Ethical Issues in Secondary Uses of Human Biological Materials from Mass Disasters

This paper addresses the ethical issues of secondary uses of samples collected for identification purposes following mass disasters. It studies norms governing secondary use of samples (general/deceased/vulnerable), ultimately concluding that limited secondary research uses of these samples should be permissible.     

The governance of human genetic research databases in mental health research

The field of mental health offers a valuable context in which to examine new challenges presented by human genetic research databases to the legal, ethical and regulatory frameworks for human genetic research. Longitudinal prospective genetic research of psychiatric disorders often involves access to human genetic research databases and to stored tissue for future uses that cannot be specified at the time the patient consents to their collection. The potential of such research to contribute to an improved understanding and treatment of complex genetic diseases such as schizophrenia presupposes sound ethical, legal and regulatory frameworks to ensure public trust and preparedness to participate in such research. This article provides a brief overview of some of the ethical and legal challenges posed by human genetic research databases and their implications for how genetic research should be conducted in the field of mental health.     

Dealing with allelic dropout when reporting the evidential value in DNA relatedness analysis

A method is suggested that allows the use of loci that have shown allelic dropout in kinship analysis as used for disaster victim identification (DVI) and missing person work (MP). This approach uses an extension of a previously published approach to modelling allelic dropout. This method may salvage some information in cases where allelic dropout is hindering DVI or MP work particularly in reconciliations involving a large number of bodies and pedigrees. It should not replace the pursuit of more complete DNA profiles by the normal rework process for such samples.     

Dealing with allelic dropout when reporting the evidential value in DNA relatedness analysis

A method is suggested that allows the use of loci that have shown allelic dropout in kinship analysis as used for disaster victim identification (DVI) and missing person work (MP). This approach uses an extension of a previously published approach to modelling allelic dropout. This method may salvage some information in cases where allelic dropout is hindering DVI or MP work particularly in reconciliations involving a large number of bodies and pedigrees. It should not replace the pursuit of more complete DNA profiles by the normal rework process for such samples.     

Advanced evidence collection and analysis of web browser activity

A Web browser is an essential application program for accessing the Internet. If a suspect uses the Internet as a source of information, the evidence related to the crime would be saved in the log file of the Web browser. Therefore, investigating the Web browser’s log file can help to collect information relevant to the case. After considering existing research and tools, this paper suggests a new evidence collection and analysis methodology and tool to aid this process.     

The genomic data deficit: On the need to inform research subjects of the informational content of their genomic sequence data in consent for genomic research

Research subject consent plays a significant role in the legitimation of genomic research in Europe – both ethically and legally. One key criterion for any consent to be legitimate is that the research subject is ‘informed’. This criterion implies that the research subject is given all relevant information to allow them to decide whether engaging with a genomic research infrastructure or project would be normatively desirable and whether they wish to accept the risks associated with engagement. This article makes the normative argument that, in order to be truly ‘informed’, the research subject should be provided with information on the informational content of their genomic sequence data. Information should be provided, in the first instance, prior to the initial consent transaction, and should include: information on the fact that genomic sequence data will be collected and processed, information on the types of information which can currently be extracted from sequence data and information on the uncertainties surrounding the types of information which may eventually be extractable from sequence data. Information should also be provided, on an ongoing basis, as relevant and necessary, throughout the research process, and should include: information on novel information which can be extracted from sequence data and information on the novel uses and utility of sequence data. The article argues that current elaborations of ‘informed’ consent fail to adequately address the requirements set out in the normative argument and that this inadequacy constitutes an issue in need of a solution. The article finishes with a set of observations as to the fora best suited to deliver a solution and as to the substantive content of a solution.     

