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https://www.readbyqxmd.com/read/29124112/concise-informed-consent-to-increase-data-and-biospecimen-access-may-accelerate-innovative-alzheimer-s-disease-treatments
#1
REVIEW
Ann M Hake, Penny A Dacks, Stephen P Arnerić
Introduction: Informed consent forms that restrict the distribution of data and samples have been an impediment to advancing Alzheimer's disease (AD) understandings and treatments. The Coalition Against Major Disease public-private partnership developed concise addenda to responsibly broaden data access of informed consent forms. Methods: Coalition Against Major Disease members identified key elements for ensuring data and biospecimen access, and patient privacy protection according to applicable US law...
November 2017: Alzheimer's & Dementia: Translational Research & Clinical Interventions
https://www.readbyqxmd.com/read/28922617/training-the-next-generation-of-biobankers-a-two-year-master-s-course-in-the-management-of-biobanks
#2
Emmanuelle Gormally, Isabelle Hardy, Elodie Caboux, Jeanne-Hélène di Donato, Pierre Hainaut, Paul Hofman
The growing complexity of biobanking requires dedicated professional staff who are trained in multiple aspects of the biobanking process, including technical, managerial, regulatory, and ethical aspects, and who have a good understanding of the challenges of biospecimen research, but also of the challenges related to the sustainability of future biobanks. Up to the present, biobanking staff have been trained in an ad-hoc manner, usually through specific short duration courses, for example, summer schools. In this article, we describe the development/establishment of a systematic 2-year training program at the Master level intended for students with a background in life sciences and providing them with a professional qualification as a "Biobank Manager...
September 18, 2017: Biopreservation and Biobanking
https://www.readbyqxmd.com/read/28873014/impact-of-preanalytical-variations-in-blood-derived-biospecimens-on-omics-studies-toward-precision-biobanking
#3
Jae-Eun Lee, Young-Youl Kim
Research data and outcomes do vary across populations and persons, but this is not always due to experimental or true biological variation. Preanalytical components of experiments, be they biospecimen acquisition, preparation, storage, or transportation to the laboratory, may all contribute to apparent variability in research data, outcomes, and interpretation. The present review article and biobanking innovation analysis offer new insights with a summary of such preanalytical variables, for example, the type of blood collection tube, centrifugation conditions, long-term sample storage temperature, and duration, on output of omics analyses of blood-derived biospecimens: whole blood, serum, plasma, buffy coat, and peripheral blood mononuclear cells...
September 2017: Omics: a Journal of Integrative Biology
https://www.readbyqxmd.com/read/28852559/clinical-genomics-big-data-and-electronic-medical-records-reconciling-patient-rights-with-research-when-privacy-and-science-collide
#4
Jennifer Kulynych, Henry T Greely
Widespread use of medical records for research, without consent, attracts little scrutiny compared to biospecimen research, where concerns about genomic privacy prompted recent federal proposals to mandate consent. This paper explores an important consequence of the proliferation of electronic health records (EHRs) in this permissive atmosphere: with the advent of clinical gene sequencing, EHR-based secondary research poses genetic privacy risks akin to those of biospecimen research, yet regulators still permit researchers to call gene sequence data 'de-identified', removing such data from the protection of the federal Privacy Rule and federal human subjects regulations...
April 2017: Journal of Law and the Biosciences
https://www.readbyqxmd.com/read/28851229/the-california-hiv-aids-research-program-history-impact-and-hiv-cure-initiative
#5
Lisa Loeb Stanga, Anwer Mujeeb, Laura Packel, Tyler Martz, George Lemp
This Special Issue of AIDS Research and Human Retroviruses features results from the HIV Cure Initiative, funded by the California HIV/AIDS Research Program (CHRP). As a publicly-funded grant maker, CHRP has served for more than three decades as a unique resource for innovative researchers in California whose work seeks to address all aspects of the HIV epidemic and the communities affected by it. Early initiatives at CHRP pioneered what would become enduring cornerstones of HIV science: isolation of the virus; efficacy and toxicities of the first HIV treatments; the emergence of drug resistance; the first biospecimen banks for HIV-related research; the first community-based laboratory service for HIV diagnostic serology; and the first population-based longitudinal cohort study of persons living with HIV - The Gay Men's Health Study...
