Protecting the Volunteer: A Question of Law versus Ethics

2007 ◽  
Vol 3 (2) ◽  
pp. 54-60 ◽  
Author(s):  
Leander A. A. Edmunds
Keyword(s):  
Clinical Trials ◽  
Human Beings ◽  
Ethical Guidelines ◽  
The Law ◽  
The Voice

Human beings can be ethically frail under the pressure of situational forces, therefore the constraining force of the law is required. The ethics community need to have the confidence and courage to seek for the best ethical guidelines to become such constraining laws. However laws are themselves only ethical when they informed by a consensus that includes and represents the needs of the parties they are intended to protect, therefore the voice of the volunteer must be heard. Specific examples are adduced to show how the current Clinical Trials Regulations are either insufficient in their scope, or not being fully met. To conclude eight suggestions are given as to how volunteers might be better protected. These include the establishment of an independent funded body to inform and support volunteers, a volunteers charter, greater consultation with volunteers, and a change in ethos involving a more egalitarian partnership between all those involved in the development of new medicines

scholarly journals Informed Consent in Clinical Trials and the Role of Institutional Ethics Committees: A Socio-Legal Analysis

2014 ◽  
Vol 3 (1) ◽  
pp. 1-16
Author(s):  
P C Harigovind
Keyword(s):  
Health Care ◽  
Clinical Trials ◽  
Informed Consent ◽  
International Law ◽  
Health Care System ◽  
Health Issues ◽  
Human Beings ◽  
The Public ◽  
The Law ◽  
Care System

Experimenting new drugs on human beings, is one of the crucial human right issues faced by the third world countries in the present century. It is true that the international law had taken high concern of this social issue after the Nuremberg Trials. The international law mandates informed consent to be obtained from the participants of clinical trials and this is the sole mechanism through which the rights of the trial subjects are being protected. The public health issues caused by illegal and unethical trials over patients are now evident in Indian health care system. The issue has come up for consideration before the Supreme Court of India recently. In India the law runs in tune with the international parameters for conducting human experimentation. The law on informed consent has a fatal impact over public health care issues, especially over the matter of clinical trials. Recent experiences in India reveal the threats caused to the society by clinical experimentations. Clinical trials and allied health issues are also brought to the notice of the judiciary. The law on informed consent in India is in its infant state. Exploring the doctrine of informed consent is crucial to this study. The present issue of clinical research which threatens the health care system is analysed and the doctrine of informed consent to regulate the system is assessed to check its efficacy and veracity. Analysis of the issue will help to communicate to the public about the need for better exercise of the rights of those who are subjected to clinical researches. The law of informed consent is in many ways inadequate to deal with the issues relating to clinical trials in India. The doctrine of informed consent has to be redefined to a great extent. The institutional review boards and Non- Government Organisations (NGO) can play a vital role in assuring proper observation of rules relating to regulation of human trials.

Secondary-Cause Autonomy and Divine Motivation

2016 ◽  
Vol 8 (3) ◽  
pp. 75-92
Author(s):  
Christian Schröer
Keyword(s):  
Human Dignity ◽  
Human Action ◽  
Thomas Aquinas ◽  
Moral Autonomy ◽  
Human Beings ◽  
Religious Motivation ◽  
Basic Principles ◽  
Theoretical View ◽  
Human Autonomy ◽  
The Voice

An act-theoretical view on the profile of responsibility discourse shows in what sense not only all kinds of technical, pragmatic and moral reason, but also all kinds of religious motivation cannot justify a human action sufficiently without acknowledgment to three basic principles of human autonomy as supreme limiting conditions that are human dignity, sense, and justifiability. According to Thomas Aquinas human beings ultimately owe their moral autonomy to a divine creator. So this autonomy can be considered as an expression of secondary-cause autonomy and as the voice of God in the enlightened conscience.

Interpersonal Communication

1988 ◽  
Vol 5 (2) ◽  
pp. 239-246
Author(s):  
Mohammad A. Siddiqui
Keyword(s):  
Interpersonal Communication ◽  
Mass Communication ◽  
Social Process ◽  
Political Scientist ◽  
Human Beings ◽  
Common Object ◽  
The Face ◽  
The Common ◽  
The Voice ◽  
Basic Social Process

