lunes, 30 de septiembre de 2013

2013 Mar;21(3):261-5. doi: 10.1038/ejhg.2012.179. Epub 2012 Aug 15.

Intentions to receive individual results from whole-genome sequencing among participants in the ClinSeq study.

Facio FM, Eidem H, Fisher T, Brooks S, Linn A, Kaphingst KA, Biesecker LG, Biesecker BB.

Source

Social and Behavioral Research Branch, National Human Genome Research Institute, National Institutes of Health, Bethesda, MD, USA.

Abstract

Genome sequencing has been rapidly integrated into clinical research and is currently marketed to health-care practitioners and consumers alike. The volume of sequencing data generated for a single individual and the wide range of findings from whole-genome sequencing raise critical questions about the return of results and their potential value for end-users. We conducted a mixed-methods study of 311 sequential participants in the NIH ClinSeq study to assess general preferences and specific attitudes toward learning results. We tested how these variables predicted intentions to receive results within four categories of findings ranging from medically actionable to variants of unknown significance. Two hundred and ninety-four participants indicated a preference to learn their genome sequencing results. Most often, participants cited disease prevention as their reason, including intention to change their lifestyle behaviors. Participants held positive attitudes, strongly perceived social norms and strong intentions to learn results, although there were significant mean differences among four categories of findings (P<0 .01="" a="" ability="" actionable="" all="" among="" and="" attitudes="" behooves="" belief="" by="" carrier="" clinical="" confidence="" desire="" despite="" disease="" distinguished="" even="" expectations="" facilitate="" for="" from="" future="" genomic="" highest.="" in="" information.="" information="" intentions="" investigators="" it="" its="" learn="" may="" medically="" most="" motivated="" norms="" of="" p="" participants="" personal="" presented.="" prevent="" promoting="" quality="" range="" rated="" realistic="" receive="" results="" sequencing="" similar="" social="" strong="" the="" their="" these="" they="" to="" types="" uninterpretable="" use="" utility.="" value="" were="" while="">

PMID:: 22892536; [PubMed - indexed for MEDLINE]
PMCID:: PMC3573208; [Available on 2014/3/1]

PHG Foundation | Ethical issues in infectious disease genomics

Ethical issues in infectious disease genomics

19 September 2013 | By Dr Philippa Brice | News story

Source: Eureka Alert

A US centre has received new funding from the National Human Genome Research Institute (NHGRI) to examine the ethical, legal and social implications (ELSI) of genomic research in infectious disease treatment and prevention.

The John Hopkins Berman Institute of Bioethics is to establish GUIDE: Genomic Uses in Infectious Disease & Epidemics, a centre that will use ‘expertise in the ethics of human genomics and public health’ to study genomics and infectious disease.

The centre will focus initially on two areas, pandemic influenza and Hepatitis C. Research into pandemic influenza will include examination of how human genome variation influences individual responses to flu infections and vaccines, with a view to potential stratification of populations to identify those with different levels of infection risk. Research into ELSI arising from Hepatitis C investigations will examine issues of clinical disclosure and decision-making related to genetically determined variation in response to Hepatitis C virus (HCV) infection and treatment; in particular, should those most likely to respond well and clear infection be prioritised for treatment?

Comment: Infectious disease genomics are certainly a current priority for public health genomics, and the case studies the new centre will examine provide examples of some important clinical and public health ethical issues that human genomic variation may provoke in this context – identifying different subpopulations and tailoring vaccination or treatment accordingly. This is a form of personalised medicine that we can expect to see much more of in the future.

However, infectious disease genomics is a much wider area than this, and in fact the emerging capacity to rapidly sequence and analyse the genomes of infectious agents themselves is arguably a more pressing clinical and public health issue. Practitioners can use pathogen genomics for precise diagnosis of microbes, and to determine their susceptibility to different antibiotics. This is important not only for controlling disease in the patient, but also for monitoring and controlling the spread of disease in hospitals and communities, and of the growing tide of antimicrobial resistance (see previous news). Moreover, the movement of genome sequencing into infectious disease practice calls for urgent consideration of clinical, economic and logistic issues – as well as ethical, legal, social implications.

Keywords: Post-Genomic Projects, Public Health

PHG Foundation | Public consultation on NIH genomic data sharing policy

Public consultation on NIH genomic data sharing policy

24 September 2013 | By Dr Philippa Brice | News story

Sources: Draft GDS policy, Consultation form

The US National Institutes of Health (NIH) is seeking views on a draft Genomic Data Sharing (GDS) policy.

The policy follows on from the 2008 policy for NIH-funded genome-wide association studies (GWAS) studies, and is intended to promote the sharing of large-scale human and nonhuman genomic data arising from NIH-funded research. It is argued that this will accelerate further research, especially by allowing the combination of multiple datasets, and is ‘essential to facilitate the translation of research results into knowledge, products, and procedures that improve human health’.

The draft GDS policy is intended to uphold the NIH’s commitment to ‘responsible data stewardship’, which is said to be essential in order to maintain public trust in biomedical research. To this end it includes measures to protect the privacy and confidentiality of research participants, as well as requirements for appropriate informed consent. For studies taking place after the policy becomes effective, informed consent is to involve a clear understanding that genomic and phenotypic data may be shared broadly for future research purposes

Open-access datasets are to be made publicly available without restriction, whereas controlled-access data will necessitate approval for use by other researchers. The NIH emphasises that it ‘discourages the use of patents to prevent the use of or block access to genomic or genotype-phenotype data’ developed with their financial support, and stipulates that data may not have any licensing requirements attached to them; however, the development and patenting of downstream technologies and products that may address public needs is encouraged.

