Implementation of Nagoya Protocol on access and benefit-sharing in Peru: Implications for researchers.

ETHNOPHARMACOLOGICAL RELEVANCE: The Peruvian Amazon holds more than 1000 plant species with commercial potential and the national sales of natural products derived from medicinal and aromatic plants have exceeded $ 400 million per year. Research and development activities carried out on the genetic and biochemical composition of Peruvian flora have to abide by national and international regulations, such as the Nagoya Protocol (NP). AIM OF THE STUDY: The aim of this paper is to describe the implications of the current implementation of the NP in Peru for performing research on national genetic resources. MATERIALS AND METHODS: A review of the current legal framework and status of the NP in Peru was performed accompanied by first-hand experience undertaken by submitting a request for access to genetic resources related to wild continental species. RESULTS: So far, Peru has issued 16 Internationally Recognized Certificates of Compliance (IRCCs) through 2 of the identified National Authorities. Some of the difficulties and challenges observed have to do with the degree of effective implementation of the Access and Benefit-Sharing (ABS) system, the fact that the application process is not sufficiently clear, and the wide gap between this formal system and what occurs informally outside of it. In response to this, training and implementation projects have been launched and a new law on the access to genetic resources has been proposed. CONCLUSIONS: The difficulties observed still represent an obstacle to scientific research and the development of new commercial products based on Peruvian traditional knowledge and genetic resources. Although improvements have been made to the ABS framework, there remain major challenges to encouraging and ascertaining the equitable and sustainable use of Peru's biodiversity.

Access and Management: Indigenous Perspectives on Genomic Data Sharing.

As genomic researchers are encouraged to engage in broad genomic data sharing, American Indian/Alaska Native/Native Hawaiian (AI/AN/NH) leaders have raised questions about ownership of data and biospecimens and concerns over emerging challenges and potential threats to tribal sovereignty. Using a community-engaged research approach, we conducted 42 semi-structured interviews with tribal leaders, clinicians, researchers, policy makers, and tribal research review board members about their perspectives on ethical issues related to genetics in AI/AN/NH communities. We report findings related to perspectives on genetic research, data sharing, and envisioning stronger oversight and management of data. In particular, participants voiced concerns about different models of data sharing, infrastructure and logistics for housing data, and who should have authority to grant access to data. The results will ultimately guide policy-making and the creation of guidelines and new strategies for tribes to drive the research agenda and promote ethically and culturally appropriate research.

Ethical issues associated with HIV phylogenetics in HIV transmission dynamics research: A review of the literature using the Emanuel Framework.

The reduced costs of DNA sequencing and the use of such data for HIV-1 clinical management and phylogenetic analysis have led to a massive increase of HIV-1 sequences in the last few years. Phylogenetic analysis has shed light on the origin, spread and characteristics of HIV-1 epidemics and outbreaks. Phylogenetic analysis is now also being used to advance our knowledge of the drivers of HIV-1 transmission in order to design effective interventions. However, HIV phylogenetic analysis presents unique ethical challenges, which have not been fully explored. This review presents an analysis of what appear to be key ethical issues in HIV phylogenetics in the hope of stimulating further conceptual and empirical work in this rapidly emerging area. We structure the review using the Emanuel Framework, a systematic, holistic framework, which has been adapted for use in developing countries, which bear the brunt of the HIV-1 pandemic.

Collectivizing rescue obligations in bioethics.

Bioethicists invoke a duty to rescue in a wide range of cases. Indeed, arguably, there exists an entire medical paradigm whereby vast numbers of medical encounters are treated as rescue cases. The intuitive power of the rescue paradigm is considerable, but much of this power stems from the problematic way that rescue cases are conceptualized-namely, as random, unanticipated, unavoidable, interpersonal events for which context is irrelevant and beneficence is the paramount value. In this article, I critique the basic assumptions of the rescue paradigm, reframe the ethical landscape in which rescue obligations are understood, and defend the necessity and value of a wider social and institutional view. Along the way, I move back and forth between ethical theory and a concrete case where the duty to rescue has been problematically applied: the purported duty to regularly return incidental findings and individual research results in genomic and genetic research.

Rethinking our public health genetics research paradigm.

Since the sequencing of the human genome, tremendous resources have been dedicated to understanding how genetic determinants may drive the production of disease. Despite some successes, the promise of genetics research in these areas remains largely unrealized. The focus on isolating individual (or clusters of) genes that may be associated with narrowly defined phenotypes in large part explains this discrepancy. In particular, efforts to identify genotypes associated with narrow phenotypes force the field to use study designs that capitalize on homogeneous samples to minimize the potential for competing influences or confounders, which imposes important limitations on understanding the role of genes in human health. We argue that a population health genetics that incorporates genetics into large, multiwave, multilevel cohorts has the best potential to clarify how genes, in combination and with the environment, jointly influence population health.