IntroductionCommunication today is increasingly seen as a process through whichthe exchange and sharing of meaning is made possible. Commtinication asa subject of scientific inquiry is not unique to the field of mass communication.Mathematicians, engineers, sociologists, psychologists, political scientists,anthropologists, and speech communicators have been taking an interest inthe study of communication. This is not surprising because communicationis the basic social process of human beings. Although communication hasgrown into a well developed field of study, Muslim scholars have rdrely hcusedon the study of communication. Thus, a brief introduction to the widely usedcommunication concepts and a framework for the study of communicationwithin the context of this paper is provided.In 1909, Charles Cooley defined communication from a sociologicalperspective as:The mechanism through which human relations exist and develop -all the symbols of mind, together with the means of conveyingthem through space and preserving them in time. It includes theexpression of the face, attitude and gesture, the tones of the voice,words, writing, printing, railways, telegraph, and whatever elsemay be the latest achievement in the conquest of space and time.In 1949, two engineers, Claude Shannon and Warren Weaver, definedcommunication in a broader sense to include all procedures:By which one mind may affect another. This, of course, involvesnot only written and oral speeches, but also music, the pictorialarts, the theater, the ballet, and, in kct, all human behavior.Harold Lasswell, a political scientist, defines communication simply as:A convenient way to describe the act of communication is to answerthe following question: Who, says what, in which channel, towhom, with what effect?S.S. Stevens, a behavioral psychologist, defines the act of communication as:Communication occurs when some environmental disturbance (thestimulus) impinges on an organism and the organism doessomething about it (makes a discriminatory response) . . . Themessage that gets no response is not a commnication.Social psychologist Theodore Newcomb assumes that:In any communication situation, at least two persons will becommunicating about a common object or topic. A major functionof communication is to enable them to maintain simultaneousorientation toward one another and toward the common object ofcommunication.Wilbur Schramm, a pioneer in American mass communication research,provides this definition:When we communicate we are trying to share information, anidea, or an attitude. Communication always requires threeelements-the source, the message, and the destination (thereceiver).

On the Artifactual—and Natural— Character of Legal Institutions

2018 ◽  
Author(s):  
Corrado Roversi
Keyword(s):  
Natural Law ◽  
Common Ground ◽  
Legal Positivism ◽  
Legal Institutions ◽  
Human Beings ◽  
Legal Realism ◽  
Natural Law Theory ◽  
The Law ◽  
Theory Of Law

Are legal institutions artifacts? If artifacts are conceived as entities whose existence depends on human beings, then yes, legal institutions are, of course, artifacts. But an artifact theory of law makes a stronger claim, namely, that there is actually an explanatory gain to be had by investigating legal institutions as artifacts, or through the features of ordinary artifacts. This is the proposition explored in this chapter: that while this understanding of legal institutions makes it possible to find common ground between legal positivism and legal realism, it does not capture all of the insights offered by these two traditions. An artifact theory of law can therefore be necessary in explaining the law, but it will not suffice to that end. This chapter also posits that legal artifacts bear a relevant connection to certain conceptions of nature, thus vindicating one of the original insights behind natural law theory.

scholarly journals Fair and equitable subject selection in concurrent COVID-19 clinical trials

2020 ◽  
Vol 47 (1) ◽  
pp. 7-11
Author(s):  
Maud O. Jansen ◽  
Peter Angelos ◽  
Stephen J. Schrantz ◽  
Jessica S. Donington ◽  
Maria Lucia L. Madariaga ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Research Design ◽  
Ethics Committees ◽  
Scientific Uncertainty ◽  
Moral Concern ◽  
Structural Barriers ◽  
Ethical Guidelines ◽  
Academic Medical Centre ◽  
Subject Selection ◽  
Study Results

Clinical trials emerged in rapid succession as the COVID-19 pandemic created an unprecedented need for life-saving therapies. Fair and equitable subject selection in clinical trials offering investigational therapies ought to be an urgent moral concern. Subject selection determines the distribution of risks and benefits, and impacts the applicability of the study results for the larger population. While Research Ethics Committees monitor fair subject selection within each trial, no standard oversight exists for subject selection across multiple trials for the same disease. Drawing on the experience of multiple clinical trials at a single academic medical centre in the USA, we posit that concurrent COVID-19 trials are liable to unfair and inequitable subject selection on account of scientific uncertainty, lack of transparency, scarcity and, lastly, structural barriers to equity compounded by implicit bias. To address the critical gap in the current literature and international regulation, we propose new ethical guidelines for research design and conduct that bolsters fair and equitable subject selection. Although the proposed guidelines are tailored to the research design and protocol of concurrent trials in the COVID-19 pandemic, they may have broader relevance to single COVID-19 trials.

