Health care is transitioning from genetics to genomics, in which single-gene testing for diagnosis is being replaced by multi-gene panels, genome-wide sequencing, and other multi-genic tests for disease diagnosis, prediction, prognosis, and treatment. This health care transition is spurring a new set of increased or novel liability risks for health care providers and test laboratories. This article describes this transition in both medical care and liability, and addresses 11 areas of potential increased or novel liability risk, offering (...) recommendations to both health care and legal actors to address and manage those liability risks. (shrink)

This article examines problems that may arise when addressing liability resulting from the genetic modification of microbes, animals, and plants. More specifically, it evaluates how uncertainties relating to the outcomes of these biotechnological innovations affect—or may affect—the courts' application of the reasonable foreseeability requirement and, hence, liability under the tort of negligence. The article also examines how concern expressed by society about injuries feared to result from these genetically modified products could have an impact on the way (...) the courts assess reasonable foreseeability in this area. (shrink)

This article investigates a high-profile and ongoing dilemma for healthcare professionals, namely whether the existence of a duty of care to genetic relatives of a patient is a help or a hindrance in deciding what to do in cases where a patient’s genetic information may have relevance to the health of the patient’s family members. The English case ABC v St George’s Healthcare NHS Trust and others considered if a duty of confidentiality owed to the patient and a (...) putative duty of care to the patient’s close relatives could coexist in this context. This article examines whether embracing the concept of coexisting duties could enable HCPs to respect duties in line with their clinical judgement, thereby providing legal support and clarity to professionals to allow them to provide the best possible genetics service to both the patient and their family. We argue that these dual duties, framed as a novel, composite duty to consider the interests of genetic relatives, could allow HCPs to exercise and act on their professional judgements about the relative value of information to family members, without fears of liability for negligence or breach of confidence. (shrink)

The transhumanist project of reshaping human beings by promoting their improvement through technological innovations has a broad agenda. This study focuses on the enhancement of the human organism through genetic modification techniques. Transhumanism values and a discussion of their philosophical background provide a framework to understand its ideals. Genetics and ethics are employed to assess the claims of the transhumanist program of human enhancement. A succinct description of central concepts in genetics and an explanation of current techniques to edit (...) the human genome serve to assess the capabilities and limitations of editing techniques. Potential benefits and liabilities of human enhancement through genome editing are discussed to appraise its feasibility. Ethical considerations of genome editing inform a reflection on the implications of introducing heritable changes in the genome of individuals. It is concluded that the transhumanist program is underpinned by a large number of hypotheses rather than by sufficient evidence. (shrink)

Biobanks hold out the prospect of significant public and private benefit, as genetic information contained in tissue samples is mined for information. However, the storing of human tissue samples and genetic information for research and/or therapeutic purposes raises a number of serious privacy and autonomy concerns. These concerns are compounded when one considers the possibility that a biobank or its owner might go bankrupt. Insolvency impairs the ability of enforcement regimes, and liability-based regimes in particular, to enforce (...) legal norms. The goal of this essay is to develop guideposts for thinking about private and public enforcement of privacy imposed by donors on tissue samples and/or genetic information when a biobank becomes insolvent. (shrink)

Biobanks hold out the prospect of significant public and private benefit, as genetic information contained in tissue samples is mined for information. However, the storing of human tissue samples and genetic information for research and/or therapeutic purposes raises a number of serious privacy and autonomy concerns. These concerns are compounded when one considers the possibility that a biobank or its owner might go bankrupt. Insolvency impairs the ability of enforcement regimes, and liability-based regimes in particular, to enforce (...) legal norms. The goal of this essay is to develop guideposts for thinking about private and public enforcement of privacy imposed by donors on tissue samples and/or genetic information when a biobank becomes insolvent. (shrink)

Discussions of socioeconomic liability and compensation must necessarily start from an understanding of the socioeconomic, legal, and scientific basis for identifying, assessing, managing, and apportioning blame for hazards related to innovations. Public discussions about the nature of the liability challenge related to genetically modified (GM) crops and other modified organisms have focused less on direct, traditional health, public safety, technical, or environmental failures (e.g., innovations that generate hazards directly for users or indirectly to bystanders) and more on socioeconomic (...) concerns, such as comingled product that offends product quality standards. This article examines the theoretical and legal underpinnings of the current risk analysis framework used in most Organization for Economic Cooperation and Development countries and uses it to assess two areas of significant controversy—the release of herbicide-tolerant canola and flax varieties in Western Canada. The article offers lessons for the management of liabilities arising from the introduction of GM crops. (shrink)

