Law and Ethics in Biomedical Research

Law and Ethics in Biomedical Research: Regulation, Conflict of Interest and Liability

TRUDO LEMMENS
DUFF R. WARING
Copyright Date: 2006
Pages: 384
https://www.jstor.org/stable/10.3138/9781442676596
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  • Book Info
    Law and Ethics in Biomedical Research
    Book Description:

    When a young man named Jesse Gelsinger died in 1999 as a result of his participation in a gene transfer research study, regulatory agencies in the United States began to take a closer look at what was happening in medical research. The resulting temporary shutdown of some of the most prestigious academic research centres confirmed what various recent reports in the United States as well as Canada had claimed; that the current system of regulatory oversight was in need of improvement.

    Law and Ethics in Biomedical Researchuses the Gelinger case as a touchstone, illustrating how three major aspects of that case - the flaws in the regulatory system, conflicts of interest, and legal liability - embody the major challenges in the current medical research environment. Editors Trudo Lemmens and Duff R. Waring, along with a host of top scholars in the field, demonstrate why existing models of research review and human subject protection are in need of improvement, and how more stringent regulatory and legal means can be used to strengthen the protection of research subjects and the integrity of research.

    The contributors also address conflicts of interest, paying particular attention to the growing commercialization of medical research, as well as the legal liability of scientific investigators, research institutions, and governmental agencies. Legal liability is a growing concern in medical research and this fascinating study is, in the international context, one of the first to explore the liability of various parties involved in the research enterprise.

    eISBN: 978-1-4426-7659-6
    Subjects: Health Sciences

Table of Contents

  1. Front Matter
    (pp. i-vi)
  2. Table of Contents
    (pp. vii-viii)
  3. Acknowledgments
    (pp. ix-2)
  4. Introduction
    (pp. 3-11)
    TRUDO LEMMENS and DUFF R. WARING

    Research ethics has developed in the shadow of controversy. Throughout the twentieth century, various scandals prompted professional organizations, governmental agencies, and courts to look closely at how medical research was being conducted and how the well-being of human research subjects could be better protected. The Nuremberg Doctors’ Trial and names such as Tuskegee, Willowbrook, and the Brooklyn Jewish Chronic Disease Hospital have become enshrined in the collective consciousness of the medical research community as dire symbols of how, in their zeal to conduct research, physician investigators can ignore the welfare of patients. These scandals concerned studies involving vulnerable persons at...

  5. 1 Uninformed Consent: The Case of Jesse Gelsinger
    (pp. 12-32)
    PAUL L. GELSINGER

    It has been four years since we first became involved with a clinical research protocol for gene therapy conducted at the University of Pennsylvania (Penn). Penn, the oldest medical university in the United States, had established the Institute for Human Gene Therapy (IHGT) in 1992. In the spring of 1993 James Wilson, MD, PhD, was lured to Penn to head the IHGT. It was hoped that Dr Wilson’s endeavours there would open the doors into a new and promising field of medicine. The premise and the promise of gene therapy would bring untold fame and wealth to those able to...

  6. PART ONE: REGULATION

    • 2 Questions and Challenges in the Governance of Research Involving Humans: A Canadian Perspective
      (pp. 35-46)
      KATHLEEN CRANLEY GLASS

      Most Canadians strongly support the promotion of socially beneficial research. Contemporary health research holds the promise of significant positive developments. But it also clearly poses significant challenges. Issues such as individual, community, and societal risk and personal or institutional conflicts of interest are inadequately addressed in the multi-layered, fragmented, and complex structure of research governance in Canada. Universities and hospitals are confronted with a research funding environment that increasingly relies on private sources of funding and a push to commercialize research results.¹ Yet their researchers receive little assistance in recognizing and managing the conflicts of interest they face, leaving some...

    • 3 Swinging on the Pendulum: Shifting Views of Justice in Human Subjects Research
      (pp. 47-60)
      ANNA MASTROIANNI and JEFFREY KAHN

      Justice has long been one of the central principles in the ethical conduct of research on human subjects. But its application, as reflected in U.S. federal policies pertaining to human subjects research, has undergone a remarkable shift over a relatively short span of time. Understanding this shift is important not only for interpreting claims about justice in human subjects research, but also for assessing the status and adequacy of policies for protecting subjects.

      In the 1970s, these policies emphasized the protection of human subjects from the risks of harm in research, and justice was seen as part of this protection....

