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Contents - JLME - 2012 Volume 40: 4
Table of Contents
  1. Table Of Contents
Letter From The Editor
  1. Letter From The Editor
Introduction
  1. Introduction: The Challenge of Nanomedicine Human Subjects Research: Protecting Participants, Workers, Bystanders, and the Environment
  2. Introduction: Research Ethics: Reexamining Key Concerns
Symposium Articles
  1. Recommendations for Nanomedicine Human Subjects Research Oversight: An Evolutionary Approach for an Emerging Field
  2. An Empirical Examination of the Current State of Publically Available Nanotechnology Guidance Materials
  3. A Portrait of Nanomedicine and Its Bioethical Implications
  4. What Is Unique About Nanomedicine? The Significance of the Mesoscale
  5. Toward Correlation in In Vivo and In Vitro Nanotoxicology Studies
  6. Building an Ethical Foundation for First-in-Human Nanotrials
  7. Concepts of Risk in Nanomedicine Research
  8. Nanomedicine First-in-Human Research: Challenges for Informed Consent
  9. Prudent Precaution in Clinical Trials of Nanomedicines
  10. Beyond Human Subjects: Risk, Ethics, and Clinical Development of Nanomedicines
  11. Responsible Conduct in Nanomedicine Research: Environmental Concerns Beyond the Common Rule
  12. Handling Worker and Third-Party Exposures to Nanotherapeutics During Clinical Trials
  13. Bad Blood Thirty Years Later: A Q&A with James H. Jones
  14. The Troubling Persistence of Race in Pharmacogenomics
  15. Ethical Dimensions of Disparities in Depression Research and Treatment in the Pharmacogenomic Era
  16. Practical Steps to Community Engaged Research: From Inputs to Outcomes
  17. Alive and Well: The Research Imperative
  18. Revolution or Reform in Human Subjects Research Oversight
  19. A Non-Paternalistic Model of Research Ethics and Oversight: Assessing the Benefits of Prospective Review
  20. Questions Concerning the Clinical Translation of Cell-Based Interventions under an Innovation Pathway
  21. IRB Decision-Making with Imperfect Knowledge: A Framework for Evidence- Based Research Ethics Review
  22. In Plain Sight: A Solution to a Fundamental Challenge in Human Research
  23. More Than Cheating: Deception, IRB Shopping, and the Normative Legitimacy of IRBs
  24. Rethinking Local Institutional Review Board (IRB) Review at State Health Departments: Implications for a Consolidated, Independent Public Health IRB
  25. What Research Ethics Should Learn from Genomics and Society Research: Lessons from the ELSI Congress of 2011
Independent Articles
  1. Medication Information for Patients with Limited English Proficiency: Lessons from the European Union
Columns
  1. Public Health and Law: A Modern Survey on Teaching Public Health Law in the United States
  2. Currents in Contemporary Bioethics: Identifying Consanguinity through Routine Genomic Analysis: Reporting Requirements
Table of Contents
Table Of Contents
ASLME - [PDF] (Free Download)
THE JOURNAL OF LAW, MEDICINE & ETHICS CONTENTS VOLUME 40:4 WINTER 2012 712 Introduction: The Challenge of Nanomedicine Human Subjects Research: Protecting Participants, Workers, Bystanders, and the Environment - Susan M. Wolf
Letter From the Editor
Letter From The Editor
ASLME - [PDF]

Well, the Journal of Law, Medicine & Ethics is now officially over the hill. With this issue, we mark the end of the 40th volume of publication of JLME and the end of the 40th year anniversary of our organization's re-charting as the American Society of Law, Medicine & Ethics. It has indeed been an exciting and wildly successful year. Among many other initiatives, we hosted two national academic conferences, including the Public Health Law conference in October, which was attended by more than 500 people, and our annual Health Law Professors conference in June. We also co-hosted numerous webinars and other educational programs. Next year will be another busy one for ASLME, as we have a number of new conferences and programs planned.
Introductions
Introduction: The Challenge of Nanomedicine Human Subjects Research: Protecting Participants, Workers, Bystanders, and the Environment
Susan M. Wolf - [PDF]

