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gslPart A:Boundaries Between Practice&Rearch
hkexA.Boundaries Between Practice and Rearch
It is important to distinguish between biomedical and behavioral rearch,on the one hand,and the practice of accepted therapy on the other,in order to know what activities ought to undergo review for the protection of human subjects of rearch.The distinction between rearch and practice is blurred partly becau both often occur together(as in rearch designed to evaluate a therapy)and partly becau notable departures from standard practice are often called"experimental"when the terms"experimental"and"rearch"are not carefully defined.
For the most part,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 purpo of medical or behavioral practice is to provide diagnosis,preventive treatment or therapy to particular individuals.(2)By contrast,the term"rearch'designates an activity designed to test an hypothesis,permit conclusions to be drawn,and thereby to develop or contribute to generalizable knowledge(expresd,for example,in theories, principles,and statements of relationships).Rearch is usually described in a formal protocol that ts forth an objective and a t of procedures designed to reach that objective.
Part B:Basic Ethical Principles
B.Basic Ethical Principles
The expression"basic ethical principles"refers to tho general judgments that rve as a basic justification for the many particular ethical prescriptions and evaluations of human actions.Three basic principles,among tho generally accepted in our cultural tradition,are particularly relevant to the ethics of rearch involving human subjects:the principles of respect of persons, beneficence and justice.
1.Respect for Persons.--Respect for persons incorporates at least two ethical convictions:first,that individuals should be treated as autonomous agents,and cond,that persons with diminished autonomy are entitled to protection.The principle of respect for persons thus divides into two parate moral requirements:the requirement to acknowledge autonomy and the requirement to protect tho with diminished autonomy.
In most cas of rearch involving human subjects,respect for persons demands that subjects enter into the rearch voluntarily and with adequate information.In some situations,however,application of the principle is not obvious.The involvement of prisoners as subject恭喜英文
s of rearch provides an instructive example.On the one hand,it would em that the principle of
visiblerespect for persons requires that prisoners not be deprived of the opportunity to volunteer for rearch.On the other hand,under prison conditions they may be subtly coerced or unduly influenced to engage in rearch activities for which they would not otherwi volunteer.Respect for persons would then dictate that prisoners be protected.Whether to allow prisoners to"volunteer"or to"protect" them prents a dilemma.Respecting persons,in most hard cas,is often a matter of balancing competing claims urged by the principle of respect itlf.strengthandhonor
2.Beneficence.--Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm,but also by making efforts to cure their well-being.Such treatment falls under the principle of beneficence.The term"beneficence"is often understood to cover acts of kindness or charity that go beyond strict obligation.In this document, beneficence is understood in a stronger n,as an obligation.Two general rules have been formulated as complementary expressions of beneficent actions in this n:(1)do not harm and(2)maximize possible benefits and minimize possible harms.
umemaroThe Hippocratic maxim"do no harm"has long been a fundamental principle of medical ethics.Claude
Bernard extended it to the realm of rearch,saying that one should not injure one person regardless of the benefits that might come to others.However,even avoiding harm requires learning what is harmful;and,in the process of obtaining this information,persons may be expod to risk of harm.Further,the Hippocratic Oath requires physicians to benefit their patients "according to their best judgment."Learning what will in fact benefit may require exposing persons to risk.The problem pod by the imperatives is to decide when it is justifiable to ek certain benefits despite the risks involved, and when the benefits should be foregone becau of the risks.
3.Justice.--Who ought to receive the benefits of rearch and bear its burdens? This is a question of justice,in the n of"fairness in distribution"or"what is derved."An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is impod unduly.Another way of conceiving the principle of justice is that equals ought to be treated equally.However,this statement requires explication.Who is equal and who is unequal?What considerations justify departure from equal distribution?Almost all commentators allow that distinctions bad on experience,age,deprivation, competence,merit and position do sometimes constitute criteria justifying differential treatment for certain purpos.It is necessary,then,to explain in what respects people should be treated equally.There are veral widely accepted formulations of
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just ways to distribute burdens and benefits.Each formulation mentions some relevant property on the basis of which burdens and benefits should be distributed.The 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.
C.Applications Applications of the general principles to the conduct of rearch leads to consideration of the following requirements:informed
connt,risk/benefit asssment,and the lection of subjects of rearch.
1.Informed Connt.--Respect for persons requires that subjects,to the degree that they are capable,be given the opportunity to choo what shall or shall not happen to them.This opportunity is provided when adequate standards for informed connt are satisfied.
适合初中生看的书2.Asssment of Risks and Benefits.--The asssment of risks and benefits requires a careful arrayal of relevant data,including,in some cas,alternative ways of obtaining the benefits sought in the rearch.Thus,the asssment prents both an opportunity and a responsibility to gather syste
matic and comprehensive information about propod rearch.For the investigator,it is a means to examine whether the propod rearch is properly designed.For a review committee,it is a method for determining whether the risks that will be prented to subjects are justified.For prospective subjects,the asssment will assist the determination whether or not to participate.
3.Selection of Subjects.--Just as the principle of respect for persons finds expression in the requirements for connt,and the principle of beneficence in risk/benefit asssment,the principle of justice gives ri to moral requirements that there be fair procedures and outcomes in the lection of rearch subjects.
Justice is relevant to the lection of subjects of rearch at two levels:the social and the individual.Individual justice in the lection of subjects would require that rearchers exhibit fairness:thus,they should not offer potentially beneficial rearch only to some patients who are in their favor or lect only "undesirable"persons for risky rearch.Social
justice requires that distinction be drawn between class of subjects that ought, and ought not,to participate in any particular kind of rearch,bad on the ability of members of that class to bear burdens and on the appropriateness of placing further burdens on already burdened persons.Thus,it
bobby是什么意思can be considered a matter of social justice that there is an order of preference in the lection of class of ,adults before children)and that some class of potential ,the institutionalized mentally infirm or prisoners)may be involved as rearch subjects,if at all,only on certain conditions.
