Freeing archival research from the accidental and overbearing IRB regulation that costs human lives.

Author:Briggs, William K.
Position::Institutional review boards - I. Introduction through III. Regulation of Archival Research, p. 237-270
 
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  1. INTRODUCTION

    Few kinds of biomedical research have contributed more and can contribute more to saving human lives and protecting human health than "archival research." Several kinds of medical institutions, such as biobanks, have stored samples of human tissue, blood, urine, saliva, and other biological material, often with associated health and demographic data. (1) With over 300,000,000 such specimens stored in the U.S. in over 150 biobanks, researchers can examine large populations and see otherwise invisible patterns. (2) The result is "faster, cheaper, and better research," (3) which society depends upon for such medical advances as the discovery of the underlying molecular basis for diseases, more efficient development of drugs, and the uncovering of personalized treatment and prevention methods. (4) After all, this is the type of research which allowed Richard Doll and A. Bradford Hill to detect the link between cigarette smoking and lung cancer much earlier than would otherwise have been possible. (5)

    Archival research has another benefit. Unlike some kinds of biomedical research, it does not put human bodies at risk. (6) Yet this exceptionally safe research has come to be regulated just as fiercely as the most dangerous research with human beings. (7) Indeed, it has become regulated so fiercely that archival research--research which is at the forefront of finding a cure for society's most hated diseases and cancers--is routinely impeded, impaired, and even made impossible. (8) Institutional review boards ("IRBs"), hospital and university committees with unreviewable discretion, are at the forefront of this overregulation. (9)

    Two such restrictions frequently implemented by IRBs are the right to withdraw and mandatory re-consent for future research. (10) The right to withdraw allows donors to withdraw their tissue and fluids from studies whenever they wish and no matter the cost. (11) Such a requirement results in selection bias and statistical significance problems that can kill the usefulness of this beneficial scientific research. (12) Similar problems are presented by re-consent, a requirement that forces researchers to obtain repeated consent from prior donors for each new use of their material, no matter how impractical it is to seek them out. (13) Such a requirement not only runs contrary to the wishes of the vast majority of donors, but also consumes valuable resources in tracking down donors and creates disincentives to starting new research projects using already gathered material. (14)

    While there is no particular regulation at fault for these two practices, scholarship and biobank consent forms reveal a strong pattern of practice. (15) The right to withdraw and re-consent is often viewed by scholars, and IRBs themselves, as essential features of the IRB's job of regulating archival research. (16) Unfortunately, the costs of such regulations have to be counted in human lives. (17) In the United Kingdom, for example, it is estimated that tens of thousands of lives are lost every year because regulations, such as the right to withdraw, prevent medical researchers from obtaining the patient data necessary for large population-scale studies. (18)

    Unfortunately, these costly restrictions on this valuable research serve little purpose. (19) The "regulationists" who advocate them suggest that the right to withdraw and mandatory re-consent protect the autonomy and privacy of donors, as well as their dignitary interests. (20) Yet while these interests are of great importance, they are not promoted by these regulations; donors stand only the most trivial chance of losing their privacy, and this interest is already protected by a multitude of statutes and regulations. (21) As for autonomy and dignity, these restrictions actually cause harm to these interests. (22) Donors, the overwhelming majority of whom desire to provide unrestricted use of their material, are prevented from freely contracting to waive the right to withdraw or the need for future re-consent. (23)

    As a result, society is left with restrictions, which harm and even prevent the research it depends upon for the saving of lives and protection of health, without receiving any compensating benefits. It is time to free archival research--and society itself--from these restrictions.

  2. VALUE OF ARCHIVAL RESEARCH

    It is important to start by explaining the value of archival research. Answering the questions of why and how this research means so much to society sets the stage for quantifying just how damning the right to withdraw and mandatory re-consent are. (24) The "why" is explained by the both the nature of archival material--its composition, source, and ability to be stored--and the nature of research on this material--cheap and risk-free. (25) To answer the "how," one need not look further than archival research's continuing track record of catalyzing medical advances across an array of fields. (26)

    1. Why is it so Valuable?

      It is uniqueness which makes archival material so useful to researchers. From the breadth of its composition and the nature of its sources to its ability to be preserved long-term, archival material permits valuable research otherwise impossible. (27) But not only does archival material make this research possible, it also allows for such research to be risk-free to the donors and incomparably cheap. (28)

      Consider first the virtues of the material studied. To start with, archival material allows researchers to study large populations of biological samples along with associated health and demographic data. (29) The breadth of samples available, even in the United States alone, is only limited by the extent of the human body. (30) Tissue samples, both those healthy and those ravaged by diseases and various forms of cancer, are available for any organ in the body. (31) The same is true for a diverse range of stem cells, such as embryonic, dental, and cord. (32) Urine, bones, marrow, protein, blood cells, plasma, platelets, teeth--basically anything biological--can all be found. (33) And samples available are as small as cell lines and DNA, and as large as eyes and brains. (34)

      But not only do biobanks preserve this wide array of biological samples, they also preserve individualized data for each. (35) Each sample is associated with loads of information regarding the donor, including medical and family history, demographic information--age, sex, occupation, residence, body fat, bone density, etc.--, and behavioral data such as smoking, prescription drug use, exercise tendencies, and sleeping habits. (36) Combining the large numbers of samples with this associated data allows archival research to take on unmatched depth. (37)

      The breadth of samples and information available is especially valuable because studies are not limited to tissue and data within a single laboratory. (38) Instead researchers can bring together samples from multiple archives, making possible studies that extend worldwide and reach staggering population sizes. (39) The numbers of samples involved in such archival research can be staggering. (40) For example, the U.K. Biobank recruited over 500,000 volunteers who provided over 1,000,000 samples of blood, urine, and saliva, along with detailed personal information resulting from physical tests and personal interviews. (41) Similarly, the Coriell Personalized Medicine Collaborative, a United States Air Force initiative, aims to enroll at least 100,000 donors to provide saliva samples. (42)

      This ability to aggregate large, diverse populations, not only through access to biological samples but also associated data, makes possible otherwise impossible scientific discoveries. (43) These large numbers allow researchers to see patterns that would otherwise be invisible. (44) For example, with enough samples researchers can pick out the gene profiles of those suffering from a certain disease and begin to screen other individuals for such profiles, potentially allowing for discovery of the disease in individuals at an earlier stage. (45) With such early discovery, it opens up the "next generation of treatments for disease" by allowing for more aggressive and more effective treatment. (46) But, without access to samples from as large and diverse a group of individuals as possible, this type of research, and this "next generation of treatment," is not possible. (47)

      But the value of archival material extends beyond its breadth. (48) It also comes from its sources: waste generated in the ordinary course of hospital care and generous...

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