The growing capacity to build and manipulate materials at the nanoscale is both thrilling and challenging. Engineering at the level of atoms allows much needed problem-solving and innovation, but also raises questions about how to assess the effects and safety of the materials created. The promise and the challenge are especially acute in the domain of nanomedicine. Nanotherapeutics and in vivo nanodiagnostics (diagnostics used within the human body) have the potential to solve long-standing problems, including how to ferry drugs across the blood brain barrier to treat brain tumors, how to find and destroy tiny micrometastases before cancer progresses, and how to transport corrective genes into human cells without the dangers of viral vectors. But none of these applications is possible without first testing the safety and efficacy of these interventions in human beings. And human subjects research in nanomedicine raises fundamental questions.
Introduction: Research Ethics: Reexamining Key Concerns
Nancy M. P. King and Ana S. Iltis - [PDF]

The year 2011 marked, among other things, the 30-year anniversary of the publication of Bad Blood: The Tuskegee Syphilis Experiment; revelations about the United States Public Health Service/Tuskegee study that infected mental patients and prisoners in Guatemala with syphilis in the late 1940s in order to determine the efficacy of treatment; and the promulgation of an Advance Notice of Proposed Rulemaking to amend 45 CFR Part 46, the U.S. Department of Health and Human Servicesí core set of regulations governing research with human subjects. These key events served as the impetus for the reexamination of research ethics that the papers in this symposium represent.
Symposium Articles
Recommendations for Nanomedicine Human Subjects Research Oversight: An Evolutionary Approach for an Emerging Field
Leili Fatehi, Susan M. Wolf, Jeffrey McCullough, Ralph Hall, Frances Lawrenz, Jeffrey P. Kahn, Cortney Jones, Stephen A. Campbell, Rebecca S. Dresser, Arthur G. Erdman, Christy L. Haynes, Robert A. Hoerr, Linda F. Hogle, Moira A. Keane, George Khushf, Nan - [PDF]

The nanomedicine field is fast evolving toward complex, "active," and interactive formulations. Like many emerging technologies, nanomedicine raises questions of how human subjects research (HSR) should be conducted and the adequacy of current oversight, as well as how to integrate concerns over occupational, bystander, and environmental exposures. The history of oversight for HSR investigating emerging technologies is a patchwork quilt without systematic justification of when ordinary oversight for HSR is enough versus when added oversight is warranted. Nanomedicine HSR provides an occasion to think systematically about appropriate oversight, especially early in the evolution of a technology, when hazard and risk information may remain incomplete. This paper presents the consensus recommendations of a multidisciplinary, NIH-funded project group, to ensure a sciencebased and ethically informed approach to HSR issues in nanomedicine, and to integrate HSR analysis with analysis of occupational, bystander, and environmental concerns. We recommend creating two bodies, an interagency Human Subjects Research in Nanomedicine (HSR/N) Working Group and a Secretary's Advisory Committee on Nanomedicine (SAC/N). HSR/N and SAC/N should perform 3 primary functions: (1) analysis of the attributes and subsets of nanomedicine interventions that raise HSR challenges and current gaps in oversight; (2) providing advice to relevant agencies and institutional bodies on the HSR issues, as well as federal and federal-institutional coordination; and (3) gathering and analyzing information on HSR issues as they emerge in nanomedicine. HSR/N and SAC/N will create a home for HSR analysis and coordination in DHHS (the key agency for relevant HSR oversight), optimize federal and institutional approaches, and allow HSR review to evolve with greater knowledge about nanomedicine interventions and greater clarity about attributes of concern.
An Empirical Examination of the Current State of Publically Available Nanotechnology Guidance Materials
Laura Fleege and Frances Lawrenz - [PDF]

As part of "Nanodiagnostics and Nanotherapeutics: Building Research Ethics and Oversight," an empirical search was conducted to identify publicly available resources that guided understanding about human subjects issues in nanomedicine or nanotechnology including policy statements, guidance documents, or consent forms. The authors conducted 5,083 internet searches and analyzed 175 documents. Results show that very little guidance is publicly available and most documents focused on occupational and environmental concerns.
A Portrait of Nanomedicine and Its Bioethical Implications
Rebecca M. Hall, Tony Sun, and Mauro Ferrari - [PDF]

This review addresses the current and future potential of nanomedicine, and its ethical considerations within the comprehensive framework of the four dimensions of medical ethics: Beneficence, Non-Maleficence, Respect, and Justice. From this perspective, the ethical considerations for nanomedicine are not novel, but have been addressed by precedents throughout the history of medicine. While these ethical challenges are not unique to nanomedicine, some require additional consideration, given the envisioned pervasive impact of nanomedicine on society.
What Is Unique About Nanomedicine? The Significance of the Mesoscale
George Khushf and Ronald A. Siegel - [PDF]

