No Humans Here

2022 ◽  
Vol 6 (GROUP) ◽  
pp. 1-13
Author(s):  
Jessica Pater ◽  
Casey Fiesler ◽  
Michael Zimmer
Keyword(s):  
Data Privacy ◽  
Ethical Decision Making ◽  
Human Subjects ◽  
Open Science ◽  
Unintended Consequences ◽  
Institutional Review Boards ◽  
Research Communities ◽  
Institutional Review ◽  
Public Data ◽  
Regulatory Bodies

Many research communities routinely conduct activities that fall outside the bounds of traditional human subjects research, yet still frequently rely on the determinations of institutional review boards (IRBs) or similar regulatory bodies to scope ethical decision-making. Presented as a U.S. university-based fictional memo describing a post-hoc IRB review of a research study about social media and public health, this design fiction draws inspiration from current debates and uncertainties in the HCI and social computing communities around issues such as the use of public data, privacy, open science, and unintended consequences, in order to highlight the limitations of regulatory bodies as arbiters of ethics and the importance of forward-thinking ethical considerations from researchers and research communities.

Human Subjects Protection and Large-N Research: When Exempt is Non-Exempt and Research is Non-Research

2008 ◽  
Vol 41 (03) ◽  
pp. 477-482 ◽  
Author(s):  
Mitchell A. Seligson
Keyword(s):  
Human Subjects ◽  
Public Policies ◽  
Social Science Research ◽  
Science Research ◽  
Unintended Consequences ◽  
Medical Community ◽  
Institutional Review Boards ◽  
The Road ◽  
Institutional Review ◽  
Protection Of Human Subjects

Social scientists are well aware of the unintended consequences of public policies. The protection of human subjects regulations, which emerged in response to a serious problem in the medical community, provides an ideal example of such unintended consequences; to paraphrase an old aphorism, “the road to bureaucratic hell is paved with well-intentioned public policies.” In this essay I will seek to make three points. First, the protection of human subjects by federal regulation was long overdue. Second, this benefit to society has, in its application, ignored another widely accepted regulatory principle, namely that the costs of regulation should not outweigh its benefits; a combination of “bureaucratic creep” and litigation phobia has resulted in intrusive and counterproductive regulation of social science research, such that the cure has become worse than the disease. Third, ironically, because of institutional review boards' definition of what is and what is not research, the protection of human subjects is denied to subjects who actually could be at risk.

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.

Pediatric Participation in Non-Therapeutic Research

2012 ◽  
Vol 40 (3) ◽  
pp. 665-672 ◽  
Author(s):  
Marilyn C. Morris
Keyword(s):  
Medical Condition ◽  
Human Subjects ◽  
National Commission ◽  
Institutional Review Boards ◽  
Minimal Risk ◽  
Research Risks ◽  
Institutional Review ◽  
Protection Of Human Subjects ◽  
A Minor ◽  
Therapeutic Research

Pediatric participation in non-therapeutic research that poses greater than minimal risk has been the subject of considerable thought-provoking debate in the research ethics literature. While the need for more pediatric research has been called morally imperative, and concerted efforts have been made to increase pediatric medical research, the importance of protecting children from undue research risks remains paramount.United States research regulations are derived largely from the deliberations and report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The authors of this report specifically designated children as a vulnerable population and suggested additional protections, most of which became U.S. law. One of the more contested sets of regulations surrounds non-therapeutic research, e.g., research that does not offer the potential for direct benefit to participants. Federal regulations allow local Institutional Review Boards (IRBs) to approve non-therapeutic research posing a minor increase above minimal risk when it involves children who have the disease or medical condition that the research addresses (Table 1).

Sign in / Sign up

Export Citation Format

Share Document