scholarly journals 《赫爾辛基宣言》縱橫談

2002 ◽  
Vol 4 (2) ◽  
pp. 85-118
Author(s):  
Yali CONG
Keyword(s):  
Research Ethics ◽  
Human Subject ◽  
Ethical Issues ◽  
Historical Review ◽  
Practical Significance ◽  
Moral Pluralism ◽  
Nuremberg Code ◽  
The West ◽  
Human Subject Protection ◽  
Declaration Of Helsinki

LANGUAGE NOTE | Document text in Chinese; abstract also in English.自從20世紀80年代末，隨著中國和其他國家在生物醫學科研上合作的增多，與之有關的倫理問題隨之增加。尤其是20世紀以來，如果說科研倫理學是生命倫理學領域的一顆新星不過分的話，那麼，赫爾辛基宣言就是科研倫理學的核心的說法是很恰當的。為了提高科研倫理學的意識，保護受試者的權益，預防潛在的倫理問題的發生，順著赫爾辛基宣言發展的歷史並找尋其中變遷的線索是非常必要的。具體來說，從紐倫堡法典產生的背景和內容開始，追溯1964、1975、1983、1989、1996、2000和2002年赫爾辛基宣言變化的原因，並把主要變化的內容單獨注出來，以利於讀者進行比較分析。探詢歷史發展的軌跡，是為了從中吸取經驗教訓，完善對受試者保護權益保護的機制。本文所有的材料都是為了這個目的服務的。關於國際前沿性的對最新的赫爾辛基宣言的爭論，讀者頭腦中要有各國對科研倫理學原則的多元化的理解這樣一個概念，同時要知道聲音最大的背後的原因，而且更重要的是要有結合中國實際情況的意識，以及是否適合中國的情況的分析，否則仍要停留在被動盲從的地位，不能真正實現科研倫理學應有的實踐性價值。Along with the development of biomedical research cooperation between China and other countries since late 1980s, many ethical issues have occurred. It is not exaggerating to claim that research ethics is a bright star in the field of bioethics, especially since the end of the 20th-century. It is also appropriate to say that the Declaration of Helsinki consists of the core of contemporary research ethics. This paper will trace the history of Declaration of Helsinki and seek for the clue for positive changes. To do so should be able to help to raise the consciousness of research ethics in people, to protect the rights and welfare of human subjects, and to prevent some potential ethical problems from happening.This article will describe in detail on the background from the Nuremberg Code to the Declaration of Helsinki and on changes happened in different versions of the Declaration of Helsinki in 1964, 1975, 1983, 1989, 1996, 2000 and 2002. The obvious and significant changes of different versions will be highlighted for the convenience of the reader. The aim of this historical review is to learn the experiences and related lessons in the West and thus to develop the system of human subject protection in China. All the materials of the article are directed to this aim. Regarding the current ethical debates on the latest version of the Declaration of Helsinki, we should be aware of the moral pluralism and plurality among different countries. It is important to analyze and understand the strongest voice in the debate and the background of this voice.Yet, the most challenging task is to find out what is suitable for our country- China- - and what is not. In other words, while we need to learn from the West about human subject protection such as the historic and influential document like the Declaration of the Helsinki, it is crucial to root Chinese research ethics in our particular conditions in China. Otherwise, we will always in the status of simply following the West blindly and cannot fulfill the practical significance of research ethics in Chinese reality.DOWNLOAD HISTORY | This article has been downloaded 22 times in Digital Commons before migrating into this platform.

Vulnerability as a Regulatory Category in Human Subject Research

2009 ◽  
Vol 37 (1) ◽  
pp. 12-18 ◽  
Author(s):  
Carl H. Coleman
Keyword(s):  
Research Ethics ◽  
Human Subject ◽  
Institutional Review Boards ◽  
Human Subject Research ◽  
Human Subject Protection ◽  
Research Ethics Review ◽  
Institutional Review ◽  
Research Regulations ◽  
Vulnerable Subjects ◽  
The Common

The concept of vulnerability has long played a central role in discussions of research ethics. In addition to its rhetorical use, vulnerability has become a term of art in U.S. and international research regulations and guidelines, many of which contain specific provisions applicable to research with vulnerable subjects. Yet, despite the frequency with which the term vulnerability is used, little consensus exists on what it actually means in the context of human subject protection or, more importantly, on how a finding of vulnerability should affect the process of research ethics review.The Common Rule, the centerpiece of the U.S. human subject protection regulations, uses the word vulnerable three times. First, it provides that institutional review boards (IRBs) that regularly review research involving a vulnerable category of subjects should consider including one or more individuals who are knowledgeable about and experienced in working with these subjects.

