Office of Human Subjects Research - The Diigo Meta page

• 03 Apr 12
  

  Danielle Stephens

  Belmont Report Ethical Principals Human Research

  • World War. During the Nuremberg War Crime Trials,   the Nuremberg code was drafted as a set of standards for judging   physicians and scientists who had conducted biomedical experiments   on concentration camp prisoners.
  • the term ”practice” refers   to interventions that are designed solely to enhance the   well-being of an individual patient or client and that have   a reasonable expectation of success. The purpose of medical   or behavioral practice is to provide diagnosis, preventive   treatment or therapy to particular individuals. (2)   By contrast, the term ”research' designates an activity   designed to test an hypothesis, permit conclusions to be   drawn, and thereby to develop or contribute to generalizable   knowledge (expressed, for example, in theories, principles,   and statements of relationships). Research is usually described   in a formal protocol that sets forth an objective and a   set of procedures designed to reach that objective.
  • w; the general rule is that if   there is any element of research in an activity, that activity   should undergo review for the protection of human subjects.
  • B. Basic Ethical Principles
  • 1. Respect for Persons.
  • st two ethical convictions:   first, that individuals should be treated as autonomous agents,   and second, that persons with diminished autonomy are entitled   to protection. The principle of respect for persons thus divides   into two separate moral requirements: the requirement to acknowledge   autonomy and the requirement to protect those with diminished   autonomy.
  • r, not every human being is capable of self-determination
  • In most cases of research involving human subjects, respect   for persons demands that subjects enter into the research   voluntarily and with adequate information
  • -- Persons are treated   in an ethical manner not only by respecting their decisions   and protecting them from harm, but also by making efforts   to secure their well-being.
  • 2. Beneficence.
  • ligation. Two general   rules have been formulated as complementary expressions of   beneficent actions in this sense: (1) do not harm and   (2) maximize possible benefits and minimize possible   harms.
  • The Hippocratic maxim ”do no harm”
  • t one should   not injure one person regardless of the benefits that might   come to others.
  • 3. Justice.
  • ” An injustice occurs when   some benefit to which a person is entitled is denied without   good reason or when some burden is imposed unduly
  • ons some relevant property on the basis of which burdens   and benefits should be distributed. These formulations are   (1) to each person an equal share, (2) to each   person according to individual need, (3) to each person   according to individual effort, (4) to each person   according to societal contribution, and (5) to each   person according to merit.
  • bjects in Nazi concentration camps was condemned   as a particularly flagrant injustice. In this country, in   the 1940's, the Tuskegee syphilis study used disadvantaged,   rural black men to study the untreated course of a disease   that is by no means confined to that population.

