scholarly journals Normative framework of informed consent in clinical research in Germany, Poland, and Russia

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marcin Orzechowski ◽  
Katarzyna Woniak ◽  
Cristian Timmermann ◽  
Florian Steger
Keyword(s):  
Informed Consent ◽  
Clinical Research ◽  
Biomedical Research ◽  
Human Subjects ◽  
Ethical Conduct ◽  
Vulnerable Groups ◽  
Research Subjects ◽  
Normative Framework ◽  
Declaration Of Helsinki ◽  
Normative Requirements

Abstract Background Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed consent in biomedical research in Germany, Poland, and Russia to determine how each national regulatory framework relates to the provisions of the Declaration of Helsinki. Methods For this analysis, we conducted a search of the legal databases “Gesetze im Internet” for Germany, “Internetowy System Aktow Prawnych” for Poland, and “ГAPAHT – Garant” for Russia. The search was complemented by a review of secondary literature contained in the databases Google Scholar, PubMed, Polish National Library, and eLibrary.ru. We have identified 21 normative regulations containing provisions on informed consent in clinical research in all three countries. The content of these documents was systematically categorized and analyzed. Results The normative framework in all three countries shows a strong commitment towards the core ethical principles of research envisaged in the Declaration of Helsinki. Nevertheless, provisions on informed consent vary between these three countries. The differences range from the method and language in which information should be provided, through the amount of information required to be disclosed, to the form of documenting consent or withdrawal. In the case of research on vulnerable groups, these differences are particularly visible. Conclusions The identified differences can negatively impact the ethical conduct of international clinical studies. Attention needs to be paid that flexibilities within national regulations are not misused to undermine the protection of research subjects. Achieving global or regional legislative harmonization might prove impossible. Such lack of legal consensus reinforces the significance of the international ethical agreements. Trial registration: Not applicable.

scholarly journals The Declaration of Helsinki on Medical Research involving Human Subjects: A Review of Seventh Revision

2020 ◽  
Vol 17 (4) ◽  
pp. 548-552 ◽  
Author(s):  
Badri Shrestha ◽  
Louese Dunn
Keyword(s):  
Clinical Research ◽  
Medical Research ◽  
Human Subjects ◽  
Medical Science ◽  
Vulnerable Groups ◽  
Experimental Medicine ◽  
Medicine Research ◽  
Declaration Of Helsinki ◽  
The World ◽  
Post Trial

The pinnacle of success achieved by the medical science and the benefits accrued to the patients have become possible through the medical research where human participants in the research are exposed to hazards inherent to the experiments. To protect the human subjects and to maintain high ethical standards, the World Medical Association has adopted “The Declaration of Helsinki” in 1964. After two years of consultation with the experts throughout the world, the seventh revision of the Declaration was adopted on 19th October 2013 in Brazil. The aim of this article is to review the seventh revision of the Declaration of Helsinki in relation to medical research involving human subjects and highlight the amendments made in the latest revision which are relevant to clinical research in human subjects. The latest revision has made four substantial changes on the existing Declaration, whch include dealing with the compensation of the trial-related injuries, approval of use of placebos in the clinical trials, protection of vulnerable groups and the post-trial provisions. The implications of these amendments in the clinical research are highlighted.Keywords: Consent; Declaration of Helsinki; ethics; experimental medicine; research; seventh revision.

Medical Research Ethics: What We Need to Comply When Obtaining Informed Consent from Human Subjects?

2009 ◽  
Vol 16 (4) ◽  
pp. 271-276
Author(s):  
CSK Tay
Keyword(s):  
Patient Safety ◽  
Informed Consent ◽  
Medical Ethics ◽  
Clinical Research ◽  
Medical Research ◽  
Research Ethics ◽  
Human Subjects ◽  
Well Being ◽  
Research Subjects ◽  
Medical Research Ethics

Patient safety and well-being are very important to safeguard in medical research. A subject's life cannot be sacrificed for the benefits of future mankind, as medical ethics of autonomy dictate the respect of an individual. By reference to the Declaration of Helsinki, this article discusses the ethical principles and processes in obtaining a valid and proper informed consent from the research subjects who should freely consent and voluntarily participate in the clinical research, including the ‘contents’ of the informed consent and the ‘skills’ of obtaining informed consent.

