Assigning Rights and Protecting Interests: Constructing Ethical and Efficient Legal Rights in Human Tissue Research

Article excerpt

TABLE OF CONTENTS

I. INTRODUCTION
II. THE INTERESTS AT STAKE
    A. The Interests of Tissue Providers
       1. Control
       2. Confidentiality
       3. Commercialization
       4. Cure
    B. Some Interests of Researchers and Society

III. A NEW APPROACH
    A. Informational Property
       1. Defining Informational Property
       2. Informational Property as a Personal Right
       3. Operationalizing Informational Property: Copyleft Licensing
       4. Operationalizing Informational Property: Fair Utilization
    B. Integrating Informational Property with Existing Systems
       1. Tort
       2. Contract
       3. Property
IV. ASSIGNING RIGHTS TO PROTECT INTERESTS
V. CONCLUSION

I. INTRODUCTION

On March 11, 2009, nine families filed suit against the state of Minnesota, arguing that the state, after collecting blood samples from newborns for routine screening, unlawfully retained the samples indefinitely and shared the samples with private research institutions and hospitals--all without parental knowledge or consent. (1) A day later, parents in Texas filed a lawsuit in the U.S. District Court for the Western District of Texas, alleging similar conduct by Texas officials and arguing that retaining and using newborn blood without parental knowledge or consent violates the U.S. and Texas Constitutions. (2) In both of these cases, families objected to the unconsented-to use of human tissue for unidentified research purposes, including genetic research. Meanwhile, on May 12, 2009, the American Civil Liberties Union filed suit against the U.S. Patent and Trademark Office ("USPTO") and Myriad Genetics, seeking to invalidate patents Myriad holds for two genes responsible for most hereditary breast and ovarian cancers. (3)

These are only a few of the most recent cases to raise claims regarding the appropriate regulation of genetic research and its results. (4) As genetic and other research involving human cells progress, similar cases--especially those addressing the nature of the rights retained by those providing the tissue used in research--are likely to arise. (5) Through genetic analysis, researchers hope to identify disease-related and other genes and to measure the frequency of such genes' occurrence across large populations. This kind of research requires population-wide bio-repositories of samples available for study. Already, more than 300 million tissue samples from more than 178 million individuals are stored in the United States, and this number has been growing by more than 20 million samples every year. (6)

Yet, as these and other recent cases suggest, individuals providing tissue for research may hesitate to do so if they fear that their interests will not be respected. (7) Tissue providers may have concerns that their cells and genetic material--materials with which they may strongly self-identify--will be used for research they find morally repugnant or about which they were not informed. Unanticipated disclosure of genetic information may negatively impact the ability of unwitting tissue providers and their close genetic relatives to obtain insurance coverage or appropriate medical treatment. (8) And tissue providers may have strong interests concerning the commercialization of their cells and genetic material, especially if they are not permitted to share in the profits. (9)

Researchers and society at large also have strong interests in how tissue is used in research. (10) Scientific research using human cells can be (and has been) immensely beneficial. (11) Inappropriate or onerous restrictions on human tissue research may negatively impact the progress of science and medicine. This concern has been clearly articulated by several courts that have faced the issue of balancing the interests of tissue providers and the interests of researchers in ongoing research. For instance, the district court in Washington University v. Catalona, (12) which recognized Washington University as the exclusive owner of disputed tissues, worried that "[m]edical research can only advance if access to these materials to the scientific community is not thwarted by private agendas. …