The primary theme of this paper is the normative case against ownership of one's genetic information along with the source of that information (usually human tissues samples). The argument presented here against such “upstream” property rights is based primarily on utilitarian grounds. This issue has new salience thanks to the Human Genome Project and “bio-prospecting” initiatives based on the aggregation of genetic information, such as the one being managed by deCODE Genetics in Iceland. The rationale for ownership is (...) twofold: ownership will protect the basic human rights of privacy and autonomy and it will enable the data subjects to share in the tangible benefits of the genetic research. Proponents of this viewpoint often cite the principle of genetic exceptionalism, which asserts that genetic information needs a higher level of protection than other kinds of personal information such as financial data. We argue, however, that the recognition of such ownership rights would lead to inefficiency along with the disutility of genetic discoveries. Biomedical research will be hampered if property rights in genes and genetic material are too extensive. We contend that other mechanisms such as informed consent and strict confidentiality rules can accomplish the same result as a property right without the liabilities of an exclusive entitlement. (shrink)

This article provides a brief introduction to some contemporary challenges found in the intersection of bioethics and international criminal law involving genetic privacy, organ trafficking, genetic engineering, and cloning. These challenges push us to re-evaluate the question of whether the international criminal law should hold corporations criminally liable. I argue that a minimalist and Strawsonian conception of corporate responsibility could be useful for deterring the wrongs outlined in first few sections and in answering compelling objections to corporate criminal (...) liability. (shrink)

In March 2004, the U.K. government announced its intention to grant limited authorization for the growing of commercial genetically modified (GM) crops. This article reviews the potential liabilities that may arise from GM cropping, for environmental damage and for economic losses claimed by non-GM producers. It considers the application of the European Community (EC) Environmental Liability Directive of 2004 to genetically modified organisms (GMO) releases, and the proposed statutory scheme for the coexistence of GM and non-GM agriculture in England (...) and Wales. It also examines the application of the common law of nuisance to the release of GMOs and considers the relevant case law of the English courts. Although there will be a residual role for liability at common law following the establishment of a statutory coexistence scheme, the article highlights a number of formidable problems facing attempts to establish claims for liability arising from GMO releases at common law. (shrink)

The law of patents has long struggled with the status of intent in determining liability for infringement. This struggle has recently been given a sharper edge by the emergence of biotechnological products with the inherent ability of auto-dispersal and regeneration. The question thus is whether a person on whose backyard a patented genetic organism has grown without the active intervention of that person is liable in infringement to the patentee of that organism. This article examines the ramifications of (...) the legal conundrum and argues that on a proper construction of the theories of liability in patent law intent to infringe is necessarily crucial if the nature of the subject matter of the patent makes it unjust and absurd to argue otherwise. (shrink)

A "wrongful life" suit is based on the purported tortious liability of a genetic counsellor towards an infant with hereditary defects, with the latter asserting that he or she would not have been born at all if not for the counsellor's negligence. This negligence allegedly lies in the failure on the part of the defendant adequately to advice the parents or to conduct properly the relevant testing and thereby prevent the child's conception or birth. This paper will offer (...) support for the thesis that it would be both feasible and desirable to endorse "wrongful life" compensation actions. The genetic counsellor owed a duty of due professional care to the impaired newborn who now claims that but for the counsellor's negligence, he or she would not have been born at all. The plaintiff's defective life constitutes a compensable injury. A sufficient causal link may exist between the plaintiff's injury and the defendant's breach of duty of due professional care and an appropriate measure of damages can be allocated to the disabled newborn. Sanctioning a "wrongful life" cause of action does not necessarily entail abandoning valuable constraints with regard to abortion and euthanasia. Nor does it inevitably lead to an uncontrolled slide down a "slippery slope". (shrink)

The role of fixed charges present at the surface of biological membranes is usually described by the Gouy-Chapman-Grahame theory of the electric double-layer where the Grahame equation is applied independently on each side of the membrane and where the capacitive charges are disregarded. In this article, we generalize the Gouy-Chapman-Grahame theory by taking into account both intrinsic charges and capacitive charges, in the density value of the membrane surface charges. In the first part, we show that capacitive charges couple electrostatic (...) potentials present on both sides of the membrane. The intensity of this coupling depends both on the value of the membrane specific capacitance and the transmembrane electric potential difference. In the second part, we suggest some physiological implications of membrane electric double-layers. (shrink)

