients of the benefits.
p.(None):
p.(None): One special instance of injustice results from the involvement of vulnerable subjects. Certain groups, such as racial
p.(None): minorities, the economically disadvantaged, the very sick, and the institutionalized may continually be sought as
p.(None): research subjects, owing to their ready availability in settings where research is conducted.
p.(None): Given their dependent status and their frequently compromised capacity for free consent, they should be protected
p.(None): against the danger of being involved in research solely for administrative convenience, or because they are easy to
p.(None): manipulate as a result of their illness or socioeconomic condition.
p.(None):
p.(None):
p.(None): [1] Since 1945, various codes for the proper and responsible conduct of human experimentation in medical research have
p.(None): been adopted by different organizations. The best known of these codes are the Nuremberg Code of 1947, the Helsinki
p.(None): Declaration of 1964 (revised in 1975), and the 1971 Guidelines (codified into Federal Regulations in 1974) issued by
p.(None): the U.S. Department of Health, Education, and Welfare Codes for the conduct of social and behavioral research have also
p.(None): been adopted, the best known being that of the American Psychological Association, published in 1973.
p.(None):
p.(None): [2] Although practice usually involves interventions designed solely to enhance the well-being of a particular
p.(None): individual, interventions are sometimes applied to one individual for the enhancement of the well-being of another
p.(None): (e.g., blood donation, skin grafts, organ transplants) or an intervention may have the dual purpose of enhancing the
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.(None): participation.
p.(None):
p.(None): A special problem of consent arises where informing subjects of some pertinent aspect of the research is likely to
p.(None): impair the validity of the research. In many cases, it is sufficient to indicate to subjects that they are being
p.(None): invited to participate in research of which some features will not be revealed until the research is concluded. In all
p.(None): cases of research involving incomplete disclosure, such research is justified only if it is clear that (1) incomplete
p.(None): disclosure is truly necessary to accomplish the goals of the research, (2) there are no undisclosed risks to subjects
p.(None): that are more than minimal, and (3) there is an adequate plan for debriefing subjects, when appropriate, and for
p.(None): dissemination of research results to them. Information about risks should never be withheld for the purpose of
p.(None): eliciting the cooperation of subjects, and truthful answers should always be given to direct questions about the
p.(None): research. Care should be taken to distinguish cases in which disclosure would destroy or invalidate the research from
p.(None): cases in which disclosure would simply inconvenience the investigator.
p.(None):
p.(None): Comprehension. The manner and context in which information is conveyed is as important as the information itself. For
p.(None): example, presenting information in a disorganized and rapid fashion, allowing too little time for consideration or
p.(None): curtailing opportunities for questioning, all may adversely affect a subject's ability to make an informed choice.
p.(None):
p.(None): Because the subject's ability to understand is a function of intelligence, rationality, maturity and language, it is
p.(None): necessary to adapt the presentation of the information to the subject's capacities. Investigators are responsible for
p.(None): ascertaining that the subject has comprehended the information. While there is always an obligation to ascertain that
p.(None): the information about risk to subjects is complete and adequately comprehended, when the risks are more serious, that
p.(None): obligation increases. On occasion, it may be suitable to give some oral or written tests of comprehension.
p.(None):
p.(None): Special provision may need to be made when comprehension is severely limited -- for example, by conditions of
p.(None): immaturity or mental disability. Each class of subjects that one might consider as incompetent (e.g., infants and young
p.(None): children, mentally disable patients, the terminally ill and the comatose) should be considered on its own terms. Even
p.(None): for these persons, however, respect requires giving them the opportunity to choose to the extent they are able, whether
p.(None): or not to participate in research. The objections of these subjects to involvement should be honored, unless the
p.(None): research entails providing them a therapy unavailable elsewhere. Respect for persons also requires seeking the
p.(None): permission of other parties in order to protect the subjects from harm. Such persons are thus respected both by
...
Social / Presence of Coercion
Searching for indicator coerced:
(return to top)
p.(None): them as they mature or while they are incapacitated.
p.(None):
p.(None): Some persons are in need of extensive protection, even to the point of excluding them from activities which may harm
p.(None): them; other persons require little protection beyond making sure they undertake activities freely and with awareness of
p.(None): possible adverse consequence. The extent of protection afforded should depend upon the risk of harm and the likelihood
p.(None): of benefit. The judgment that any individual lacks autonomy should be periodically reevaluated and will vary in
p.(None): different situations.
p.(None):
p.(None): In most cases of research involving human subjects, respect for persons demands that subjects enter into the research
p.(None): voluntarily and with adequate information. In some situations, however, application of the principle is not obvious.
p.(None): The involvement of prisoners as subjects of research provides an instructive example. On the one hand, it would seem
p.(None): that the principle of respect for persons requires that prisoners not be deprived of the opportunity to volunteer for
p.(None): research. On the other hand, under prison conditions they may be subtly coerced or unduly influenced to engage in
p.(None): research activities for which they would not otherwise volunteer. Respect for persons would then dictate that prisoners
p.(None): be protected. Whether to allow
p.(None):
p.(None): prisoners to "volunteer" or to "protect" them presents a dilemma. Respecting persons, in most hard cases, is often a
p.(None): matter of balancing competing claims urged by the principle of respect itself.
p.(None):
p.(None): 2. Beneficence. — Persons are treated in an ethical manner not only by respecting their decisions and protecting them
p.(None): from harm, but also by making efforts to secure their well-being. Such treatment falls under the principle of
p.(None): beneficence. The term "beneficence" is often understood to cover acts of kindness or charity that go beyond strict
p.(None): obligation. In this document, beneficence is understood in a stronger sense, as an obligation. Two general rules have
p.(None): been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize
p.(None): possible benefits and minimize possible harms.
p.(None):
p.(None): The Hippocratic maxim "do no harm" has long been a fundamental principle of medical ethics. Claude Bernard extended it
p.(None): to the realm of research, saying that one should not injure one person regardless of the benefits that might come to
...
Social / Property Ownership
Searching for indicator property:
(return to top)
p.(None): involved. Some have argued that such research is inadmissible, while others have pointed out that this limit would rule
p.(None): out much research promising great benefit to children in the future. Here again, as with all hard cases, the different
p.(None): claims covered by the principle of beneficence may come into conflict and force difficult choices.
p.(None):
p.(None): 3. Justice. — Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the
p.(None): sense of "fairness in distribution" or "what is deserved." An injustice occurs when some benefit to which a person is
p.(None): entitled is denied without good reason or when some burden is imposed unduly. Another way of conceiving the principle
p.(None): of justice is that equals ought to be treated equally. However, this statement requires explication. Who is equal and
p.(None): who is unequal? What considerations justify departure from equal distribution? Almost all commentators allow that
p.(None): distinctions based on experience, age, deprivation, competence, merit and position do sometimes constitute criteria
p.(None): justifying differential treatment for certain purposes. It is necessary, then, to explain in what respects people
p.(None): should be treated equally. There are several widely accepted formulations of just ways to distribute burdens and
p.(None): benefits. Each formulation mentions some relevant property on the basis of which burdens and benefits should be
p.(None): distributed. These formulations are (1) to each person an equal share, (2) to each person according to individual need,
p.(None): (3) to each person according to individual effort, (4) to each person according to societal contribution, and (5) to
p.(None): each person according to merit.
p.(None):
p.(None): Questions of justice have long been associated with social practices such as punishment, taxation and political
p.(None): representation. Until recently these questions have not generally been associated with scientific research. However,
p.(None): they are foreshadowed even in the earliest reflections on the ethics of research involving human subjects. For
p.(None): example, during the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor
p.(None): ward patients, while the benefits of improved medical care flowed primarily to private patients. Subsequently, the
p.(None): exploitation of unwilling prisoners as research subjects in Nazi concentration camps was condemned as a particularly
p.(None): flagrant injustice. In this country, in the 1940's, the Tuskegee syphilis study used disadvantaged, rural black men to
p.(None): study the untreated course of a disease that is by no means confined to that population. These subjects were deprived
p.(None): of demonstrably effective treatment in order not to interrupt the project, long after such treatment became generally
p.(None): available.
p.(None):
...
