Litigation in Clinical Research: Malpractice Doctrines versus Research Realities

2004 ◽  
Vol 32 (3) ◽  
pp. 474-484 ◽  
Author(s):  
E. Haavi Morreim
Keyword(s):  
Clinical Research ◽  
Human Subjects ◽  
New Drugs ◽  
National Commission ◽  
Institutional Review Boards ◽  
Research Subjects ◽  
Public Attention ◽  
Institutional Review ◽  
Protection Of Human Subjects ◽  
Clinical Research Trials

Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health (NIH) doubled its spending over the past five years, while in the private sector the top twenty pharmaceutical companies have more than doubled their investment in research and development over a roughly comparable period. To date, some twenty million Americans have participated in clinical research trials that now are as common in the private practice setting as in academia.For many years human clinical trials received relatively little public attention. In the wake of several well-publicized research abuses, Congress created in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to formulate recommendations to protect human research subjects. The Commission’s 1979 Belmont Report helped to guide the Institutional Review Boards (IRBs) that review the ethics of federally funded research.

Protecting Human Subjects of Research: An Analysis on Proposed Amendments to HEW Policy

1979 ◽  
Vol 12 (04) ◽  
pp. 452-455 ◽  
Author(s):  
Ithiel de Sola Pool
Keyword(s):  
Executive Director ◽  
Human Subjects ◽  
Substantial Improvement ◽  
National Commission ◽  
Institutional Review Boards ◽  
Research Subjects ◽  
Institutional Review ◽  
Conducting Research ◽  
Protection Of Human Subjects ◽  
Review Boards

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.

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).

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.

Ethical Issues in Prehospital Research

1993 ◽  
Vol 8 (S1) ◽  
pp. S11-S14 ◽  
Author(s):  
Eric A. Davis ◽  
Ronald F. Maio
Keyword(s):  
World War Ii ◽  
Medical Research ◽  
Ethical Issues ◽  
Human Subjects ◽  
Medical Science ◽  
Institutional Review Boards ◽  
Research Subjects ◽  
Institutional Review ◽  
Protection Of Human Subjects ◽  
The Individual

The atrocities committed by Nazi physicians and scientists, in the name of furthering medical science, is an appalling page of the history of medical research. In the wake of World War II, the scientific community strived to develop regulations to guard against future abuses in medical research. However, a particularly sobering thought is that the atrocities in Germany were being carried out in a country that had specific regulations for protecting human research subjects: Nazi Germany was the only European country to have such regulations. A more in-depth look at these regulations reveals institutional or department heads were held accountable, but not the individual researcher. The lesson from this analysis is clear: individual investigators must bear the responsibility of conducting ethical research. Governmental regulations and Institutional Review Boards never can replace investigators who are advocates for the protection of human subjects.The purpose of this paper is to address issues broadly regarding ethics and prehospital research, with a focus on the topic of informed consent.

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.

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 The Invisible Hand in Clinical Research: The Study Coordinator's Critical Role in Human Subjects Protection

2002 ◽  
Vol 30 (3) ◽  
pp. 411-419 ◽  
Author(s):  
Arlene M. Davis ◽  
Sara Chandros Hull ◽  
Christine Grady ◽  
Benjamin S. Wilfond ◽  
Gail E. Henderson
Keyword(s):  
Informed Consent ◽  
Clinical Research ◽  
Human Subjects ◽  
Critical Role ◽  
Invisible Hand ◽  
Community Settings ◽  
Institutional Review ◽  
Research Organizations ◽  
Study Staff ◽  
Protection Of Human Subjects

Over the past decade, the number of clinical trials registered with the Food and Drug Administration (FDA) has increased dramatically. The business of clinical research has become more diverse, involving academic institutions, clinician-researchers in community settings, pharmaceutical companies, and contract research organizations. This growth has been accompanied by increasing concerns about the ethical conduct of research. Much of this concern has been directed to procedural issues including institutional review board (IRB) review, data monitoring, and informed consent forms. However, the protection of human subjects cannot be achieved by relying solely on procedural safeguards. There are more nuanced issues related to recruitment and retention of subjects, and to the process of informed consent, that are generated during the interaction between study staff and subjects. It is only through an examination of these relationships that one can more fully define and understand the challenges of protecting subjects in research.

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