Unlike drugs and medical devices, for which long standing and continuously improving quality assurance/quality control infrastructures exist, many nano-based products lack well-defined standards that are useful to manufacturers and regulators. Inherent variabilities in nanoparticle sizes and shapes, their large surface-to-volume ratios, and their mesoscale interactions with subcellular structures, suggest new complexities and challenges that must be met before widespread application of nanomedicines can be expected.
Toward Correlation in In Vivo and In Vitro Nanotoxicology Studies
Melissa A. Mauer-Jones and Christy L. Haynes - [PDF]

Nanomaterials have the promise of revolutionizing current treatment and diagnosis of diseases, which has led to 33 nanotherapeutics drugs currently on the market and many more in various stages of clinical trials. With an increasing number of products available and in development, along with the unique, emergent properties of the nanoparticle therapeutics themselves, regulatory agencies are now faced with decisions regarding the regulation of such novel technologies. Regulatory guidance, particularly in pre-clinical stages, has the potential to facilitate quick and safe development of these novel materials, but new regulation beyond what is currently in place must be justified in a clear and distinctive toxic response. Herein, we examine literature that compares and correlates in vivo and in vitro nanotoxicity studies to gain a deeper understanding of the modes of nanoparticle toxicity. Additionally, this comparison aims to identify clear and unique toxicity responses caused by nanoparticles, which informs our perspective on pre-clinical nanotherapeutic oversight.
Building an Ethical Foundation for First-in-Human Nanotrials
Rebecca Dresser - [PDF]

Novel nanomedical interventions require human testing to evaluate their safety and effectiveness. To establish a proper evidentiary basis for human trials, nanomedical innovations must first be subjected to animal and other laboratory testing. But it is uncertain whether the traditional laboratory approaches to safety evaluation will supply adequate information on nanotechnology risks to humans. This uncertainty, together with other features of nanomedical innovation, heightens the ethical challenges in conducting FIH nanotrials.
Concepts of Risk in Nanomedicine Research
Linda F. Hogle - [PDF]

Risk takes center stage in ethical debates over nanomedical technologies. Yet concepts of risk may hold different meanings, and they are embedded within particular political, economic, and social contexts. This article discusses framings of risk in debates over medical innovations such as nanomedicine, and draws attention to organizational and institutional forms of risk which are less visible in bioethical policy debates. While significant, possibly unique risks may exist in specific nano-based products, risk may also arise from the very processes and procedures that develop, test, and oversee any novel technology. This supports recommendations to coordinate efforts through an interagency Working Group and a Secretary-level Advisory Committee to provide flexibility and sensitivity to emerging issues of concern.
Nanomedicine First-in-Human Research: Challenges for Informed Consent
Nancy M. P. King - [PDF]

Risks of harm, translational uncertainty, ambiguities in potential direct benefit, and long-term follow-up merit consideration in first-in-human research. Some nanomedical technologies have additional characteristics that should be addressed, including: defining and describing nanomedical interventions; bystander risks; the therapeutic misconception; and a decision-making context that includes both common use of nanomaterials outside medicine and persistent unknowns about the effects of nanosize. This paper considers how to address these issues in informed consent to first-in-human nanomedicine research.
Prudent Precaution in Clinical Trials of Nanomedicines
Gary E. Marchant and Rachel A. Lindor - [PDF]

Clinical trials of nanotechnology medical products present complex risk management challenges that involve many uncertainties and important risk-risk trade-offs. This paper inquires whether the precautionary principle can help to inform risk management approaches to nanomedicine clinical trials. It concludes that prudent precaution may be appropriate for ensuring the safety of such trials, but that the precautionary principle itself, especially in its more extreme forms, does not provide useful guidance for specific safety measures.
Beyond Human Subjects: Risk, Ethics, and Clinical Development of Nanomedicines
Jonathan Kimmelman - [PDF]