Kant on the Ground of Human Dignity

2021 ◽  
pp. 1-19
Author(s):  
Apaar Kumar
Keyword(s):  
Human Dignity ◽  
Reciprocal Relationship ◽  
Human Beings ◽  
Moral Law ◽  
Human Constitution ◽  
The Law

Abstract Kant interpreters have contrasting views on what Kant takes to be the basis for human dignity. Several commentators have argued that human dignity can be traced back to some feature of human beings. Others contend that humans in themselves lack dignity, but dignity can be attributed to them because the moral law demands respect for humanity. I argue, alternatively, that human dignity in Kant’s system can be seen to be grounded in the reciprocal relationship between the dignity of the moral law and the dignity inherent in the human constitution. The latter includes the dignity of personhood, construed as rational inner purposiveness, and the dignity of giving oneself the law and striving to follow it.

scholarly journals Ethical dimension of circle Integrative Community Therapy on qualitative research

2014 ◽  
Vol 48 (spe2) ◽  
pp. 148-154
Author(s):  
Paula Renata Miranda dos Santos ◽  
Elisangela Cerencovich ◽  
Laura Filomena Santos de Araújo ◽  
Roseney Bellato ◽  
Sonia Ayako Tao Maruyama
Keyword(s):  
Qualitative Research ◽  
Ethical Issues ◽  
Social Research ◽  
Ethical Dimension ◽  
Human Beings ◽  
Ethical Guidelines ◽  
Social Differences ◽  
Health Council ◽  
Care Guidelines ◽  
The Relationship

This study discusses ethical issues in research involving human beings and seeks to understand the relationship between qualitative research and the ethical care guidelines for Integrative Community Therapy (ICT) circles based on Resolution 466/12 of the National Health Council of the Ministry of Health of Brazil. This is documentary research, which analyzed Resolution 466/12 and ICT circles seeking to make a connection between the ethical guidelines contained in both. The analysis of the corpus was directed toward the construction of the following results: the person's perception, cultural diversity and community. It also brings in consideration of the influence of the ethical dimension of the ICT circles on qualitative research. We conclude that ICT circles are innovative in the sense of the diversity of participants and respect for cultural and social differences. Thus, ICT circles promote acquisition of quality information for social research as well as compliance with the ethical guidelines outlined in Resolution No. 466/12.

scholarly journals The Importance and Necessity of Paying Attention to Law and Legalism in Social Areas from the Perspective of the Holy Quran

2016 ◽  
Vol 3 (1) ◽  
pp. 1
Author(s):  
Reza Alami ◽  
Farzad Emamian ◽  
Seyed Nima Karimi ◽  
Seyed Sadegh Mousavi Takami ◽  
Mahdi Rezaei
Keyword(s):  
Social Life ◽  
Natural Rights ◽  
Human Society ◽  
Human Beings ◽  
Law And Order ◽  
Holy Quran ◽  
The Holy Quran ◽  
The Law ◽  
Laws And Regulations

<p>Social life is an inevitable necessity for human beings and order, security and justice is required for social life. In this regard, everything that can be effective social life of for human beings should be seriously considered. Law is among these phenomena that people can benefit from social life in its light in addition to benefiting from their natural rights. Therefore, it can be said that the strength and cohesion of any society is paying attention to the law and obeying it. Obviously, this religion in order to convey its purpose should have a plan for them. Therefore, God, as the drafter of this religion sent the Quran to people which is full of solutions and values and a better life for them. In Islam and Quran, the condition of salvation and happiness of a society depends on adherence to God's laws and regulations in all facets and social arenas. The results of this study show that in the shadow of respecting law and order the possibility of planning, implementing and guiding in human society is done. A society can only be lawful by fulfilling God's commandments in Quran.</p>

Paediatric Research under the New eu Regulation on Clinical Trials: Old Issues New Challenges

2016 ◽  
Vol 23 (4) ◽  
pp. 325-349 ◽  
Author(s):  
Éloïse Gennet ◽  
Annagrazia Altavilla
Keyword(s):  
Clinical Trials ◽  
Implementation Process ◽  
Paediatric Research ◽  
Ethical Guidelines ◽  
Eu Regulation ◽  
Paediatric Regulation ◽  
New Challenges

Regulating paediatric research means searching for the balance between two valuable goals: protecting children while ensuring they benefit from safe and efficient medicines. Different legal instruments were adopted in the eu in order to regulate clinical trials, foster paediatric research and promote European and international ethical guidelines. However a new Regulation on clinical trials was adopted in 2014, and might change the current framework of paediatric research. How does the new Regulation 536/2014 foster research on children taking into account both the eu Paediatric Regulation and the eu Ethical Recommendations? Does it live up to the standards of the Directive 2001/20/ec and does it represent a step forward in accordance with international ethical guidelines? This article shows that, despite the adoption of new rules, many clarifications are still needed. Stakeholders involved in paediatric research have to play a driving role in the implementation process of the new Regulation.

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