Social / Racial Minority
Searching for indicator racial:
(return to top)
p.(None):
p.(None): Questions of justice have long been associated with social practices such as punishment, taxation and political
p.(None): representation. Until recently these questions have not generally been associated with scientific research. However,
p.(None): they are foreshadowed even in the earliest reflections on the ethics of research involving human subjects. For
p.(None): example, during the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor
p.(None): ward patients, while the benefits of improved medical care flowed primarily to private patients. Subsequently, the
p.(None): exploitation of unwilling prisoners as research subjects in Nazi concentration camps was condemned as a particularly
p.(None): flagrant injustice. In this country, in the 1940's, the Tuskegee syphilis study used disadvantaged, rural black men to
p.(None): study the untreated course of a disease that is by no means confined to that population. These subjects were deprived
p.(None): of demonstrably effective treatment in order not to interrupt the project, long after such treatment became generally
p.(None): available.
p.(None):
p.(None): Against this historical background, it can be seen how conceptions of justice are relevant to research involving human
p.(None): subjects. For example, the selection of research subjects needs to be scrutinized in order to determine whether some
p.(None): classes (e.g., welfare patients, particular racial and ethnic minorities, or persons confined to institutions) are
p.(None): being systematically selected simply because of their easy availability, their compromised position, or their
p.(None): manipulability, rather than for reasons directly related to the problem being studied. Finally, whenever research
p.(None): supported by public funds leads to the development of therapeutic devices and procedures, justice demands both that
p.(None): these not provide advantages only to those who can afford them and that such research should not unduly involve persons
p.(None): from groups unlikely to be among the beneficiaries of subsequent applications of the research.
p.(None):
p.(None):
p.(None):
p.(None): Part C: Applications
p.(None): C. Applications
p.(None):
p.(None): Applications of the general principles to the conduct of research leads to consideration of the following requirements:
p.(None): informed consent, risk/benefit assessment, and the selection of subjects of research.
p.(None):
p.(None): 1. Informed Consent. — Respect for persons requires that subjects, to the degree that they are capable, be given the
p.(None): opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for
p.(None): informed consent are satisfied.
p.(None):
p.(None): While the importance of informed consent is unquestioned, controversy prevails over the nature and possibility of an
...
p.(None): requirements that there be fair procedures and outcomes in the selection of research subjects.
p.(None):
p.(None): Justice is relevant to the selection of subjects of research at two levels: the social and the individual. Individual
p.(None): justice in the selection of subjects would require that researchers exhibit fairness: thus, they should not offer
p.(None): potentially beneficial research only to some patients who are in their favor or select only "undesirable" persons for
p.(None): risky research. Social justice requires that distinction be drawn between classes of subjects that ought, and ought
p.(None): not, to participate in any particular kind of research, based on the ability of members of that class to bear burdens
p.(None): and on the appropriateness of placing further burdens on already burdened persons. Thus, it can be considered a matter
p.(None): of social justice that there is an order of preference in the selection of classes of subjects (e.g., adults before
p.(None): children) and that some classes of potential subjects (e.g., the institutionalized mentally infirm or prisoners) may be
p.(None): involved as research subjects, if at all, only on certain conditions.
p.(None):
p.(None): Injustice may appear in the selection of subjects, even if individual subjects are selected fairly by investigators and
p.(None): treated fairly in the course of research. Thus injustice arises from social, racial, sexual and cultural biases
p.(None): institutionalized in society. Thus, even if individual researchers are treating their research subjects fairly, and
p.(None): even if IRBs are taking care to assure that subjects are selected fairly within a particular institution, unjust social
p.(None): patterns may nevertheless appear in the overall distribution of the burdens and benefits of research. Although
p.(None): individual institutions or investigators may not be able to resolve a problem that is pervasive in their social
p.(None): setting, they can consider distributive justice in selecting research subjects.
p.(None):
p.(None): Some populations, especially institutionalized ones, are already burdened in many ways by their infirmities and
p.(None): environments. When research is proposed that involves risks and does not include a therapeutic component, other less
p.(None): burdened classes of persons should be called upon first to accept these risks of research, except where the research is
p.(None): directly related to the specific conditions of the class involved. Also, even though public funds for research may
p.(None): often flow in the same directions as public funds for health care, it seems unfair that populations dependent on public
p.(None): health care constitute a pool of preferred research subjects if more advantaged populations are likely to be the
p.(None): recipients of the benefits.
p.(None):
p.(None): One special instance of injustice results from the involvement of vulnerable subjects. Certain groups, such as racial
p.(None): minorities, the economically disadvantaged, the very sick, and the institutionalized may continually be sought as
p.(None): research subjects, owing to their ready availability in settings where research is conducted.
p.(None): Given their dependent status and their frequently compromised capacity for free consent, they should be protected
p.(None): against the danger of being involved in research solely for administrative convenience, or because they are easy to
p.(None): manipulate as a result of their illness or socioeconomic condition.
p.(None):
p.(None):
p.(None): [1] Since 1945, various codes for the proper and responsible conduct of human experimentation in medical research have
p.(None): been adopted by different organizations. The best known of these codes are the Nuremberg Code of 1947, the Helsinki
p.(None): Declaration of 1964 (revised in 1975), and the 1971 Guidelines (codified into Federal Regulations in 1974) issued by
p.(None): the U.S. Department of Health, Education, and Welfare Codes for the conduct of social and behavioral research have also
p.(None): been adopted, the best known being that of the American Psychological Association, published in 1973.
p.(None):
p.(None): [2] Although practice usually involves interventions designed solely to enhance the well-being of a particular
...
Social / Religion
Searching for indicator religion:
(return to top)
p.(None): of its charge, is available as DHEW Publication No. (OS) 78-0013 and No. (OS) 78-0014, for sale by the Superintendent
p.(None): of Documents, U.S. Government Printing Office, Washington, D.C. 20402.
p.(None):
p.(None): Unlike most other reports of the Commission, the Belmont Report does not make specific recommendations for
p.(None): administrative action by the Secretary of Health, Education, and Welfare. Rather, the Commission recommended that the
p.(None): Belmont Report be adopted in its entirety, as a statement of the Department's policy. The Department requests public
p.(None): comment on this recommendation.
p.(None):
p.(None):
p.(None):
p.(None): National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
p.(None): Members of the Commission
p.(None): Kenneth John Ryan, M.D., Chairman, Chief of Staff, Boston Hospital for Women. Joseph V. Brady, Ph.D., Professor of
p.(None): Behavioral Biology, Johns Hopkins University. Robert E. Cooke, M.D., President, Medical College of Pennsylvania.
p.(None): Dorothy I. Height, President, National Council of Negro Women, Inc.
p.(None): Albert R. Jonsen, Ph.D., Associate Professor of Bioethics, University of California at San Francisco. Patricia King,
p.(None): J.D., Associate Professor of Law, Georgetown University Law Center.
p.(None): Karen Lebacqz, Ph.D., Associate Professor of Christian Ethics, Pacific School of Religion.
p.(None): *** David W. Louisell, J.D., Professor of Law, University of California at Berkeley.
p.(None): Donald W. Seldin, M.D., Professor and Chairman, Department of Internal Medicine, University of Texas at Dallas.
p.(None): *** Eliot Stellar, Ph.D., Provost of the University and Professor of Physiological Psychology, University of
p.(None): Pennsylvania.
p.(None): *** Robert H. Turtle, LL.B., Attorney, VomBaur, Coburn, Simmons & Turtle, Washington, D.C.
p.(None): *** Deceased.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Table of Contents
p.(None): Ethical Principles and Guidelines for Research Involving Human Subjects
p.(None): A. Boundaries Between Practice and Research
p.(None): B. Basic Ethical Principles
p.(None): 1. Respect for Persons
p.(None): 2. Beneficence
p.(None): 3. Justice
p.(None): C. Applications
p.(None): 1. Informed Consent
p.(None): 2. Assessment of Risk and Benefits
p.(None): 3. Selection of Subjects
p.(None):
p.(None):
p.(None):
p.(None): Ethical Principles & Guidelines for Research Involving Human Subjects
p.(None): Scientific research has produced substantial social benefits. It has also posed some troubling ethical questions.
p.(None): Public attention was drawn to these questions by reported abuses of human subjects in biomedical experiments,
p.(None): especially during the Second World War. During the Nuremberg War Crime Trials, the Nuremberg code was drafted as a set
p.(None): of standards for judging physicians and scientists who had conducted biomedical experiments on concentration camp
...