  • s,   justice demands both that these not provide advantages only   to those who can afford them and that such research should   not unduly involve persons from groups unlikely to be among   the beneficiaries of subsequent applications of the research.
  • C. Applications
  • 1. Informed Consent
  • given the opportunity to choose what shall   or shall not happen to them.
  • Information
  • of research establish specific   items for disclosure intended to assure that subjects are   given sufficient information. These items generally include:   the research procedure, their purposes, risks and anticipated   benefits, alternative procedures (where therapy is involved),   and a statement offering the subject the opportunity to   ask questions and to withdraw at any time from the research
  • In many cases, it is sufficient   to indicate to subjects that they are being invited to participate   in research of which some features will not be revealed   until the research is concluded.
  • (1) incomplete disclosure   is truly necessary to accomplish the goals of the research,   (2) there are no undisclosed risks to subjects that   are more than minimal, and (3) there is an adequate   plan for debriefing subjects, when appropriate, and for   dissemination of research results to them. Information about   risks should never be withheld for the purpose of eliciting   the cooperation of subjects, and truthful answers should   always be given to direct questions about the research.
  • Comprehension.
  • Because the subject's ability to understand is a function   of intelligence, rationality, maturity and language, it   is necessary to adapt the presentation of the information   to the subject's capacities
  • Special provision may need to be made when comprehension   is severely limited -- for example, by conditions of immaturity   or mental disability.
  • . The person authorized   to act on behalf of the subject should be given an opportunity   to observe the research as it proceeds in order to be able   to withdraw the subject from the research, if such action   appears in the subject's best interest.
  • An agreement to participate in research   constitutes a valid consent only if voluntarily given.
  • Voluntariness.
  • But undue influence   would include actions such as manipulating a person's choice   through the controlling influence of a close relative and   threatening to withdraw health services to which an individual   would otherwise be entitled.
  • - The assessment of risks and benefits requires a careful   arrayal of relevant data, including, in some cases, alternative   ways of obtaining the benefits sought in the research.
  • 2. Assessment of Risks and Benefits.
  • . For the investigator, it is a means to examine whether   the proposed research is properly designed. For a review committee,   it is a method for determining whether the risks that will   be presented to subjects are justified.
  • The Nature and Scope of Risks and Benefits
  • s.   The term ”risk” refers to a possibility that harm   may occur.
  • The term ”benefit” is used in the research context   to refer to something of positive value related to health   or welfare.
  • The Systematic Assessment of Risks and Benefit
  • The method of ascertaining risks should be explicit,   especially where there is no alternative to the use of such   vague categories as small or slight risk.
  • : (i)   Brutal or inhumane treatment of human subjects is never   morally justified. (ii) Risks should be reduced to   those necessary to achieve the research objective.
  • (iii) When research involves significant   risk of serious impairment, review committees should be   extraordinarily insistent on the justification of the risk   (looking usually to the likelihood of benefit to the subject   -- or, in some rare cases, to the manifest voluntariness   of the participation). (iv) When vulnerable populations   are involved in research, the appropriateness of involving   them should itself be demonstrated.
  • . (v)   Relevant risks and benefits must be thoroughly arrayed in   documents and procedures used in the informed consent process.
  • 3. Selection of Subjects. -
  • .   Given their dependent status and their frequently compromised   capacity for free consent, they should be protected against   the danger of being involved in research solely for administrative   convenience, or because they are easy to manipulate as a   result of their illness or socioeconomic condition.

  43 more annotations...

• 04 Mar 12
  

  Susan Striepe

  ethics research

• 09 Jan 12
  

  robertskoro
  • ethical principles that should underlie the conduct   of biomedical and behavioral research involving human subjects
  • Three principles,
  • the term ”practice” refers   to interventions that are designed solely to enhance the   well-being of an individual patient or client and that have   a reasonable expectation of success.
  • ”research' designates an activity   designed to test an hypothesis, permit conclusions to be   drawn, and thereby to develop or contribute to generalizable   knowledge (expressed, for example, in theories, principles,   and statements of relationships).
  • Research and practice may be carried on together when research   is designed to evaluate the safety and efficacy of a therapy.
  • as autonomous agents,
  • persons with diminished autonomy are entitled   to protection
  • autonomous person is an individual capable of deliberation   about personal goals and of acting under the direction of   such deliberation.
  • unless they are   clearly detrimental to others.
  • by making efforts   to secure their well-being
  • maximize possible benefits and minimize possible   harms
  • Respect   for persons requires that subjects, to the degree that they   are capable, be given the opportunity to choose what shall   or shall not happen to them.
  • nature and possibility of   an informed consent.
  • pecific   items for disclosure
  • research procedure, their purposes, risks and anticipated   benefits, alternative procedures (where therapy is involved),   and a statement offering the subject the opportunity to   ask questions and to withdraw at any time from the research
  • it is sufficient   to indicate to subjects that they are being invited to participate   in research of which some features will not be revealed   until the research is concluded.
  • necessary to adapt the presentation of the information   to the subject's capacities
  • Previous   codes and Federal regulations have required that risks to   subjects be outweighed by the sum of both the anticipated   benefit to the subject, if any, and the anticipated benefit   to society in the form of knowledge to be gained from the   research.