Ethical issues in action-oriented research in Indonesia

2017 ◽  
Vol 24 (6) ◽  
pp. 686-693 ◽  
Author(s):  
Rini Rachmawaty
Keyword(s):  
Research Ethics ◽  
Human Subject ◽  
Ethical Issues ◽  
Human Subjects ◽  
Ethics Committee ◽  
International Standards ◽  
Local Health ◽  
Human Subject Research ◽  
Research Ethics Committee ◽  
Oriented Research

Background: Action-oriented research is one of the most frequent research types implemented to transform community health in Indonesia. Three researchers and 11 graduate students from a developed country in East Asia conducted a fieldwork program in a remote area in South Sulawesi Province. Although the project was completed, whether or not the international standards for human subject research were applied into that study remains unclear. Objectives: This study aimed to examine ethical issues raised from that case, analyze constraints to the problems, and recommend alternatives to protect vulnerable populations from being exploited by local/international researchers. Methods: A problem-solving approach was used in this study. It began with problem identification, evaluation of the action-oriented research goal, investigation of the constraints to the problem, and recommendation of some relevant alternatives to address the central issue. Ethical Consideration: The approval for conducting the action-oriented research that being investigated in this work was only obtained from the Head of local district. Results: Some ethical issues were found in this case. No special protection for this population, no informed consent was obtained from the participants, exposure to social and economic risks, no future benefits for the subjects, and conflict of interests. Lack of control from the local research ethics committee and lack of competence of local researchers on human subject research were considered as the constraints to the problems. Discussion: Creating an independent research ethics committee, providing research ethics training to the local researchers, obtaining written/video consents from underserved populations, and meeting local health needs were recommended alternatives to solve these problems. Conclusion: Indonesian government bodies should reform their international collaborative system on research involving human subjects. Exploitation may not occur if all participants as well as all local and national governing bodies understand the research ethics on human subjects and apply it into their practice.

Silent Partners

2016 ◽  
Author(s):  
Rebecca Dresser
Keyword(s):  
Healthy Volunteers ◽  
Research Ethics ◽  
Human Subject ◽  
Large Body ◽  
Research Participation ◽  
Drop Out ◽  
Research Subjects ◽  
Human Subject Protection ◽  
Ethical Research ◽  
Regulatory Standards

Scientists and ethicists often speak of subjects as partners in research, but the reality is quite different. Experienced subjects are rarely appointed to the committees that create guidelines for ethical research or the committees that review individual studies to determine whether they meet ethical and regulatory standards. Yet experienced research subjects can make valuable contributions to research ethics. People who have been in studies know facts about the experience that others may overlook. Their experience as subjects gives them special insights into ethics too. Experienced subjects know about problems that can lead people to refuse to join studies or to drop out before studies are complete. A large body of work describes the perceptions and viewpoints of people who have participated in research, but experts rarely use this material to guide improvements in human subject protection. Although subjects have the power to decide whether to participate in a study, they have little control over anything else that goes on in research. Silent Partners moves research subjects to the forefront, examining what research participation is like for healthy volunteers and patients and explaining why subjects’ voices should influence research ethics. Silent Partners shows how experienced research subjects can become real—not just symbolic—partners in research.

How Important Is Consent for Controlled Clinical Trials?

1996 ◽  
Vol 5 (2) ◽  
pp. 221-227 ◽  
Author(s):  
Barbara MacKinnon
Keyword(s):  
Biomedical Research ◽  
Ethical Issues ◽  
Human Subjects ◽  
Medical Knowledge ◽  
Experimental Therapy ◽  
Human Beings ◽  
Nuremberg Code ◽  
Declaration Of Helsinki ◽  
Voluntary Consent ◽  
Risk And Benefit

The Nuremberg Code of ethical principles for experiments involving human beings has as its first requirement that “the voluntary consent of the human subject is absolutely essential.” Since the time of the trials that supplied its motivation the principles have been amplified and detail and distinctions have been added. For example, the Declaration of Helsinki, adopted by the World Medical Association in 1964, again laid down general principles related to voluntariness, balance of risk and benefit, and scientific soundness. However, it also noted that the ethical issues with regard to two distinctly different types of human experiment vary. These two types are clinical research (i.e., “medical research combined with profession care”) and nonclinical biomedical research (i.e., “nontherapeutic biomedical research involving human subjects”). In actuality, we may distinguish three types of human biomedical experimentation. Two of these are therapeutic and nontherapeutic experimentation. The first is directed primarily to the benefit of the experimental subjects who are being treated with some new experimental therapy for their ailment. In the second an experiment is designed to increase medical knowledge and uses volunteers who are healthy or whose illness is not related to the experimental study. One key difference between the ethical requirements specified by the Declaration of Helsinki for therapeutic and nontherapeutic experimentation was that the second approach required participation only by volunteers whom we assume are able to and do give their informed consent. However, in the first approach if consent were not obtained, the physician must specify the reasons and present these before an independent committee.

