scholarly journals Ethical review, remit and responsibility in biomedical research in South Asia

2010 ◽  
Author(s):  
Bob Simpson ◽  
Vajira H W Dissanayake ◽  
Rachel Douglas-Jones ◽  
Salla Sariola
Keyword(s):  
South Asia ◽  
Biomedical Research ◽  
Ethical Review

The Ethics of AI in Biomedical Research, Patient Care, and Public Health

2020 ◽  
pp. 702-718 ◽  
Author(s):  
Alessandro Blasimme ◽  
Effy Vayena
Keyword(s):  
Public Health ◽  
Patient Care ◽  
Biomedical Research ◽  
Disease Surveillance ◽  
Ethical Issues ◽  
Ethical Review ◽  
Ethical Challenges ◽  
Healthcare Provision ◽  
Social Scientists ◽  
Ethical Frameworks

This chapter explores ethical issues raised by the use of artificial intelligence (AI) in the domain of biomedical research, healthcare provision, and public health. The litany of ethical challenges that AI in medicine raises cannot be addressed sufficiently by current regulatory and ethical frameworks. The chapter then advances the systemic oversight approach as a governance blueprint, which is based on six principles offering guidance as to the desirable features of oversight structures and processes in the domain of data-intense biomedicine: adaptivity, flexibility, inclusiveness, reflexivity, responsiveness, and monitoring (AFIRRM). In the research domain, ethical review committees will have to incorporate reflexive assessment of the scientific and social merits of AI-driven research and, as a consequence, will have to open their ranks to new professional figures such as social scientists. In the domain of patient care, clinical validation is a crucial issue. Hospitals could equip themselves with “clinical AI oversight bodies” charged with the task of advising clinical administrators. Meanwhile, in the public health sphere, the new level of granularity enabled by AI in disease surveillance or health promotion will have to be negotiated at the level of targeted communities.

scholarly journals Scandals, Ethics, and Regulatory Change in Biomedical Research

2016 ◽  
Vol 42 (4) ◽  
pp. 577-599 ◽  
Author(s):  
Adam Hedgecoe
Keyword(s):  
Biomedical Research ◽  
Ethical Review ◽  
Regulatory Change ◽  
Gradual Change ◽  
Exogenous Shocks ◽  
Research Ethics Review ◽  
Theoretical Approaches ◽  
Uk National Health Service ◽  
The Uk

This paper explores how a particular form of regulation—prior ethical review of research—developed over time in a specific context, testing the claims of standard explanations for such change (which center on the role of exogenous shocks in the form of research scandals) against more recent theoretical approaches to institutional changes, which emphasize the role of gradual change. To makes its case, this paper draws on archival and interview material focusing on the research ethics review system in the UK National Health Service. Key insights center on the minimal role scandals play in shaping changes in this regulatory setting and how these depend upon the absence of a single coherent profession (and accompanying social contract) associated with biomedical research.

scholarly journals Ethical aspects of voluntary informed consent in vacсination against COVID-19

2021 ◽  
Author(s):  
KV Zorin ◽  
KG Gurevich
Keyword(s):  
Clinical Practice ◽  
Informed Consent ◽  
Biomedical Research ◽  
Large Scale ◽  
Ethical Review ◽  
Efficacy And Safety ◽  
Ethical Aspects ◽  
Coronavirus Infection ◽  
Voluntary Informed Consent ◽  
Main Strategy

Not only quarantine measures should be the main strategy for preventing COVID-19, but also large-scale vaccination of the population. Therefore, there are many ethical questions associated with obtaining voluntary informed consent in biomedical research and clinical practice. An ethical review of vaccination against a new coronavirus infection can be carried out fully and adequately provided that the ethical aspects of voluntary informed consent are observed. Without this, it is impossible to control the quality, efficacy and safety of the vaccine, and, consequently, the vaccination of patients and its results.

scholarly journals Ethics in economic and management sciences: a researcher’s resource

2010 ◽  
Vol 13 (2) ◽  
pp. 177-189
Author(s):  
Jaco Pienaar
Keyword(s):  
Systematic Review ◽  
Best Practices ◽  
Biomedical Research ◽  
International Research ◽  
Science Research ◽  
Ethical Review ◽  
Economic Science ◽  
Biomedical Model ◽  
The Social ◽  
Research Climate