Nanomedicine First-in-Human Research: Challenges for Informed Consent

2012 ◽  
Vol 40 (4) ◽  
pp. 823-830 ◽  
Author(s):  
Nancy M. P. King
Keyword(s):  
Clinical Trial ◽  
Informed Consent ◽  
Clinical Research ◽  
Human Subjects ◽  
Consent Form ◽  
Human Research ◽  
Research Challenges ◽  
Starting Point ◽  
Human Subjects Protections

First-in-human (FIH) research has several characteristics that require special attention with respect to ethics and human subjects protections. At least some nanomedical technologies may also have characteristics that merit special attention in clinical research, as other papers in this symposium show. This paper considers how to address these characteristics in the consent form and process for FIH nanomedicine research, focusing principally on experimental nanotherapeutic interventions but also considering nanodiagnostic interventions.It is essential, as a starting point, to recognize that the consent form and process are by no means the primary protectors of human subjects (although they are sometimes so regarded). Instead, consideration of the form and content of informed consent becomes relevant only after a clinical trial has been reviewed and deemed scientifically and ethically acceptable.Two convergent types of challenges to informed consent are posed by nanomedicine FIH research. First, some issues appear generally applicable to FIH research, but have specific nanomedicine implications.

scholarly journals Tuskegee Syphilis Study of 1932–1973 and the Rise of Bioethics as Shown Through Government Documents and Actions

2019 ◽  
Vol 47 (4) ◽  
pp. 11
Author(s):  
Laura A. Barrett
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Information Science ◽  
Human Subjects ◽  
Medical Studies ◽  
Research Subjects ◽  
Tuskegee Syphilis Study ◽  
Institutional Review ◽  
Government Documents ◽  
Science Community

One government source regarding clinical trials is Clinicaltrials.gov (https://clinicaltrials.gov), which is available to health information seekers as a resource to find information about past, current, and recruiting clinical trials. Currently, if you participate in a clinical trial you are required to provide your “informed consent.” This means you have been informed of the risks, benefits, purpose of the study, and your rights. This information is provided to you so that you, as the potential participant, can make an informed decision before deciding whether or not to participate. If you work with or in research, you will become very familiar with the term IRB, which stands for “Institutional Review Board.” An IRB is a panel intended to oversee the entire scope of one or more medical research studies including protecting the rights and welfare of human research subjects. Although it may seem like common sense that these two things are necessary, there was a time when they did not exist. A new approach to bioethics and the regulation of clinical trials and medical studies using living human subjects came about from public and governmental outrage over one study, known as the Tuskegee Syphilis Study. By looking specifically at this case, which led to the rise of bioethics at the federal-government level in the 1970s, the origin of IRBs and informed consent as they relate to medical studies and human subjects will be illuminated. The issues of IRBs, informed consent, and bioethics are important in the library and information science community because we often interact with a public that is impacted by the policies and regulations related to these issues. In addition, we are the very researchers, or hold relationships with researchers, that are held to the strict standards set in place by IRBs and bioethics in general.

scholarly journals Revised CIOMS International Ethical Guidelines for Biomedical Research

10.5912/jcb66 ◽  
1969 ◽  
Vol 10 (2) ◽  
Author(s):  
Jane Gregory
Keyword(s):  
Medical Association ◽  
Biomedical Research ◽  
Human Subjects ◽  
Ethical Principles ◽  
World Medical Association ◽  
Ethical Guidelines ◽  
National Policies ◽  
Low Resource ◽  
Declaration Of Helsinki ◽  
The World

The revised CIOMS 2002 International Ethical Guidelines for Biomedical Research Involving Human Subjects supersede the previous 1993 Guidelines and consist of a statement of general ethical principles, a preamble and 21 guidelines with extensive commentaries. The Guidelines provide advice on the implementation in practice of the World Medical Association (WMA) Declaration of Helsinki and are designed to be of use, particularly to low-resource countries, in defining national policies and regulations on the ethics of biomedical research. The Guidelines are available on the CIOMS website.