Social / Threat of Stigma
Searching for indicator threat:
(return to top)
p.(None): for these persons, however, respect requires giving them the opportunity to choose to the extent they are able, whether
p.(None): or not to participate in research. The objections of these subjects to involvement should be honored, unless the
p.(None): research entails providing them a therapy unavailable elsewhere. Respect for persons also requires seeking the
p.(None): permission of other parties in order to protect the subjects from harm. Such persons are thus respected both by
p.(None): acknowledging their own wishes and by the use of third parties to protect them from harm.
p.(None):
p.(None): The third parties chosen should be those who are most likely to understand the incompetent subject's situation and to
p.(None): act in that person's best interest. The person authorized to act on behalf of the subject should be given an
p.(None): opportunity to observe the research as it proceeds in order to be able to withdraw the subject from the research, if
p.(None): such action appears in the subject's best interest.
p.(None):
p.(None): Voluntariness. An agreement to participate in research constitutes a valid consent only if voluntarily given. This
p.(None): element of informed consent requires conditions free of coercion and undue influence. Coercion occurs when an overt
p.(None): threat of harm is intentionally presented by one person to another in order to obtain compliance. Undue influence, by
p.(None): contrast, occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in
p.(None): order to obtain compliance. Also, inducements that would ordinarily be acceptable may become undue influences if the
p.(None): subject is especially vulnerable.
p.(None):
p.(None): Unjustifiable pressures usually occur when persons in positions of authority or commanding influence -- especially
p.(None): where possible sanctions are involved -- urge a course of action for a subject. A continuum of
p.(None):
p.(None): such influencing factors exists, however, and it is impossible to state precisely where justifiable persuasion ends and
p.(None): undue influence begins. But undue influence would include actions such as manipulating a person's choice through the
p.(None): controlling influence of a close relative and threatening to withdraw health services to which an individual would
p.(None): otherwise be entitled.
p.(None):
p.(None): 2. Assessment of Risks and Benefits. — The assessment of risks and benefits requires a careful arrayal of relevant
p.(None): data, including, in some cases, alternative ways of obtaining the benefits sought in the research. Thus, the assessment
p.(None): presents both an opportunity and a responsibility to gather systematic and comprehensive information about proposed
...
Social / Women
Searching for indicator women:
(return to top)
p.(None): that were held over a period of nearly four years. It is a statement of basic ethical principles and guidelines that
p.(None): should assist in resolving the ethical problems that surround the conduct of research with human subjects. By
p.(None): publishing the Report in the Federal Register, and providing reprints upon request, the Secretary intends that it may
p.(None): be made readily available to scientists, members of Institutional Review Boards, and Federal employees. The two-volume
p.(None): Appendix, containing the lengthy reports of experts and specialists who assisted the Commission in fulfilling this part
p.(None): of its charge, is available as DHEW Publication No. (OS) 78-0013 and No. (OS) 78-0014, for sale by the Superintendent
p.(None): of Documents, U.S. Government Printing Office, Washington, D.C. 20402.
p.(None):
p.(None): Unlike most other reports of the Commission, the Belmont Report does not make specific recommendations for
p.(None): administrative action by the Secretary of Health, Education, and Welfare. Rather, the Commission recommended that the
p.(None): Belmont Report be adopted in its entirety, as a statement of the Department's policy. The Department requests public
p.(None): comment on this recommendation.
p.(None):
p.(None):
p.(None):
p.(None): National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
p.(None): Members of the Commission
p.(None): Kenneth John Ryan, M.D., Chairman, Chief of Staff, Boston Hospital for Women. Joseph V. Brady, Ph.D., Professor of
p.(None): Behavioral Biology, Johns Hopkins University. Robert E. Cooke, M.D., President, Medical College of Pennsylvania.
p.(None): Dorothy I. Height, President, National Council of Negro Women, Inc.
p.(None): Albert R. Jonsen, Ph.D., Associate Professor of Bioethics, University of California at San Francisco. Patricia King,
p.(None): J.D., Associate Professor of Law, Georgetown University Law Center.
p.(None): Karen Lebacqz, Ph.D., Associate Professor of Christian Ethics, Pacific School of Religion.
p.(None): *** David W. Louisell, J.D., Professor of Law, University of California at Berkeley.
p.(None): Donald W. Seldin, M.D., Professor and Chairman, Department of Internal Medicine, University of Texas at Dallas.
p.(None): *** Eliot Stellar, Ph.D., Provost of the University and Professor of Physiological Psychology, University of
p.(None): Pennsylvania.
p.(None): *** Robert H. Turtle, LL.B., Attorney, VomBaur, Coburn, Simmons & Turtle, Washington, D.C.
p.(None): *** Deceased.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Table of Contents
p.(None): Ethical Principles and Guidelines for Research Involving Human Subjects
p.(None): A. Boundaries Between Practice and Research
p.(None): B. Basic Ethical Principles
p.(None): 1. Respect for Persons
p.(None): 2. Beneficence
p.(None): 3. Justice
p.(None): C. Applications
p.(None): 1. Informed Consent
p.(None): 2. Assessment of Risk and Benefits
p.(None): 3. Selection of Subjects
p.(None):
p.(None):
p.(None):
p.(None): Ethical Principles & Guidelines for Research Involving Human Subjects
p.(None): Scientific research has produced substantial social benefits. It has also posed some troubling ethical questions.
p.(None): Public attention was drawn to these questions by reported abuses of human subjects in biomedical experiments,
...
Social / education
Searching for indicator education:
(return to top)
p.(None): THE BELMONT REPORT
p.(None): Office of the Secretary
p.(None): Ethical Principles and Guidelines for the Protection of Human Subjects of Research
p.(None): The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
p.(None): April 18, 1979
p.(None):
p.(None):
p.(None):
p.(None): AGENCY: Department of Health, Education, and Welfare.
p.(None):
p.(None): ACTION: Notice of Report for Public Comment.
p.(None):
p.(None): SUMMARY: On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the
p.(None): National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to
p.(None): the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and
p.(None): behavioral research involving human subjects and to develop guidelines which should be followed to assure that such
p.(None): research is conducted in accordance with those principles. In carrying out the above, the Commission was directed to
p.(None): consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine practice of
p.(None): medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research
p.(None): involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in such
p.(None): research and (iv) the nature and definition of informed consent in various research settings.
p.(None):
p.(None): The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its
p.(None): deliberations. It is the outgrowth of an intensive four-day period of discussions that were held in February 1976 at
p.(None): the Smithsonian Institution's Belmont Conference Center supplemented by the monthly deliberations of the Commission
p.(None): that were held over a period of nearly four years. It is a statement of basic ethical principles and guidelines that
p.(None): should assist in resolving the ethical problems that surround the conduct of research with human subjects. By
p.(None): publishing the Report in the Federal Register, and providing reprints upon request, the Secretary intends that it may
p.(None): be made readily available to scientists, members of Institutional Review Boards, and Federal employees. The two-volume
p.(None): Appendix, containing the lengthy reports of experts and specialists who assisted the Commission in fulfilling this part
p.(None): of its charge, is available as DHEW Publication No. (OS) 78-0013 and No. (OS) 78-0014, for sale by the Superintendent
p.(None): of Documents, U.S. Government Printing Office, Washington, D.C. 20402.
p.(None):
p.(None): Unlike most other reports of the Commission, the Belmont Report does not make specific recommendations for
p.(None): administrative action by the Secretary of Health, Education, and Welfare. Rather, the Commission recommended that the
p.(None): Belmont Report be adopted in its entirety, as a statement of the Department's policy. The Department requests public
p.(None): comment on this recommendation.
p.(None):
p.(None):
p.(None):
p.(None): National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
p.(None): Members of the Commission
p.(None): Kenneth John Ryan, M.D., Chairman, Chief of Staff, Boston Hospital for Women. Joseph V. Brady, Ph.D., Professor of
p.(None): Behavioral Biology, Johns Hopkins University. Robert E. Cooke, M.D., President, Medical College of Pennsylvania.
p.(None): Dorothy I. Height, President, National Council of Negro Women, Inc.
p.(None): Albert R. Jonsen, Ph.D., Associate Professor of Bioethics, University of California at San Francisco. Patricia King,
p.(None): J.D., Associate Professor of Law, Georgetown University Law Center.
p.(None): Karen Lebacqz, Ph.D., Associate Professor of Christian Ethics, Pacific School of Religion.
p.(None): *** David W. Louisell, J.D., Professor of Law, University of California at Berkeley.
p.(None): Donald W. Seldin, M.D., Professor and Chairman, Department of Internal Medicine, University of Texas at Dallas.
p.(None): *** Eliot Stellar, Ph.D., Provost of the University and Professor of Physiological Psychology, University of
p.(None): Pennsylvania.
p.(None): *** Robert H. Turtle, LL.B., Attorney, VomBaur, Coburn, Simmons & Turtle, Washington, D.C.
