Turning Ethics into Institutions: The Techno-politics of Human Research Regulation in Taiwan

2018 ◽  
Vol 23 (2) ◽  
pp. 289-306 ◽  
Author(s):  
Wen-Hua Kuo
Keyword(s):  
Human Subjects ◽  
Dominant Role ◽  
Legal Framework ◽  
Ethical Framework ◽  
Institutional Review Boards ◽  
Human Research ◽  
Institutional Review ◽  
Social Settings ◽  
The Government ◽  
International Conventions

This article provides a critical assessment of the development of Taiwan’s ethical framework for regulating medical and biopharmaceutical innovations. Advancing science, technology and society scholarship that treats ethics as subject to modification, adjustment and negotiation rather than as an abstract set of principles, this article examines the dominant role of East Asian states in the development of the life sciences. It also looks at the logic these states utilise to legitimise their therapeutic standards and to support the biopharmaceutical infrastructure in order to increase their economic competitiveness. In particular, this article traces the establishment of legal regulations in different social settings where innovations in clinical practice and medicine are introduced. It argues that, instead of a comprehensive, coherent ethical framework based on the adoption of international conventions, Taiwan’s 2011 Human Subjects Research Act is a techno-political assemblage, an inconsistent legal product involving not only policy makers but also physicians, the pharmaceutical industry and the state. This article also takes a critical stance towards institutional review boards (IRBs), which resolve jurisprudential conflicts within this legal framework of human research. It argues that, rather than being passive organisations that protect research from unethical fraud, IRBs in Taiwan have been institutions in which negotiations among investigators, research sponsors and the government are conducted in the name of health governance.

The Institutional Review Board and Protecting Human Subjects: 10 Frequently Asked Questions

2005 ◽  
Vol 15 (3) ◽  
pp. 291-295
Author(s):  
Sheldon Zink ◽  
Laura Kimberly ◽  
Stacey Wertlieb
Keyword(s):  
Human Subjects ◽  
Institutional Review Board ◽  
Institutional Review Boards ◽  
Research Subjects ◽  
Human Research ◽  
Institutional Review Board Approval ◽  
Institutional Review ◽  
Human Research Subjects ◽  
Review Boards

It is essential that anyone involved in research involving human subjects be familiar with the purpose and role of institutional review boards. Institutional review boards are designed, first and foremost, to protect human research subjects by overseeing the implementation of federal regulations regarding protection of human subjects. The federal government requires institutional review board approval for any human subject research that receives federal funding, and many scholarly journals require proof of institutional review board approval of the research before publication. In this article, the answers to 10 frequently asked questions about the role of institutional review boards highlight the important contributions made by institutional review boards to the conduct of ethically sound research. The aim is to generate a working knowledge of the institutional review board's function that can be used by every researcher contemplating working with human research subjects. This is the first in a series of 3 articles examining common issues in research ethics.

Rethinking Local Institutional Review Board (IRB) Review at State Health Departments: Implications for a Consolidated, Independent Public Health IRB

2012 ◽  
Vol 40 (4) ◽  
pp. 997-1007 ◽  
Author(s):  
David Perlman
Keyword(s):  
Public Health ◽  
Human Subjects ◽  
Public Health Practice ◽  
Institutional Review Board ◽  
Institutional Review Boards ◽  
Human Research ◽  
Institutional Review ◽  
Or Practice ◽  
Human Research Protection Program ◽  
Human Research Protection

A number of unique problems plague human research protection efforts at United States (US) State and Territorial Departments of Health (DOHs). The first problem is related to the number of Institutional Review Boards (IRBs) operated by and Federalwide Assurances (FWAs) held by DOHs. The lack of these two essential regulatory human research protection program mechanisms points to a possible inadequacy of infrastructure at DOHs for protecting human subjects. The second and third problems are related to the use and interpretation of research protection laws and regulations at DOHs. Parsing public health activities into research or practice (1) can be vexing and (2) likely produces variability in (a) how individual DOHs make the determination between research and practice and (b) the outcomes of such decisions for the same or similar projects. A related problem is that DOH or Institutional Review Board (IRB) officials might misclassify public health practice activities as research (and vice versa), which can have costly, adverse consequences.

scholarly journals Some Questions of Ethics in RCTs

2021 ◽  
Author(s):  
Reetika Khera
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Ethical Issues ◽  
Human Subjects ◽  
Belmont Report ◽  
Institutional Review Boards ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Institutional Review ◽  
Areas Of Concern

Questions of ethics in Randomized Controlled Trials (RCTs) in development economics need greater attention and a wider perspective. RCTs are meant to be governed by the three principles laid out in the Belmont Report, but often violated them, e.g. when local laws are flouted. In other cases, the framework of the Belmont Report itself has proved inadequate: for instance, when there are unintended outcomes or adverse events for which no-one is held accountable. Primarily using RCTs conducted in India, this paper highlights eight areas of concern. RCTs also have a disproportionate influence on shaping research agendas and on policy. Though ethical issues have been raised, there has been little engagement from the RCT community – a manifestation of its power in the profession. As current safeguards (such as oversight by Institutional Review Boards) have failed to protect human subjects, the concluding section discusses possible ways to resolve these issues.

