Do you think the Solidarity Clinical Trial is ethical? May you explain your answer in the context of three principles stated in the Belmont Report. If it's okay, may you elaborate the answers. Thank you so much for your hard work. Solidarity Clinical Trial Link: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments

RESPECT FOR PERSONS:

BENEFICENCE:

JUSTICE:

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Here are my notes

BELMONT REPORT

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 autonomyand therequirement 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.

In other words, class, we have to recognize each person's capacity to think and decide for themselves and refrain from manipulating them in any way.

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.

In this case, we can provide children or minors as examples. It is general knowledge that we consider children to have limited capacity to understand the whole situation, that is why there are restrictions in laws like driving, drinking, marriage etc, Likewise, there are also people are continuously in need of assistance and care particularly those who demonstrate intellectual disabilities. Because of this, we have to exclude them from activities which may harm them

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 thatprisoners 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 ofbalancing competing claims urged by the principle of respect itself.

2. Beneficence. Persons are treated in an ethical manner not only by respecting their decisions andprotecting them from harm,but also by making efforts tosecure their well-being.Such treatment falls under the principle of beneficence. The term "beneficence" is often understood to coveracts 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 thatone should not injure one person regardless of the benefits that might come to others. However,even avoiding harm requires learning what is harmful(twitter worthy, hehe); 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.

In other words, there will really be instances when it is impossible to avoid harm. Harm is inevitable in some situations. Okay? In cases like this, the practitioner should choose which is the best option based on his best judgment.

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 themaximization 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 torecognize the longer term benefits and risks that may result from the improvement of knowledgeand from the development of novel medical, psychotherapeutic, and social procedures.

This means, class, that when considering the feasibility of the study, we also take into consideration what we will get from it. This will somehow justify the process. If the costs outweigh benefit, then we might as well, refrain from conducting the research.

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 thatequals ought to 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:

• to each person an equal share
• to each person according to individual need
• to each person according to individual effort
• to each person according to societal contribution, and
• to each person according to merit