p.(None): *** Deceased.
p.(None):
p.(None):
...
p.(None): health care constitute a pool of preferred research subjects if more advantaged populations are likely to be the
p.(None): recipients of the benefits.
p.(None):
p.(None): One special instance of injustice results from the involvement of vulnerable subjects. Certain groups, such as racial
p.(None): minorities, the economically disadvantaged, the very sick, and the institutionalized may continually be sought as
p.(None): research subjects, owing to their ready availability in settings where research is conducted.
p.(None): Given their dependent status and their frequently compromised capacity for free consent, they should be protected
p.(None): against the danger of being involved in research solely for administrative convenience, or because they are easy to
p.(None): manipulate as a result of their illness or socioeconomic condition.
p.(None):
p.(None):
p.(None): [1] Since 1945, various codes for the proper and responsible conduct of human experimentation in medical research have
p.(None): been adopted by different organizations. The best known of these codes are the Nuremberg Code of 1947, the Helsinki
p.(None): Declaration of 1964 (revised in 1975), and the 1971 Guidelines (codified into Federal Regulations in 1974) issued by
p.(None): the U.S. Department of Health, Education, and Welfare Codes for the conduct of social and behavioral research have also
p.(None): been adopted, the best known being that of the American Psychological Association, published in 1973.
p.(None):
p.(None): [2] Although practice usually involves interventions designed solely to enhance the well-being of a particular
p.(None): individual, interventions are sometimes applied to one individual for the enhancement of the well-being of another
p.(None): (e.g., blood donation, skin grafts, organ transplants) or an intervention may have the dual purpose of enhancing the
p.(None): well-being of a particular individual, and, at the same time, providing some benefit to others (e.g., vaccination,
p.(None): which protects both the person who is vaccinated and society generally). The fact that some forms of practice have
p.(None): elements other than immediate benefit to the individual receiving an intervention, however, should not confuse the
p.(None): general distinction between research and practice. Even when a procedure applied in practice may benefit some other
p.(None): person, it remains an intervention designed to enhance the well-being of a particular individual or groups of
p.(None): individuals; thus, it is practice and need not be reviewed as research.
p.(None):
p.(None): [3] Because the problems related to social experimentation may differ substantially from those of biomedical and
p.(None): behavioral research, the Commission specifically declines to make any policy determination regarding such research at
...
Social / employees
Searching for indicator employees:
(return to top)
p.(None): behavioral research involving human subjects and to develop guidelines which should be followed to assure that such
p.(None): research is conducted in accordance with those principles. In carrying out the above, the Commission was directed to
p.(None): consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine practice of
p.(None): medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research
p.(None): involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in such
p.(None): research and (iv) the nature and definition of informed consent in various research settings.
p.(None):
p.(None): The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its
p.(None): deliberations. It is the outgrowth of an intensive four-day period of discussions that were held in February 1976 at
p.(None): the Smithsonian Institution's Belmont Conference Center supplemented by the monthly deliberations of the Commission
p.(None): that were held over a period of nearly four years. It is a statement of basic ethical principles and guidelines that
p.(None): should assist in resolving the ethical problems that surround the conduct of research with human subjects. By
p.(None): publishing the Report in the Federal Register, and providing reprints upon request, the Secretary intends that it may
p.(None): be made readily available to scientists, members of Institutional Review Boards, and Federal employees. The two-volume
p.(None): Appendix, containing the lengthy reports of experts and specialists who assisted the Commission in fulfilling this part
p.(None): of its charge, is available as DHEW Publication No. (OS) 78-0013 and No. (OS) 78-0014, for sale by the Superintendent
p.(None): of Documents, U.S. Government Printing Office, Washington, D.C. 20402.
p.(None):
p.(None): Unlike most other reports of the Commission, the Belmont Report does not make specific recommendations for
p.(None): administrative action by the Secretary of Health, Education, and Welfare. Rather, the Commission recommended that the
p.(None): Belmont Report be adopted in its entirety, as a statement of the Department's policy. The Department requests public
p.(None): comment on this recommendation.
p.(None):
p.(None):
p.(None):
p.(None): National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
p.(None): Members of the Commission
p.(None): Kenneth John Ryan, M.D., Chairman, Chief of Staff, Boston Hospital for Women. Joseph V. Brady, Ph.D., Professor of
p.(None): Behavioral Biology, Johns Hopkins University. Robert E. Cooke, M.D., President, Medical College of Pennsylvania.
p.(None): Dorothy I. Height, President, National Council of Negro Women, Inc.
p.(None): Albert R. Jonsen, Ph.D., Associate Professor of Bioethics, University of California at San Francisco. Patricia King,
p.(None): J.D., Associate Professor of Law, Georgetown University Law Center.
...
Economic / Economic/Poverty
Searching for indicator poor:
(return to top)
p.(None): of justice is that equals ought to be treated equally. However, this statement requires explication. Who is equal and
p.(None): who is unequal? What considerations justify departure from equal distribution? Almost all commentators allow that
p.(None): distinctions based on experience, age, deprivation, competence, merit and position do sometimes constitute criteria
p.(None): justifying differential treatment for certain purposes. It is necessary, then, to explain in what respects people
p.(None): should be treated equally. There are several widely accepted formulations of just ways to distribute burdens and
p.(None): benefits. Each formulation mentions some relevant property on the basis of which burdens and benefits should be
p.(None): distributed. These formulations are (1) to each person an equal share, (2) to each person according to individual need,
p.(None): (3) to each person according to individual effort, (4) to each person according to societal contribution, and (5) to
p.(None): each person according to merit.
p.(None):
p.(None): Questions of justice have long been associated with social practices such as punishment, taxation and political
p.(None): representation. Until recently these questions have not generally been associated with scientific research. However,
p.(None): they are foreshadowed even in the earliest reflections on the ethics of research involving human subjects. For
p.(None): example, during the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor
p.(None): ward patients, while the benefits of improved medical care flowed primarily to private patients. Subsequently, the
p.(None): exploitation of unwilling prisoners as research subjects in Nazi concentration camps was condemned as a particularly
p.(None): flagrant injustice. In this country, in the 1940's, the Tuskegee syphilis study used disadvantaged, rural black men to
p.(None): study the untreated course of a disease that is by no means confined to that population. These subjects were deprived
p.(None): of demonstrably effective treatment in order not to interrupt the project, long after such treatment became generally
p.(None): available.
p.(None):
p.(None): Against this historical background, it can be seen how conceptions of justice are relevant to research involving human
p.(None): subjects. For example, the selection of research subjects needs to be scrutinized in order to determine whether some
p.(None): classes (e.g., welfare patients, particular racial and ethnic minorities, or persons confined to institutions) are
p.(None): being systematically selected simply because of their easy availability, their compromised position, or their
p.(None): manipulability, rather than for reasons directly related to the problem being studied. Finally, whenever research
p.(None): supported by public funds leads to the development of therapeutic devices and procedures, justice demands both that
...
General/Other / Dependent
Searching for indicator dependent:
(return to top)
p.(None): involved as research subjects, if at all, only on certain conditions.
p.(None):
p.(None): Injustice may appear in the selection of subjects, even if individual subjects are selected fairly by investigators and
p.(None): treated fairly in the course of research. Thus injustice arises from social, racial, sexual and cultural biases
p.(None): institutionalized in society. Thus, even if individual researchers are treating their research subjects fairly, and
p.(None): even if IRBs are taking care to assure that subjects are selected fairly within a particular institution, unjust social
p.(None): patterns may nevertheless appear in the overall distribution of the burdens and benefits of research. Although
p.(None): individual institutions or investigators may not be able to resolve a problem that is pervasive in their social
p.(None): setting, they can consider distributive justice in selecting research subjects.
p.(None):
p.(None): Some populations, especially institutionalized ones, are already burdened in many ways by their infirmities and
p.(None): environments. When research is proposed that involves risks and does not include a therapeutic component, other less
p.(None): burdened classes of persons should be called upon first to accept these risks of research, except where the research is
p.(None): directly related to the specific conditions of the class involved. Also, even though public funds for research may
p.(None): often flow in the same directions as public funds for health care, it seems unfair that populations dependent on public
p.(None): health care constitute a pool of preferred research subjects if more advantaged populations are likely to be the
p.(None): recipients of the benefits.
p.(None):
p.(None): One special instance of injustice results from the involvement of vulnerable subjects. Certain groups, such as racial
p.(None): minorities, the economically disadvantaged, the very sick, and the institutionalized may continually be sought as
p.(None): research subjects, owing to their ready availability in settings where research is conducted.
p.(None): Given their dependent status and their frequently compromised capacity for free consent, they should be protected
p.(None): against the danger of being involved in research solely for administrative convenience, or because they are easy to
p.(None): manipulate as a result of their illness or socioeconomic condition.
p.(None):
p.(None):
p.(None): [1] Since 1945, various codes for the proper and responsible conduct of human experimentation in medical research have
p.(None): been adopted by different organizations. The best known of these codes are the Nuremberg Code of 1947, the Helsinki
p.(None): Declaration of 1964 (revised in 1975), and the 1971 Guidelines (codified into Federal Regulations in 1974) issued by
p.(None): the U.S. Department of Health, Education, and Welfare Codes for the conduct of social and behavioral research have also
p.(None): been adopted, the best known being that of the American Psychological Association, published in 1973.
p.(None):
p.(None): [2] Although practice usually involves interventions designed solely to enhance the well-being of a particular
p.(None): individual, interventions are sometimes applied to one individual for the enhancement of the well-being of another
p.(None): (e.g., blood donation, skin grafts, organ transplants) or an intervention may have the dual purpose of enhancing the
p.(None): well-being of a particular individual, and, at the same time, providing some benefit to others (e.g., vaccination,
...