The Epic of Evolution is a course taught at Northern Arizona University. It engages the task of formulating a new epic myth that is based on the physical, natural, social, and cultural sciences. It aims to serve the need of providing meaning for human living in the vast and complex universe that the sciences now depict for us. It is an interdisciplinary effort in an academic setting that is often divided by specializations; it focuses on values in a climate of (...) relativism; and it concentrates on an enterprise for which there are few textbooks at hand. The course is presented in three segments: the cosmos before humans appeared, the human phenomenon, and scenarios for the future of evolution. (shrink)

Building on the emerging literature on the ethics of social enterprises (SEs), this paper advances the underexplored role of frontline workers (FLWs) as embedded agents at the interface between communities and SEs. Specifically, we uncover the subjectivity of FLWs as they navigate moral ambiguities while performing their professional roles, dealing with rules and regulations within the organizational hierarchy and living as members of local communities. Based on an inductive case study of a microfinance organization in Cameroon, we find that FLWs (...) engage in three rationalization strategies: cautious disengaging, safeguarding self-interest, and justifying relevance. Our findings offer a better understanding of the ethics of SEs by unpacking the subjectivity of FLWs. We highlight a bottom-up account of caring SEs, identify a boundary condition to subjectivity, and present a nuanced view of FLWs in embedded organizations. We also discuss the practical implications for SEs to improve their compassion and cater for the mental wellbeing of FLWs. (shrink)

By exploring whether nanotechnologies have the potential to generate green innovations, we consider the paradox between the negative and positive side-effects that could come with the development of nanotechnologies. Starting from the conceptual framework of green product innovation, the potential green innovation activity of more than 14,000 firms of the nanotech sector is investigated. Using a query-search method, their patenting activity is explored. Results first show that there is an increasing trend toward the creation of fundamental green knowledge by firms (...) involved in nanotechnologies; second, they demonstrate that energy efficiency is the main driver of green knowledge creation in the sector and third they reveal the main characteristics of nanotech firms creating green knowledge. Beyond their contribution to the debate between positive and negative outcomes of nanotechnology developments, these results also enrich the conceptual framework of green product innovation—a key route to achieving sustainability at the same time as growth. (shrink)

The rapidly changing field of genetics affects society through advances in health-care and through implications of genetic research. This study addresses the impacts of new genetic discoveries and technologies on different segments of today's society. The book begins with a chapter on genetic complexity, and subsequent chapters discuss moral and ethical questions arising from today's genetics from the perspectives of health care professionals, the media, the general public, special interest groups and commercial interests.

Society has historically not taken a benign view of genetic disease. The laws permitting sterilization of the mentally re tarded~ and those proscribing consanguineous marriages are but two examples. Indeed as far back as the 5th-10th centuries, B.C.E., consanguineous unions were outlawed (Leviticus XVIII, 6). Case law has traditionally tended toward the conservative. It is reactive rather than directive, exerting its influence only after an individual or group has sustained injury and brought suit. In contrast, state legislatures have not (...) been inhibited in enacting statutes. Many of their products can be characterized as hasty, unnecessary, ill-conceived, and based on the heart rather than the head. Moreover the lack of expert consultation sought has also been remarkable. One state legislature, for example, has advocated immunization for sickle cell anemia! Many others have enacted laws for the screening of inborn errors of metabolism, e.g., phenylketon uria, but have poorly defined the lines of responsibility to secure compliance. A spate of specific disease-related bills has emerged in the u.S. Congress, each seeking recognition and appropriations. Sickle cell anemia, hemophilia, Cooley's anemia and Tay-Sachs disease have been among the front-runners for support. Finally, in 1975, Congress has begun to examine an omnibus bill concerning all forms of genetic disease. The bill, termed the National Genetic Diseases Act is, however, still far from being enacted. (shrink)