  16 more annotations...

• 20 Oct 11
  

  David Socha

  irb

• 26 Sep 11
  

  Allison Hyman

  ethics research science

• 11 Sep 11
  

  Anissa Goyal

  research

• 13 Jun 11
  

  Kerri Fenton
  • dual patient or client and that have   a reasonabl
  • the term ”practice” refers   to interventions that are designed solely to enhance the   well-being of an individual patient or client and that have   a reasonable expectation of success.
  • ”research' designates an activity   designed to test an hypothesis, permit conclusions to be   drawn, and thereby to develop or contribute to generalizable   knowledge
  • Research and practice may be carried on together when research   is designed to evaluate the safety and efficacy of a therapy.
  • first, that individuals should be treated as autonomous agents,   and second, that persons with diminished autonomy are entitled   to protection
  • An autonomous person is an individual capable of deliberation   about personal goals and of acting under the direction of   such deliberation.
  • Some persons are in need of extensive protection, even to   the point of excluding them from activities which may harm   them; other persons require little protection beyond making   sure they undertake activities freely and with awareness   of possible adverse consequence.
  • ”beneficence”   is often understood to cover acts of kindness or charity that   go beyond strict obligatio
  • obligation. Two general   rules have been formulated as complementary expressions of   beneficent actions in this sense: (1) do not harm and   (2) maximize possible benefits and minimize possible   harms.
  • In the case   of scientific research in general, members of the larger   society are obliged to recognize the longer term benefits   and risks that may result fro
  • m the improvement of knowledge   and from the development of novel medical, psychotherapeutic,   and social procedures.
  • 3. Justice. -- Who ought

    to receive   the benefits

    of research and bear its burdens? This is a question   of justice, in the sense of ”fairness in distribution”   or ”what is deserved.”
  • mentions some relevant property on the basis of which burdens   and benefits should be distributed. These formulations are   (1) to each person an equal share, (2) to each   person according to individual need, (3) to each person   according to individual effort, (4) to each person   according to societal contribution, and (5) to each   person according to merit.
  • ed.   Finally, whenever research supported by public funds leads   to the development of therapeutic devices and procedures,   j

    ustice demands both that these not provide advantages only   to those who can afford them and that such research should   not unduly involve persons from groups unlikely to be among   the beneficiaries of subsequent applications of the research.
  • Most codes of research establish specific   items for disclosure intended to assure that subjects are   given sufficient information. These items generally include:   the research procedure, their purposes, risks and anticipated   benefits, alternative procedures (where therapy is involved),   and a statement offering the subject the opportunity to   ask questions and to withdraw at any time from the research.
  • t (1) incomplete disclosure   is truly necessary to accomplish the goals of the research,   (2) there are no undisclosed risks to subjects that   are more than minimal, and (3) there is an adequate   plan for debriefing subjects, when appropriate, and for   dissemination of research results to them
  • Comprehension.
  • ons are   thus respected both by acknowledging their own wishes and   by the use of third parties to protect them from harm.
  • Voluntarines
  • 2. Assessment of Risks and Benefits.
  • The Nature and Scope of Risks and Benefits
  • Previous   codes and Federal regulations have required that risks to   subjects be outweighed by the sum of both the anticipated   be
  • nefit to the subject, if any, and the anticipated benefit   to society in the form of knowledge to be gained from the   research.
  • Thus, it can be considered   a matter of social justice that there is an order of preference   in the selection of classes of subjects (e.g., adults before   children) and that some classes of potential subjects (e.g.,   the i
  • nstitutionalized mentally infirm or prisoners) may   be involved as research subjects, if at all, only on certain   conditions.
  • e Nuremberg Code of 1947,   the Helsinki Declaration of 1964 (revised in 1975), and the   1971 Guidelines (codified into Federal Regulations in 1974)   issued by the U.S. Department of Health, Education, and Welfare   Codes for the conduct of social and behavioral research have   also been adopted, the best known being that of the American   Psychological Association, published in 1973.
  • Even when a procedure applied in practice may   benefit some other person, it remains an intervention designed   to enhance the well-being of a particular individual or groups   of individuals; thus, it is practice and need not be reviewed   as research.

