scholarly journals The ethical issues of research involving human beings contained in the editorial guidelines of Brazilian medical journals

2010 ◽  
Vol 35 (3) ◽  
Author(s):  
Guilherme Malafaia ◽  
Aline Sueli De Lima Rodrigues ◽  
André Talvani
Keyword(s):  
Ethical Issues ◽  
Human Subjects ◽  
Ethics Committee ◽  
Ethical Standards ◽  
Human Beings ◽  
Highly Qualified ◽  
Ethical Aspects ◽  
Medical Journals ◽  
Present Information ◽  
Need For Approval

The present study aimed to analyze the ethical aspects contained in the sections “Instructions to authors” of Brazilian medical journals which were highly qualified on the assessment of the Qualis program of Conselho Técnico Científico da Educação Superior (CTC-ES) (Medicine I area - reference year 2007). Moreover, we searched in the journals that present information about the ethical issues involved in research with humans, if these journals inform the authors about how they should confirm to the editors the compliance with ethical issues of their studies. The editorial guidelines of 34 journals (17.6%, B2 score; 35.3% B3 score; 47.1% B4 score) were analyzed. It was observed that only 7 (20.6%) journals do no mention some ethical questions related to research involving human subjects and that 25 (73.5%) journals indicate the need for approval of research by Ethics Committee of the institution where the study was conducted. However, less than half (44.1%) of the journals clearly indicate in their “Instructions to authors” that information about the ethical aspects of research involving human subjects should be cited in the text of the manuscript submitted. Thus, further improvement is still necessary regarding the approach of ethical issues in the editorial guidelines of the Brazilian medical journals analyzed. Researches like this seek to contribute with the discussion about the awareness of editors, so that they mention in the instructions of their journals the principles, rules and ethical standards that must be considered in the research involving human beings.

Ethics Review on Externally- Sponsored Research in Developing Countries

2009 ◽  
pp. 112-125 ◽  
Author(s):  
Alireza Bagheri
Keyword(s):  
Developing Countries ◽  
Local Community ◽  
Ethical Issues ◽  
Human Subjects ◽  
Ethics Committees ◽  
Developed Countries ◽  
Ethics Committee ◽  
Benefit Sharing ◽  
Sponsored Research ◽  
Poor Countries

This chapter elaborates on some of the existing concerns and ethical issues that may arise when biomedical research protocols are proposed or funded by research institutes (private or public) in developed countries but human subjects are recruited from resource-poor countries. Over the last two decades, clinical research conducted by sponsors and researchers from developed countries to be carried out in developing countries has increased dramatically. The article examines the situations in which vulnerable populations in developing countries are likely to be exploited and/or there is no guarantee of any benefit from the research product, if proven successful, to the local community. By examining the structure and functions of ethics committees in developing countries, the article focuses on the issues which a local ethics committee should take into account when reviewing externally-sponsored research. In conclusion, by emphasizing capacity building for local research ethics committees, the article suggests that assigning the national ethics committee (if one exists) or an ethics committee specifically charged with the task of reviewing externally-sponsored proposals would bring better results in protecting human subjects as well as ensuring benefit-sharing with the local community.

scholarly journals Current ethical issues of clinical trials of drugs for the pathogenetic therapy of multiple sclerosis in the context of the COVID-19 pandemic

2021 ◽  
Vol 13 (1S) ◽  
pp. 69-72
Author(s):  
E. V. Ivashkova ◽  
A. M. Petrov ◽  
M. V. Votintseva ◽  
I. D. Stolyarov
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trials ◽  
Immunosuppressive Therapy ◽  
Ethical Issues ◽  
Ethical Standards ◽  
Ethical Aspects ◽  
Medical Institutions ◽  
Immune Mediated ◽  
Pathogenetic Therapy ◽  
Coronavirus Infection

The spread of the COVID-19 pandemic posed a serious challenge for scientific and clinical medical institutions in terms of research for new multiple sclerosis (MS) treatments. In this review we discuss the associations between coronavirus infection and MS and provide data on the features of MS pathogenetic therapy during a pandemic. We also analyze the ethical aspects of clinical trials, the problems faced by researchers and patients, especially when using immunosuppressive therapy for MS. We provide examples of violations during research caused by the influence of a pandemic, as well as ways of solving them. Improving ethical standards is an essential component of ensuring the safety of MS and other immune-mediated diseases treatment.

Social and Ethical Aspects of Biomedical Research

2009 ◽  
pp. 126-144
Author(s):  
Gerrhard Fortwengel
Keyword(s):  
Biomedical Research ◽  
Ethical Issues ◽  
Human Subjects ◽  
Biomedical Science ◽  
Basic Requirement ◽  
Ethical Aspects ◽  
Core Section ◽  
Social And Ethical Issues ◽  
Definition Of ◽  
The Individual

At the beginning of this section the authors provide a definition of biomedical research and an interpretation of the meaning of ethics and social values of research. They continue with the introduction of the risk-benefit approach as basic requirement for any biomedical research involving human subjects and illustrate the need for uniformity with respect to social and ethical issues. The differences and similarities between social and ethical research are described in the core section; social and ethical aspects are presented according to central and peripheral dimensions. In reference to specific areas of research in biomedical science it is exemplary shown that more general principles are not sufficient to cover all types of research, and that depending on research characteristics, the techniques used and the purpose of the research, other specific aspects might need to be considered as well. The chapter ends with a short conclusion calling for continued reflection and review of social and ethical issues speeding an age of fast changes in science and technologies to thereby ensure proper protection of the individual and the best future for society.

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.

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.

