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.

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 Post-trial access and the new version of the Declaration of Helsinki

2013 ◽  
pp. 206-207 ◽  
Author(s):  
Ricardo Palacios
Keyword(s):  
Clinical Research ◽  
Therapeutic Response ◽  
Human Subjects ◽  
The United States ◽  
Continuous Treatment ◽  
Trial Participant ◽  
Declaration Of Helsinki ◽  
Critical Issues ◽  
Protection Of Human Subjects ◽  
Post Trial

In October 2013, the World Medical Association (WMA) approved the latest version of the Declaration of Helsinki (DoH) in Fortaleza, Brazil. Post-trial access of favorable interventions was again one of the critical issues raised during the meeting. The call to clinical research actors, other than physicians, in this discussion is not new, but this is the first time, after 49 years and nine amendments, when governments are requested to take responsibilities. The primary purpose of the DoH is the protection of human subjects involved in clinical research, but since the 2000 amendment, the WMA extended their concerns to what happens to the trial participants after the study. This issue, along with the use of placebo, was one of the key points that led to the withdrawal of the DoH as reference in the United States regulation. However, only the 2013 version acknowledges that the burden of providing post-trial access for those patients on continuous treatment is far beyond the investigator’s scope. The delay between the end of a blind study and the unblinding could take several months. Meantime, the investigator is unaware if the participant received either control or experimental product. In case of therapeutic response, the investigator should provide to the participant the same treatment until the unblinding, even if it is the control product, i.e. placebo? A trial participant can get therapeutic response with an experimental product that during the unblinded analysis has failed. The risk benefit analysis on individual basis might be challenging if one considers that the clinical development can stop due to safety concerns, lack of efficacy or release of alternatives more advantageous than the investigational product. Before retaining a product still under development after a study, the physician should consider safety and efficacy information as well as therapeutic alternatives to take decisions on an individual participant, even if the patient has a favorable response with acceptable tolerance. Furthermore, product manufacturing can be discontinued, raising the need to switch the experimental product to a sustainable alternative.

The 2008 Declaration of Helsinki — First among Equals in Research Ethics?

2010 ◽  
Vol 38 (1) ◽  
pp. 143-148 ◽  
Author(s):  
Annette Rid ◽  
Harald Schmidt
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Standard Of Care ◽  
The United States ◽  
Basic Principles ◽  
Declaration Of Helsinki ◽  
The World ◽  
Ethical Guidance ◽  
Post Trial ◽  
The U.S

The World Medical Association's (WMA) Declaration of Helsinki is one of the most important and influential international research ethics documents. Launched in 1964, when ethical guidance for research was scarce, the Declaration comprised eleven basic principles and provisions on clinical research. The document has since evolved to a complex set of principles, norms, and directions for action of varying degrees of specificity, ranging from specific rules to broad aspirational statements. It has been revised six times in an effort to maintain its influence. While all revisions were the result of vigorous debate, the 2000 revision and two subsequent notes of clarification spurred particular controversy surrounding the use of placebo in clinical research and the standard of care and post-trial obligations in research in developing countries. Several institutions opted to cite earlier versions of the Declaration, and the U.S. Food and Drug Administration (FDA) recently removed all reference to the Declaration in its approval requirements for drugs and biological products that are studied outside the United States.

Bioentrepreneurship in Medical Biotechnology

2021 ◽  
pp. 201-228
Author(s):  
Neeti Sharma
Keyword(s):  
Medical Research ◽  
Business Models ◽  
Medical Science ◽  
Living Cells ◽  
Multiple Features ◽  
Research Product ◽  
Disruptive Technologies ◽  
Sustainable Environment ◽  
Treatment And Prevention ◽  
The World

Being a developing sector, biotechnology combines both medical science and various facets of a sustainable environment. Scientific innovations from academics and industry contribute towards the rise of bioentrepreneurship across the world. Medical biotechnology helps the treatment and prevention of human diseases by using living cells and cell materials to research and produce pharmaceutical and diagnostic products. It requires incubation of research, product, and its yield for the improvement of humans to transform medical research into an entrepreneurial industry. Biotechnology provides an opportunity for entrepreneurs to harness the power of genomics for the development and marketing of new therapeutics. These opportunities allow entrepreneurs to visualize the creation of both disruptive business and disruptive technologies for today's business models. This chapter will summarize multiple features of entrepreneurship in the biotechnology industry in combination with other industries and will explain the significance of bio-entrepreneurship in the field of medical biotechnology.

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 Ethics in clinical research

2012 ◽  
Vol 3 (3) ◽  
pp. 16-20 ◽  
Author(s):  
Md Fakruddin ◽  
Abhijit Chowdhury ◽  
Md Nur Hossain ◽  
Khanjada Shahnewaj Bin Mannan
Keyword(s):  
Clinical Research ◽  
Human Subjects ◽  
Second World War ◽  
Ethical Review ◽  
Ethical Guidelines ◽  
Nuremberg Code ◽  
The World ◽  
Long Time ◽  
History Of ◽  
Second World

History of unethical clinical research practice date back to a very long time, though the most remarkable unethical clinical research was those by the Nazis during second world war, which eventually shaken the scientific community and gives birth to the first guideline of ethics in clinical research, the Nuremberg Code. Following Nuremberg code, a number of ethical guidelines has been formulated most important of which are the declaration of Helsinski. To make any research involving human subjects or samples ethically acceptable, a number of key features have to be considered by the scientists. These guidelines are internationally accepted and without following these guidelines, no clinical research is acceptable in the world. Though, there are many countries in the world like Bangladesh, which don’t have any ethical guidelines of their own and thus scientists in those countries do not adhere the any ethical guideline while conducting their research. Each country should have their own ethical guidelines and each clinical research institutes should have own ethical review committee to ensure ethical clinical research. DOI: http://dx.doi.org/10.3329/bioethics.v3i3.12560 Bangladesh Journal of Bioethics 2012; 3(3):16-20

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