  7. PART TWO: CONFLICT OF INTEREST

    • 4 The Ethical and Legal Foundations of Scientific ‘Conflict of Interest’
      (pp. 63-81)
      SHELDON KRIMSKY

      ‘Conflict of interest’ is embedded in many areas of public ethics. Certain enactments named for their ethical content, such as the U.S.Ethics in Government Act, have sections devoted to ‘conflict of interest,’ and the legal community, government officials, financial organizations, and many news organizations have strict guidelines on such conflict. Yet the term is rather new to the scientific and medical research communities. Prior to 1980 little public attention was given to scientists with competing interests in their research. The first medical journal to introduce a conflict of interest disclosure requirement was theNew England Journal of Medicinein...

    • 5 Self-Censorship
      (pp. 82-94)
      JAMES ROBERT BROWN

      The ideals of science are easier to describe precisely and endorse cheerfully than they are to observe scrupulously. Open and free inquiry, shared results, an absence of taboo subjects, and so on, are part of the package. We often hear that ‘political correctness’ is undermining these laudable aims by hampering research into sensitive subjects, such as race or gender and cognition. Scientists who pursue such topics claim to be unfairly hounded on non-scientific grounds, and so other researchers, not wanting to feel similar unpleasant pressures, censor themselves and pursue less socially sensitive topics.

      I am quite sceptical about this alleged...

    • 6 Promoting Integrity in Industry-Sponsored Clinical Drug Trials: Conflict of Interest Issues for Canadian Health Sciences Centres
      (pp. 95-131)
      LORRAINE E. FERRIS and C. DAVID NAYLOR

      Canadians have an interest in gaining access to safe and efficacious new drugs, while manufacturers have a related interest in developing pharmaceutical agents and moving them to market. The process of regulatory approval for new drugs seeks to align these interests through safeguards to prevent introduction of drugs that are inefficacious for their stated indications, or that have unacceptable risk-benefit ratios owing to serious adverse effects.

      Investigational drugs typically first undergo animal toxicity and pharmacokinetic studies. A sponsor (e.g., the pharmaceutical manufacturer)¹ can then apply to Health Canada’s Therapeutic Products Directorate (TPD) for entry into the pre-approval process. This authorizes...

    • 7 The Human Subjects Trade: Ethical, Legal, and Regulatory Remedies to Deal with Recruitment Incentives and to Protect Scientific Integrity
      (pp. 132-180)
      TRUDO LEMMENS and PAUL B. MILLER

      Over the past five years, a series of articles in leading American newspapers has revealed the extent to which the conduct of clinical trials may be affected by inducements offered by corporate research sponsors and accepted by some unscrupulous physicians.¹ The cases described were disturbing. They involved physicians engaged in excessive ‘enrolment activities’ in exchange for money. Some of these physicians perpetrated fraud, falsifying their recruitment records in order to increase their profits. Others ignored exclusion criteria designed to ensure the safety of subjects and the validity of research results, referring their patients to research investigating treatments for conditions from...

  8. PART THREE: LIABILITY

    • 8 Bringing Research into Therapy: Liability Anyone?
      (pp. 183-205)
      MARY M. THOMSON

      Gene therapy, better described as gene transfer research, is a technique used to correct defective genes responsible for disease development. The scientific community has promoted the potential of gene therapy for the past thirty years, and clinical trials have been ongoing for more than a decade. Yet there have been troubling developments and heartbreaking stories as this science moves from the laboratory to the clinic, from research to therapy, and from the theoretical to the practical. Because the promise of gene transfer research is so great, the setbacks seem enormously discouraging. Where the gap between expectation and outcome is marked,...

    • 9 Legal Liability for Harm to Research Participants: The Case of Placebo-Controlled Trials
      (pp. 206-227)
      DUFF R. WARING and KATHLEEN CRANLEY GLASS

      The choice of treatments for patients in the control arm of a randomized clinical trial (RCT or trial) has long been recognized as a contentious issue. Much has been written about the science and ethics of using placebo controls in RCTs when established, effective treatment is available.¹ However, little consideration has been given to questions of the legal liability of physician investigators if a research participant is harmed when effective treatment is withheld or withdrawn in the placebo arm of a trial.²

      There is no Canadian or American legislation involving placebo-controlled trials, nor are we aware of a reported case...

    • 10 Her Majesty’s Research Subjects: Liability of the Crown in Research Involving Humans
      (pp. 228-252)
      SANA HALWANI

      A number of health crises have recently confronted Canada: the Krever Inquiry into Canada’s blood supply,¹ the Walkerton inquiry into water supply in Ontario,² and the coroner’s investigation into the death of Vanessa Young and the role of the drug regulatory system³ have all revealed inadequacies in critical regulatory systems. Perhaps partly in response to these crises, the 2002 Speech from the Throne contained a commitment to ‘renew federal health protection legislation to better address emerging risks, adapt modern technology and emphasize prevention.’⁴ Both the crises and the commitment indicate that there is room to improve the regulatory systems in...

  9. Contributors
    (pp. 253-258)
  10. Index
    (pp. 259-267)