Progressive supranuclear palsy is a movement disorder with prominent tau neuropathology. Brain diseases with abnormal tau deposits are called tauopathies, the most common of which is Alzheimer's disease. Environmental causes of tauopathies include repetitive head trauma associated with some sports. To identify common genetic variation contributing to risk for tauopathies, we carried out a genome-wide association study of 1,114 individuals with PSP and 3,247 controls followed by a second stage in which we genotyped 1,051 cases and 3,560 controls for (...) the stage 1 SNPs that yielded P ≤ 10-3. We found significant previously unidentified signals associated with PSP risk at STX6, EIF2AK3 and MOBP. We confirmed two independent variants in MAPT affecting risk for PSP, one of which influences MAPT brain expression. The genes implicated encode proteins for vesicle-membrane fusion at the Golgi-endosomal interface, for the endoplasmic reticulum unfolded protein response and for a myelin structural component. © 2011 Nature America, Inc. All rights reserved. (shrink)

BackgroundClinical ethical practice (CEP) is required for healthcare workers (HCWs) to improve health-care delivery. However, there are gaps between accepted ethical standards and CEP in Ethiopia. There have been limited studies conducted on CEP in the country. Therefore, this study aimed to determine the magnitude and associated factors of CEP among healthcare workers in healthcare facilities in Ethiopia.MethodFrom February to April 2021, a mixed-method study was conducted in 24 health facilities, combining quantitative and qualitative methods. Quantitative (survey questionnaire) and qualitative (...) (semi-structured interviews) data were collected. For quantitative and qualitative data analysis, Stata version 14 and Atlas.ti version 7 were utilized. Multiple logistic regression and thematic analysis for quantative and qualitative respectively used.ResultsFrom a total of 432 study participants, 407 HCWs were involved in the quantitative analysis, 36 participants were involved in five focus group discussions (FGDs), and eleven key informant interviews (KIIs) were involved in the qualitative analysis. The score of good CEP was 32.68%. Similarly, the scores of good knowledge and attitude were 33.50% and 25.31%, respectively. In the multiple logistic regression models, satisfaction with the current profession, availability of functional CECs, compassionate leaders, previously thought clinical ethics in pre-service education and good attitude were significant factors associated with CEP. Among these significant factors, knowledge, compassionate leaders, poor infrastructure, a conducive environment and positive attitudes were also determinants of CEP according to qualitative findings.ConclusionsThe CEP in health care services in Ethiopia is low. Satisfaction with the current profession, functional CECs, positive attitude, compassionate leaders and previously thought clinical ethics were significant factors associated with CEP. The Ministry of Health (MoH) should integrate interventions by considering CECs, compassionate leadership, and positive attitudes and enhance the knowledge of health professionals. Additionally, digitalization, intersectoral collaboration and institutionalization are important for promoting CEP. (shrink)

Recent trends in psychiatry involve a transition from categorical to dimensional frameworks, in which the boundary between health and pathology is understood as a difference in degree rather than as a difference in kind. A major tenet of dimensional approaches is that no qualitative distinction can be made between health and pathology. As a consequence, these approaches tend to characterize such a threshold as pragmatic or conventional in nature. However, dimensional approaches to psychopathology raise several epistemological and ontological issues. First, (...) we review major sources of evidence usually recruited in support of the dimensional trend (focusing on clinical observation and biological data), and we show that these are connected to different conceptualizations of how dimensional traits extend across health and pathology. Second, we criticize two unquestioned assumptions that stand at the core of the dimensional trend: a) that there is continuity from health to pathology at the symptomatic level; b) that such continuity reflects an underlying continuity in the genetic liability for pathological conditions. Third, we argue against the idea of a conventional threshold by showing that such a view implies a linear relationship between the genotype and the phenotype. Fourth, drawing on epigenetics and developmental biology, we offer a characterization of mental disorders as stable and dynamic constellations of multi-level variables that differ qualitatively from ‘healthy states’. We conclude by showing that our account has several theoretical advantages over both categorical and dimensional approaches. Notably, it provides crucial insights into psychological development over time and individual differences, with major implications in terms of intervention and clinical decision-making. (shrink)

This paper challenges the common assumption that some phenotypic traits are quantitative while others are qualitative. The distinction between these two kinds of traits is widely influential in biological and biomedical research as well as in scientific education and communication. This is probably due to both historical and epistemological reasons. However, the quantitative/qualitative distinction involves a variety of simplifications on the genetic causes of phenotypic variability and on the development of complex traits. Here, I examine three cases from the (...) life sciences that show inconsistencies in the distinction: Mendelian traits, Mendelian diseases, and polygenic mental disorders. I show that these traits can be framed both quantitatively and qualitatively depending, for instance, on the methods through which they are investigated and on specific epistemic purposes. This suggests that the received view of quantitative and qualitative traits has a limited heuristic power—limited to some local contexts or to the specific methodologies adopted. Throughout the paper, I provide directions for framing phenotypes beyond the quantitative/qualitative distinction. I conclude by pointing at the necessity of developing a principled characterisation of what phenotypic traits, in general, are. (shrink)

