Academic journal article
By Saver, Richard S.
William and Mary Law Review , Vol. 46, No. 2
TABLE OF CONTENTS INTRODUCTION I. LEGAL BACKGROUND: THE EVOLUTION OF IRBS AND THEIR ROLE IN RESEARCH REGULATION A. The Initial Peer Review Committees in the 1950s and 1960s B. The National Research Act, Report of the National Commission, and Initial Regulations C. Alternatives and What Might Have Been D. Regulatory Requirements and the Role of IRBs Today II. THE SHARED MONITORING LIMITATIONS OF IRBS AND CORPORATE BOARDS A. Agency Relationships and the Classic Monitoring Function of Both Boards B. Imperfect Agents and Weak Monitoring Bodies 1. Election and Removal 2. Board Size, Composition, and Insider/Outsider Mix 3. Time Constraints 4. Information Constraints 5. Compensation 6. Vague Performance Standards and Difficulty in Evaluating Effort 7. Limited Liability 8. Group-Think Problems, Social Bonds, and Conformity Pressures III. MULTIPLE BOARD ROLES AND THE MONITORING TRADE-OFF A. The Mediating Hierarch Role B. Monitoring Trade-off Problems C. Service Role and Further Exploration of the Monitoring Trade-off D. Problems with One-Size-Fits-All IRB Reform IV. IMPLICATIONS OF THE CORPORATE GOVERNANCE PERSPECTIVE FOR IRB REFORM A. Increasing the Number of Outsiders on IRBs B. Enhanced IRB Role in Reviewing Financial Conflicts of Interest V. THE IMPORTANCE OF NORMS FOR UNDERSTANDING IRB CONDUCT A. Norms Theory and Board Dynamics B. Norms and IRB Reform CONCLUSION
Dr. John Mendelsohn did not have a very good year in 2001. As president of the prestigious University of Texas M.D. Anderson Cancer Center, Mendelsohn enjoyed a reputation as one of the best cancer doctors in the country. He also worked as a high profile ambassador for the institution. Under his tenure, M.D. Anderson raised its public visibility, attracted record donations from private philanthropists, and doubled both its budget and federal research funding. (1)
But, in 2001 two seemingly unrelated business disasters hit in succession--Enron and ImClone. Dr. Mendelsohn figured prominently in the news again, but this was not the typical favorable coverage. In the ImClone fiasco, Mendelsohn's involvement made more sense. Dr. Mendelsohn served on the corporate board of ImClone, a New York biotechnology company, owned ImClone stock, and helped develop its leading experimental cancer drug, Erbitux. (2) In early 2001, ImClone's fortunes seemed to be riding high on the prospects of Erbitux receiving full approval by the Food and Drug Administration (FDA) relatively early in the drug's testing cycle. In late December of that year, however, the FDA declined to give the drug early approval, questioning some of the clinical trial data and concluding that more testing needed to be done before it could be cleared as safe and effective for clinical care. ImClone's stock price plummeted when this bad news hit the financial markets. (3) The downward turn of events then generated an insider trading scandal of epic proportions. Securities regulators accused Samuel Waksal, ImClone's CEO, of tipping family members to sell their ImClone stock in advance of the FDA announcement. (4) The ImClone scandal also engulfed lifestyle entrepreneur Martha Stewart. Ms. Stewart was convicted on federal criminal charges of obstruction of justice and related counts arising from a governmental investigation as to whether she sold her ImClone stock based on an illegal inside tip. (5)
With the Waksal and Stewart charges dominating the news, another troubling aspect of the ImClone saga received considerably less attention. Clinical investigators tested Erbitux on approximately 195 research subjects at M.D. Anderson. All this occurred while Dr. Mendelsohn simultaneously served as M. …