  25 more annotations...

• 

  Erica Jackson
  • (1) to each person an equal share, (2) to each   person according to individual need, (3) to each person   according to individual effort, (4) to each person   according to societal contribution, and (5) to each   person according to merit.
  • For example, the selection of research subjects needs to   be scrutinized in order to determine whether some classes   (e.g., welfare patients, particular racial and ethnic minorities,   or persons confined to institutions) are being systematically   selected simply because of their easy availability, their   compromised position, or their manipulability, rather than   for reasons directly related to the problem being studied.   Finally, whenever research supported by public funds leads   to the development of therapeutic devices and procedures,   justice demands both that these not provide advantages only   to those who can afford them and that such research should   not unduly involve persons from groups unlikely to be among   the beneficiaries of subsequent applications of the research.
  • the consent process can be analyzed as containing three   elements: information, comprehension and voluntariness.
  • In all cases of research   involving incomplete disclosure, such research is justified   only if it is clear that (1) incomplete disclosure   is truly necessary to accomplish the goals of the research,   (2) there are no undisclosed risks to subjects that   are more than minimal, and (3) there is an adequate   plan for debriefing subjects, when appropriate, and for   dissemination of research results to them.
  • nformation about   risks should never be withheld for the purpose of eliciting   the cooperation of subjects, and truthful answers should   always be given to direct questions about the research.   Care should be taken to distinguish cases in which disclosure   would destroy or invalidate the research from cases in which   disclosure would simply inconvenience the investigator.
  • This   element of informed consent requires conditions free of   coercion and undue influence. Coercion occurs when an overt   threat of harm is intentionally presented by one person   to another in order to obtain compliance. Undue influence,   by contrast, occurs through an offer of an excessive, unwarranted,   inappropriate or improper reward or other overture in order   to obtain compliance. Also, inducements that would ordinarily   be acceptable may become undue influences if the subject   is especially vulnerable.
  • It   is commonly said that benefits and risks must be ”balanced”   and shown to be ”in a favorable ratio.” The metaphorical   character of these terms draws attention to the difficulty   of making precise judgments.
  • (i)   Brutal or inhumane treatment of human subjects is never   morally justified. (ii) Risks should be reduced to   those necessary to achieve the research objective. It should   be determined whether it is in fact necessary to use human   subjects at all. Risk can perhaps never be entirely eliminated,   but it can often be reduced by careful attention to alternative   procedures. (iii) When research involves significant   risk of serious impairment, review committees should be   extraordinarily insistent on the justification of the risk   (looking usually to the likelihood of benefit to the subject   -- or, in some rare cases, to the manifest voluntariness   of the participation). (iv) When vulnerable populations   are involved in research, the appropriateness of involving   them should itself be demonstrated. A number of variables   go into such judgments, including the nature and degree   of risk, the condition of the particular population involved,   and the nature and level of the anticipated benefits. (v)   Relevant risks and benefits must be thoroughly arrayed in   documents and procedures used in the informed consent process.
  • Justice is relevant to the selection of subjects of research   at two levels: the social and the individual. Individual   justice in the selection of subjects would require that   researchers exhibit fairness: thus, they should not offer   potentially beneficial research only to some patients who   are in their favor or select only ”undesirable”   persons for risky research.

  7 more annotations...

