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Editor's Note: Towards Best Practices for Biobanking
by Margaret E. Peloso
I. INTRODUCTION
Last fall the Stanford Journal of Law, Science, & Policy was privileged to host a distinguished group of scientists, research administrators, and legal scholars for our fall symposium: Biobanking, Bioethics, and the Law. We were fortunate to benefit not only from an exciting day-long symposium but also to be joined by most of the panelists for a workshop the following day in which we discussed proposals for the development of a set of best practices for biobanking. In particular, we focused on the tension between the Office for Human Research Protections guidelines on what qualifies as research involving human subjects and our own understandings of what the informed consent process is designed to protect. Although much biobanking research does not currently fall under the protections of the Common Rule, we attempted to describe best practices that are consistent with its protections. Participants noted the wide variation in practices across institutions and we discussed potential mechanisms for standardization of practices. What follows in this Note is a summary of the views expressed on a range of issues we discussed that we believe could be used as the basis for forming best practices. While this summary does not fully encapsulate the views of all participants, I do my best to express the consensus views that emerged from our two days of discussion.
Biobanking of Blastocysts for Research To Improve Human Health: The Need for Coherent National Policy
by Susan Stayn
I. INTRODUCTION
II. FEDERAL POLICY AND UNIQUE ISSUES FOR THE BIOBANKING OF BLASTOCYSTS.
A. Federal Standards Commonly Applicable to Biobanks
B. The Application of Federal Policies to a Biobank of Blastocysts
III. A MEDLEY AND MINEFIELD OF STATE LAWS
A. Supportive States
B. Restrictive States
C. Other States
D. State Privacy Issues
IV. OPPORTUNITIES TO FACILITATE BIOBANK RESEARCH TO IMPROVE HUMAN HEALTH
I. INTRODUCTION
Almost every person in America knows someone with a health condition that is incurable. Many people have a desire to “do something” to help those with such conditions. An increasingly available option is to support medical research through the most personal of donations: providing a blood or other specimen for use in research.1 Biobanking, or the collection of human specimens such as blood, tissue, or other bodily materials for research purposes, is a common and important way to advance our understanding of human health. Banked specimens come from many sources, such as (1) patients’ families and altruistic individuals who volunteer to give blood or other specimens for research; (2) participants in clinical trials, who permit the use of their specimens for a given study and possible future
Managing Global Biospecimen and Data Collection & Placement Programs
by Christina L. DeHayes
I. TRENDS DRIVING GLOBAL EXPANSION OF BIOSPECIMEN AND DATA COLLECTION AND PLACEMENT PROGRAMS
A. Global Variability in Disease Incidence
B. Divergent Global Standards of Care
C. Regional Localization of Biospecimen Management
II. EXPANSION OF BIOSPECIMEN AND DATA COLLECTION PROGRAMS TO MULTIPLE SITES
A. Variability of Definitions in State Laws
B. Additional Regulation Arising From State Law
C. Going Global: Examining European Directives
D. Collection Program Type Influence on Multi-national Transfers of Biospecimens and Data
I. TRENDS DRIVING GLOBAL EXPANSION OF BIOSPECIMEN AND DATA COLLECTION AND PLACEMENT PROGRAMS
A. Global Variability in Disease Incidence
The legal landscape in the United States offers numerous challenges for those entities that undertake management of biospecimen and data collection and placement programs. These challenges can be amplified when such programs operate on a global scale. Global biospecimen management programs can take many forms, each of which presents unique issues that can impact the way principles of informed consent, privacy, ownership, and control of specimens are implemented. Many global biospecimen programs face these issues at the original sites of collection, which may be located in multiple countries. Many future genomic studies will likely demand that a global population be represented in the applicable biorepository. Many scientists assert that emphasizing the differences or diversity of genomes of various groups of people may reveal information about why certain populations are more susceptible to diseases than to others.1 Likewise, insight into the resistance of certain groups of people to diseases may lead to diagnostics
Biobanking on a Small Scale: Practical Considerations of Establishing a Single-Researcher Biobank
by Elena L. Grigorenko & Susan Bouregy
In this paper, practical issues of biobanking within the context of a single, relatively small project are considered. Definitions of biobanking assume the collection and storage of samples for later analysis under conditions that permit efficient retrieval and optimum sample stability. No requirements on sample size or number of studies are imposed in the definitions of biobanks. Correspondingly, a single laboratory can establish and maintain a biobank. Regardless of size and intention, a single investigator establishing a biobank faces a number of issues, including obtaining IRB approvals, developing strategies for specimen collection and optimal storage, and negotiating such issues as (1) response rates; (2) biobank size; (3) various sampling biases; (4) establishing safeguards against sample duplication and overlap with other biobanks; and (5) securing resources for sample processing and maintenance. This paper will review and comment on all of these considerations.