General/Other / Diminished Autonomy
Searching for indicator diminished:
(return to top)
p.(None): does not automatically place it in the category of research. Radically new procedures of this
p.(None):
p.(None): description should, however, be made the object of formal research at an early stage in order to determine whether they
p.(None): are safe and effective. Thus, it is the responsibility of medical practice committees, for example, to insist that a
p.(None): major innovation be incorporated into a formal research project [3].
p.(None):
p.(None): Research and practice may be carried on together when research is designed to evaluate the safety and efficacy of a
p.(None): therapy. This need not cause any confusion regarding whether or not the activity requires review; the general rule is
p.(None): that if there is any element of research in an activity, that activity should undergo review for the protection of
p.(None): human subjects.
p.(None):
p.(None):
p.(None):
p.(None): Part B: Basic Ethical Principles
p.(None): B. Basic Ethical Principles
p.(None):
p.(None): The expression "basic ethical principles" refers to those general judgments that serve as a basic justification for the
p.(None): many particular ethical prescriptions and evaluations of human actions. Three basic principles, among those generally
p.(None): accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects: the
p.(None): principles of respect of persons, beneficence and justice.
p.(None):
p.(None): 1. Respect for Persons. — Respect for persons incorporates at least two ethical convictions: first, that individuals
p.(None): should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection.
p.(None): The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge
p.(None): autonomy and the requirement to protect those with diminished autonomy.
p.(None):
p.(None): An autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of
p.(None): such deliberation. To respect autonomy is to give weight to autonomous persons' considered opinions and choices while
p.(None): refraining from obstructing their actions unless they are clearly detrimental to others. To show lack of respect for an
p.(None): autonomous agent is to repudiate that person's considered judgments, to deny an individual the freedom to act on those
p.(None): considered judgments, or to withhold information necessary to make a considered judgment, when there are no compelling
p.(None): reasons to do so.
p.(None):
p.(None): However, not every human being is capable of self-determination. The capacity for self-determination matures during an
p.(None): individual's life, and some individuals lose this capacity wholly or in part because of illness, mental disability, or
p.(None): circumstances that severely restrict liberty. Respect for the immature and the incapacitated may require protecting
p.(None): them as they mature or while they are incapacitated.
p.(None):
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
(return to top)
p.(None):
p.(None): description should, however, be made the object of formal research at an early stage in order to determine whether they
p.(None): are safe and effective. Thus, it is the responsibility of medical practice committees, for example, to insist that a
p.(None): major innovation be incorporated into a formal research project [3].
p.(None):
p.(None): Research and practice may be carried on together when research is designed to evaluate the safety and efficacy of a
p.(None): therapy. This need not cause any confusion regarding whether or not the activity requires review; the general rule is
p.(None): that if there is any element of research in an activity, that activity should undergo review for the protection of
p.(None): human subjects.
p.(None):
p.(None):
p.(None):
p.(None): Part B: Basic Ethical Principles
p.(None): B. Basic Ethical Principles
p.(None):
p.(None): The expression "basic ethical principles" refers to those general judgments that serve as a basic justification for the
p.(None): many particular ethical prescriptions and evaluations of human actions. Three basic principles, among those generally
p.(None): accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects: the
p.(None): principles of respect of persons, beneficence and justice.
p.(None):
p.(None): 1. Respect for Persons. — Respect for persons incorporates at least two ethical convictions: first, that individuals
p.(None): should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection.
p.(None): The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge
p.(None): autonomy and the requirement to protect those with diminished autonomy.
p.(None):
p.(None): An autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of
p.(None): such deliberation. To respect autonomy is to give weight to autonomous persons' considered opinions and choices while
p.(None): refraining from obstructing their actions unless they are clearly detrimental to others. To show lack of respect for an
p.(None): autonomous agent is to repudiate that person's considered judgments, to deny an individual the freedom to act on those
p.(None): considered judgments, or to withhold information necessary to make a considered judgment, when there are no compelling
p.(None): reasons to do so.
p.(None):
p.(None): However, not every human being is capable of self-determination. The capacity for self-determination matures during an
p.(None): individual's life, and some individuals lose this capacity wholly or in part because of illness, mental disability, or
p.(None): circumstances that severely restrict liberty. Respect for the immature and the incapacitated may require protecting
p.(None): them as they mature or while they are incapacitated.
p.(None):
p.(None): Some persons are in need of extensive protection, even to the point of excluding them from activities which may harm
p.(None): them; other persons require little protection beyond making sure they undertake activities freely and with awareness of
p.(None): possible adverse consequence. The extent of protection afforded should depend upon the risk of harm and the likelihood
p.(None): of benefit. The judgment that any individual lacks autonomy should be periodically reevaluated and will vary in
p.(None): different situations.
p.(None):
p.(None): In most cases of research involving human subjects, respect for persons demands that subjects enter into the research
p.(None): voluntarily and with adequate information. In some situations, however, application of the principle is not obvious.
p.(None): The involvement of prisoners as subjects of research provides an instructive example. On the one hand, it would seem
p.(None): that the principle of respect for persons requires that prisoners not be deprived of the opportunity to volunteer for
p.(None): research. On the other hand, under prison conditions they may be subtly coerced or unduly influenced to engage in
p.(None): research activities for which they would not otherwise volunteer. Respect for persons would then dictate that prisoners
p.(None): be protected. Whether to allow
p.(None):
p.(None): prisoners to "volunteer" or to "protect" them presents a dilemma. Respecting persons, in most hard cases, is often a
p.(None): matter of balancing competing claims urged by the principle of respect itself.
p.(None):
p.(None): 2. Beneficence. — Persons are treated in an ethical manner not only by respecting their decisions and protecting them
...
General/Other / Incapacitated
Searching for indicator incapacitated:
(return to top)
p.(None): autonomy and the requirement to protect those with diminished autonomy.
p.(None):
p.(None): An autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of
p.(None): such deliberation. To respect autonomy is to give weight to autonomous persons' considered opinions and choices while
p.(None): refraining from obstructing their actions unless they are clearly detrimental to others. To show lack of respect for an
p.(None): autonomous agent is to repudiate that person's considered judgments, to deny an individual the freedom to act on those
p.(None): considered judgments, or to withhold information necessary to make a considered judgment, when there are no compelling
p.(None): reasons to do so.
p.(None):
p.(None): However, not every human being is capable of self-determination. The capacity for self-determination matures during an
p.(None): individual's life, and some individuals lose this capacity wholly or in part because of illness, mental disability, or
p.(None): circumstances that severely restrict liberty. Respect for the immature and the incapacitated may require protecting
p.(None): them as they mature or while they are incapacitated.
p.(None):
p.(None): Some persons are in need of extensive protection, even to the point of excluding them from activities which may harm
p.(None): them; other persons require little protection beyond making sure they undertake activities freely and with awareness of
p.(None): possible adverse consequence. The extent of protection afforded should depend upon the risk of harm and the likelihood
p.(None): of benefit. The judgment that any individual lacks autonomy should be periodically reevaluated and will vary in
p.(None): different situations.
p.(None):
p.(None): In most cases of research involving human subjects, respect for persons demands that subjects enter into the research
p.(None): voluntarily and with adequate information. In some situations, however, application of the principle is not obvious.
p.(None): The involvement of prisoners as subjects of research provides an instructive example. On the one hand, it would seem
p.(None): that the principle of respect for persons requires that prisoners not be deprived of the opportunity to volunteer for
p.(None): research. On the other hand, under prison conditions they may be subtly coerced or unduly influenced to engage in
...