• 05 Feb 11
  

  Randy Osmun

  Belmont Report

  Antioch CITI

• 11 Sep 10
  

  Lauren kane
  • On July 12, 1974, the National Research Act (Pub. L. 93-348)   was signed into law, there-by creating the National Commission   for the Protection of Human Subjects of Biomedical and Behavioral   Research
  • One of the charges to the Commission was to identify   the basic ethical principles that should underlie the conduct   of biomedical and behavioral research involving human subjects   and to develop guidelines which should be followed
  • Commission was   directed to consider: (i) the boundaries between   biomedical and behavioral research and the accepted and   routine practice of medicine, (ii) the role of assessment   of risk-benefit criteria in the determination of the appropriateness   of research involving human subjects, (iii) appropriate   guidelines for the selection of human subjects for participation   in such research and (iv) the nature and definition   of informed consent in various research settings.
  • The Belmont Report attempts to summarize the basic ethical   principles identified by the Commission in the course of   its deliberations.
  • It is   a statement of basic ethical principles and guidelines that   should assist in resolving the ethical problems that surround   the conduct of research with human subjects.

  • Table of Contents

      
     
    1. Ethical Principles and Guidelines for Research Involving Human Subjects
     
    2. Boundaries Between Practice and Research
     
    3. Basic Ethical Principles 
        
       1. Respect for Persons
        
       2. Beneficence
        
       3. Justice
        
        
     
