scholarly journals The Suitability of IRB Liability

2005 ◽  
Vol 67 (2) ◽  
Author(s):  
Sharona Hoffman ◽  
Jessica Wilen Berg
Keyword(s):  
United States ◽  
Biomedical Research ◽  
Clinical Studies ◽  
Human Subjects ◽  
The United States ◽  
Institutional Review Boards ◽  
Federal Regulations ◽  
Institutional Review ◽  
Research Oversight ◽  
Oversight System

The biomedical research oversight system in the United States delegates most responsibilities to local review entities known as institutional review boards (IRBs). The IRBs are charged with responsibility for safeguarding the welfare of research participants and ensuring that clinical studies involving human subjects comply with federal regulations.

Research with Human Participants in the United States

2021 ◽  
Author(s):  
Carl H. Coleman
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Conflicts Of Interest ◽  
The United States ◽  
Institutional Review Boards ◽  
Federal Regulations ◽  
Institutional Review ◽  
Regulatory Standards ◽  
Human Participants ◽  
Key Aspects

This chapter discusses research with human participants in the United States, most of which has been subject to federal regulations requiring prospective ethical oversight by entities known as institutional review boards (IRBs) since the 1970s. Research that is subject to the federal regulations may not begin until IRB approval has been obtained. The chapter begins by examining key aspects of the federal regulations governing IRB review of research with human participants, including the type of activities that fall under the IRB’s jurisdiction, how IRBs are organized, and some of the key substantive standards that IRBs apply. It then looks at additional regulatory standards that apply to studies involving particular populations, including pregnant women and fetuses, prisoners, and children. Finally, the chapter examines several other bodies of law related to research with human participants, including policies governing the inclusion of women and racial minorities in clinical trials; legal principles governing compensation for injuries to research participants; and requirements for registering clinical trials, reporting trial results, and disclosing research-related conflicts of interest.

RAC Oversight of Gene Transfer Research: A Model Worth Extending?

2002 ◽  
Vol 30 (3) ◽  
pp. 381-389 ◽  
Author(s):  
Nancy M. P. King
Keyword(s):  
Gene Transfer ◽  
Recombinant Dna ◽  
Human Subjects ◽  
The United States ◽  
Layered System ◽  
Institutional Review ◽  
Research Oversight ◽  
Significant Addition ◽  
Protection Of Human Subjects ◽  
Oversight System

Clinical gene transfer research (GTR) has both a unique history and a complex and layered system of research oversight, featuring a unique review body, the Recombinant DNA Advisory Committee (RAC). This paper briefly describes the process of decision-making about clinical GTR, considers whether the questions, problems, and issues raised in clinical GTR are unique, and concludes by examining whether the RAC's oversight is a useful model that should be reproduced for other similar areas of clinical research.Clinical GTR is governed by the same oversight system as most clinical trials, with a significant addition: the RAC. Like other research with human subjects, GTR, if it is affiliated with a federally funded institution, must be approved by an institutional review board (IRB) whose activities are governed by the common rule, that is, the federal regulations for protection of human subjects in research. Like other research intended to produce a drug, device, or biologic to be marketed in the United States, GTR is also overseen by the Food and Drug Administration (FDA).

MRI Research Proposals Involving Child Subjects: Concerns Hindering Research Ethics Boards from Approving Them and a Checklist to Help Evaluate Them

2011 ◽  
Vol 20 (1) ◽  
pp. 115-129 ◽  
Author(s):  
J. DEBORAH SHILOFF ◽  
BRYAN MAGWOOD ◽  
KRISZTINA L. MALISZA
Keyword(s):  
United States ◽  
Research Ethics ◽  
Gold Standard ◽  
The United States ◽  
Institutional Review Boards ◽  
Scientific Review ◽  
Initial Development ◽  
Institutional Review ◽  
Research Ethics Boards ◽  
A Current

The process of research is often lengthy and can be extremely arduous. It may take many years to proceed from the initial development of an idea through to the comparison of the new modalities against a current gold-standard practice. Each step along the way involves rigorous scientific review, where protocols are scrutinized by multiple scientists not only in the specific field at hand but related fields as well. In addition to scientific review, most countries require a further review by a panel that will specifically address the ethics of the proposed research. In Canada, those panels are referred to as Research Ethics Boards (REB), with the United States counterparts known as Institutional Review Boards (IRB).

scholarly journals Structure and Practice of Institutional Review Boards in the United States

1996 ◽  
Vol 3 (8) ◽  
pp. 804-809 ◽  
Author(s):  
Jeffrey S. Jones ◽  
Lynn J. White ◽  
Linda C. Pool ◽  
James M. Dougherty
Keyword(s):  
United States ◽  
The United States ◽  
Institutional Review Boards ◽  
Institutional Review ◽  
Review Boards

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.

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.

Indigenous Research Ethics Requirements: An Examination of Six Tribal Institutional Review Board Applications and Processes in the United States

2020 ◽  
Vol 15 (4) ◽  
pp. 279-291
Author(s):  
Nicole S. Kuhn ◽  
Myra Parker ◽  
Clarita Lefthand-Begay
Keyword(s):  
United States ◽  
Research Ethics ◽  
Management Practices ◽  
The United States ◽  
Institutional Review Boards ◽  
Indigenous Research ◽  
Cultural Appropriation ◽  
Building Relationships ◽  
Institutional Review ◽  
Indigenous Knowledge Systems

Tribal Institutional Review Boards (TIRBs) in the United States assert their rights within sovereign nations by developing ethical research processes that align with tribal values to protect indigenous knowledge systems and their community from cultural appropriation, exploitation, misuse, and harm. We reviewed six TIRB applications and processes to gain a better understanding about their requirements and research ethics. We located 48 activated and deactivated TIRBs in a database, mapped them in relation to tribal reservation lands, and then conducted in-depth content analysis. Our analysis demonstrates the importance of building relationships, becoming fully acquainted with the TIRB’s operating environment before seeking research approval, and issues related to tribal data management practices.

Online Research and Obtaining Human Subjects/IRB Approvals

2015 ◽  
pp. 261-276
Author(s):  
Benjamin J. Bates ◽  
Ben Birch
Keyword(s):  
Data Collection ◽  
New Technologies ◽  
Human Subjects ◽  
Institutional Review Boards ◽  
The Internet ◽  
Online Research ◽  
Federal Regulations ◽  
Research Practices ◽  
Institutional Review ◽  
Review Boards

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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