General/Other / Manipulable
Searching for indicator manipulate:
(return to top)
p.(None): environments. When research is proposed that involves risks and does not include a therapeutic component, other less
p.(None): burdened classes of persons should be called upon first to accept these risks of research, except where the research is
p.(None): directly related to the specific conditions of the class involved. Also, even though public funds for research may
p.(None): often flow in the same directions as public funds for health care, it seems unfair that populations dependent on public
p.(None): health care constitute a pool of preferred research subjects if more advantaged populations are likely to be the
p.(None): recipients of the benefits.
p.(None):
p.(None): One special instance of injustice results from the involvement of vulnerable subjects. Certain groups, such as racial
p.(None): minorities, the economically disadvantaged, the very sick, and the institutionalized may continually be sought as
p.(None): research subjects, owing to their ready availability in settings where research is conducted.
p.(None): Given their dependent status and their frequently compromised capacity for free consent, they should be protected
p.(None): against the danger of being involved in research solely for administrative convenience, or because they are easy to
p.(None): manipulate as a result of their illness or socioeconomic condition.
p.(None):
p.(None):
p.(None): [1] Since 1945, various codes for the proper and responsible conduct of human experimentation in medical research have
p.(None): been adopted by different organizations. The best known of these codes are the Nuremberg Code of 1947, the Helsinki
p.(None): Declaration of 1964 (revised in 1975), and the 1971 Guidelines (codified into Federal Regulations in 1974) issued by
p.(None): the U.S. Department of Health, Education, and Welfare Codes for the conduct of social and behavioral research have also
p.(None): been adopted, the best known being that of the American Psychological Association, published in 1973.
p.(None):
p.(None): [2] Although practice usually involves interventions designed solely to enhance the well-being of a particular
p.(None): individual, interventions are sometimes applied to one individual for the enhancement of the well-being of another
p.(None): (e.g., blood donation, skin grafts, organ transplants) or an intervention may have the dual purpose of enhancing the
p.(None): well-being of a particular individual, and, at the same time, providing some benefit to others (e.g., vaccination,
p.(None): which protects both the person who is vaccinated and society generally). The fact that some forms of practice have
p.(None): elements other than immediate benefit to the individual receiving an intervention, however, should not confuse the
p.(None): general distinction between research and practice. Even when a procedure applied in practice may benefit some other
p.(None): person, it remains an intervention designed to enhance the well-being of a particular individual or groups of
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None):
p.(None): The third parties chosen should be those who are most likely to understand the incompetent subject's situation and to
p.(None): act in that person's best interest. The person authorized to act on behalf of the subject should be given an
p.(None): opportunity to observe the research as it proceeds in order to be able to withdraw the subject from the research, if
p.(None): such action appears in the subject's best interest.
p.(None):
p.(None): Voluntariness. An agreement to participate in research constitutes a valid consent only if voluntarily given. This
p.(None): element of informed consent requires conditions free of coercion and undue influence. Coercion occurs when an overt
p.(None): threat of harm is intentionally presented by one person to another in order to obtain compliance. Undue influence, by
p.(None): contrast, occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in
p.(None): order to obtain compliance. Also, inducements that would ordinarily be acceptable may become undue influences if the
p.(None): subject is especially vulnerable.
p.(None):
p.(None): Unjustifiable pressures usually occur when persons in positions of authority or commanding influence -- especially
p.(None): where possible sanctions are involved -- urge a course of action for a subject. A continuum of
p.(None):
p.(None): such influencing factors exists, however, and it is impossible to state precisely where justifiable persuasion ends and
p.(None): undue influence begins. But undue influence would include actions such as manipulating a person's choice through the
p.(None): controlling influence of a close relative and threatening to withdraw health services to which an individual would
p.(None): otherwise be entitled.
p.(None):
p.(None): 2. Assessment of Risks and Benefits. — The assessment of risks and benefits requires a careful arrayal of relevant
p.(None): data, including, in some cases, alternative ways of obtaining the benefits sought in the research. Thus, the assessment
p.(None): presents both an opportunity and a responsibility to gather systematic and comprehensive information about proposed
p.(None): research. For the investigator, it is a means to examine whether the proposed research is properly designed. For a
p.(None): review committee, it is a method for determining whether the risks that will be presented to subjects are justified.
p.(None): For prospective subjects, the assessment will assist the determination whether or not to participate.
p.(None):
p.(None): The Nature and Scope of Risks and Benefits. The requirement that research be justified on the basis of a favorable
p.(None): risk/benefit assessment bears a close relation to the principle of beneficence, just as the moral requirement that
...
General/Other / Undue Influence
Searching for indicator undue influence:
(return to top)
p.(None): for these persons, however, respect requires giving them the opportunity to choose to the extent they are able, whether
p.(None): or not to participate in research. The objections of these subjects to involvement should be honored, unless the
p.(None): research entails providing them a therapy unavailable elsewhere. Respect for persons also requires seeking the
p.(None): permission of other parties in order to protect the subjects from harm. Such persons are thus respected both by
p.(None): acknowledging their own wishes and by the use of third parties to protect them from harm.
p.(None):
p.(None): The third parties chosen should be those who are most likely to understand the incompetent subject's situation and to
p.(None): act in that person's best interest. The person authorized to act on behalf of the subject should be given an
p.(None): opportunity to observe the research as it proceeds in order to be able to withdraw the subject from the research, if
p.(None): such action appears in the subject's best interest.
p.(None):
p.(None): Voluntariness. An agreement to participate in research constitutes a valid consent only if voluntarily given. This
p.(None): element of informed consent requires conditions free of coercion and undue influence. Coercion occurs when an overt
p.(None): threat of harm is intentionally presented by one person to another in order to obtain compliance. Undue influence, by
p.(None): contrast, occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in
p.(None): order to obtain compliance. Also, inducements that would ordinarily be acceptable may become undue influences if the
p.(None): subject is especially vulnerable.
p.(None):
p.(None): Unjustifiable pressures usually occur when persons in positions of authority or commanding influence -- especially
p.(None): where possible sanctions are involved -- urge a course of action for a subject. A continuum of
p.(None):
p.(None): such influencing factors exists, however, and it is impossible to state precisely where justifiable persuasion ends and
p.(None): undue influence begins. But undue influence would include actions such as manipulating a person's choice through the
p.(None): controlling influence of a close relative and threatening to withdraw health services to which an individual would
p.(None): otherwise be entitled.
p.(None):
p.(None): 2. Assessment of Risks and Benefits. — The assessment of risks and benefits requires a careful arrayal of relevant
p.(None): data, including, in some cases, alternative ways of obtaining the benefits sought in the research. Thus, the assessment
p.(None): presents both an opportunity and a responsibility to gather systematic and comprehensive information about proposed
p.(None): research. For the investigator, it is a means to examine whether the proposed research is properly designed. For a
p.(None): review committee, it is a method for determining whether the risks that will be presented to subjects are justified.
p.(None): For prospective subjects, the assessment will assist the determination whether or not to participate.
p.(None):
p.(None): The Nature and Scope of Risks and Benefits. The requirement that research be justified on the basis of a favorable
p.(None): risk/benefit assessment bears a close relation to the principle of beneficence, just as the moral requirement that
p.(None): informed consent be obtained is derived primarily from the principle of respect for persons. The term "risk" refers to
p.(None): a possibility that harm may occur. However, when expressions such as "small risk" or "high risk" are used, they usually
...