scholarly journals Responsible research for the construction of maximally humanlike automata: the paradox of unattainable informed consent

2017 ◽  
Vol 22 (4) ◽  
pp. 297-305 ◽  
Author(s):  
Lantz Fleming Miller
Keyword(s):  
Informed Consent ◽  
Research And Development ◽  
Human Subjects ◽  
Moral Rights ◽  
Human Beings ◽  
Research Subjects ◽  
Nuremberg Code ◽  
Human Research ◽  
Ethical Codes ◽  
Responsible Research

Abstract Since the Nuremberg Code and the first Declaration of Helsinki, globally there has been increasing adoption and adherence to procedures for ensuring that human subjects in research are as well informed as possible of the study’s reasons and risks and voluntarily consent to serving as subject. To do otherwise is essentially viewed as violation of the human research subject’s legal and moral rights. However, with the recent philosophical concerns about responsible robotics, the limits and ambiguities of research-subjects ethical codes become apparent on the matter of constructing automata that maximally resemble human beings (as defined hereunder). In this case, the automata themselves, as products of research and development, are in the very process of their construction subjects of research and development. However, such research faces a paradox: The subjects cannot give their informed consent to this research for their own development, although their consent would be needed for the research. According to ethical codes, this research would be unethical. The article then explores whether the background concepts giving rise to this paradox could be reframed in order to allow such research to proceed ethically.

scholarly journals THE NUREMBERG TRIALS AND THEIR LEGACY FOR THE RIGHTS OF PATIENTS AND RESEARCH SUBJECTS

2015 ◽  
Vol 27 ◽  
pp. 258-278
Author(s):  
Paul Weindling
Keyword(s):  
Twentieth Century ◽  
Clinical Research ◽  
Human Subjects ◽  
Crimes Against Humanity ◽  
Research Subject ◽  
Research Subjects ◽  
Military Tribunal ◽  
Nuremberg Trials ◽  
The Voice ◽  
Nazi Doctors

When does clinical research designed to save lives and advance medicine become assault and murder? In the twentieth century the line between legitimate research on human subjects and criminal assault has been variously drawn. The demands of the researcher and the voice of the research subject and patient have received varying recognition. With the upswing of clinical research in the early twentieth century and some dramatic breakthroughs in medicine there was a tendency to heroise the researcher in the ‘fight’ against disease. In Nazi Germany, there were strong pressures to conduct research on lives deemed worthless in the hope of producing valuable breakthroughs in medical research to benefit the nation and race. After all, if the mentally ill and racially inferior Jews and Gypsies were going to be killed, their bodies might still serve a useful purpose. After WW2 the Nuremberg Trials were conducted on the basis of ‘crimes against humanity’, and by documenting wartime atrocities did much to safeguard human rights and dignity. After the four-power International Military Tribunal at Nuremberg came the trial against 20 Nazi doctors and three SS administrators: this concluded with a declaration on the conduct of research based on the autonomy and consent of the research subject.

Litigation in Clinical Research: Malpractice Doctrines versus Research Realities

2004 ◽  
Vol 32 (3) ◽  
pp. 474-484 ◽  
Author(s):  
E. Haavi Morreim
Keyword(s):  
Clinical Research ◽  
Human Subjects ◽  
New Drugs ◽  
National Commission ◽  
Institutional Review Boards ◽  
Research Subjects ◽  
Public Attention ◽  
Institutional Review ◽  
Protection Of Human Subjects ◽  
Clinical Research Trials

Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health (NIH) doubled its spending over the past five years, while in the private sector the top twenty pharmaceutical companies have more than doubled their investment in research and development over a roughly comparable period. To date, some twenty million Americans have participated in clinical research trials that now are as common in the private practice setting as in academia.For many years human clinical trials received relatively little public attention. In the wake of several well-publicized research abuses, Congress created in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to formulate recommendations to protect human research subjects. The Commission’s 1979 Belmont Report helped to guide the Institutional Review Boards (IRBs) that review the ethics of federally funded research.

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