August 29, 2017: AIDS Research and Human Retroviruses
https://www.readbyqxmd.com/read/28725790/biobanking-budgets-and-the-role-of-pathology-biobanks-in-precision-medicine
#6
Chris Andry, Elizabeth Duffy, Christopher A Moskaluk, Shannon McCall, Michael H A Roehrl, Daniel Remick
Biobanks have become an important component of the routine practice of pathology. At the 2016 meeting of the Association of Pathology Chairs, a series of presentations covered several important aspects of biobanking. An often overlooked aspect of biobanking is the fiscal considerations. A biobank budget must address the costs of consenting, procuring, processing, and preserving high-quality biospecimens. Multiple revenue streams will frequently be necessary to create a sustainable biobank; partnering with other key stakeholders has been shown to be successful at academic institutions which may serve as a model...
January 2017: Acad Pathol
https://www.readbyqxmd.com/read/28441720/association-of-polyphenol-biomarkers-with-cardiovascular-disease-and-mortality-risk-a-systematic-review-and-meta-analysis-of-observational-studies
#7
REVIEW
Johanna Rienks, Janett Barbaresko, Ute Nöthlings
Epidemiologic studies have suggested an inverse association between flavonoids and cardiovascular disease (CVD). However, the results might have been influenced by the use of dietary assessment methods, which are error prone. The aim of this paper was to systematically review and analyse the literature for evidence of associations between polyphenol biomarkers and CVD and mortality risk in observational studies. Eligible studies were identified through PubMed, Web of Science, and reference lists. Multivariable adjusted associations were extracted...
April 22, 2017: Nutrients
https://www.readbyqxmd.com/read/28421883/ctsa-institution-responses-to-proposed-common-rule-changes-did-they-get-what-they-wanted
#8
Suzanne M Rivera, Lisa Nichols, Lois Brako, Genevieve Croft, Toni Russo, Tara Tran
In 2015, the U.S. Department of Health and Human Services (HHS) and 15 other federal departments and agencies proposed revisions to the Federal Policy for the Protection of Human Subjects. In this Notice of Proposed Rulemaking (NPRM), the departments sought to strengthen, modernize, and make more effective human subjects regulations while reducing administrative burden, delay, and ambiguity. We reviewed public comments from National Institutes of Health (NIH)-funded Clinical and Translational Science Awards (CTSA) institutions on key provisions of the NPRM to understand how the proposed changed were received at research-intensive institutions...
April 2017: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/28415965/the-pregnancy-environment-and-lifestyle-study-petals-a-population-based-longitudinal-multi-racial-birth-cohort
#9
Yeyi Zhu, Monique M Hedderson, Juanran Feng, Ashley A Mevi, Assiamira Ferrara
BACKGROUND: Increasing recognition has been received regarding the proven and suggested links between multi-level environmental exposures on a broad scale (e.g., chemical, clinical, behavioral, physical and social) and health deficits originated from the critical window of development. However, such prospective human data are limited. In 2016, the National Institutes of Health funded 35 centers comprising 84 extant cohorts for the Environmental Influences on Child Health Outcomes (ECHO) pediatric cohorts program...
April 17, 2017: BMC Pregnancy and Childbirth
https://www.readbyqxmd.com/read/28103080/organization-of-bbmri-pl-the-polish-biobanking-network
#10
Małgorzata Witoń, Dominik Strapagiel, Joanna Gleńska-Olender, Anna Chróścicka, Katarzyna Ferdyn, Jarosław Skokowski, Leszek Kalinowski, Jakub Pawlikowski, Błażej Marciniak, Markus Pasterk, Agnieszka Matera-Witkiewicz, Łukasz Kozera
In Poland storage of human biological samples takes place at most universities and scientific institutions conducting research projects in the field of biomedicine. The First International Biobanking Conference organized by the Ministry of Science and Higher Education in 2014 shed a light on the situation of Polish biobanking infrastructures. The country has around 40 large biorepositories, which store unique biological material such as whole brains, muscle fibers from patients with rare diseases, as well as thousands of samples from patients with lifestyle diseases...