General/Other / belmont
Searching for indicator belmont:
(return to top)
p.(None): THE BELMONT REPORT
p.(None): Office of the Secretary
p.(None): Ethical Principles and Guidelines for the Protection of Human Subjects of Research
p.(None): The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
p.(None): April 18, 1979
p.(None):
p.(None):
p.(None):
p.(None): AGENCY: Department of Health, Education, and Welfare.
p.(None):
p.(None): ACTION: Notice of Report for Public Comment.
p.(None):
p.(None): SUMMARY: On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the
p.(None): National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to
p.(None): the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and
p.(None): behavioral research involving human subjects and to develop guidelines which should be followed to assure that such
p.(None): research is conducted in accordance with those principles. In carrying out the above, the Commission was directed to
p.(None): consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine practice of
p.(None): medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research
p.(None): involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in such
p.(None): research and (iv) the nature and definition of informed consent in various research settings.
p.(None):
p.(None): The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its
p.(None): deliberations. It is the outgrowth of an intensive four-day period of discussions that were held in February 1976 at
p.(None): the Smithsonian Institution's Belmont Conference Center supplemented by the monthly deliberations of the Commission
p.(None): that were held over a period of nearly four years. It is a statement of basic ethical principles and guidelines that
p.(None): should assist in resolving the ethical problems that surround the conduct of research with human subjects. By
p.(None): publishing the Report in the Federal Register, and providing reprints upon request, the Secretary intends that it may
p.(None): be made readily available to scientists, members of Institutional Review Boards, and Federal employees. The two-volume
p.(None): Appendix, containing the lengthy reports of experts and specialists who assisted the Commission in fulfilling this part
p.(None): of its charge, is available as DHEW Publication No. (OS) 78-0013 and No. (OS) 78-0014, for sale by the Superintendent
p.(None): of Documents, U.S. Government Printing Office, Washington, D.C. 20402.
p.(None):
p.(None): Unlike most other reports of the Commission, the Belmont Report does not make specific recommendations for
p.(None): administrative action by the Secretary of Health, Education, and Welfare. Rather, the Commission recommended that the
p.(None): Belmont Report be adopted in its entirety, as a statement of the Department's policy. The Department requests public
p.(None): comment on this recommendation.
p.(None):
p.(None):
p.(None):
p.(None): National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
p.(None): Members of the Commission
p.(None): Kenneth John Ryan, M.D., Chairman, Chief of Staff, Boston Hospital for Women. Joseph V. Brady, Ph.D., Professor of
p.(None): Behavioral Biology, Johns Hopkins University. Robert E. Cooke, M.D., President, Medical College of Pennsylvania.
p.(None): Dorothy I. Height, President, National Council of Negro Women, Inc.
p.(None): Albert R. Jonsen, Ph.D., Associate Professor of Bioethics, University of California at San Francisco. Patricia King,
p.(None): J.D., Associate Professor of Law, Georgetown University Law Center.
p.(None): Karen Lebacqz, Ph.D., Associate Professor of Christian Ethics, Pacific School of Religion.
p.(None): *** David W. Louisell, J.D., Professor of Law, University of California at Berkeley.
p.(None): Donald W. Seldin, M.D., Professor and Chairman, Department of Internal Medicine, University of Texas at Dallas.
p.(None): *** Eliot Stellar, Ph.D., Provost of the University and Professor of Physiological Psychology, University of
p.(None): Pennsylvania.
p.(None): *** Robert H. Turtle, LL.B., Attorney, VomBaur, Coburn, Simmons & Turtle, Washington, D.C.
p.(None): *** Deceased.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Table of Contents
p.(None): Ethical Principles and Guidelines for Research Involving Human Subjects
p.(None): A. Boundaries Between Practice and Research
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.(None): often flow in the same directions as public funds for health care, it seems unfair that populations dependent on public
p.(None): health care constitute a pool of preferred research subjects if more advantaged populations are likely to be the
p.(None): recipients of the benefits.
p.(None):
p.(None): One special instance of injustice results from the involvement of vulnerable subjects. Certain groups, such as racial
p.(None): minorities, the economically disadvantaged, the very sick, and the institutionalized may continually be sought as
p.(None): research subjects, owing to their ready availability in settings where research is conducted.
p.(None): Given their dependent status and their frequently compromised capacity for free consent, they should be protected
p.(None): against the danger of being involved in research solely for administrative convenience, or because they are easy to
p.(None): manipulate as a result of their illness or socioeconomic condition.
p.(None):
p.(None):
p.(None): [1] Since 1945, various codes for the proper and responsible conduct of human experimentation in medical research have
p.(None): been adopted by different organizations. The best known of these codes are the Nuremberg Code of 1947, the Helsinki
p.(None): Declaration of 1964 (revised in 1975), and the 1971 Guidelines (codified into Federal Regulations in 1974) issued by
p.(None): the U.S. Department of Health, Education, and Welfare Codes for the conduct of social and behavioral research have also
p.(None): been adopted, the best known being that of the American Psychological Association, published in 1973.
p.(None):
p.(None): [2] Although practice usually involves interventions designed solely to enhance the well-being of a particular
p.(None): individual, interventions are sometimes applied to one individual for the enhancement of the well-being of another
p.(None): (e.g., blood donation, skin grafts, organ transplants) or an intervention may have the dual purpose of enhancing the
p.(None): well-being of a particular individual, and, at the same time, providing some benefit to others (e.g., vaccination,
p.(None): which protects both the person who is vaccinated and society generally). The fact that some forms of practice have
p.(None): elements other than immediate benefit to the individual receiving an intervention, however, should not confuse the
p.(None): general distinction between research and practice. Even when a procedure applied in practice may benefit some other
p.(None): person, it remains an intervention designed to enhance the well-being of a particular individual or groups of
p.(None): individuals; thus, it is practice and need not be reviewed as research.
p.(None):
p.(None): [3] Because the problems related to social experimentation may differ substantially from those of biomedical and
p.(None): behavioral research, the Commission specifically declines to make any policy determination regarding such research at
...
Orphaned Trigger Words
p.(None): subjects would be carried out in an ethical manner.
p.(None):
p.(None): The codes consist of rules, some general, others specific, that guide the investigators or the reviewers of research in
p.(None): their work. Such rules often are inadequate to cover complex situations; at times they come into conflict, and they are
p.(None): frequently difficult to interpret or apply. Broader ethical principles will provide a basis on which specific rules may
p.(None): be formulated, criticized and interpreted.
p.(None):
p.(None): Three principles, or general prescriptive judgments, that are relevant to research involving human subjects are
p.(None): identified in this statement. Other principles may also be relevant. These three are comprehensive, however, and are
p.(None): stated at a level of generalization that should assist scientists, subjects, reviewers and interested citizens to
p.(None): understand the ethical issues inherent in research involving human subjects. These principles cannot always be applied
p.(None): so as to resolve beyond dispute particular ethical problems. The objective is to provide an analytical framework that
p.(None): will guide the resolution of ethical problems arising from research involving human subjects.
p.(None):
p.(None): This statement consists of a distinction between research and practice, a discussion of the three basic ethical
p.(None): principles, and remarks about the application of these principles.
p.(None):
p.(None):
p.(None):
p.(None): Part A: Boundaries Between Practice & Research
p.(None): A. Boundaries Between Practice and Research
p.(None):
p.(None): It is important to distinguish between biomedical and behavioral research, on the one hand, and the practice of
p.(None): accepted therapy on the other, in order to know what activities ought to undergo review for the protection of human
p.(None): subjects of research. The distinction between research and practice is blurred partly because both often occur together
p.(None): (as in research designed to evaluate a therapy) and partly because notable departures from standard practice are often
p.(None): called "experimental" when the terms "experimental" and "research" are not carefully defined.
p.(None):
p.(None): For the most part, the term "practice" refers to interventions that are designed solely to enhance the well- being of
p.(None): an individual patient or client and that have a reasonable expectation of success. The purpose of medical or behavioral
p.(None): practice is to provide diagnosis, preventive treatment or therapy to particular individuals [2]. By contrast, the term
p.(None): "research' designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to
p.(None): develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of
p.(None): relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures
p.(None): designed to reach that objective.
p.(None):
p.(None): When a clinician departs in a significant way from standard or accepted practice, the innovation does not, in and of
p.(None): itself, constitute research. The fact that a procedure is "experimental," in the sense of new, untested or different,
p.(None): does not automatically place it in the category of research. Radically new procedures of this
p.(None):
p.(None): description should, however, be made the object of formal research at an early stage in order to determine whether they
p.(None): are safe and effective. Thus, it is the responsibility of medical practice committees, for example, to insist that a
p.(None): major innovation be incorporated into a formal research project [3].
p.(None):
...
p.(None): being systematically selected simply because of their easy availability, their compromised position, or their
p.(None): manipulability, rather than for reasons directly related to the problem being studied. Finally, whenever research
p.(None): supported by public funds leads to the development of therapeutic devices and procedures, justice demands both that
p.(None): these not provide advantages only to those who can afford them and that such research should not unduly involve persons
p.(None): from groups unlikely to be among the beneficiaries of subsequent applications of the research.
p.(None):
p.(None):
p.(None):
p.(None): Part C: Applications
p.(None): C. Applications
p.(None):
p.(None): Applications of the general principles to the conduct of research leads to consideration of the following requirements:
p.(None): informed consent, risk/benefit assessment, and the selection of subjects of research.