Editor’s Pick: Regulatory and Ethical Issues in the New Era of Radiomics and Radiogenomics

EMJ Radiology ◽  
2020 ◽  
Author(s):  
Filippo Pesapane
Keyword(s):  
Ethical Issues ◽  
Medical Images ◽  
Practical Significance ◽  
Innovative Technology ◽  
New Era ◽  
Naked Eye ◽  
Disease Characteristics ◽  
The Future ◽  
Using Data ◽  
The Relationship

Radiomics is a science that investigates a large number of features from medical images using data-characterisation algorithms, with the aim to analyse disease characteristics that are indistinguishable to the naked eye. Radiogenomics attempts to establish and examine the relationship between tumour genomic characteristics and their radiologic appearance. Although there is certainly a lot to learn from these relationships, one could ask the question: what is the practical significance of radiogenomic discoveries? This increasing interest in such applications inevitably raises numerous legal and ethical questions. In an environment such as the technology field, which changes quickly and unpredictably, regulations need to be timely in order to be relevant.  In this paper, issues that must be solved to make the future applications of this innovative technology safe and useful are analysed.

Research Ethics Committees’ Oversight of Biomedical Research in South Africa: A Thematic Analysis of Ethical Issues Raised During Ethics Review of Non-Expedited Protocols

2019 ◽  
Vol 14 (2) ◽  
pp. 107-116 ◽  
Author(s):  
Blessing Silaigwana ◽  
Douglas Wassenaar
Keyword(s):  
South Africa ◽  
Research Ethics ◽  
South African ◽  
Biomedical Research ◽  
Ethical Issues ◽  
Ethics Committees ◽  
Financial Contracts ◽  
Scientific Validity ◽  
Participant Selection ◽  
Education And Awareness

In South Africa, biomedical research cannot commence until it has been reviewed and approved by a local research ethics committee (REC). There remains a dearth of empirical data on the nature and frequency of ethical issues raised by such committees. This study sought to identify ethical concerns typically raised by two South African RECs. Meeting minutes for 180 protocols reviewed between 2009 and 2014 were coded and analyzed using a preexisting framework. Results showed that the most frequent queries involved informed consent, respect for participants, and scientific validity. Interestingly, administrative issues (non-ethical) such as missing researchers’ CVs and financial contracts emerged more frequently than ethical questions such as favorable risk/benefit ratio and fair participant selection. Although not generalizable to all RECs, our data provide insights into two South African RECs’ review concerns. More education and awareness of the actual ethical issues typically raised by such committees might help improve review outcomes and relationships between researchers and RECs.

scholarly journals Is It Time to Re-Evaluate the Ethics Governance of Social Media Research?

2018 ◽  
Vol 13 (4) ◽  
pp. 452-454 ◽  
Author(s):  
G. Samuel ◽  
W. Ahmed ◽  
H. Kara ◽  
C. Jessop ◽  
S. Quinton ◽  
...  
Keyword(s):  
Social Media ◽  
Research Ethics ◽  
Ethical Issues ◽  
Real Life ◽  
Ethics Committees ◽  
Research Ethics Committees ◽  
Media Ethics ◽  
Research Institution ◽  
Media Research ◽  
Social Media Research

This article reports on a U.K. workshop on social media research ethics held in May 2018. There were 10 expert speakers and an audience of researchers, research ethics committee members, and research institution representatives. Participants reviewed the current state of social media ethics, discussing well-rehearsed questions such as what needs consent in social media research, and how the public/private divide differs between virtual and real-life environments. The lack of answers to such questions was noted, along with the difficulties posed for ethical governance structures in general and the work of research ethics committees in particular. Discussions of these issues enabled the creation of two recommendations. The first is for research ethics committees and journal editors to add the category of ‘data subject research’ to the existing categories of ‘text research’ and ‘human subject research’. This would reflect the fact that social media research does not fall into either of the existing categories and so needs a category of its own. The second is that ethical issues should be considered at all stages of social media research, up to and including aftercare. This acknowledges that social media research throws up a large number of ethical issues throughout the process which, under current arrangements for ethical research governance, risks remaining unaddressed.

Human Subject Protection and Special Population Issues

2010 ◽  
pp. 247-266
Author(s):  
Christine Moretto Wishnoff ◽  
Pamela Hayes-Shell ◽  
David Shore ◽  
Cheryl Anne Boyce
Keyword(s):  
Human Subject ◽  
Special Population ◽  
Human Subject Protection

scholarly journals Comparative Study of Cultural Value Orientation between China and America

2021 ◽  
Vol 11 (1) ◽  
pp. 97
Author(s):  
Jie Yan ◽  
Yuying Li
Keyword(s):  
Cultural Values ◽  
Economic Integration ◽  
The United States ◽  
Value Orientation ◽  
Cultural Barriers ◽  
Cultural Value ◽  
Practical Significance ◽  
Cultural Communication ◽  
The West ◽  
Cultural Exchanges

In today's world, cultural exchanges have become more and more frequent because of the economic integration and technological globalization, but people from different countries may have different culture values. China and the United States, as representatives of the East and the West, also have great differences in value orientation. Therefore, understanding the differences between each culture has both theoretical and practical significance for their inter-cultural communication. This paper analyzes the differences between Chinese and American cultural values from five aspects: nature, humanity, time, relationship, and human actions. It will have an important guiding role in eliminating cultural barriers and promoting the development of Chinese and American culture in inter-cultural communication.

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