Access Committee Research Articles

Data Sharing in the Post-Genomic World: The Experience of the International Cancer Genome Consortium (ICGC) Data Access Compliance Office (DACO)

The scientific community, research funders, and governments have repeatedly recognized the importance of open access to genomic data for scientific research and medical progress [1]–[4]. Open access is becoming a well-established practice for large-scale, publicly funded, data-intensive community science projects, particularly in the field of genomics. Given this consensus, restrictions to open access should be regarded as exceptional and treated with caution. Yet, several developments [5] have led scientists and policymakers to investigate and implement open access restrictions [5]–[9]. Notably, there are privacy concerns within the genomics community and critiques from some researchers that open access, if left completely unregulated, could raise significant scientific, ethical, and legal issues (e.g., quality of the data, appropriate credit to data generators, relevance of the system for small and medium projects, etc.) [1]–[10]. A recent paper by Greenbaum and colleagues in this journal [11] identified protecting the privacy of study participants as the main challenge to open genomic data sharing. One possible way to reconcile open data sharing with privacy concerns is to use a tiered access system to separate access into “open” and “controlled.” Open access remains the norm for data that cannot be linked with other data to generate a dataset that would uniquely identify an individual. A controlled access mechanism, on the other hand, regulates access to certain, more sensitive data (e.g., detailed phenotype and outcome data, genome sequences files, raw genotype calls) by requiring third parties to apply to a body (e.g., custodian, original data collectors, independent body, or data access committee) and complete an access application that contains privacy safeguards. This mechanism, while primarily designed to protect study participants, can also be used to protect investigators, database hosting institutions, and funders from perceptions or acts of favoritism or impropriety. The experience of controlled access bodies to date has been only minimally documented in the literature [9], [12]. To address this lacuna, we present the experience of the Data Access Compliance Office (DACO) of the International Cancer Genome Consortium (ICGC). The goal is to provide information on this increasingly important type of database governance body.

PMO-182 HCV research UK: a UK national resource to support research into HCV infection

IntroductionBackground: Hepatitis C virus (HCV) infection has been identified by the MRC and Department of Health MRC as a priority area for research and development to meet the clinical challenges...

P5-21-03: The Breast Cancer Campaign Tissue Bank.

Abstract The breast cancer research community has recognised that access to a source of carefully collected well-annotated human breast tissue is essential for translational research. Research institutions often face barriers in gaining access to this resource as collections typically have restrictive access policies or an over burdensome application process. This was formally recognised by around 50 prominent breast cancer researchers through a Gap Analysis conducted in London, UK in 20061. As a direct result of this report, 4 leading UK centres (Barts Cancer Institute, the Universities of Dundee, Leeds and Nottingham) with multi disciplinary expertise in pathology, basic science, bioinformatics and computer science have collaborated with a leading breast cancer charity to form the Breast Cancer Campaign Tissue Bank (BCCTB; http://www.breastcancercampaigntissuebank.org). BCCTB is a unique resource of biological materials and supportive clinical data, efficiently and ethically collected from patients with breast cancer, to provide researchers with high quality, relevant materials, helping to raise the standard of breast cancer research and facilitating the co-ordinated translation of scientific findings into the clinical setting. A wide range of biological materials are banked, including fresh frozen tumour and surrounding tissue, isolated purified cell populations (which can be provided for culture or DNA/RNA/protein extraction), whole blood and serum samples, as well as formalin-fixed paraffin-embedded material. Specialised collections are also available through the Bank on a collaborative basis. BCCTB has a centralised IT system allowing efficient tracking of samples and recording of raw data from studies, and providing a user-friendly web-based search portal to view material available. A purpose-built Bioinformatics platform allows mining breast cancer literature data from multiple sources and integrating different types of -omics and clinical data alongside publically relevant annotations from a growing number of biological resources such as NCBI, Ensembl, UniProt and Reactome. This platform is also fully interoperable with the International Cancer Genome Consortium (ICGC) and can be automatically cross-queried from the ICGC data portal which allows direct cross-comparison of experimental findings generated from the ICGC breast cancer projects with literature-derived information stored in our portal. Together this results in the highly efficient and co-ordinated use of samples, reducing duplication of effort and facilitating data mining and analysis. As science is constantly evolving we have an inbuilt R&D program, including cell immortalisation, investigating improved sample storage and collection methods and on-going IT development, all of which will ensure the bank remains cutting-edge. Tissue is released following review by a Tissue Access Committee comprising clinical and non-clinical breast cancer researchers and patient advocates. Direct interaction with end users ensures the materials and data supplied meets the researcher needs. Currently BCCTB is accepting applications from UK based researchers with projects funded by Breast Cancer Campaign. It will launch to the wider breast cancer community in the next 18 months. 1Thompson A et al., Breast Cancer Research 2008, 10:R26. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P5-21-03.