In an international research climate of increasingly demanding ethical review, based on a biomedical model, reflection on best practices in social, behavioural and economic science research is necessary. It is widely believed that these sciences cannot be held to the same practical requirements as those for biomedical research, although the principles of ethical research are surely universal. This article considers the ethical requirements, principles and guidelines directing research in the social, behavioural and economic sciences, recognised in the national and international arena. By means of a systematic review of available best practices, it is anticipated that general guidelines for social, behavioural and economic science research could be developed and offered to researchers in these fields. Specific consideration is given to the unique characteristics of social, behavioural and economic science research.

scholarly journals Why Protect Decapod Crustaceans Used as Models in Biomedical Research and in Ecotoxicology? Ethical and Legislative Considerations

Animals ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. 73
Author(s):  
Annamaria Passantino ◽  
Robert William Elwood ◽  
Paolo Coluccio
Keyword(s):  
Biomedical Research ◽  
Experimental Models ◽  
Ethical Concern ◽  
Ethical Review ◽  
Decapod Crustaceans ◽  
Protective Measures ◽  
Precautionary Approach ◽  
Pain And Suffering ◽  
Continued Use ◽  
Experience Pain

Decapod crustaceans are widely used as experimental models, due to their biology, their sensitivity to pollutants and/or their convenience of collection and use. Decapods have been viewed as being non-sentient, and are not covered by current legislation from the European Parliament. However, recent studies suggest it is likely that they experience pain and may have the capacity to suffer. Accordingly, there is ethical concern regarding their continued use in research in the absence of protective measures. We argue that their welfare should be taken into account and included in ethical review processes that include the assessment of welfare and the minimization or alleviation of potential pain. We review the current use of these animals in research and the recent experiments that suggest sentience in this group. We also review recent changes in the views of scientists, veterinary scientists and animal charity groups, and their conclusion that these animals are likely to be sentient, and that changes in legislation are needed to protect them. A precautionary approach should be adopted to safeguard these animals from possible pain and suffering. Finally, we recommend that decapods be included in the European legislation concerning the welfare of animals used in experimentation.

scholarly journals Exploring the risk/benefit balance in biomedical research: some considerations

2017 ◽  
Vol 25 (2) ◽  
pp. 320-327
Author(s):  
Derrick E. Aarons
Keyword(s):  
Research Ethics ◽  
Biomedical Research ◽  
Ethics Committees ◽  
Responsibility To Protect ◽  
Ethical Review ◽  
Research Ethics Committees ◽  
Risks And Benefits ◽  
Potential Benefits ◽  
Human Participants ◽  
Risk And Benefit

Abstract Risk and benefit assessment is one of the fundamental requirements in the ethical review of research involving human participants. As a result, researchers should evaluate and seek to minimize all foreseeable risks involved in their proposed research and members of research ethics committees should evaluate and balance the risks and potential benefits involved in each research proposal as a part of their ethical obligations regarding research protocols. However, current literature provides little detailed guidance on the specifics of how this balancing process should occur. Consequently, this article provides some details of the process to balance risks and benefits in biomedical research and reminds members of research ethics committees of their responsibility to protect those who are vulnerable from exploitation in research projects.

scholarly journals PO 8536 BIOMEDICAL ETHICS AND REGULATORY CAPACITY BUILDING PARTNERSHIP FOR PORTUGUESE-SPEAKING AFRICAN COUNTRIES (BERC-LUSO)

2019 ◽  
Vol 4 (Suppl 3) ◽  
pp. A50.2-A50
Author(s):  
Maria do Céu Patrão Neves ◽  
Maria A Ribeiro ◽  
Ana S Carvalho ◽  
Joana Araújo ◽  
Sofia Oliveira Martins ◽  
...  
Keyword(s):  
Capacity Building ◽  
Biomedical Research ◽  
Mother Tongue ◽  
Education Programme ◽  
Biomedical Ethics ◽  
Ethical Review ◽  
List Type ◽  
Digital Repository ◽  
African Countries ◽  
Regulatory Capacity

