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Advocacy >  Ethical Principles for Clinical Research 

Last update: 03/10/2014

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The following will be of interest and importance to research advocates.  The material was captured from a government site as training for members of institutional review boards.

Basic Ethical Principles: Respect for Persons | Beneficence | Justice

Part B: Basic Ethical Principles

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. -- Respect for persons incorporates at least 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.

An autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of such deliberation. To respect autonomy is to give weight to autonomous persons' considered opinions and choices while refraining from obstructing their actions unless they are clearly detrimental to others. To show lack of respect for an autonomous agent is to repudiate that person's considered judgments, to deny an individual the freedom to act on those considered judgments, or to withhold information necessary to make a considered judgment, when there are no compelling reasons to do so.

However, not every human being is capable of self-determination. The capacity for self-determination matures during an individual's life, and some individuals lose this capacity wholly or in part because of illness, mental disability, or circumstances that severely restrict liberty. Respect for the immature and the incapacitated may require protecting them as they mature or while they are incapacitated.

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. The extent of protection afforded should depend upon the risk of harm and the likelihood of benefit. The judgment that any individual lacks autonomy should be periodically reevaluated and will vary in different situations.

In most cases of research involving human subjects, respect for persons demands that subjects enter into the research voluntarily and with adequate information. In some situations, however, application of the principle is not obvious. The involvement of prisoners as subjects of research provides an instructive example. On the one hand, it would seem that the principle of respect for persons requires that prisoners not be deprived of the opportunity to volunteer for research. On the other hand, under prison conditions they may be subtly coerced or unduly influenced to engage in research activities for which they would not otherwise volunteer. Respect for persons would then dictate that prisoners be protected. Whether to allow prisoners to "volunteer" or to "protect" them presents a dilemma. Respecting persons, in most hard cases, is often a matter of balancing competing claims urged by the principle of respect itself.

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 secure 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 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. However, even avoiding harm requires learning what is harmful; and, in the process of obtaining this information, persons may be exposed 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 posed by these imperatives is to decide when it is justifiable to seek certain benefits despite the risks involved, and when the benefits should be foregone because of the risks.

The obligations of beneficence affect both individual investigators and society at large, because they extend both to particular research projects and to the entire enterprise of research. In the case of particular projects, investigators and members of their institutions are obliged to give forethought to the maximization of benefits and the reduction of risk that might occur from the research investigation. 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 from the improvement of knowledge and from the development of novel medical, psychotherapeutic, and social procedures.

The principle of beneficence often occupies a well-defined justifying role in many areas of research involving human subjects. An example is found in research involving children. Effective ways of treating childhood diseases and fostering healthy development are benefits that serve to justify research involving children -- even when individual research subjects are not direct beneficiaries. Research also makes it possible to avoid the harm that may result from the application of previously accepted routine practices that on closer investigation turn out to be dangerous. But the role of the principle of beneficence is not always so unambiguous. A difficult ethical problem remains, for example, about research that presents more than minimal risk without immediate prospect of direct benefit to the children involved. Some have argued that such research is inadmissible, while others have pointed out that this limit would rule out much research promising great benefit to children in the future. Here again, as with all hard cases, the different claims covered by the principle of beneficence may come into conflict and force difficult choices.

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. 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 based on experience, age, deprivation, competence, merit and position do sometimes constitute criteria justifying differential treatment for certain purposes. 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.

Questions of justice have long been associated with social practices such as punishment, taxation and political representation. Until recently these questions have not generally been associated with scientific research. However, they are foreshadowed even in the earliest reflections on the ethics of research involving human subjects. For example, during the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients. Subsequently, the exploitation of unwilling prisoners as research subjects 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. These subjects were deprived of demonstrably effective treatment in order not to interrupt the project, long after such treatment became generally available.

Against this historical background, it can be seen how conceptions of justice are relevant to research involving human subjects. 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.