Secondary uses and the governance of de-identified data: lessons from the human genome diversity panel.

BackgroundRecent changes to regulatory guidance in the US and Europe have complicated oversight of secondary research by rendering most uses of de-identified data exempt from human subjects oversight. To identify the implications of such guidelines for harms to participants and communities, this paper explores the secondary uses of one de-identified DNA sample collection with limited oversight: the Human Genome Diversity Project (HGDP)-Centre d'Etude du Polymorphisme Humain, Fondation Jean Dausset (CEPH) Human Genome Diversity Panel.MethodsUsing a combination of keyword and cited reference search, we identified English-language scientific articles published between 2002 and 2009 that reported analysis of HGDP Diversity Panel samples and/or data. We then reviewed each article to identify the specific research use to which the samples and/or data was applied. Secondary uses were categorized according to the type and kind of research supported by the collection.ResultsA wide variety of secondary uses were identified from 148 peer-reviewed articles. While the vast majority of these uses were consistent with the original intent of the collection, a minority of published reports described research whose primary findings could be regarded as controversial, objectionable, or potentially stigmatizing in their interpretation.ConclusionsWe conclude that potential risks to participants and communities cannot be wholly eliminated by anonymization of individual data and suggest that explicit review of proposed secondary uses, by a Data Access Committee or similar internal oversight body with suitable stakeholder representation, should be a required component of the trustworthy governance of any repository of data or specimens.

An Integrative View of the Institutional Repositories in Hong Kong: Strategies and Challenges

This paper reports on the developmental strategies, challenges and directions of the institutional repositories of the higher educational institutions in Hong Kong. The study integrates the size, content, full text and public accessibility of these repositories. The paper also compares archived output with research output as registered by the Hong Kong University Grants Committee. Percentages of archived work are low for journal and conference papers, but moderate for graduate theses. These deposit rates reflect the differing institutional policies. In recognizing these challenges, the Hong Kong Open Access Committee has been formed to address regional issues in knowledge sharing.

An Integrative View of the Institutional Repositories in Hong Kong: Strategies and Challenges

This paper reports on the developmental strategies, challenges and directions of the institutional repositories of the higher educational institutions in Hong Kong. The study integrates the size, content, full text and public accessibility of these repositories. The paper also compares archived output with research output as registered by the Hong Kong University Grants Committee. Percentages of archived work are low for journal and conference papers, but moderate for graduate theses. These deposit rates reflect the differing institutional policies. In recognizing these challenges, the Hong Kong Open Access Committee has been formed to address regional issues in knowledge sharing.

