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.

Ethics

2011 ◽  
Author(s):  
Alan Weir ◽  
Kate Macdougall
Keyword(s):  
Medical Ethics ◽  
Medical Research ◽  
Research Ethics ◽  
Human Subjects ◽  
Modern World ◽  
Past Century ◽  
Scientific Validity ◽  
Research Participants ◽  
Human Material ◽  
Medical Research Ethics

Ethics, as a whole, aim to create a framework upon which complex issues can be thought about and discussed in a reasoned manner. Medical ethics take these reasoned frameworks and apply them to problems that arise within healthcare, often focusing on the doctor–patient relationship. Medical research ethics are very closely related to medical ethics, but look at issues from the researcher–participant perspective. Medical research ethics have come to the fore in the past century with the regulation of medical research, which has focused on safeguarding research participants. The central concern has been to ensure that the interests of society and the researcher do not override the interests of the participant. Prior to the Second World War there was no internationally accepted code of conduct for research involving human subjects. The appalling experimentation carried out by some Nazi doctors led, in 1947, to the publication of the Nuremberg Code. This document outlined ten points that defined legitimate medical research, including voluntary consent and scientific validity. The following year these principles were tied to the Declaration of Geneva. This declaration was a statement of the physician’s ethical duty as a clinician, and has been amended several times since, the latest being in 2006. This declaration was intended as a revision of the Hippocratic oath into a formulation of morals that could be comprehended in the modern world. Following these first steps to create an ethical code for medical researchers came the document that is held to be the authority and basis of medical research ethics. In 1964 the 18th World Medical Association (WMA) General Assembly, held in Helsinki, developed and accepted the Declaration of Helsinki. The document is a statement of ethical principles governing medical research involving human subjects, including research on identifiable human material and data. It deals with the rights and protections of research participants, clearly making the distinction between participants and patients. This is not a legally binding document in international law but draws its authority from the degree to which it has been codified in, or has influenced, national or regional legislation and regulations.

scholarly journals Ethical Regulations of Medical Research Involving Human Subjects: Exploring the Perspective of Trial Participants

2019 ◽  
Vol 9 (1) ◽  
pp. 34-49
Author(s):  
Anna Kravets
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Medical Research ◽  
Broad Spectrum ◽  
Human Subjects ◽  
Well Being ◽  
Research Protocols ◽  
Ethnographic Data ◽  
Protection Of Human Subjects ◽  
Trial Participants

In this paper I address the question of whether the existing ethical regulations of clinical research ensure protection and well-being of human subjects. Drawing on ethnographic data gathered in Berlin, Germany, I show that German institutions which are meant to ensure the ethical validity of clinical research cannot address posed issues. It appears that these institutions (Berlin Ethik-Kommission in particular) only evaluate research protocols and do not consider the broad spectrum of processes and interactions involved in clinical research. The experience of professional human subjects, as well as the consideration of the every-day life in a clinic, shows that there is much more to clinical trials. The argument of this paper is that the inability of institutions to address protection of human subjects originates from the bureaucratic logic of their organization. Drawing on Bauman’s (1992) argument that the bureaucratic machine is characterized by separation between morality and purpose, with the example of Berlin Ethik-Kommission, I argue that the bureaucratic machine cannot be sensitive to morality and ethics, even if these are its main purposes.

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 Developing a policy to reduce the salt content of food consumed outside the home in Malaysia: protocol of a qualitative study

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e044628
Author(s):  
Mhairi Karen Brown ◽  
Suzana Shahar ◽  
Yee Xing You ◽  
Viola Michael ◽  
Hazreen Abdul Majid ◽  
...  
Keyword(s):  
Medical Research ◽  
Research Ethics ◽  
Salt Intake ◽  
Salt Content ◽  
Ethics Committee ◽  
Salt Reduction ◽  
Reduction Strategy ◽  
Research Ethics Committee ◽  
School Canteen ◽  
Medical Research Ethics

IntroductionCurrent salt intake in Malaysia is high. The existing national salt reduction policy has faced slow progress and does not yet include measures to address the out of home sector. Dishes consumed in the out of home sector are a known leading contributor to daily salt intake. This study aims to develop a salt reduction strategy, tailored to the out of home sector in Malaysia.Methods and analysisThis study is a qualitative analysis of stakeholder views towards salt reduction. Participants will be recruited from five zones of Malaysia (Western, Northern, Eastern and Southern regions and East Malaysia), including policy-makers, non-governmental organisations, food industries, school canteen operators, street food vendors and consumers, to participate in focus group discussions or in-depth interviews. Interviews will be transcribed and analysed using thematic analysis. Barriers will be identified and used to develop a tailored salt reduction strategy.Ethics and disseminationEthical approval has been obtained from the Universiti Kebangsaan Malaysia Medical Research Ethics Committee (UKM PPI/1118/JEP-2020–524), the Malaysian National Medical Research Ethics Committee (NMRR-20-1387-55481 (IIR)) and Queen Mary University of London Research Ethics Committee (QMERC2020/37) . Results will be presented orally and in report form and made available to the relevant ministries for example, Ministry of Health, Ministry of Education and Ministry of Trade to encourage adoption of strategy as policy. The findings of this study will be disseminated through conference presentations, peer-reviewed publications and webinars.