Beneficence

What This Module Covers:

  • Risks and benefits
  • Privacy and Confidentiality
  • Institutional Review Boards (IRBs)
  • Data and Safety Monitoring

The Objectives For This Module Are:

  • To understand what aspects of research may constitute a benefit to research participants
  • To identify possible risks to be considered in evaluating research
  • To discuss methods to protect privacy of individuals and confidentiality of data
  • To define the role of an IRB to ensure the rights and welfare of human subjects and
  • To outline requirements for Data and Safety Monitoring for clinical trials

 

Beneficence

Quote from the Belmont Report: '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. 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 sense, as an obligation.' Text: Beneficience - next to the quote.

Two general rules have been articulated as complementary expressions of beneficent actions:

  1. Do no harm
  2. Maximize possible benefits and minimize possible harms

Investigators and members of their institutions are obliged to give forethought to the maximization of benefits and the reduction of risk that might occur from the research investigation

 

Respect for Persons

Quote from the Belmont Report: 'To respect autonomy is to give weight to the autonomous person's considered opinions and choices while refraining from obstructing his or her actions…' Text: Respect for Persons - next to the quote.

The principle of respect for persons can be broken down into two basic ideas:

1. Individuals should be treated as autonomous agents
Silhouetted male and female shapes, standing next to each other with text: Autonomous Agents.

An autonomous personis able to:

“An individual capable of deliberation about personal goals and of acting under the direction of such deliberation.”

 

  • Consider the potential harms and benefits of a situation
  • Analyze how those risks and potential benefits relate to his or her personal goals and values
  • Take action based on that analysis

Prospective research participants must be given the information they need to determine whether or not they want to participate in research. There should be no pressure to participate and ample time to decide. Respect for persons demands that participants enter into the research voluntarily and with adequate information. This is called informed consent, and will be covered in detail in other sections of this training.

A legally-effective, voluntary agreement that is given by a prospective research participant following comprehension and consideration of all relevant information pertinent to the decision to participate in a study.
2. Persons with diminished autonomy are entitled to additional protections
Special provisions may need to be made when an individual’s comprehension is severely limited or when a class of research participants is considered incapable of informed decision making (e.g. children, people with severe developmental disorders, or individuals suffering from dementias). Even for these persons, however, respect for persons requires giving them the opportunity to choose, to the extent they are able, whether or not they wish to participate in research activities. In some cases, respect for persons may require seeking the permissionof other parties, such as a parent or legal guardian.
“Persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.”
“The agreement of parent(s) or guardian to the participation of their child or ward in research.”    

 

The challenges in applying the Belmont principle of respect for persons are in:

  • Making sure that potential participants comprehend the risks and potential benefits of participating in research
  • Avoiding influencing potential participants’ decisions either through explicit or implied threats (coercion) or through excessive compensation (undue influence)

Justice

Quote from the Belmont Report: 'Just as the principle of respect for persons finds expression in the requirements for consent, and the principle of beneficence in risk/benefit assessment, the principle of justice gives rise to moral requirements that there be fair procedures and outcomes in the selection of research subjects'. Text: Justice - next to the quote.

Justice requires that individuals and groups be treated fairly and equitably in terms of bearing the burdens and receiving the benefits of research.

The principle of justice may arise in decisions about inclusion and exclusion criteria for participation in research and requires investigatorsto question whether groups are considered for inclusion simply because of their availability, their compromised position, or their vulnerability — rather than for reasons directly related to the problem being studied.

 

The challenge of applying the Belmont principle of justice is how to decide which criteria should be used to ensure that harms and benefits of research are equitably distributed to individuals and populations.

Subpart A - Basic HHS Policy for Protection of Human Research Subjects

Document titled with text: Subpart A, Basic HHS Policy for the Protection of Human Research Subjects. Text - The Common Rule - above the document.

Subpart A, also called “The Common Rule”, describes the required protections for all human subjects.

Subpart A defines a human subject as “a living individual about whom an investigator...conducting research obtains:

 

  1. Data through intervention or interaction with the individual, or
  2. Identifiable private information.”

Subpart A defines research as “a systematic investigation...designed to develop or contribute to generalizable knowledge.”

This definition includes:

  • Research development
  • Testing
  • Evaluation

 

 
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