Identifiability of DNA Data: The Need for Consistent Federal Policy

Identifiability of DNA Data: The Need for Consistent Federal Policy

Methodology for clinical practice guidelines for the management of arteriovenous access

The Society for Vascular Surgery considers the placement and maintenance of arteriovenous hemodialysis access to be an important component of any vascular surgery practice. Therefore, the Society has long been involved in setting the standards for the management of arteriovenous access. Formulating clinical recommendations in this area is the latest effort by the Society to improve the management of arteriovenous access on a national level. To provide an unbiased study of the evidence and to help in formulating the recommendations, the Society used the Knowledge and Encounter Research (KER) Unit of the Mayo Clinic College of Medicine, Rochester, Minn, to review the available evidence and advise a multidisciplinary group of access surgeons and nephrologists in formulating the clinical recommendations. To review the evidence, randomized and observational study designs were both considered. Whenever possible, systematic reviews and meta-analyses of the literature were used because, compared with individual studies, they generate more precise estimates of treatment effects and their results are applicable to a wider range of patients. On behalf of the Society, the group issued its recommendations following the Grading of Recommendations Assessment, Development and Evaluation (GRADE) format; this format disentangles the strength of recommendations from the quality of the evidence and encourages statements about the underlying values and preferences relevant to the particular recommendation. The recommendations are classified as strong (denoted by the phrase "we recommend") or weak (denoted by the phrase "we suggest"); and the quality of evidence is classified as high, moderate, low, or very low. These recommendations are not meant to supersede clinical judgment; rather, they should be used as a guide for the practicing surgeon and nephrologist as the decision is being made for the placement and subsequent procedures and management of arteriovenous hemodialysis access are being considered.

Abstract ED06-01: PLCO biospecimen resource for etiologic and early marker research

Abstract ED06-01 The Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial is a large randomized trial evaluating the effects of screening on cancer-related mortality and cancer incidence. Ten screening centers located across the United States have enrolled 76,705 men and 78,237 women, ages 55 to 74, and randomized them to an intervention arm or control arm. Participants in the intervention arm of the trial receive screening for the PLCO cancers during their first 6 years of participation in the trial and follow-up continues for at least 7 additional years. Participants in the control arm are followed for at least 13 years after enrollment, but do not receive the screening examination as part of the trial. Blood samples were collected from screen arm subjects during annual screens. Approximately 2.9 million specimens are stored centrally in the PLCO biorepository. Several characteristics highlight the value of this resource: 1) up to 6 annually collected serial specimens are available; 2) specimens are collected prospectively, before cancer diagnosis; 3) specimens are linked to detailed epidemiological and clinical data; 4) large sample size allows statistical power. Specimens available include serum, plasma, buffy coat, red blood cells, and cryo-preserved whole blood from screened arm subjects; and buccal cells from control arm subjects. Epidemiological and clinical data available include baseline demographic and risk factor information; food frequency questionnaire; information on all-cancer incidence and selected other medical conditions (Table1 & 2). A newly added PLCO resource provides Tissue Microarrays (TMA) of tumor samples from PLCO participants who developed cancer. TMAs for colorectal cancer, colorectal adenomas, and ovarian cancer are now available. TMA construction for prostate cancer and lung cancer is under way. Additional collections for other cancers may be added. A unique advantage of the PLCO tumor samples is the availability of corresponding pre-diagnostic blood samples from the same patients. The longitudinally collected, pre-diagnostic serum/plasma samples are particularly suitable for the validation of promising early detection or screening biomarkers. Recently, PLCO embarked on an effort to coordinate biomarker validation studies using PLCO samples. The goal of this coordination effort is to: 1) ensure proper study design; 2) maximize the amount of useful information that may be obtained from studies using high-quality PLCO specimens; 3) ensure proper reporting of key results in publications. The study design, approach, statistical data analysis plan developed in this effort should be informative for other investigators who wish to conduct high-quality biomarker validation studies. Results from these studies will be available in the near future. The PLCO biospecimens resource has been providing samples to the entire scientific community since 2005. PLCO samples been extensively used for genetic and biochemical investigations of risk factors for cancers. For example, SNPs in genes in various genetic pathways have been identified to be associated with risk of cancers; serum levels of Vitamin D metabolites have been examined for correlation with risk of prostate cancer, breast cancer, and colorectal adenomas; a NCI cohort consortium pooling project is looking into Vitamin D in rare cancers. Other projects include dietary, BMI, alcohol, smoking and other life style factors and risk of cancers. A wealth of data has been published using PLCO samples. For example, genome-wide association study (GWAS) data is now available for prostate cancer and breast cancer through the NCI Data Access Committee (http://cgems.cancer.gov/). GWAS studies for pancreatic, lung, colorectal cancer are currently on-going from which data will also become available in the near future. Over 50 peer-reviewed research articles have been published using PLCO samples. The PLCO biospecimen and data resource is available to all qualified researchers through a panel review process. Applications are accepted twice a year in June and December. Detailed information about the panel review process, sample collection protocol, and application materials are available on the PLCO program website: www.parplco.org. Table1: Summary of Data and Specimens Available Table2: Cancer cases with biospecimens Abstract for AACR, November 16, 2008 Page 1 of 3 Citation Information: Cancer Prev Res 2008;1(7 Suppl):ED06-01.