Regulation of gene expression by yoga, meditation and related practices: a review of recent studies.

Integrative medicine (IM) approaches have gained significant interest in recent years to provide a solution for the health care challenges we face today. Yogic cognitive-behavioral practices are among the most widely used IM approaches and include diverse practices such as yoga asanas, meditation, breathing exercises, Qi Gong, Tai Chi Chih, and various others. Studies to date suggest that these yogic/meditative practices have significant positive effects on the mind-body system and thereby can increase wellness and support the healing process from disease. Previous work has provided evidence for both psychological and physiological effects of these practices; however, the mechanisms of these effects, especially at the molecular level, have largely been missing. Three recent studies started to provide some of this information through gene expression profiling in circulating immune cells, which support the hypothesis that yogic/meditative practices have a measurable effect at the molecular level. These studies are reviewed herein and some future perspectives are considered.

Science and society: some "made-in-Canada" options for improving integration.

In this article, the authors describe relatively recent efforts by scientific research agencies to promote, through various funding programs, the integration of social sciences and humanities with the natural sciences. This "integrated" approach seeks to study science through a broader interdisciplinary lens in order to better anticipate, understand, and address its ethical, legal, and social implications. The authors review the origins and evolution of this trend, as well the arguments which have been formulated by both proponents and critics of integration. By using Genome Canada's "GE(3)LS" Research Program as a case study, the authors discuss the successes and continuing challenges of this model based on evaluation results available to date. The authors then go on to examine and compare three possible models for improving the future success of the GE(3)LS research program, including: 1) enhancing the current integrated research approach through incremental refinements based on concrete evidence and lessons learned; 2) promoting greater interaction and synergy across GE(3)LS research projects through a deliberate, systematic and coordinated "hub and spoke" approach; and 3) taking a broad programmatic approach to GE(3)LS research by creating a central resource of available expertise and advisory capacity.

A new bioinformatics paradigm for the theory, research, and practice of therapeutic hypnosis.

In a 2008 pilot study we used DNA microarrays to explore the historical ideo-plastic faculty of therapeutic hypnosis. We documented how to measure changes in activity or experience-dependent gene expression over relatively brief time periods (1 hour and 24 hours) following a single intervention of therapeutic hypnosis (about 1 hour). In the present paper we utilize bioinformatic software to explore the possible meaning and significance of this ideo-plastic faculty of therapeutic hypnosis. Indications suggest that the ideo-plastic process of therapeutic hypnosis may be associated with (1) the heightening of a molecular-genomic signature for the up-regulation (heightened activity) of genes characteristic of stem cell growth, (2) a reduction in cellular oxidative stress, and (3) a reduction in chronic inflammation. We identify these three empirical associations as an initial beta version of the molecular-genomic signature of the ideo-plastic process of therapeutic hypnosis, which can serve as a theoretical and practical guide for clinical excellence by beginners as well as senior professionals. We propose this molecular-genomic level of discourse as a supplement to the traditional cognitive-behavioral description of therapeutic suggestion, hypnosis, and psychotherapy that is consistent with "translational research" currently funded by the National Institute of Mental Health (NIMH).

Negotiating the boundary between medicine and consumer culture: online marketing of nutrigenetic tests.

Genomics researchers and policy makers have accused nutrigenetic testing companies--which provide DNA-based nutritional advice online--of misleading the public. The UK and USA regulation of the tests has hinged on whether they are classed as "medical" devices, and alternative regulatory categories for "lifestyle" and less-serious genetic tests have been proposed. This article presents the findings of a qualitative thematic analysis of the webpages of nine nutrigenetic testing companies. We argue that the companies, mirroring and negotiating the regulatory debates, were creating a new social space for products between medicine and consumer culture. This space was articulated through three themes: (i) how "genes" and tests were framed, (ii) how the individual was imagined vis a vis health information, and (iii) the advice and treatments offered. The themes mapped onto four frames or models for genetic testing: (i) clinical genetics, (ii) medicine, (iii) intermediate, and (iv) lifestyle. We suggest that the genomics researchers and policy makers appeared to perform what Gieryn (Gieryn, T.F. (1983). Boundary-work and the demarcation of science from non-science: strains and interests in professional ideologies of scientists. American Sociological Review, 48, 781-795.) has termed "boundary work", i.e., to delegitimize the tests as outside proper medicine and science. Yet, they legitimated them, though in a different way, by defining them as lifestyle, and we contend that the transformation of the boundaries of science into a creation of such hybrid or compromise categories is symptomatic of current historical times. Social scientists studying medicine have referred to the emergence of "lifestyle" products. This article contributes to this literature by examining the historical, regulatory and marketing processes through which certain goods and services become defined this way.