p.(None):
p.(None): 1. Informed Consent. — Respect for persons requires that subjects, to the degree that they are capable, be given the
p.(None): opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for
p.(None): informed consent are satisfied.
p.(None):
p.(None): While the importance of informed consent is unquestioned, controversy prevails over the nature and possibility of an
p.(None): informed consent. Nonetheless, there is widespread agreement that the consent process can be analyzed as containing
p.(None): three elements: information, comprehension and voluntariness.
p.(None):
p.(None): Information. Most codes of research establish specific items for disclosure intended to assure that subjects are given
p.(None): sufficient information. These items generally include: the research procedure, their purposes, risks and anticipated
p.(None): benefits, alternative procedures (where therapy is involved), and a statement offering the subject the opportunity to
p.(None): ask questions and to withdraw at any time from the research. Additional items have been proposed, including how
p.(None): subjects are selected, the person responsible for the research, etc.
p.(None):
p.(None): However, a simple listing of items does not answer the question of what the standard should be for judging how much and
p.(None): what sort of information should be provided. One standard frequently invoked in medical practice, namely the
p.(None): information commonly provided by practitioners in the field or in the locale, is inadequate since research takes place
p.(None): precisely when a common understanding does not exist. Another standard, currently popular in malpractice law, requires
p.(None): the practitioner to reveal the information that reasonable persons would wish to know in order to make a decision
p.(None): regarding their care. This, too, seems insufficient since the research subject, being in essence a volunteer, may wish
p.(None): to know considerably more about risks gratuitously undertaken than do patients who deliver themselves into the hand of
p.(None): a clinician for
p.(None):
p.(None): needed care. It may be that a standard of "the reasonable volunteer" should be proposed: the extent and nature of
p.(None): information should be such that persons, knowing that the procedure is neither necessary for their care nor perhaps
p.(None): fully understood, can decide whether they wish to participate in the furthering of knowledge. Even when some direct
p.(None): benefit to them is anticipated, the subjects should understand clearly the range of risk and the voluntary nature of
p.(None): participation.
p.(None):
p.(None): A special problem of consent arises where informing subjects of some pertinent aspect of the research is likely to
p.(None): impair the validity of the research. In many cases, it is sufficient to indicate to subjects that they are being
p.(None): invited to participate in research of which some features will not be revealed until the research is concluded. In all
p.(None): cases of research involving incomplete disclosure, such research is justified only if it is clear that (1) incomplete
p.(None): disclosure is truly necessary to accomplish the goals of the research, (2) there are no undisclosed risks to subjects
p.(None): that are more than minimal, and (3) there is an adequate plan for debriefing subjects, when appropriate, and for
p.(None): dissemination of research results to them. Information about risks should never be withheld for the purpose of
p.(None): eliciting the cooperation of subjects, and truthful answers should always be given to direct questions about the
p.(None): research. Care should be taken to distinguish cases in which disclosure would destroy or invalidate the research from
p.(None): cases in which disclosure would simply inconvenience the investigator.
p.(None):
p.(None): Comprehension. The manner and context in which information is conveyed is as important as the information itself. For
...
p.(None): otherwise be entitled.
p.(None):
p.(None): 2. Assessment of Risks and Benefits. — The assessment of risks and benefits requires a careful arrayal of relevant
p.(None): data, including, in some cases, alternative ways of obtaining the benefits sought in the research. Thus, the assessment
p.(None): presents both an opportunity and a responsibility to gather systematic and comprehensive information about proposed
p.(None): research. For the investigator, it is a means to examine whether the proposed research is properly designed. For a
p.(None): review committee, it is a method for determining whether the risks that will be presented to subjects are justified.
p.(None): For prospective subjects, the assessment will assist the determination whether or not to participate.
p.(None):
p.(None): The Nature and Scope of Risks and Benefits. The requirement that research be justified on the basis of a favorable
p.(None): risk/benefit assessment bears a close relation to the principle of beneficence, just as the moral requirement that
p.(None): informed consent be obtained is derived primarily from the principle of respect for persons. The term "risk" refers to
p.(None): a possibility that harm may occur. However, when expressions such as "small risk" or "high risk" are used, they usually
p.(None): refer (often ambiguously) both to the chance (probability) of experiencing a harm and the severity (magnitude) of the
p.(None): envisioned harm.
p.(None):
p.(None): The term "benefit" is used in the research context to refer to something of positive value related to health or
p.(None): welfare. Unlike, "risk," "benefit" is not a term that expresses probabilities. Risk is properly contrasted to
p.(None): probability of benefits, and benefits are properly contrasted with harms rather than risks of harm.
p.(None): Accordingly, so-called risk/benefit assessments are concerned with the probabilities and magnitudes of possible harm
p.(None): and anticipated benefits. Many kinds of possible harms and benefits need to be taken into account. There are, for
p.(None): example, risks of psychological harm, physical harm, legal harm, social harm and economic harm and the corresponding
p.(None): benefits. While the most likely types of harms to research subjects are those of psychological or physical pain or
p.(None): injury, other possible kinds should not be overlooked.
p.(None):
p.(None): Risks and benefits of research may affect the individual subjects, the families of the individual subjects, and society
p.(None): at large (or special groups of subjects in society). Previous codes and Federal regulations have required that risks to
p.(None): subjects be outweighed by the sum of both the anticipated benefit to the subject, if any, and the anticipated benefit
p.(None): to society in the form of knowledge to be gained from the research. In balancing these different elements, the risks
p.(None): and benefits affecting the immediate research subject will normally carry special weight. On the other hand, interests
p.(None): other than those of the subject may on some occasions be sufficient by themselves to justify the risks involved in the
p.(None): research, so long as the subjects' rights have been protected. Beneficence thus requires that we protect against risk
p.(None): of harm to subjects and also that we be concerned about the loss of the substantial benefits that might be gained from
p.(None): research.
p.(None):
p.(None): The Systematic Assessment of Risks and Benefits. It is commonly said that benefits and risks must be "balanced" and
p.(None): shown to be "in a favorable ratio." The metaphorical character of these terms draws attention to the difficulty of
p.(None): making precise judgments. Only on rare occasions will quantitative techniques be available for the scrutiny of research
p.(None): protocols. However, the idea of systematic, nonarbitrary analysis of risks and benefits should be emulated insofar as
p.(None): possible. This ideal requires those making decisions about the justifiability of research to be thorough in the
p.(None): accumulation and assessment of information about all aspects of the research, and to consider alternatives
p.(None): systematically. This procedure renders the assessment of research more rigorous and precise, while making communication
p.(None): between review board members and investigators less subject to misinterpretation, misinformation and conflicting
p.(None): judgments. Thus, there should first be a determination of the validity of the presuppositions of the research; then the
p.(None): nature, probability and magnitude of risk should be distinguished with as much clarity as possible. The method of
p.(None): ascertaining risks should be explicit, especially where there is no alternative to the use of such vague categories as
p.(None): small or slight risk. It should also be determined whether an investigator's estimates of the probability of harm or
p.(None): benefits are reasonable, as judged by known facts or other available studies.
p.(None):
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| age | Age |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| belmont | belmont |
| children | Child |
| coerced | Presence of Coercion |
| comatose | Comatose |
| crime | Illegal Activity |
| dependent | Dependent |
| diminished | Diminished Autonomy |
| disability | Mentally Disabled |
| education | education |
| employees | employees |
| ethnic | Ethnicity |
| helsinki | declaration of helsinki |
| ill | ill |
| illness | Physically Disabled |
| impairment | Cognitive Impairment |
| incapacitated | Incapacitated |
| influence | Drug Usage |
| institutionalized | Institutionalized |
| language | Linguistic Proficiency |
| liberty | Incarcerated |
| manipulate | Manipulable |
| mentally | Mentally Disabled |
| political | political affiliation |
| poor | Economic/Poverty |
| prison | Incarcerated |
| prisoners | Criminal Convictions |
| property | Property Ownership |
| racial | Racial Minority |
| religion | Religion |
| sick | Physically Ill |
| terminally | Terminally Ill |
| threat | Threat of Stigma |
| undue influence | Undue Influence |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| disability | ['mentally'] |
| liberty | ['prison'] |
| mentally | ['disability'] |
| prison | ['liberty'] |
Trigger Words
capacity
coercion
compromised position
consent
cultural
easy availability
ethics
harm
justice
protect
protection
risk
self-determination
volunteer
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input