BERC-Luso is a project for building Ethics and Regulatory Capacity, to be developed in four sub-Saharan African countries: Angola, Guinea-Bissau, Mozambique and Cape Verde, and to be implemented in 2018–2021. National Ethics Committees (NECs) and National Regulatory Authorities (NRAs) have been engaged (6 institutions) with the partnership of 4 Portuguese institutions (experts in ethical review and regulatory supervision).Considering that: 1) clinical trials are fundamental to improve healthcare and develop biomedical research; but 2) can only take place within regulatory systems and under ethical review protocols; and 3) some African countries still lack an adequate legislative framework and the expertise to assure good ethical review and regulatory supervision, it is urgent to change the current situation.The BERC-Luso project will unfold at four different levels, each aiming at a specific goal in converging dynamics.Legislative level: Presentation of a comparative study of’the Portuguese Speaking African Partner Countries’ legislation on NECs and NRAs with recommendations for revision in compliance with the international requirements. The goal is to promote adequate internationally recognised legislation.Educational level: Implementation of an intensive and comprehensive Education Programme, both theoretical and practical, reflexive and normative, ethical and legal, addressing the needs of the countries involved, within their cultural contexts, and in their own mother tongue. The goal is to promote capacity building.Training level: Organisation of intensive internships, demanding participants to accurately apply everything they have learned to their everyday practice. The goal is to have knowledgeable and skilled experts.Networking level: Build powerful digital tools to connect partner institutions, staff and participants during the project and beyond, creating a digital repository of documents, and different tools for ethical and regulatory evaluation.These actions converge to provide internationally recognised legislation and expertise for the development of biomedical research for the benefit of the population.

scholarly journals The ethical justification for the use of animals in biomedical research

2010 ◽  
Vol 62 (3) ◽  
pp. 781-787 ◽  
Author(s):  
N.G. Kostomitsopoulos ◽  
S.F. Djurasevic
Keyword(s):  
Biomedical Research ◽  
Animal Health ◽  
Team Work ◽  
Ethical Review ◽  
Animal Science ◽  
Research Project ◽  
Ethical Justification ◽  
True Value ◽  
Ethical Review Process ◽  
Responsibility Of Scientists

Despite all the benefits, the use of animals in biomedical research is still a subject of debate with respect to its true value. The sensitivity of the community and the interest of scientists who work in the field of laboratory animal science and welfare have clearly demonstrated that the use of animals in biomedical research must be conducted under specific scientific, legal and ethical rules. The ethical justification of a research project starts from its initial designing phase until its completion and the review of the obtained results. Justification of the necessity of the project and the need to use animals in the interests of human or animal health, the importance of conducting a pilot study and a systematic review of previously published animal research on the topic, and the availability of the proper facilities, equipment and personnel are the main issues of concern in the ethical review of a research project. The ethical justification of the proposed project by the scientists themselves involves team-work, and should be a sustainable rather than a one-off procedure. This justification reflects the interest and the responsibility of scientists to reduce the number of animals, refine the procedures, and possibly replace animals in their research projects. The end-results of the ethical review process will be the creation of a trust relationship between scientists and society. .

Challenges in the Ethical Review of Clinical and Biomedical Research in Malaysia: A Mixed Methods Study

2021 ◽  
pp. 155626462110331
Author(s):  
Hooi Y. See ◽  
Mohd S. Mohamed ◽  
Siti N. M. Nor ◽  
Wah Y. Low
Keyword(s):  
Mixed Methods ◽  
Biomedical Research ◽  
Mixed Methods Research ◽  
Online Survey ◽  
Mutual Recognition ◽  
Ethical Review ◽  
Joint Research ◽  
Ethics Review ◽  
Semistructured Interviews ◽  
And Training

Empirical evidence of the ethical review of clinical and biomedical research in Malaysia is limited. We have conducted a convergent mixed methods research, which comprises an online survey and semistructured interviews to examine the challenges in the ethical review of clinical and biomedical research. Data collected reveal that the ethics review process is inconsistent, duplicate, and inadequate. The results indicate a strong need for a centralized ethical review mechanism and a national system for mutual recognition of ethics reviews to improve the effectiveness and efficiency of the ethics review system in Malaysia. A joint research ethics committee review between Malaysia and sponsoring countries for multinational research should also be encouraged as it could address the concerns of the lack of expertise and training.

scholarly journals Pharmaceuticalisation and ethical review in South Asia: Issues of scope and authority for practitioners and policy makers

2015 ◽  
Vol 131 ◽  
pp. 247-254 ◽  
Author(s):  
Bob Simpson ◽  
Rekha Khatri ◽  
Deapica Ravindran ◽  
Tharindi Udalagama
Keyword(s):  
South Asia ◽  
Ethical Review ◽  
Policy Makers
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