June 2017: Biopreservation and Biobanking
https://www.readbyqxmd.com/read/27926908/community-perceptions-of-biobanking-participation-a-qualitative-study-among-mexican-americans-in-three-texas-cities
#11
Natalia I Heredia, Sarah Krasny, Larkin L Strong, Laura Von Hatten, Lynne Nguyen, Belinda M Reininger, Lorna H McNeill, María E Fernández
BACKGROUND: Most biospecimens in the US are collected from non-Hispanic Whites, limiting the generalizability of findings. There is a need to increase participation in biobanking among ethnic and racial minorities. The purpose of this study was to use qualitative methods to identify factors that may influence Mexican-American individuals' willingness to participate in biobanking. METHODS: We conducted 15 focus groups in three Texas cities with Mexican-American individuals, in both Spanish and English...
2017: Public Health Genomics
https://www.readbyqxmd.com/read/27677055/building-a-repository-of-science-the-importance-of%C3%A2-integrating-biobanks-within-molecular-pathology-programmes
#12
REVIEW
Claire Lewis, Stephen McQuaid, Peter W Hamilton, Manuel Salto-Tellez, Darragh McArt, Jacqueline A James
Repositories containing high quality human biospecimens linked with robust and relevant clinical and pathological information are required for the discovery and validation of biomarkers for disease diagnosis, progression and response to treatment. Current molecular based discovery projects using either low or high throughput technologies rely heavily on ready access to such sample collections. It is imperative that modern biobanks align with molecular diagnostic pathology practices not only to provide the type of samples needed for discovery projects but also to ensure requirements for ongoing sample collections and the future needs of researchers are adequately addressed...
November 2016: European Journal of Cancer
https://www.readbyqxmd.com/read/27629376/generation-and-validation-of-a-universal-perinatal-database-and-biospecimen-repository-peribank
#13
K M Antony, P Hemarajata, J Chen, J Morris, C Cook, D Masalas, M Gedminas, A Brown, J Versalovic, K Aagaard
OBJECTIVE: There is a dearth of biospecimen repositories available to perinatal researchers. In order to address this need, here we describe the methodology used to establish such a resource. STUDY DESIGN: With the collaboration of MedSci.net, we generated an online perinatal database with 847 fields of clinical information. Simultaneously, we established a biospecimen repository of the same clinical participants. RESULTS: The demographic and clinical outcomes data are described for the first 10 000 participants enrolled...
September 15, 2016: Journal of Perinatology: Official Journal of the California Perinatal Association
https://www.readbyqxmd.com/read/27599083/-institutional-biobank-as-a-pillar-of-medical-science
#14
María Lourdes Garza-Rodríguez, Antonio Alí Pérez-Maya, Daniela Estefanía Monsivais-Ovalle, Juan Francisco Velázquez-Vadillo, Hugo Alberto Barrera-Saldaña
A biobank facility is one of the most valuable means that academic medical organizations have to offer researchers for improving the competitiveness of their medical research. We describe the implementation of our institutional biobank. Our efforts focused on the design and equipment of work areas, staff training, quality control, bioethical and regulatory issues, generating research collaborations and developing funding strategies. We implemented an institutional biobank at the School of Medicine of the Autonomous University of Nuevo León, Mexico...
August 2016: Salud Pública de México
https://www.readbyqxmd.com/read/27412853/the-ethics-of-conducting-molecular-autopsies-in-cases-of-sudden-death-in-the-young
#15
Amy L McGuire, Quianta Moore, Mary Majumder, Magdalena Walkiewicz, Christine M Eng, John W Belmont, Salma Nassef, Sandra Darilek, Katie Rutherford, Stacey Pereira, Steven E Scherer, V Reid Sutton, Dwayne Wolf, Richard A Gibbs, Roger Kahn, Luis A Sanchez
No abstract text is available yet for this article.
September 2016: Genome Research
https://www.readbyqxmd.com/read/27392418/views-on-clinical-trial-recruitment-biospecimen-collection-and-cancer-research-population-science-from-landscapes-of-the-haudenosaunee-people-of-the-longhouse
#16
Rodney C Haring, Whitney Ann Henry, Maui Hudson, Elisa M Rodriguez, Maile Taualii
Biomedical research in culturally distinct communities is often a challenge. Potential barriers to participation occur because science is presented in a format that lacks cultural acknowledgement. Investigations may also fail to showcase beneficial relevance to the communities or include them in true partnership. The history of biomedical research within Native American societies has been complicated by these issues. Historical trauma among many Native groups sometimes transcends into contemporary challenges in both recruitment to and participation particularly in biobanking research...