Moving in the right direction: Developments in the online availability of full-text Congressional committee hearing transcripts

Abstract A 2003 study revealed a shortage of full-text Congressional committee hearing transcripts for the 105th and 106th Congresses from both GPO Access and Congressional committee Web sites. By using hearings in the LexisNexis Congressional database as the control group, the current study analyzes the availability of full-text hearing transcripts for the 107th and 108th Congresses, and finds that there has been considerable improvement in the number and extent of full-text hearing transcripts offered by GPO Access and Congressional committee Web sites for hearings from the two most recent Congresses. There is, however, one notable exception: Senate hearing transcripts continue to be inadequately represented by both GPO Access and the Senate committees' own Web sites. Possible causes and implications of the findings are explored.

P66 The UK Blood Service/Wellcome Trust Control Collection: a unique public resource of control samples for disease association studies

Disease association studies, designed to identify genetic risk factors for common diseases (e.g. obesity and diabetes), require large numbers of samples from both patients and controls. The existence of a common control cohort that can be used in all diseases would have significant benefits. The National Blood Service and Cambridge University, funded by a grant from the Wellcome Trust, have collected DNA, plasma and viable lymphocytes from approximately 3600 UK blood donors. These samples form the UK Blood Service/Wellcome Trust Control Collection (UK‐BS/WT‐CC). A training pack was developed for collection teams of the blood services involved. Following training of team staff, donors attending regional blood collection sessions over a 6‐month period from September 2005 to February 2006 were asked to consent. For isolation of viable lymphocytes an ACD anti‐coagulated blood aliquot was collected. Corresponding plasma and leukocyte filters for DNA isolation were provided by the blood services after the processing of the whole blood donation. The samples were assigned unique numeric identifiers and following sample processing a controlled anonymisation process was performed in which all identifiers linking the sample to the donor were destroyed. In addition, a number of biometric measurements (gender, BMI, height, weight, year of birth) were obtained from each donor at the time of sample collection. This anonymised collection represents a unique public resource of control samples collected from donors throughout the geographical regions of the UK. Currently, 1500 DNA samples are being genotyped on the Affymetrix GeneChip® Human Mapping 500K Array Set as part of the Wellcome Trust Case Control study (http://www.wtccc.org.uk). Here we give an overview of the sample collection and processing together with a description of the phenotypic data that characterise the collection. The UK‐BS/WT‐CC represents a unique resource that will be available to eligible users via an access committee. The UK‐BS/WT‐CC places the NHSBT at the forefront of ongoing disease association studies.