Clinical testing of nanomedicines presents two challenges to prevailing, human subject-centered frameworks governing research ethics. First, some nanomedical applications may present risk to persons other than research subjects. Second, pressures encountered in testing nanomedicines may present threats to the kinds of collaborations and collective activities needed for supporting clinical translation and redeeming research risk. In this article, I describe how similar challenges were encountered and addressed in gene transfer, and sketch policy options that might be explored in the nanomedicine translation arena.
Responsible Conduct in Nanomedicine Research: Environmental Concerns Beyond the Common Rule
David B. Resnik - [PDF]

Nanomedicine research raises ethical concerns beyond those covered by the Common Rule. Investigators and research institutions should comply with environmental and occupational health laws protect research staff and the environment. Though the IRB should concentrate on risks to human research participants, it should also consider risks to identifiable third parties. Investigators should also address risks to identifiable third parties. Professional and governmental organizations should deal with the long-term social, ethical, and environmental consequences of nanomedicine.
Handling Worker and Third-Party Exposures to Nanotherapeutics During Clinical Trials
Gurumurthy Ramachandran, John Howard, Andrew Maynard, and Martin Philbert - [PDF]

The article focuses on issues relating to occupational exposures of researchers and lab workers, and exposures of bystanders such as health care workers and family members during HSR using nanomaterials. Such third-party exposures give rise to unique challenges relating to oversight as well as exposures to worker groups not previously studied. Given the current state of knowledge regarding health risks from such exposures, a more precautionary approach to oversight seems advisable.
Bad Blood Thirty Years Later: A Q&A with James H. Jones
James H. Jones and Nancy M. P. King - [PDF]

Historian James H. Jones published the first edition of Bad Blood, the definitive history of the Tuskegee Syphilis Experiment, in 1981.1 Its clear-eyed examination of that research and its implications remains a bioethics classic, and the 30-year anniversary of its publication served as the impetus for the reexamination of research ethics that this symposium presents. Recent revelations about the United States Public Health Service study that infected mental patients and prisoners in Guatemala with syphilis in the late 1940s in order to determine the efficacy of treatment2 represent only one of the many attestations to the persistence of ongoing, critical, and underaddressed issues in research ethics that Bad Blood first explored. Those issues include, but are not limited to: the complex and contested matters of the value of a given research question, the validity of the clinical trial designed to address it, and the priorities of science; the therapeutic misconception, especially in the context of health disparities, poverty, and deprivation; the many varieties of vulnerability in research relationships, which extend far beyond vulnerable populations of potential subjects; and the irreducible complexity of the relationship between science and society.
The Troubling Persistence of Race in Pharmacogenomics
Jonathan Kahn - [PDF]

This article is concerned about what may be happening to race and medicine in the "meantime" between today's clinical realities and the promised land of pharmacogenomics where the need for using race in medicine is supposed to fade away. It argues that previous debates over the use of race in medicine are being side-stepped as race is being reconfigured from a "crude surrogate" for genetic variation into a purportedly viable placeholder for variable drug response - to be used here and now until the specific genetic underpinnings of drug response are more fully understood. Embracing the trope of "promise" in pharmacogenomics alongside the idea of using race as a useful interim proxy for genetic variation raises concerns that new diagnostic and therapeutic interventions may reflect or be mapped upon existing social categories of race, class, gender, and ethnicity in a harmful or dangerous manner. At the most basic level, the politics of the meantime in pharmacogenomics may be promoting the scientifically unjustified and socially dangerous recasting of race as a social and historical construct into a reified genetic category.
Ethical Dimensions of Disparities in Depression Research and Treatment in the Pharmacogenomic Era
Lisa S. Parker and Valerie B. Satkoske - [PDF]

Disparities in access to, and utilization of, treatment for depression among African-American and Caucasian elderly adults have been well-documented. Less fully explored are the multidimensional factors responsible for these disparities. The intersection of cultural constructs, socioeconomic factors, multiple levels of racism, and stigma attending both mental health issues and older age may help to explain disparities in the treatment of the depressed elderly. Personalized medicine with its promise of developing interventions tailored to an individualís health needs and genetically related response to treatment might seem a promising antidote to the documented underutilization of standard depression treatments by African Americans. However, this paper examines the multidimensional factors associated with disparities in effective treatment of depression among African-American and Caucasian elderly adults and argues the scientific and ethical importance of pursuing various paths to address multiple levels and sources of stigma and mistrust if pharmacogenomics is to help, rather than exacerbate, disparities in depression treatment. Seven recommendations are offered to increase the likelihood that developments in pharmacogenomics will reduce disparities in depression treatment.
Practical Steps to Community Engaged Research: From Inputs to Outcomes
Giselle Corbie-Smith and Malika Roman Isler - [PDF]