IRB Creep: Federal Regulations Protecting Human Research Subjects and Increasing Instructors' Responsibilities

2009 ◽  
Vol 24 (1) ◽  
pp. 31-43 ◽  
Author(s):  
Diane A. Riordan ◽  
Michael P. Riordan
Keyword(s):  
Review Process ◽  
Human Subjects ◽  
Institutional Review Boards ◽  
Federal Regulations ◽  
Federally Funded ◽  
Research Subjects ◽  
Accounting Faculty ◽  
Institutional Review ◽  
Human Research Subjects ◽  
Review Boards

ABSTRACT: Federal regulations require oversight of federally sponsored research involving human subjects. Universities have responded by forming Institutional Review Boards (IRBs). Although these regulations only apply to federally funded projects, universities have extended the oversight to include all projects involving human subjects. From our own experience, we observe that not all accounting faculty are aware of their responsibilities to their local boards. The sanctions for failing to follow required procedures depend on the infraction, and range from an order to cease work on the project to termination of university service for the faculty member and expulsion for the student. This report helps accounting faculty understand how the review process may affect their role as instructors and serves as encouragement to them to become familiar with the requirements of local review boards.

scholarly journals Characterizing Current Attitudes and Practices for Human Subject Safety in Studies Involving Pupil Dilation

2020 ◽  
pp. 155626462096898
Author(s):  
Jacob Szpernal ◽  
Joseph Carroll ◽  
Ryan Spellecy ◽  
Jane A. Bachman Groth
Keyword(s):  
Informed Consent ◽  
Adverse Effects ◽  
Vision Research ◽  
Human Subject ◽  
Human Subjects ◽  
Pupil Dilation ◽  
Institutional Review Boards ◽  
Human Subjects Research ◽  
Attitudes And Practices ◽  
Institutional Review

Standards in pupil dilation practices regarding the safety of human subjects are not present in vision research despite the potential for significant adverse effects. We developed two surveys to examine current practices around pupil dilation among vision researchers and individuals associated with oversight of human subjects research. While both groups note an absence of adverse events associated with pupil dilation, vision researcher practices differed with informed consent use and measures taken to minimize complications. For Institutional Review Boards, general risk assumption associated with dilation was not unanimous and there was a lack of specific guidance available to researchers for minimizing risk. These results uncover the need for standardized practices regarding pupil dilation in human subjects research.

The Role of the Institutional Review Board in Research Involving Human Subjects

1983 ◽  
Vol 17 (11) ◽  
pp. 828-834 ◽  
Author(s):  
John A. Bosso
Keyword(s):  
Experimental Research ◽  
Human Subjects ◽  
Institutional Review Board ◽  
Institutional Review Boards ◽  
Federal Regulations ◽  
Research Subjects ◽  
Basic Composition ◽  
Institutional Review ◽  
Policies And Procedures

Concern with the rights and welfare of human experimental research subjects has given rise to the evolution of institutional review boards. This article describes the basic composition and purposes of these boards, as well as the federal regulations by which they are governed. Since many of these regulations are open to interpretation, the policies and procedures of one such board are included to represent an example of how these regulations are interpreted and applied.

scholarly journals Virtual Worlds, the IRB and a User's Bill of Rights

1970 ◽  
Vol 3 (1) ◽  
Author(s):  
Jeffrey M. Stanton
Keyword(s):  
Virtual Worlds ◽  
Virtual World ◽  
Social Research ◽  
Human Subjects ◽  
Institutional Review Boards ◽  
Bill Of Rights ◽  
Social Phenomena ◽  
Institutional Review ◽  
Preliminary Version

Virtual worlds provide a vibrant and exciting new venue for the conduct of social research. New social phenomena have emerged in the context of these worlds as individuals and groups use the worlds’ social communication tools to overcome limitations of time and distance. Yet these worlds also pose some novel ethical problems for social researchers who wish to conduct their work in these contexts. The present paper discusses ethical dimensions of research in virtual worlds in order to uncover some of these novel problems. The paper reports and analyzes a case study in which the author participated in a virtual world research study. The paper discusses a preliminary version of a virtual world subject’s bill of rights that can serve as the basis for further discussion among social researchers. The paper concludes with recommendations for virtual worlds researchers on strategies for working with their institutional review boards (human subjects ethics review) to obtain approval for their research proposals.

Educational Research and the Protection of Human Subjects

1977 ◽  
Vol 2 (2) ◽  
pp. 477-519 ◽  
Author(s):  
Benjamin S. DuVal
Keyword(s):  
Educational Research ◽  
Human Subjects ◽  
Institutional Review Boards ◽  
Research Subjects ◽  
Institutional Review ◽  
Legal Restrictions ◽  
Research On Human Subjects ◽  
Protection Of Human Subjects ◽  
Judicial Recognition ◽  
Review Boards

Educational research is increasingly subject to legal restrictions designed for the protection of human subjects of research. In this article the author discusses legal restrictions–both in the courts and under HEW regulations–on educational research, comparing these restrictions with those on biomedical research. He finds that although educational research in particular instances may give rise to suits for damages for invasion of privacy or intentional infliction of psychological distress, the legal issues relating to educational research will most often be resolved in proceedings before institutional review boards charged by HEW with the responsibility for passing upon proposals to conduct research on human subjects. He argues that the interests protected in proceedings before institutional review boards are not limited to those that have received judicial recognition in suits for damages. The author finds that the requirement that the informed consent of subjects be obtained presents difficult issues for educational research. He notes in particular the problems presented by research proposals that as an element of the research design contemplate the observation of subjects without their knowledge and the use of children as research subjects.

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