scholarly journals The principles of medical ethics and medical research

1999 ◽  
Vol 15 (suppl 1) ◽  
pp. S7-S13 ◽  
Author(s):  
John Harris
Keyword(s):  
Public Health ◽  
Medical Ethics ◽  
Medical Research ◽  
Late Onset ◽  
Human Subjects ◽  
Predictive Testing ◽  
Public Health Issue ◽  
Public Health Medicine ◽  
International Ethics ◽  
Ongoing Research

In this paper I discuss the application of the principles of medical ethics and of medical research to the case of children and others whose consent to treatment and to research is problematic. Public health depends substantially on the possibility of ongoing research into all conditions which affect the health of the people. Constraints on this research are therefore a public health issue. Moreover and more importantly the possibility of predictive testing and indeed of screening for health-relevant conditions is an important public health tool, and limitations on the use of this tool are of great significance to public health medicine. Having considered the particular problems created by research and predictive testing on children for late-onset conditions I go on to discuss research on those whose consent is problematic more generally. I conclude with radical recommendations for the reform of The Declaration of Helsinki and of the International Ethics Guidelines for Biomedical Research Involving Human Subjects, prepared by the Council for International Organizations of Medical Sciences (CIOMS).

scholarly journals The Hennepin Ketamine Study Investigators’ Reply

2019 ◽  
Vol 34 (02) ◽  
pp. 111-113
Author(s):  
Jeffrey D. Ho ◽  
Jon B. Cole ◽  
Lauren R. Klein ◽  
Travis D. Olives ◽  
Brian E. Driver ◽  
...  
Keyword(s):  
Emergency Medicine ◽  
Social Media ◽  
Informed Consent ◽  
Clinical Research ◽  
Emergency Medical Services ◽  
Research Ethics ◽  
Public Controversy ◽  
Future Studies ◽  
Strongly Agree ◽  
Recent Editorial

We read with interest the recent editorial, “The Hennepin Ketamine Study,” by Dr. Samuel Stratton commenting on the research ethics, methodology, and the current public controversy surrounding this study.1 As researchers and investigators of this study, we strongly agree that prospective clinical research in the prehospital environment is necessary to advance the science of Emergency Medical Services (EMS) and emergency medicine. We also agree that accomplishing this is challenging as the prehospital environment often encounters patient populations who cannot provide meaningful informed consent due to their emergent conditions. To ensure that fellow emergency medicine researchers understand the facts of our work so they may plan future studies, and to address some of the questions and concerns in Dr. Stratton’s editorial, the lay press, and in social media,2 we would like to call attention to some inaccuracies in Dr. Stratton’s editorial, and to the lay media stories on which it appears to be based.Ho JD, Cole JB, Klein LR, Olives TD, Driver BE, Moore JC, Nystrom PC, Arens AM, Simpson NS, Hick JL, Chavez RA, Lynch WL, Miner JR. The Hennepin Ketamine Study investigators’ reply. Prehosp Disaster Med. 2019;34(2):111–113

Reply to ‘Hormone replacement therapy: informed consent without assessment?’

2019 ◽  
Vol 45 (12) ◽  
pp. 826-827 ◽  
Author(s):  
Florence Ashley
Keyword(s):  
Hormone Replacement Therapy ◽  
Informed Consent ◽  
Medical Ethics ◽  
Replacement Therapy ◽  
Hormone Replacement ◽  
Well Being ◽  
Protective Role ◽  
Depression And Anxiety ◽  
Mental Well Being ◽  
Assessment Requirements

In a previous article, I argued that assessment requirements for transgender hormone replacement therapy (HRT) are unethical and dehumanising. A recent response published by the Journal of Medical Ethics criticises this proposal. In this reply, I advance that their response misunderstood core parts of my argument and fails to provide independent support for assessment requirements. Though transition-related care may have similarities with cosmetic surgeries, this does not suffice to establish a need for assessments, and nor do the high rates of depression and anxiety justify assessments, especially given the protective role HRT plays towards mental well-being.

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.

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