I. INTRODUCTION
II. DEFINITIONS OF BIOBANKS
III. “DESIGNING” A BIOBANK
A. Rates of Consenting, Donating, and Withdrawal
B. Representation of Participant Subgroups
C. Sample Storage
D. Data Sharing
VI. NAVIGATING THE INSTITUTIONAL REVIEW BOARD (IRB)
A. Collection of Samples
B. Maintenance and Subsequent Use of Biobank Specimens
V. CONTROL AND OWNERSHIP OF THE BIOBANK
VI. MAINTENANCE OF THE BANK
VII. DESTRUCTION OF THE BANK
VIII. CONCLUSION
How To Get a Fair Share: IP Policies For Publicly Supported Biobanks
by Brenda M. Simon
I. INTRODUCTION
II. ADDRESSING ACCESS TO DATA
A. Allow Patents on Genetic Information, but Limit Restrictions on Access to Data
B. Allow Patents on Correlations, but Limit Restrictions on Access to Data
III. AVAILABILITY OF PATENTED DISCOVERIES FOR EXPERIMENTAL USE
IV. BIOBANKS WITH BENEFITS
V. CONCLUSION
I. INTRODUCTION
Medicine is no longer one size fits all. Hundreds of thousands of women in the United States take tamoxifen, a drug used in breast cancer treatment with unpleasant side effects; however, a genetic test can reveal whether the drug will even work for them.1 Genetic testing might also help determine more accurately individualized dosing for the blood thinner warfarin; thousands of patients are hospitalized each year because of blood clots from an inadequate dose or internal bleeding from an overdose.2 To obtain the benefits of personalized medicine, many have argued that large-scale participation in biobanks is necessary.3 For this article, the term “biobanks” includes repositories of biological materials or the data associated with them, including genetic databases, DNA databases, tissue or biological banks, and population collections. Researchers often depend on governmental support in public biobanking.4 The terms “publicly supported biobanking” or “public biobanking” refer to biobanking research
The Perils of Taking Property Too Far
by Christopher Heaney, Julia Carbone, Richard Gold, Tania Bubela, Christopher M. Holman, Alessandra Colaianni, Tracy Lewis, Robert Cook-Deegan
I. INTRODUCTION
II. GENETIC DIAGNOSTIC TESTING & CANAVAN DISEASE
III. GENETIC DIAGNOSTIC TESTING FOR INHERITED BREAST AND OVARIAN CANCER (“BRCA”)
IV GOING PUBLIC: MEDIA ACCOUNTS OF MYRIAD GENETICS
V. LESSONS FROM THE UNIVERSITY
VI. BIOBANKS’ OBLIGATIONS
VII. INVOLVING AFFECTED CONSTITUENCIES IN DECISION-MAKING
VIII. PARTICIPATION IN THE GENOMIC AGE
IX. CONCLUSION
I. INTRODUCTION
Many policies governing biobanks revolve around ownership and control of the materials and information in them. Those who manage biobanks may be tempted to seek the broadest legal rights possible over material and data. However, we suggest that even if ownership and control were clearly defined by the law and readily obtained by biobanks, how legal rights are used in practice matters as much or more than the rules for ownership. We draw lessons from cases in genetic testing where the use or assertion of legal rights led to preventable controversy and suboptimal outcomes. In the cases we describe, the attempt to acquire and exercise intellectual property rights antagonized and alienated stakeholders, who we define broadly to include the donors, patients, doctors, research institutions, health care providers, governments,