Heterogeneity in IRB Policies with Regard to Disclosures about Payment for Participation in Recruitment Materials

2014 ◽  
Vol 42 (3) ◽  
pp. 375-382 ◽  
Author(s):  
Megan S. Wright ◽  
Christopher T. Robertson
Keyword(s):  
National Science Foundation ◽  
Human Subjects ◽  
Federal Agencies ◽  
Institutional Review Boards ◽  
Fda Guidance ◽  
Institutional Review ◽  
National Science ◽  
The Common ◽  
Bold Type ◽  
Specific Amount

The payment of human subjects is an area where Institutional Review Boards (IRBs) have wide discretion. Although the “Common Rule” requires the provision of full information to human research participants to secure valid consent, the Rule is silent on the issue of payment. Still, some federal agencies offer guidance on the matter. For example, the National Science Foundation (NSF) cautions that high payments for risky research “may induce a needy participant to take a risk that they normally would prefer not to take.” For research under its purview, the Food and Drug Administration (FDA) guidance provides that “[a]dvertisements may state that subjects will be paid, but should not emphasize the payment or the amount to be paid, by such means as larger or bold type.” One might read the FDA guidance to permit the advertisement for human subjects to state the specific amount of payment, as long as it is not emphasized.

Currents in Contemporary Ethics

2005 ◽  
Vol 33 (1) ◽  
pp. 154-159 ◽  
Author(s):  
Mark A. Rothstein
Keyword(s):  
Privacy Protection ◽  
Human Subjects ◽  
Institutional Review Boards ◽  
Research Subjects ◽  
Common Rule ◽  
Privacy Rule ◽  
Institutional Review ◽  
The Common ◽  
Protection Of Human Subjects ◽  
Privacy Issues

For nearly twenty-five years, federal regulation of privacy issues in research involving human subjects was the primary province of the federal rule for Protection of Human Subjects (Common Rule). As of April 14, 2003, the compliance date for the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA), however, the Common Rule and the Privacy Rule jointly regulate research privacy. Although, in theory, the Privacy Rule is intended to complement the Common Rule, there are several areas in which the rules diverge. In some instances the inconsistencies result in gaps in privacy protection; in other instances the inconsistencies result in added burdens on researchers without additional privacy protections. In all instances, the lack of harmonization of these rules has created confusion, frustration, and misunderstanding by researchers, research subjects, and institutional review boards (IRBs). In this article, I review the major provisions of the Privacy Rule for research, explain the areas in which the Privacy Rule and Common Rule differ, and conclude that the two rules should be revised to promote consistency and maximize privacy protections while minimizing the burdens on research.

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.

Upholding “Colonial Unknowing” Through the IRB: Reframing Institutional Research Ethics

2018 ◽  
Vol 25 (9-10) ◽  
pp. 1056-1064 ◽  
Author(s):  
Sheeva Sabati
Keyword(s):  
Research Ethics ◽  
Academic Research ◽  
Institutional Review Boards ◽  
Institutional Research ◽  
Origin Stories ◽  
History Of Research ◽  
Institutional Review ◽  
History Of ◽  
The Common ◽  
A Site

This article considers the institutionalization of research ethics as a site of “colonial unknowing” in which the racial colonial entanglements of academic research and institutions are obscured. I examine the origin stories situating Institutional Review Boards (IRBs) as a response to cases of exceptional violence, most notably the Tuskegee syphilis experiment, within an otherwise neutral history of research. I then consider how the 2018 revisions to the Common Rule extend “colonial unknowing” by decontextualizing the forms of risk involved in social and behavioral research. I situate these complicities as necessary starting points toward anticolonial research ethics of “answerability.”

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.

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