If First You Don't Succeed: Re-Analyze the Data or: Drilling down Dialysis Data

ISSUE: Catheter related Bacteremia (CRB) is an ongoing concern in the Hemodialysis Population. The Hospital outpatient unit experienced an increase in CRB rates above the Centers for Disease Control (CDC) comparative data. This prompted multifaceted and multidisciplinary interventions. These interventions resulted in a downward trend of CRB and Localized site infections but the decrease in CRB was not sustained. PROJECT: Detailed analysis of the CDC- Dialysis Surveillance Network data for our unit from 2001 through 2005 revealed a total of 287 CRB. Sixty-seven patients (54%) experienced 80% of the infections with an average of 3.5 infections per patient (range 2-11). Subsequent infections were commonly due different organisms. Fifty-five patients (45%) had only one episode of CRB. Our analysis indicates that the likelihood of CRB is greater with a previous CRB and interventions to prevent the initial CRB might be beneficial. A plan was implemented to focus on preventing initial infections as a means to prevent subsequent infections. An Access Committee worked to promote early placement of Arterial Venous Fistulas (AVF), thereby reducing the number of tunneled catheters being placed and used as means of initial dialysis access. RESULTS: The average percent of patients with perm catheters dropped from 48% to 26% by the end of 2005. During this same time period the number of new patients increased by 25%. A vascular awareness program was implemented for patients and staff that included decreasing the number of manipulations of the catheters, awareness of patient staff ratios, re-education of patients and continued competencies for staff. LESSONS LEARNED: All Bacteremia are not equal and dialysis patients who experience repeated infections may require novel approaches to prevention and control of CRB. It may not be possible to eliminate or have sustained low levels of initial infections in the presence of large numbers of catheters. When analyzing dialysis Bacteremia, a case control study may be beneficial to further identify patients at risk for CRB. Early prevention strategies could then be targeted to this population.

Focally Elevated Creatine Detected in Amyloid Precursor Protein (APP) Transgenic Mice and Alzheimer Disease Brain Tissue

The creatine/phosphocreatine system, regulated by creatine kinase, plays an important role in maintaining energy balance in the brain. Energy metabolism and the function of creatine kinase are known to be affected in Alzheimer diseased brain and in cells exposed to the beta-amyloid peptide. We used infrared microspectroscopy to examine hippocampal, cortical, and caudal tissue from 21-89-week-old transgenic mice expressing doubly mutant (K670N/M671L and V717F) amyloid precursor protein and displaying robust pathology from an early age. Microcrystalline deposits of creatine, suggestive of perturbed energetic status, were detected by infrared microspectroscopy in all animals with advanced plaque pathology. Relatively large creatine deposits were also found in hippocampal sections from post-mortem Alzheimer diseased human brain, compared with hippocampus from non-demented brain. We therefore speculate that this molecule is a marker of the disease process.

Development and Results of a Case Coordination Activity Tracking Tool

This study describes the development of a tool used to track the who, what, when, and how much of case coordination for elderly, community-based clients. The Case Coordination Activity Tracking Form measures phase of coordination (assessment, plan development, plan implementation, monitoring reassessient, and discharge), type of activity (in-person, telephone, documentation, research, travel, case conference), with whom contact took place (client, family, client/family together, supervisor/colleague, service provider, physician, program access committee), and special circumstances (e.g., infection control). Over a 6-month span, we used the tool to study case coordination of services for elderly, community-based clients. The average amount of coordination time was 5.15 hours (n = 234), with 71% of the clients requiring between 2 and 6hours of coordination, and 26% of the clients accounting for 49% of the total coordination time. Frequency and average amount of coordination declined greatly after the first month. Not all clients required coordination each month, and monitoring was the most common activity in later months. The tool was found to be reliable and easy to use, and of benefit to decision makers, managers, and case coordinators in measuring, analyzing, and describing case coordination. This tool could be readily used with other client groups.

A Snapshot of Availability of U.S. Congressional Committee Hearings

U.S. congressional hearings are among the most heavily used sources of government information made available through the Federal Depository Library Program. The traditional distribution of full-text hearings in tangible format (paper and microfiche) is only beginning to be supplemented by online distribution through GPO Access. Alternate online sources of committee hearings are the Web pages of individual congressional committees. This study identifies and tallies the number of hearings held by committees of the 105th and 106th Congresses and distributed in tangible format by the Government Printing Office. Data from the initial step is then compared to those listed on GPO Access and congressional committee Web sites between October 2001 and May 2002 to determine the comprehensiveness of the online lists. Finally, the study tabulates and compares the availability of full-text hearings records (transcripts) on both the GPO Access and congressional committee sites. Although the study indicates fuller coverage for the more recent Congress, analysis indicates that neither GPO Access nor Web sites provide complete availability of full-text hearings, and that the coverage varies greatly from committee to committee, and from Congress to Congress.