Achievement of genetics in plant reproduction research: the past decade for the coming decade.

In the last decade, a variety of innovations of emerging technologies in science have been accomplished. Advanced research environment in plant science has made it possible to obtain whole genome sequence in plant species. But now we recognize this by itself is not sufficient to understand the overall biological significance. Since Gregor Mendel established a principle of genetics, known as Mendel's Laws of Inheritance, genetics plays a prominent role in life science, and this aspect is indispensable even in modern plant biology. In this review, we focus on achievements of genetics on plant sexual reproduction research in the last decade and discuss the role of genetics for the coming decade. It is our hope that this will shed light on the importance of genetics in plant biology and provide valuable information to plant biologists.

[Public Health Genomics. The integration of genome-based knowledge into public health research, policies and health services]. / Public Health Genomics: Die Integration genombasierten Wissens in die Public-Health-Forschung, Politik und Gesundheitsversorgung.

Which consequences can be drawn from genome-based knowledge and how can it be responsibly and timely translated into policies and practice? What are recent developments in genetics and molecular biology, what are the challenges, what are the risks of these developments? Which policies can provide an acceptable balance between providing strong protection of individuals'interests and needs while enabling society to benefit from the genomic advances and empowering individuals? How can molecular medicine contribute to more effective and efficient health care services, and what infrastructures and policies can already now be implemented to assure a benefit for population health? Thus, Public Health Genomics (PHG) tries to answer these challenging questions. This integration of genomics into the aims of public health is called Public Health Genomics (PHG) and is defined as "the responsible and effective translation of genome-based knowledge and technologies into public policy and health services for the benefit of population health".

Lessons from history: why race and ethnicity have played a major role in biomedical research.

Before any citizen enters the role of scientist, medical practitioner, lawyer, epidemiologist, and so on, each and all grow up in a society in which the categories of human differentiation are folk categories that organize perceptions, relations, and behavior. That was true during slavery, during Reconstruction, the eugenics period, the two World Wars, and is no less true today. While every period understandably claims to transcend those categories, medicine, law, and science are profoundly and demonstrably influenced by the embedded folk notions of race and ethnicity.

North-South benefit sharing arrangements in bioprospecting and genetic research: a critical ethical and legal analysis.

Most pharmaceutical research carried out today is focused on the treatment and management of the lifestyle diseases of the developed world. Diseases that affect mainly poor people are neglected in research advancements in treatment because they cannot generate large financial returns on research and development costs. Benefit sharing arrangements for the use of indigenous resources and genetic research could only marginally address this gap in research and development in diseases that affect the poor. Benefit sharing as a strategy is conceptually problematic, even if one, as we do, agrees that impoverished indigenous communities should not be exploited and that they should be assisted in improving their living conditions. The accepted concept of intellectual property protection envisages clearly defined originators and owners of knowledge, whereas the concept of community membership is fluid and indigenous knowledge is, by its very nature, open, with the originator(s) lost in the mists of time. The delineation of 'community' presents serious conceptual and practical difficulties as few communities form discrete, easily discernable groups, and most have problematic leadership structures. Benefit sharing is no substitute for governments' responsibility to uplift impoverished communities. Benefit sharing arrangements may be fraught with difficulties but considerations of respect and equity demand that prior informed consent and consultation around commercialisation of knowledge take place with the source community and their government.

Nurses' views of longitudinal genetic screening of and research on children.

There is a lack of empirical data exploring ethical issues of genetic screening and longitudinal research involving children. Therefore, this pilot interview study explored the perceptions of nurses and midwives in relation to their involvement in an ongoing genetic preventive screening process involving children - the All Babies in South-east Sweden (ABIS) study (n=17,005). Data were collected through semistructured interviews with 10 nurses involved in all information and sampling procedures. While providing the preliminary nature of this study, it supports the idea of the importance of further research, both from a nursing professional perspective and from other parties involved in clinical research. The findings made in this study suggest that for such studies it is vital that nurses and midwives are fully informed about aims, methods, and potential intervention/prevention since in many cases they have a central role in several areas of screening and clinical longitudinal research involving children, e.g. information to potential research participants, obtaining informed consent, and data collection. With a thorough understanding of the research, including both basic aims and methods as well as potential future prevention aims, the nursing staff involved will be better placed to help participants make an informed choice and to provide additional information to the participants. Further research may be needed that aims to develop effective methods in preparing data collectors. It is also suggested that the design of the information process, and especially in longitudinal research involving young children, is of utmost importance before such studies are commenced.