Cultural Challenges to Biotechnology: Native American Genetic Resources and the Concept of Cultural Harm

This article examines the intercultural context of issues related to genetic research on Native peoples. In particular, the article probes the disconnect between Western and indigenous concepts of property, ownership, and privacy, and examines the harms to Native peoples that may arise from unauthorized uses of blood and tissue samples or the information derived from such samples. The article concludes that existing legal and ethical frameworks are inadequate to address Native peoples' rights to their genetic resources and suggests an intercultural framework for accommodation based on theories of intergroup equality and fundamental human rights.     

傅里叶显微红外光谱成像技术研究进展及其法医学应用

傅里叶显微红外光谱成像技术可收集微小物体的红外光谱信息,针对组织切片和细胞进行扫描,记录选择区域像素位点的红外光谱信息,并通过计算机软件构建出组织和细胞中光谱吸收峰的二维和三维光谱映射图像.由于红外光谱对生物大分子的敏感性,通过该技术可以有效分析组织和细胞的生化构成、分子分布、代谢变化.本文阐述了傅里叶显微红外光谱成像...     

Dissemination of information on unapproved/new uses for marketed drugs, biologics, and devices--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to issue new regulations pertaining to the dissemination of information on unapproved uses (also referred to as "new uses" and "off-label uses") for marketed drug, including biologics, and devices. The proposal, which would implement the dissemination provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA), would describe the content of and establish procedures for a manufacturer's submissions to FDA before it may begin disseminating information on the new use. The proposal also would describe how manufacturers seeking to disseminate new use information must agree to submit a supplement for that use within a specified period of time, unless a supplemental application already has been submitted or FDA has exempted the manufacturer from the requirement to submit a supplement. The proposal also would provide for requests to extend the time period for submitting a supplement for a new use, and it would describe how a manufacturer can seek an exemption from the requirement to submit a supplement. Additionally, the proposal would discuss FDA actions in response to manufacturer's submissions, corrective actions that FDA may take, and recordkeeping and reporting requirements.     

Using market research to convert federal technology into marketable products

This paper discusses the need for a new market-research strategy to ensure timely applications of federally-developed technology in the private sector. It emphasizes the use of market research to facilitate the conversion of new technology into marketable new products and to guide decisions regarding future directions for technology research. Market research is a widely used source of information in the private sector, but historically it has been excluded from federal research programs.     

Case commentary: anonymisation is not exoneration

This case commentary analyses a ruling that any use of information given in confidence for unconsented purposes is a breach of confidence capable of supporting a legal action (even if the information has previously been anonymised and aggregated). The ruling is being appealed. It is argued that, while it is reasonable to delineate a narrower duty of confidentiality (not to disclose personal information, against breach of which anonymisation protects), this must be within a broad duty of confidence (not to use private information, which using anonymous information can still breach). Thus, the ruling is fundamentally correct in holding that anonymisation does not permit information obtained in confidence to be used for unconsented purposes. This, however, implies that information obtained for a patient's treatment may not be used lawfully for medical research or NHS management purposes without consent, even if it is anonymised. Such a consequence is unacceptable as a matter of public policy. However, it is equally unacceptable to seek an exemption through the idea that patients give "implied consent" for medical research and NHS management purposes. It is also unacceptable to maintain that the public interest in medical research (regardless of its aims) justifies unconsented use of information obtained in confidence, even if the information is anonymised. The way in which Section 33 of the Data Protection Act 1998 creates an exemption to its Second Data Protection Principle provides a ready-made model for a public interest based exemption for medical research and statistical NHS purposes.     

Commercial speech and off-label drug uses: what role for wide acceptance, general recognition and research incentives?