Development and Results of a Case Coordination Activity Tracking Tool

This study describes the development of a tool used to track the who, what, when, and how much of case coordination for elderly, community-based clients. The Case Coordination Activity Tracking Form measures phase of coordination (assessment, plan development, plan implementation, monitoring, reassessment, and discharge), type of activity (in-person, telephone, documentation, research, travel, case conference), with whom contact took place (client, family, client/family together, supervisor/colleague, service provider, physician, program access committee), and special circumstances (e.g., infection control). Over a 6-month span, we used the tool to study case coordination of services for elderly, community-based clients. The average amount of coordination time was 5.15 hours (n = 234), with 71% of the clients requiring between 2 and 6 hours of coordination, and 26% of the clients accounting for 49% of the total coordination time. Frequency and average amount of coordination declined greatly after the first month. Not all clients required coordination each month, and monitoring was the most common activity in later months. The tool was found to be reliable and easy to use, and of benefit to decision makers, managers, and case coordinators in measuring, analyzing, and describing case coordination. This tool could be readily used with other client groups.

Committee on Antibiotic Resistance

Australian Veterinary JournalVolume 76, Issue 12 p. 780-780 Free Access Committee on Antibiotic Resistance First published: 10 March 2008 https://doi.org/10.1111/j.1751-0813.1998.tb12323.xAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat No abstract is available for this article. Volume76, Issue12December 1998Pages 780-780 RelatedInformation

Committee involvement crucial to Union's activities

Eos, Transactions American Geophysical UnionVolume 79, Issue 7 p. 81-81 Free Access Committee involvement crucial to Union's activities John A. Knauss, John A. Knauss AGU,Search for more papers by this author John A. Knauss, John A. Knauss AGU,Search for more papers by this author First published: 19 October 2006 https://doi.org/10.1029/98EO00055AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article. Volume79, Issue717 February 1998Pages 81-81 RelatedInformation

EUROPEAN SOCIAL CHARTER

Journal Article EUROPEAN SOCIAL CHARTER Get access Committee of Independent Experts of the European Social Charter. Conclusions X–1 . Council of Europe, Strasbourg, 1987 . BOB HEPPLE BOB HEPPLE Search for other works by this author on: Oxford Academic Google Scholar Industrial Law Journal, Volume 17, Issue 1, 1988, Pages 124–125, https://doi.org/10.1093/ilj/17.1.124 Published: 01 June 1988

Access and the project manager

The role of the project manager has traditionally concentrated upon the execution of a project, from conception to completion. The commissioning and operation have been a secondary priority, for good reasons which are discussed in this paper. Nowhere has this been more true than in building construction, despite the fact that a building is a place where there is maximum interaction with people of all types. Some 10% of people worldwide are disabled, which prevents them from using buildings and facilities designed for able-bodied people. All this is changing rapidly. No longer should buildings be designed to be accessible only to the majority, nor should special arrangements be provided as an ‘extra’ for disabled people. Design philosophy is being impelled to provide for all building users. Great impetus was provided by the 1981 International Year of Disabled Persons, designated by the United Nations. In the UK, The Prince of Wales' Advisory Group on Disability and the Access Committee for England are influential and active organizations that are exerting a powerful influence for change. New building regulations are introducing a statutory imperative. The attention of project managers is drawn to what is happening in this area, and it is suggested that in their unique position they can influence the bridging of the gap between designers and building operators, to ensure that buildings can be used by all, and that nothing is overlooked at any stage. Legislation alone cannot solve the problem, and a change in attitude is necessary.