Both scientific evidence and folklore have suggested that madness is associated with creativity, especially in the arts. Recently, more rigorous studies have confirmed to some extent these previous observations. The current view is that it is not severe and acute insanity that is related to heightened creativity, but the personality roots and soft manifestations of both schizophrenic and bipolar psychoses. The affective and cognitive peculiarities associated with schizotypic and hypomanic personalities may be preferentially related to different kinds of creative endeavours, (...) such as the sciences and arts, respectively. The connection between personality traits and creativity is produced because they share some biological-cognitive-personality features, such as cognitive disinhibition. Additionally, it has been shown that the genetic liability for both bipolar and schizophrenic psychoses is related to creativity. A prevailing hypothesis is that creativity may be one type of 'compensatory advantage' for those carrying the genes for psychosis. (shrink)

Myriad Genetics holds a patent on testing for the hereditary breast and ovarian cancer genes, BRCA1 and BRCA2, and therefore has a forced monopoly on this critical genetic test. Myriad launched a Direct-to-Consumer (DTC) marketing campaign in the Northeast United States in September 2007 and plans to expand that campaign to Florida and Texas in 2008. The ethics of Myriad's patent, forced monopoly and DTC campaign will be reviewed, as well as the impact of this situation on patient access (...) and care, physician liability, and the future of DTC campaigns for genetic testing. (shrink)

Embryo litigation -- Access to ART treatment : insurance and discrimination -- General professional liability litigation -- Paternity and donor insemination -- Maternity and egg donation -- Traditional and gestational surrogacy arrangements -- Posthumous reproduction : access and parentage -- Same-sex parentage and ART -- Genetics (PGD) and ART -- ART-related embryonic stem cell legal developments -- ART-related adoption litigation -- ART-related fetal litigation and abortion-related litigation.

Purpose Although the term “responsibility” plays a central role in bioethics and public health, its meaning and implications are often unclear. This paper defends the importance of a more systematic conception of responsibility to improve moral philosophical as well as descriptive analysis. Methods We start with a formal analysis of the relational conception of responsibility and its meta-ethical presuppositions. In a brief historical overview, we compare global-collective, professional, personal, and social responsibility. The value of our analytical matrix is illustrated by (...) sorting out the plurality of responsibility models in three cases (organ transplantation, advance directives, and genetic testing). Results Responsibility is a relational term involving at least seven relata. The analysis of the relata allows distinguishing between individual versus collective agency, retrospective versus prospective direction, and liability versus power relations. Various bioethical ambiguities result from insufficient, implicit, or inappropriate ascriptions of responsibility. Conclusions A systematic conception of responsibility is an important tool for bioethical reflection. It allows an in-depth understanding and critique of moral claims on a meta-ethical level without presuming one particular normative approach. Considering the concept of responsibility can also help to complement the current bioethical focus on individual autonomy by including the perspectives of other actors, such as family members or social groups. (shrink)

Purpose Although the term “responsibility” plays a central role in bioethics and public health, its meaning and implications are often unclear. This paper defends the importance of a more systematic conception of responsibility to improve moral philosophical as well as descriptive analysis. Methods We start with a formal analysis of the relational conception of responsibility and its meta-ethical presuppositions. In a brief historical overview, we compare global-collective, professional, personal, and social responsibility. The value of our analytical matrix is illustrated by (...) sorting out the plurality of responsibility models in three cases (organ transplantation, advance directives, and genetic testing). Results Responsibility is a relational term involving at least seven relata. The analysis of the relata allows distinguishing between individual versus collective agency, retrospective versus prospective direction, and liability versus power relations. Various bioethical ambiguities result from insufficient, implicit, or inappropriate ascriptions of responsibility. Conclusions A systematic conception of responsibility is an important tool for bioethical reflection. It allows an in-depth understanding and critique of moral claims on a meta-ethical level without presuming one particular normative approach. Considering the concept of responsibility can also help to complement the current bioethical focus on individual autonomy by including the perspectives of other actors, such as family members or social groups. (shrink)