This article provides an overview of how the constitutional protections for commercial speech affect the Food and Drug Administration's (FDA) regulation of drugs, and the emerging issues about the scope of these protections. A federal district court has already found that commercial speech allows manufacturers to distribute reprints of medical articles about a new off-label use of a drug as long as it contains disclosures to prevent deception and to inform readers about the lack of FDA review. This paper summarizes the current agency guidance that accepts the manufacturer's distribution of reprints with disclosures. Allergan, the maker of Botox, recently maintained in a lawsuit that the First Amendment permits drug companies to provide "truthful information" to doctors about "widely accepted" off-label uses of a drug. While the case was settled as part of a fraud and abuse case on other grounds, extending constitutional protections generally to "widely accepted" uses is not warranted, especially if it covers the use of a drug for a new purpose that needs more proof of efficacy, and that can involve substantial risks. A health law academic pointed out in an article examining a fraud and abuse case that off-label use of drugs is common, and that practitioners may lack adequate dosage information about the off-label uses. Drug companies may obtain approval of a drug for a narrow use, such as for a specific type of pain, but practitioners use the drug for similar uses based on their experience. The writer maintained that a controlled study may not be necessary to establish efficacy for an expanded use of a drug for pain. Even if this is the case, as discussed below in this paper, added safety risks may exist if the expansion covers a longer period of time and use by a wider number of patients. The protections for commercial speech should not be extended to allow manufacturers to distribute information about practitioner use with a disclosure about the lack of FDA approval. Distributions of information about unapproved uses should not be acceptable unless experts consider the expanded use to be generally recognized as safe and effective based on adequate studies. The last part of this paper considers the need to develop better research incentives to encourage more testing and post-market risk surveillance by drug makers on off-label uses of their drugs. Violations of the Federal Food Drug and Cosmetic Act (FFDCA) can be considered violations of the False Claims Act, which opens the way to fraud and abuse suits. The scale of penalties involved in these suits may lead to more examination of the scope of FDA regulation and commercial speech protections. Thus this symposium's consideration of these issues is timely and important.     

New soft tissue correction factors for stature estimation: results from magnetic resonance imaging

In stature reconstruction using Fully's method, it is essential that a soft tissue correction factor be added to skeletal height in order to obtain an estimate of living stature. While some anthropologists consider Fully's method to be the most reliable for stature estimation, others consider it to be inadequate as it seems to be underestimating living stature, possibly due to an error in the magnitude of Fully's soft tissue factors. A recent study by Raxter and co-workers revised Fully's technique and also presented a new "universally applicable" soft tissue correction factor. The present study examines the reliability of soft tissue correction factors of Fully and Raxter et al. on a living sample of indigenous South African males. The current study is based on data collected from 28 indigenous South African (ISA) male volunteers. Standing height of each subject was measured using a stadiometer. Fully's method was used in the calculation of total skeletal height from a full body MRI scan of each subject. Subsequent analyses of the acquired data revealed that the previously derived soft tissue correction factors are not applicable to the studied sample, and why they are not applicable. The correction factors of Fully and Raxter et al. both significantly underestimate living stature in a living sample of indigenous South African males. Consequently, a new correction factor was calculated based on the prediction of living stature from TSH using regression analysis.     

Integrated Administrative Data & Criminal Justice Research

Using integrated administrative data from criminal justice and social service systems can harness information in meaningful ways that transcend traditional “silos” and allow communities to focus collective attention on important social issues that cross systemic boundaries. Despite recent advances in use of integrated administrative data, practical information to promote adoption by new users is lacking. Here we provide an introduction to potential uses of integrated administrative data for criminal justice researchers, including general benefits of using integrated data as well as implications for innovative research design. We describe a case example of data integration through a state data warehouse for a federally funded project on impact of incarceration on families. The project utilizes data from eight agencies (corrections, juvenile justice, mental health, substance use, social services, health, education, and environmental control) and includes development of an Online Analytical Processing cube. We draw from lessons learned to provide specific recommendations for developing researcher-practitioner partnerships that use integrated administrative data to improve translational criminal justice research and evidence-based practice and policy.     