The consultation runs for sixty days from 20^th September 2013, and the policy is expected to take effect sixty days after the final version is made public.

Keywords: Access to Research, Genetic Databases, Genetic Privacy & Consent Issues

CURSO DE MONITOREO || Investigación Clínica LATAM

Grupo: Investigacion Clinica LATAM

Asunto: CURSO DE MONITOREO

INSCRIBITE AHORA EN EL CURSO DE GCP - MONITOREO DE ENSAYOS CLINICOS ON LINE EN inscripción@investigacionclinicalatam.com

Tematica
BIOÉTICA I
BIOÉTICA II
REGULACIÓN COMPARADA
MONITOREO DE ENSAYOS CLINICOS I 07-oct-13
MONITOREO DE ENSAYOS CLINICOS II 21-oct-13
PROPIEDAD INTELECTUAL
INTRODUCCIÓN a la LOGÍSTICA EN INVESTIGACION CLINICA

PROGRAMA EN www.investigacionclinocalatam.com
Anunciado por Celso Arabetti

domingo, 29 de septiembre de 2013

Forum Conferencias - Seminario sobre TRAZABILIDAD - Miércoles 9 de Octubre 2013

Capacitación exclusiva para Empresas de Salud, Laboratorios y Droguerías

Miércoles 9 de Octubre 2013 • NH City & Tower Hotel • Buenos Aires

Estimada/o Profesional,
El 9 de octubre Forum Conferencias desarrolla la jornada "Soluciones Técnicas en la Implementación del Sistema de TRAZABILIDAD DE MEDICAMENTOS" dirigido por la Farm. Estela Izquierdo, Coordinadora de Farmacia y Directora de la Residencia en Farmacia Clínica del SANATORIO GÜEMES y Coordinadora de la Comisión de Farmacia Hospitalaria de la Sección Farmacia del COLEGIO OFICIAL DE FARMACEUTICOS Y BIOQUIMICOS
Integran el panel de expositores los siguientes expertos:

Lic. Mauricio Monsalvo | Coordinador Plan Remediar | MINISTERIO DE SALUD DE LA NACION
Farm. Yanina Saragiotto | Jefa de Farmacia | HELIOS PHARMA- DR. STAMBOULIAN
Mario Abitbol | Jefe de Desarrollo de Salud | GS1 ARGENTINA
Pablo D'Amico | IT Manager para el Cono Sur Argentina, Chile, Uruguay, Paraguay y Bolivia | BAYER ARGENTINA
Dra. Guadalupe Fernández Porto | Jefa de Farmacia | IADT - INSTITUTO ARGENTINO DE DIAGNOSTICO Y TRATAMIENTO
Farm. Bárbara Gueler | Jefa de Farmacia | FUNDACION FAVALORO
Farm. Nicolás Viudez | Encargado del Área Oncológico - Jefe de Farmacia | FUNDACION FLENI
Dr. Ricardo Saxton | Jefe del Servicio de Farmacia & Esterilización | FUNDACION FLENI
Dr. Ricardo Mandrilli | Director Médico | BRISTOL MEDICINE
Sra. Verónica Davies | Encargada de Prestaciones Médicas | BRISTOL MEDICINE

Además, el 10 de octubre le proponemos una media jornada de actualización sobre la nueva regulación sobre productos medicinales en tránsito aéreo.

Los oncólogos denuncian ante el Defensor del Pueblo el acuerdo de equivalencias de la Junta de Andalucía - JANO.es - ELSEVIER

Actualidad Ultimas noticias - JANOes - Los oncologos denuncian ante el Defensor del Pueblo el acuerdo de equivalencias de la Junta de Andalucia - JANO.es - ELSEVIER

ONCOLOGÍA

Los oncólogos denuncian ante el Defensor del Pueblo el acuerdo de equivalencias de la Junta de Andalucía

JANO.es · 27 Septiembre 2013 13:55

La SEOM entiende que esta medida merma las posibilidades terapéuticas, deteriora el valor de la innovación y limitan la capacidad del médico para prescribir a cada paciente el medicamento que considera más adecuado.

La Sociedad Española de Oncología Médica se ha reunido hoy con la Defensora del Pueblo, Soledad Becerril, a fin de solicitar su ayuda para dejar sin efecto el acuerdo de la Junta de Andaluciá sobre equivalencias terapéuticas alternativas. Según entiende la CEOM, la medida es "radicalmente contraria a la legislación estatal de prescripción y dispensación de medicamentos y discrimina gravemente a los pacientes andaluces".
Mediante esta queja, a la que se han adherido el Grupo de Tratamiento de Tumores Digestivos (TTD) y la Sociedad Andaluza de Oncología Médica (SAOM), la SEOM manifiesta su rechazo a las equivalencias que establece la Junta entre medicamentos oncológicos distintos, dado que "merman las posibilidades terapéuticas, deterioran el valor de la innovación y limitan la capacidad del médico para prescribir a cada paciente el medicamento que considera más adecuado". La sociedad médica recuerda, asimismo, que, en lo que respecta al cáncer, la elección de uno u otro tratamiento constituye "una delicadísima decisión médica en la que la Administración no puede ni debe interferir".

"El uso de los mejores tratamientos oncológicos es un derecho irrenunciable", continúa la nota divulgad por la SEOM, "que no tiene por qué estar reñido con un empleo racional de los recursos y un mayor celo en la contención del gasto".

La SEOM ha solicitado a la Defensora del Pueblo a que inste a la Consejería de Salud y Bienestar Social de Andalucía la retirada del citado acuerdo, y se ha ofrecido a informarle de las desigualdades que vaya detectando a través del Observatorio de Acceso a Fármacos Oncológicos.