Focused on the impact of stringent intellectual property mechanisms over the uses of plant agricultural biodiversity in crop improvement, the article delves into a systematic analysis of the relationship between institutional paradigms and their technological contexts of application, identified as mass selection, controlled hybridisation, molecular breeding tools and transgenics. While the strong property paradigm has proven effective in the context of major leaps forward in genetic engineering, it faces a systematic breakdown when extended to mass selection, where innovation often (...) displays a collective nature. However, it also creates partial blockages in those innovation schemes rested between on-farm observation and genetic modification, i.e. conventional plant breeding and upstream molecular biology research tools. Neither overly strong intellectual property rights, nor the absence of well delineated protection have proven an optimal fit for these two intermediary socio-technological systems of cumulative incremental innovation. To address these challenges, the authors look at appropriate institutional alternatives which can create effective incentives for in situ agrobiodiversity conservation and the equitable distribution of technologies in plant improvement, using the flexibilities of the TRIPS Agreement, the liability rules set forth in patents or plant variety rights themselves, and other ad hoc reward regimes. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Protecting Human Research SubjectsThe Office for Protection from Research RisksJoan Paine Porter (bio)The office for Protection from Research Risks (OPRR), located within the National Institutes of Health, has two divisions: Human Subject Protections and Animal Welfare. This article will address the overall responsibilities and current projects relating to human subject protections.OPRR implements the Department of Health and Human Services' (HHS) regulations for the protection of human subjects (45 CFR (...) 46 (1991)). These regulations fulfill the responsibilities set forth in the Public Health Service (PHS) Act with regard to institutional review boards (IRB) and other protections for human subjects involved in biomedical and behavioral research conducted or supported by HHS. The PHS Act also mandates a program to clarify ethical issues in biomedical research involving human subjects and to address violations of the rights of human subjects of research (P.L. 99-158 (1985)).OPRR staff negotiate assurances of compliance with institutions conducting Federally-supported research involving human subjects. The assurances describe the policies and procedures each institution will follow to fulfill the requirements of the regulations, including specific IRB composition and functions.In addition, OPRR cosponsors with the Food and Drug Administration and awardee institutions a series of regional workshops that address human subject protections issues. These are attended by IRB members, institutional officials, research investigators, and others involved with human subject protections.Current ActivitiesNumerous activities are underway in OPRR. The following describes only a few of the initiatives and studies aimed at helping develop policies and procedures to protect human subjects of research."Points to Consider" DocumentsOPRR is currently working with the National Center for Human Genome Research (NCHGR) to develop a "points to consider" document for IRBs and others involved in large genetic pedigree studies. Many questions have emerged [End Page 279] on topics such as how subjects should be recruited, with whom information should be shared about others in the family, social risks of disclosure in employment and insurance, the circumstances and timing of informing subjects about study results, and involvement of children. OPRR and NCHGR hope to assemble a group this fall to review and refine the points that are now being developed jointly. A conference in South Carolina organized by the American Association for Advancement in the Sciences entitled "Project on the Ethical and Legal Implications of Genetic Testing," helped generate advice, and identified some of the more controversial issues in design and conduct of genetic research that involves large groups of family members.Another "points to consider" effort concerns enrollment of women and minorities in research. The PHS has established a policy that members of these groups must be included in research projects unless there are valid scientific justifications for their exclusion which can be made on a project by project basis (ADAMHA/NIH Policy 1990; NIH/ADAMHA Policy 1990). OPRR has commissioned several scholarly papers to help in developing "points to consider" for IRBs as they balance issues of equitable selection of subjects and protection of these selected individuals. Concerns about enrolling women of childbearing age in research that may be harmful to a fetus, and liability issues frequently dominate discussion in this area. The papers will address ethical, legal, and statistical aspects of enrollment of minorities and women as well as provide a description of various practices and roles of IRBs in addressing goals of fair selection of participants and appropriate protections.OPRR is also working with the PHS Panel on Women, Adolescents and Children to produce a document, also in the form of "points to consider" guidance, concerning enrollment of children who are wards of the state in HIV-related research. Subpart D of the regulations for the protection of human subjects (45 CFR 46) specifically addresses research involving children who are wards of the state, including the special protections that must be provided. State and local officials who have authority to enroll foster care children in research have indicated a desire to obtain advice in this area.The IRB GuidebookA major project that is now being completed under contract to the Poynter Center at Indiana University is the IRB Guidebook. It will revise and expand the current IRB Guidebook produced in the 1980s... (shrink)