For decades, the dominant research paradigm has included trials conducted in clinical settings with little involvement from communities. The move toward community engaged research (CEnR) necessitates the inclusion of diverse perspectives to address complex problems. Using a relationship paradigm, CEnR reframes the context, considerations, practical steps, and outcomes of research.
Alive and Well: The Research Imperative
Rebecca Dresser - [PDF]

Many features of the existing biomedical research enterprise rest on questionable judgments about the value of research. Policymakers and research ethicists make assumptions about research value that arenít necessarily warranted. A more balanced view of research value could contribute to more defensible decisions about research policy and practice.
Revolution or Reform in Human Subjects Research Oversight
Steven Joffe - [PDF]

The contemporary system of prospective oversight of human subjects research has been criticized as inefficient and ineffective. Plausible approaches to research oversight range from no prospective review, to review-and-comment, to the current review-and-approve regime. Articulating this spectrum offers an opportunity to consider systematically the strengths and disadvantages of each.
A Non-Paternalistic Model of Research Ethics and Oversight: Assessing the Benefits of Prospective Review
Alex John London - [PDF]

This paper offers a non-paternalistic justification for prospective research review as providing a credible social assurance that the institutions of scientific advancement respect and affirm the moral equality of all community members and as creating a "market" in which stakeholders working to advance diverse ends also advance the common good.
Questions Concerning the Clinical Translation of Cell-Based Interventions under an Innovation Pathway
Jeremy Sugarman - [PDF]

Stem cell-based innovation is one pathway to clinical translation that stands in contrast to clinical research and medical treatment. After reviewing recently issued guidelines for responsible innovation, this article examines the potential benefits and harms of using this pathway as well as practical barriers and conceptual concerns regarding it.
IRB Decision-Making with Imperfect Knowledge: A Framework for Evidence- Based Research Ethics Review
Emily E. Anderson and James M. DuBois - [PDF]

Here we describe the five steps of evidence-based practice as applied to research ethics review and apply these steps to three exemplar dilemmas: incentive payments in substance abuse research; informed consent for biobanking; and placebo-controlled trials involving pregnant women in order to demonstrate the potential of empirical data to inform and improve IRB decision-making.
In Plain Sight: A Solution to a Fundamental Challenge in Human Research
Lois Shepherd and Margaret Foster Riley - [PDF]

The physician-researcher conflict of interest has thus far eluded satisfactory solution. Most attempts to deal with it focus on improving informed consent. But those attempts are not successful and may even make things worse. Research subjects are already voluntarily undertaking the risks of research - we should not ask them to go it alone - to undergo medical "treatment" without medical "care." The only effective solution is that in much clinical research, each research subject should have a doctor independent from the research study.
More Than Cheating: Deception, IRB Shopping, and the Normative Legitimacy of IRBs
Ryan Spellecy and Thomas May - [PDF]

Deception, cheating, and loopholes within the IRB approval process have received significant attention in the past several years. Surveys of clinical researchers indicate common deception ranging from omitting information to outright lying, and controversy surrounding the FDA's decision not to ban "IRB shopping" (the practice of submitting protocols to multiple IRBs until one is found that will approve the protocol) has raised legitimate concerns about the integrity of the IRB process. While at first blush these practices seem to cast aspersions on the integrity of clinical researchers, the moral issues raised go deeper than the ethics of cheating. To the extent that these practices are common, or represent an IRB system that places unreasonable burdens on those seeking IRB approval, we should consider whether non-compliance reflects problems of normative legitimacy for the IRB system itself.
Rethinking Local Institutional Review Board (IRB) Review at State Health Departments: Implications for a Consolidated, Independent Public Health IRB
David Perlman - [PDF]

A number of unique problems plague human research protection efforts at United States (U.S.) State and Territorial Departments of Health (DOHs) problems which might be ameliorated through a consolidated national or regional, independent, not-for-profit Institutional Review Board (IRB).
What Research Ethics Should Learn from Genomics and Society Research: Lessons from the ELSI Congress of 2011
Gail E. Henderson, Eric T. Juengst, Nancy M. P. King, Kristine Kuczynski, and Marsha Michie - [PDF]