July 9, 2016: Journal of Cancer Education: the Official Journal of the American Association for Cancer Education
https://www.readbyqxmd.com/read/27222291/the-risk-of-re-identification-versus-the-need-to-identify-individuals-in-rare-disease-research
#17
Mats G Hansson, Hanns Lochmüller, Olaf Riess, Franz Schaefer, Michael Orth, Yaffa Rubinstein, Caron Molster, Hugh Dawkins, Domenica Taruscio, Manuel Posada, Simon Woods
There is a growing concern in the ethics literature and among policy makers that de-identification or coding of personal data and biospecimens is not sufficient for protecting research subjects from privacy invasions and possible breaches of confidentiality due to the possibility of unauthorized re-identification. At the same time, there is a need in medical science to be able to identify individual patients. In particular for rare disease research there is a special and well-documented need for research collaboration so that data and biosamples from multiple independent studies can be shared across borders...
November 2016: European Journal of Human Genetics: EJHG
https://www.readbyqxmd.com/read/27046294/assays-for-qualification-and-quality-stratification-of-clinical-biospecimens-used-in-research-a-technical-report-from-the-isber-biospecimen-science-working-group
#18
Fay Betsou, Alexandre Bulla, Sang Yun Cho, Judith Clements, Rodrigo Chuaqui, Domenico Coppola, Yvonne De Souza, Annemieke De Wilde, William Grizzle, Fiorella Guadagni, Elaine Gunter, Stacey Heil, Verity Hodgkinson, Joseph Kessler, Michael Kiehntopf, Hee Sung Kim, Iren Koppandi, Katheryn Shea, Rajeev Singh, Marc Sobel, Stella Somiari, Demetri Spyropoulos, Mars Stone, Gunnel Tybring, Klara Valyi-Nagy, Gert Van den Eynden, Lalita Wadhwa
This technical report presents quality control (QC) assays that can be performed in order to qualify clinical biospecimens that have been biobanked for use in research. Some QC assays are specific to a disease area. Some QC assays are specific to a particular downstream analytical platform. When such a qualification is not possible, QC assays are presented that can be performed to stratify clinical biospecimens according to their biomolecular quality.
October 2016: Biopreservation and Biobanking
https://www.readbyqxmd.com/read/26928707/review-article-the-role-of-molecular-pathological-epidemiology-in-the-study-of-neoplastic-and-non-neoplastic-diseases-in-the-era-of-precision-medicine
#19
Shuji Ogino, Reiko Nishihara, Tyler J VanderWeele, Molin Wang, Akihiro Nishi, Paul Lochhead, Zhi Rong Qian, Xuehong Zhang, Kana Wu, Hongmei Nan, Kazuki Yoshida, Danny A Milner, Andrew T Chan, Alison E Field, Carlos A Camargo, Michelle A Williams, Edward L Giovannucci
Molecular pathology diagnostics to subclassify diseases based on pathogenesis are increasingly common in clinical translational medicine. Molecular pathological epidemiology (MPE) is an integrative transdisciplinary science based on the unique disease principle and the disease continuum theory. While it has been most commonly applied to research on breast, lung, and colorectal cancers, MPE can investigate etiologic heterogeneity in non-neoplastic diseases, such as cardiovascular diseases, obesity, diabetes mellitus, drug toxicity, and immunity-related and infectious diseases...
July 2016: Epidemiology
https://www.readbyqxmd.com/read/26828766/trends-in-biobanking-a-bibliometric-overview
#20
REVIEW
Jonas J Astrin, Fay Betsou
Biobanks have become indispensable tools for a wide array of life and environmental sciences, and biotechnology. To evaluate trends in biobanking, 20,000 bibliographic records were retrieved and analyzed between 1939 and 2014 from the Scopus database using a series of biobank-related search terms within titles and keywords. Since the 1990s, the field of biobanking has been, and still is, experiencing above-average growth in terms of publications, journals, and thematic orientations. Almost two-thirds of all indexed biobanking documents have been published in the last decade, with now >1,000 publications in 600 distinct journals per year...
February 2016: Biopreservation and Biobanking
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