Ethics in Research

2013 ◽  
Author(s):  
Jeane W. Anastas
Keyword(s):  
Social Work ◽  
Ethical Issues ◽  
Human Subjects ◽  
Ethical Review ◽  
Responsible Conduct Of Research ◽  
Human Beings ◽  
Participatory Action ◽  
Community Based Research ◽  
Marginalized Groups ◽  
Federal Guidelines

Social work researchers hold themselves to ethical standards for social science and biomedical research involving human beings, which are compatible with social work ethics. This article describes (a) the general ethical principles guiding research involving human subjects; (b) mechanisms for the ethical review of studies involving human beings; (c) ethical issues in research on vulnerable populations, such as children and adolescents, prisoners, indigenous people, recipients of care, and other socially marginalized groups; and (d) plagiarism, authorship, and conflict of interest. Current topics in the responsible conduct of research include changes in the federal guidelines for research involving human subjects, research using the Internet including Big Data research, participatory action and community-based research, and decolonizing research methodologies.

scholarly journals Human research review committee requirements in medical journals

2008 ◽  
Vol 31 (1) ◽  
pp. 49 ◽  
Author(s):  
Scott R. Freeman ◽  
Kristy Lundahl ◽  
Lisa M. Schilling ◽  
J. Daniel Jensen ◽  
Robert P. Dellavalle
Keyword(s):  
English Language ◽  
Human Subjects ◽  
Ethics Committee ◽  
Ethical Review ◽  
Research Review ◽  
Review Committee ◽  
Ethical Guidelines ◽  
Medical Journals ◽  
Human Research ◽  
Approval Letter

Purpose: Independent ethical review committees safeguard participants in human research. The purpose of this study was to describe the current ethical guidelines for human research requirements in the Instructions to Authors of the English language medical journals previously studied in 1995. Methods: The instructions to authors of English language medicine journals from the Abridged Index Medicus were searched for any policies regarding guidance on the ethical treatment of human subjects in research. Results: More medical journals require independent ethics committee approval of human research now [84/101 (83%)] than 10 years ago [48/102 (47%) (P < 0.001)], and most journals continue to require that this disclosure appear in the manuscript [71/84 (85%) vs. then 37/48 (77%) (P=0.29)]. Fewer medical journal instructions to authors provide no ethical guidelines for human research now [8/101 (8%)] than 10 years ago [25/102 (24%) (P < 0.001)]. No journal required submission of the study approval letter or of the approved protocol. Conclusions: Although medicine journals increasingly require disclosure statements of independent ethics committee approval for human research, they fail to verify such approval beyond taking authors for their word.

Environmental Health Research and Ethics

2019 ◽  
pp. 753-764
Author(s):  
David B. Resnik
Keyword(s):  
Environmental Health ◽  
Health Research ◽  
Ethical Issues ◽  
Human Subjects ◽  
Environmental Interventions ◽  
Environmental Health Research ◽  
Research Designs ◽  
Research Regulations ◽  
Kennedy Krieger Institute ◽  
Privacy And Confidentiality

This chapter discusses some of the key ethical issues that arise in environmental health research involving human subjects, including returning individualized research results, protecting privacy and confidentiality, research on environmental interventions, intentional exposure studies, research regulations, autonomy, beneficence, informed consent, payments to subjects, and protecting vulnerable human subjects. The chapter will discuss issues that are common to all research designs, as well as those unique to certain types of designs, such as intentional exposure studies. It will also address ethical issues that arose in two important cases, the Kennedy Krieger Institute lead abatement study, and the Children’s Environmental Exposure Research Study.

The ethics of pandemic preparedness revisited - autonomy, quarantine, transferability and trust

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
P Schröder-Bäck ◽  
T Schloemer ◽  
K Martakis ◽  
C Brall
Keyword(s):  
Crisis Management ◽  
Ethical Issues ◽  
Lessons Learned ◽  
Point Of View ◽  
Ethical Challenges ◽  
Pandemic Preparedness ◽  
Ethical Aspects ◽  
Outbreak Management ◽  
Ethics Framework ◽  
Ethical Point

Abstract Background The outbreak of SARS in 2002 lead to a public health ethics discourse. The crisis management of that time was ethically analysed and lessons to be learned discussed. Scholarship and WHO, among others, developed an ethics of pandemic preparedness. The current “corona crisis” also faces us with ethical challenges. This presentation is comparing the two crises from an ethical point of view and a focus on Europe. Methods An ethics framework for pandemic preparedness (Schröder et al. 2006 and Schröder-Bäck 2014) is used to make a synopsis of ethical issues. Ethical aspects of 2002 and 2020 that were discussed in the literature and in the media are compared. For 2020, the focus is on interventions in Italy, Germany, Switzerland, and the Netherlands. Results Topics that emerged from the 2002 crisis were, among others, revolving around aspects of stigmatisation and fair distribution of scarce resources (esp. vaccines, antivirals). Currently, most urgent and ethically challenging aspects relate to social distancing vs. autonomy: Isolation and quarantine are handled differently across Europe and the EU. Questions of transferability of such interventions prevail. Contexts vary vertically over time (2002 vs. 2020) and horizontally (e.g. between Italy and Germany at the same time). Furthermore, trust in authorities, media and health information is a key issue. Conclusions Ethical aspects are key for good pandemic preparedness and management. The context of the crises between 2002 and 2020 has slightly changed, also based on “lessons learned” from 2002. This has implications on ethical issues that are being discussed. New lessons will have to be learned from the 2020 crisis. Key messages Pandemic preparedness and outbreak management entail many ethical tensions that need to be addressed. Currently, questions of trust and transferability are key to the crisis management, further ethical issues could still emerge.

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