Research on the ethical, legal, and social implications (ELSI) of human genomics has devoted significant attention to the research ethics issues that arise from genomic science as it moves through the translational process. Given the prominence of these issues in today's debates over the state of research ethics overall, these studies are well positioned to contribute important data, contextual considerations, and policy arguments to the wider research ethics community's deliberations, and ultimately to develop a research ethics that can help guide biomedicine's future. In this essay, we illustrate this thesis through an analytic summary of the research presented at the 2011 ELSI Congress, an international meeting of genomics and society researchers. We identify three pivotal factors currently shaping genomic research, its clinical translation, and its societal implications: (1) the increasingly blurred boundary between research and treatment; (2) uncertainty - that is, the indefinite, indeterminate, and incomplete nature of much genomic information and the challenges that arise from making meaning and use of it; and (3) the role of negotiations between multiple scientific and non-scientific stakeholders in setting the priorities for and direction of biomedical research, as it is increasingly conducted "in the public square."
Independent Articles
Medication Information for Patients with Limited English Proficiency: Lessons from the European Union
Marsha Regenstein, Ellie Andres, Dylan Nelson, Stephanie David, Ruth Lopert, and Richard Katz - [PDF]

Misuse or misunderstanding of medication information is a common and costly problem in the U.S. The risks of misunderstanding medication information are compounded for the large and growing population of individuals with limited English proficiency that often lacks access to this information in their own language. This paper examines practices related to translation of medication information in the European Union that may serve as a model for future U.S. policy efforts to improve the quality and availability of medication information for individuals with limited English proficiency.
Columns
Public Health and Law: A Modern Survey on Teaching Public Health Law in the United States
James G. Hodge, Jr. - [PDF]

Major advances, ground-breaking scholarship, and new programs in public health law over the past several decades have helped define and reform the field. The extent to which public health law is established as a distinct topic for graduate academic study, however, is uncertain. In the early 1990s, the numbers of academics whose work focused largely on public health law were few. Only a handful of schools of law, public health, and medicine regularly offered core courses in public health law (although many graduate courses in health law, bioethics, or public health policy featured select public health law topics). Collectively, these courses laid a strong foundation of instruction in public health law. Still, questions remain as to whether public health law has progressed as a topic of academic pursuit in American graduate institutions. Who is teaching core courses in public health law? Where are these courses taught? How are they designed and what specific topics are covered?
Currents in Contemporary Bioethics: Identifying Consanguinity through Routine Genomic Analysis: Reporting Requirements
Amy L. McGuire, Melody J. Wang, and Frank J. Probst - [PDF]

Increasingly, genomic analysis is being utilized to diagnose children with developmental delay or dysmorphic facial features suggestive of a congenital disorder. Genetic testing has rapidly evolved, and the genome-wide tests that we use today are significantly different from the more targeted single-gene tests of the last decade. Chromosomal microarray analysis (CMA) is now a first line test for children with multiple birth defects, children with intellectual impairment (including autism), and children with an unusual constellation of symptoms that do not fit with a known disease.1 There are three types of CMA that are currently clinically available. CMA by oligonucleotide array-based comparative genomic hybridization (aCGH) compares the hybridization signal from the patientís DNA to that of a reference DNA sample for each oligonucleotide on the array. Depending on the specific array, this can range from tens of thousands to hundreds of thousands of oligonucleotides. A relative loss of signal from the patientís DNA is interpreted as a deletion, whereas a relative gain is interpreted as a duplication (or, in rare cases, a triplication or quadruplication). aCGH can detect very small losses or gains of DNA and typically uncovers genetic abnormalities in about 10-20% of cases.2 CMA by single nucleotide polymorphism (SNP) analysis uses a completely different technology to genotype the individual at hundreds of thousands to millions of single nucleotides that are commonly polymorphic in the genome. Gains and losses of DNA are detected by relative increases or decreases of the signal at each SNP relative to the other SNPs on the array, as well as by the specific genotypes seen at SNPs that are located in tandem in the genome.3 Like aCGH, SNP analysis will detect losses or gains of DNA, but it will sometimes miss very small changes that aCGH can detect. However, SNP analysis, unlike aCGH, can also detect areas where chromosome pairs or parts of the chromosome pairs are identical to one another. Most recently, hybrid arrays have been developed that combine both technologies into a single test.