    4. Applications  
        
       1. Informed Consent
        
       2. Assessment of Risk and Benefits
        
       3. Selection of Subjects
  • Ethical   Principles & Guidelines for Research Involving Human Subjects
  • Three principles, or general prescriptive judgments, that   are relevant to research involving human subjects are identified   in this statement.
  • These   principles cannot always be applied so as to resolve beyond   dispute particular ethical problems. The objective is to provide   an analytical framework that will guide the resolution of   ethical problems arising from research involving human subjects.
  • A. Boundaries Between Practice   and Research
  • It is important to distinguish between biomedical and behavioral   research
  • The distinction between research and practice   is blurred partly because both often occur together (as   in research designed to evaluate a therapy) and partly because   notable departures from standard practice are often called   ”experimental” when the terms ”experimental”   and ”research” are not carefully defined.
  • the term ”practice” refers   to interventions that are designed solely to enhance the   well-being of an individual patient or client and that have   a reasonable expectation of success. The purpose of medical   or behavioral practice is to provide diagnosis, preventive   treatment or therapy to particular individuals
  • the term ”research' designates an activity   designed to test an hypothesis, permit conclusions to be   drawn, and thereby to develop or contribute to generalizable   knowledge (expressed, for example, in theories, principles,   and statements of relationships). Research is usually described   in a formal protocol that sets forth an objective and a   set of procedures designed to reach that objective.
  • he fact that a procedure is   ”experimental,” in the sense of new, untested   or different, does not automatically place it in the category   of research
  • Research and practice may be carried on together when research   is designed to evaluate the safety and efficacy of a therapy
  • B. Basic Ethical Principles
  • The expression ”basic ethical principles” refers   to those general judgments that serve as a basic justification   for the many particular ethical prescriptions and evaluations   of human actions.
  • Three basic principles, among those generally   accepted in our cultural tradition, are particularly relevant   to the ethics of research involving human subjects: the   principles of respect of persons, beneficence and justice.
  • 1. Respect for Persons
  • The principle of respect for persons thus divides   into two separate moral requirements: the requirement to acknowledge   autonomy and the requirement to protect those with diminished   autonomy.
  • 2. Beneficence.
  • In this document, beneficence   is understood in a stronger sense, as an obligation. Two general   rules have been formulated as complementary expressions of   beneficent actions in this sense: (1) do not harm and   (2) maximize possible benefits and minimize possible   harms.
  • The Hippocratic maxim ”do no harm” has long been   a fundamental principle of medical ethics.
  • Claude Bernard   extended it to the realm of research, saying that one should   not injure one person regardless of the benefits that might   come to others.
  • Learning what will in fact   benefit may require exposing persons to risk
  • An example is found in research involving children.
  • 3. Justice.
  • Who ought to receive   the benefits of research and bear its burdens? This is a question   of justice, in the sense of ”fairness in distribution”   or ”what is deserved.” An injustice occurs when   some benefit to which a person is entitled is denied without   good reason or when some burden is imposed unduly.
  • It   is necessary, then, to explain in what respects people should   be treated equally. There are several widely accepted formulations   of just ways to distribute burdens and benefits. Each formulation   mentions some relevant property on the basis of which burdens   and benefits should be distributed. These formulations are   (1) to each person an equal share, (2) to each   person according to individual need, (3) to each person   according to individual effort, (4) to each person   according to societal contribution, and (5) to each   person according to merit.
  • n this country, in   the 1940's, the Tuskegee syphilis study
  • the selection of research subjects needs to   be scrutinized in order to determine whether some classes   (e.g., welfare patients, particular racial and ethnic minorities,   or persons confined to institutions) are being systematically   selected simply because of their easy availability, their   compromised position, or their manipulability, rather than   for reasons directly related to the problem being studied.
  • C. Applications
  • Applications of the general principles to the conduct of   research leads to consideration of the following requirements:   informed consent, risk/benefit assessment, and the selection   of subjects of research.
  • subjects, to the degree that they   are capable, be given the opportunity to choose what shall   or shall not happen to them. This opportunity is provided   when adequate standards for informed consent are satisfied.
  • 1. Informed Consen
  • he consent process can be analyzed as containing three   elements: information, comprehension and voluntariness.
  • ost codes of research establish specific   items for disclosure intended to assure that subjects are   given sufficient information. These items generally include:   the research procedure, their purposes, risks and anticipated   benefits, alternative procedures (where therapy is involved),   and a statement offering the subject the opportunity to   ask questions and to withdraw at any time from the research.
  • Information
  • It may be that a standard of ”the reasonable   volunteer” should be proposed: the extent and nature   of information should be such that persons, knowing that   the procedure is neither necessary for their care nor perhaps   fully understood, can decide whether they wish to participate   in the furthering of knowledge. Even when some direct benefit   to them is anticipated, the subjects should understand clearly   the range of risk and the voluntary nature of participation.
  • A special problem of consent arises where informing subjects   of some pertinent aspect of the research is likely to impair   the validity of the research.
  • In all cases of research   involving incomplete disclosure, such research is justified   only if it is clear that (1) incomplete disclosure   is truly necessary to accomplish the goals of the research,   (2) there are no undisclosed risks to subjects that   are more than minimal, and (3) there is an adequate   plan for debriefing subjects, when appropriate, and for   dissemination of research results to them.
  • Comprehension.
  • The manner and context in which information   is conveyed is as important as the information itself.
  • Because the subject's ability to understand is a function   of intelligence, rationality, maturity and language, it   is necessary to adapt the presentation of the information   to the subject's capacities.
  • An agreement to participate in research   constitutes a valid consent only if voluntarily given. This   element of informed consent requires conditions free of   coercion and undue influence.
  • Voluntariness.
  • Coercion occurs when an overt   threat of harm is intentionally presented by one person   to another in order to obtain compliance. Undue influence,   by contrast, occurs through an offer of an excessive, unwarranted,   inappropriate or improper reward or other overture in order   to obtain compliance.
  • 2. Assessment of Risks and Benefits
  • the assessment presents both an opportunity and a responsibility   to gather systematic and comprehensive information about proposed   research. For the investigator, it is a means to examine whether   the proposed research is properly designed. For a review committee,   it is a method for determining whether the risks that will   be presented to subjects are justified. For prospective subjects,   the assessment will assist the determination whether or not   to participate.
  • The Nature and Scope of Risks and Benefits.
  • term ”risk” refers to a possibility that harm   may occur. However, when expressions such as ”small   risk” or ”high risk” are used, they usually   refer (often ambiguously) both to the chance (probability)   of experiencing a harm and the severity (magnitude) of the   envisioned harm.
  • The term ”benefit” is used in the research context   to refer to something of positive value related to health   or welfare. Unlike, ”risk,” ”benefit”   is not a term that expresses probabilities. Risk is properly   contrasted to probability of benefits, and benefits are   properly contrasted with harms rather than risks of harm.
  • risk/benefit assessments are concerned   with the probabilities and magnitudes of possible harm and   anticipated benefits.
  • sychological harm, physical harm, legal harm, social   harm and economic harm and the corresponding benefits.
  • The Systematic Assessment of Risks and Benefits
  • t   is commonly said that benefits and risks must be ”balanced”   and shown to be ”in a favorable ratio.”
  • assessment of the justifiability of research should   reflect at least the following considerations: (i)   Brutal or inhumane treatment of human subjects is never   morally justified. (ii) Risks should be reduced to   those necessary to achieve the research objective. It should   be determined whether it is in fact necessary to use human   subjects at all.
  • (iii) When research involves significant   risk of serious impairment, review committees should be   extraordinarily insistent on the justification of the risk
  • (iv) When vulnerable populations   are involved in research, the appropriateness of involving   them should itself be demonstrated
  • (v)   Relevant risks and benefits must be thoroughly arrayed in   documents and procedures used in the informed consent process.
  • 3. Selection of Subjects.
  • the principle of justice gives rise to moral   requirements that there be fair procedures and outcomes   in the selection of research subjects.
  • Justice is relevant to the selection of subjects of research   at two levels: the social and the individual. Individual   justice in the selection of subjects would require that   researchers exhibit fairness: thus, they should not offer   potentially beneficial research only to some patients who   are in their favor or select only ”undesirable”   persons for risky research.
  • Social justice requires that   distinction be drawn between classes of subjects that ought,   and ought not, to participate in any particular kind of   research, based on the ability of members of that class   to bear burdens and on the appropriateness of placing further   burdens on already burdened persons
  • One special instance of injustice results from the involvement   of vulnerable subjects. Certain groups, such as racial minorities,   the economically disadvantaged, the very sick, and the institutionalized   may continually be sought as research subjects, owing to   their ready availability in settings where research is conducted.   Given their dependent status and their frequently compromised   capacity for free consent, they should be protected against   the danger of being involved in research solely for administrative   convenience, or because they are easy to manipulate as a   result of their illness or socioeconomic condition.