Ethics, Information Technology, and Public Health: New Challenges for the Clinician-Patient Relationship

Increasingly widespread adoption of health information technology tools in clinical care increases interest in ethical and legal issues related to the use of these tools for public health and the effects of these uses on the clinician-patient relationship. It is argued that patients, clinicians, and society have generally uncontroversial duties to support civil society's public health mission, information technology supports this mission, and the effects of automated and computerized public health surveillance are likely to have little if any effect on the clinician-patient relationship. It is also suggested, nevertheless, that electronic public health surveillance raises interesting and important ethical issues, some of which can be addressed if not resolved by empirical research, especially regarding patient preferences about secondary use of health data and their moral obligation to contribute to population- based health.     

Computer-aided qualitative data analysis of social media for teachers and students in legal education

This article addresses a new field for legal education researchers. It describes and discusses emergent methods for computer-aided qualitative data analysis of social media in legal education. Social media contributes opportunities for learning, teaching, and research for legal educators and students. It potentially expedites collaborations, sharing, and collection of information and commentary on relevant and important issues and topics. These sources provide content and data for learning, teaching, and research. Benefits of computer-aided qualitative data analysis of social media in legal education include a systematic approach, transparency, accountability and durability, and innovative ways to communicate insights through textual and graphical communications. The article uses two examples in which computer-aided qualitative data analysis, combined with qualitative data analysis strategies, can contribute insights in and about legal education: analysis of social media discussions involving specific topics or events – to study students’ work, or academics’ interactions at conferences; and analysis of legal educators’ scholarly communications and social media activities, toward improving the visibility and influence of legal education scholarship. Research ethics for studies involving social media and human participants are also considered.     

LAND USE AND VIOLENT CRIME*

Although research has shown specific land uses to be related to crime, systematic investigation of land uses and violent crime has been less common. This study systematically examines links between land uses and violent crime and assesses whether such links are conditioned by socioeconomic disadvantage. We employ geocoded Uniform Crime Report (UCR) data from the Indianapolis police department and information on 30 categories of land use and demographic information from the 2000 U.S. Census. We use land use variables to predict violent crime counts in 1,000 × 1,000‐feet grid cells using negative binomial regression models. Results indicate that, net of other variables, specific land uses predict variation in counts for individual violent crimes and aggregate rates. Some nonresidential land uses are associated with higher violent crime counts, whereas others are associated with lower counts. Specific land uses also condition the effects of socioeconomic disadvantage on violent crime. The implications for routine activity/opportunity and social disorganization/collective efficacy theories of crime are discussed.     

大鼠早期心肌缺血CX43免疫组化研究

目的探讨早期心肌缺血的法医病理学诊断依据。方法通过建立大鼠心肌缺血模型,用免疫组化染色方法检测大鼠心肌缺血15、30、60、120、180min以及正常对照组心肌CX43的表达情况。结果在各组早期心肌缺血区内,见CX43阳性着色的分布与正常组相比,表现为部位的不同及数量上的差异。结论CX43的免疫组化染色对诊断早期心肌缺血有一定的价值,但尚需进一步研究证实。     

Disclosing health information breaches of confidence,privacy and the notion of the "treating team"

The authors utilise cases collected during a randomised population survey to illustrate some of the legal and policy issues concerning routine transfers of information between treating practitioners. Their analysis suggests that implied consent for many routine uses of health information should not be assumed. An important part of consent to health information disclosure is the patients' ability to tailor its scope and content. This requires that they should be provided with additional information. Introducing the measures advised into the clinical setting would bring health information-gathering practices closer to compliance with the collection principles contained in Australian information privacy legislation.     

The Significance of Statistical Significance:

This essay reviews The Cult of Statistical Significance: How the Standard Error Costs Us Jobs, Justice, and Lives, by Stephen T. Ziliak and Deirdre N. McCloskey. The book's core message is that statistical significance should not be equated with substantive significance and that empirical researchers should convey more information about the magnitude of relationships and effects than many now do. This essay summarizes, approves of, and elaborates on Ziliak and McCloskey's message with special attention to concerns of the legal academy. It clarifies appropriate uses of significance tests within the research framework of controlling for plausible rival hypotheses.