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

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.

2005 ◽  
Vol 15 (3) ◽  
pp. 291-295
Author(s):  
Sheldon Zink ◽  
Laura Kimberly ◽  
Stacey Wertlieb

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.


1983 ◽  
Vol 17 (11) ◽  
pp. 828-834 ◽  
Author(s):  
John A. Bosso

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.


1977 ◽  
Vol 2 (2) ◽  
pp. 477-519 ◽  
Author(s):  
Benjamin S. DuVal

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.


2015 ◽  
pp. 261-276
Author(s):  
Benjamin J. Bates ◽  
Ben Birch

The development of digital computing and the growth of the Internet have opened up new opportunities to engage in online research. These online research practices involving human subjects, often involving relatively new technologies, can create tension between the online investigator and the Institutional Review Boards (IRBs) who are required to review and approve such research prior to data collection. This chapter aims to reduce this tension by discussing the associated ethics issues and applicable federal regulations, identifying specific concerns from the perspective of IRBs, and offering suggestions as to how best to address these concerns in applications in a way that can hopefully serve both the researcher and the review board.


1979 ◽  
Vol 12 (04) ◽  
pp. 452-455 ◽  
Author(s):  
Ithiel de Sola Pool

Editor's Note: The Department of Health, Education and Welfare has prepared amendments to regulations governing research on human subjects. The regulations were established in response to recommendations from the National Commission for the Protection of Human Subjects of Biomedicai and Behavioral Research. These regulations are implemented by the institutional review boards established by colleges, universities and research institutes. The intent of the proposed amendments is admirable: to reduce the categories of research coming under federal control and review. But specific amendments could impose restrictions and difficulties upon political scientists conducting research projects or teaching their students to conduct research.The Association's Council's concerns about the proposed regulations was expressed in this resolution passed on August 30:While endorsing the important goal of protecting human subjects of research from abuse or injury, the APSA opposes any existing or proposed regulations or procedures relating to institutional review boards that would represent a threat to academic freedom or research or freedom of speech. The Council asks the Executive Director, in cooperation with other social science associations and higher education associations to prepare and present analysts of the implications of existing and proposed research regulations for political scientists and other social scientists.Ithiel de Sola Pool has prepared the following analysis of the proposed regulations in order to inform colleagues of their possible impact. Political scientists who share his concerns are invited to write to the Executive Director of the APSA and join in forming a Committee of Concern about Institutional Review Board Practices by writing to: Ithiel de Sola Pool, 105 Irving Street, Cambridge, Massachusetts 02138.The “Proposed Regulations Amending Basic HEW Policy for Protection of Human Research Subjects” which were published in the Federal Register of Tuesday, August 14, 1979, represent a substantial improvement over previous rules and draft rules, but are still grossly improper and unconstitutional.


Author(s):  
Benjamin J. Bates ◽  
Ben Birch

The development of digital computing and the growth of the Internet have opened up new opportunities to engage in online research. These online research practices involving human subjects, often involving relatively new technologies, can create tension between the online investigator and the Institutional Review Boards (IRBs) who are required to review and approve such research prior to data collection. This chapter aims to reduce this tension by discussing the associated ethics issues and applicable federal regulations, identifying specific concerns from the perspective of IRBs, and offering suggestions as to how best to address these concerns in applications in a way that can hopefully serve both the researcher and the review board.


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