  64 more annotations...

• 12 Aug 10
  

  Lynn McClelland

  bioethics ethics health medical research irb science humansubjects

• 09 Jun 10
  

  Bradley Dilger

  via Bill H-D, the canonical text

  ethics government research irb standards

• 23 Apr 10
  

  Arif Shaon

  On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles. In carrying out the above, the Commission was directed to consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in such research and (iv) the nature and definition of informed consent in various research settings.
  
  The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations.

  ethics guidance

• 15 Jan 10
  

  no trees

  research science ethics

• 13 Jan 10
  

  Scarlett Fairchild
  • Three basic principles, among those generally accepted in our cultural  tradition, are particularly relevant to the ethics of research involving human  subjects: the principles of respect of persons, beneficence and justice.
  • An autonomous person is an individual capable of deliberation about personal  goals and of acting under the direction of such deliberation.
  • Two general rules have been formulated as complementary expressions of  beneficent actions in this sense: (1) do not harm and  (2) maximize possible benefits and minimize possible harms.

  1 more annotation...

• 09 Jan 10
  

  Chris Willmott

  Office of Human Subjects Research: The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations. It is the outgrowth of an intensive four-day period of discussions that were held in

  ethics research NIH research_ethics clinical_ethics

• 05 Sep 08
  

  Eric Hackathorn

  belmontreport research ethics privacy

• 31 Aug 08
  

  Yesenia Hernandez

  academic research Office-of-Human-Subjects-Research ethics Regulations Human-protection

• 15 Mar 07
  

  cerbopoli

  argosy news

• 23 Feb 07
  

  eric_francoeur

  belmont_report bioéthique santé

• 10 Jan 07
  

  Mary Burns

  imported EducationalResearch Ethics Research

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