Population Research

 

International Biobank and Cohort Studies: Developing a Harmonious Approach

 

Meeting Summary

February 7-8, 2005 - Sheraton Buckhead - Atlanta, GA

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The Human Genome Epidemiology Network (HuGENet), in collaboration with the Public Population Project in Genomics (P3G) and the National Heart, Lung and Blood Institute, NIH, convened a multidisciplinary group of experts including geneticists, epidemiologists, laboratorians, biostatisticians, lawyers and medical publishers in Atlanta. Participants represented the members of the P3G project, (including Cartagene), HuGE Net, the UK biobank, the KORA-gen biobank from Germany, the GenomEUtwin biobank project from Sweden, the National Heart, Lung and Blood Institute, the National Children's Study, the Marshfield Personalized Medicine Project, and the Kaiser Permanente Northern California biobank project.

In addition to informing each of the participants regarding the progress made in each of the nascent Biobank projects underway around the world and spurring collegial interactions, the main goal for the meeting was to discuss the possibility of producing an overall statement aimed at harmonizing the format and improving the quality of publications arising from Biobank-based genetic-epidemiologic studies. The meeting also focused on beginning work towards producing a statement similar to that produced for randomized clinical trials (the CONSORT statement) and for observational studies (STROBE). Discussion on this process centered around creating a checklist and flowchart that would clearly describe the data flow within each Biobank study, allowing for the proper interpretation and future use in systematic reviews or meta-analyses. Important attributes of such a statement would include a thorough description of (a) study objectives and a-priori hypotheses; (b) participants; (c) genotyping processes; (d) exposure measurements; (e) outcome definitions and measurements; (f) statistical analysis plan including power and sample size descriptions; (g) assessment of confounding (including population substratification and other genotypic confounding); and (h) methods for subanalyses. This statement would serve as guidelines for publication, and could also be used to help guide investigators in planning studies at the time investigators first approach Biobanks with project ideas.

Considerable discussion followed and focused on the best avenue for providing and archiving the large amounts of data that will be produced from Biobank studies, and how to make this data available for future use. Also, consideration of and substantial support was given for a proposal that Biobanks produce a design and conduct template outlining basic structure, including intellectual property guidance, human subjects protection, and information technology standards. Such a template of core elements could be used as a reference document, to which each Biobank-based study could refer at the time of initiation and publication. The participants also agreed on the need of an online knowledge base that could include a repository of information on biobanks and their tools (e.g. questionnaires; data entry management; informed consent; confidentiality; governance documents …) on the P3G Web site.

The meeting participants agreed to develop the following products:

1. A paper reporting on the biobank meeting and laying out the challenges and opportunities for human genome epidemiology studies in the context of biobanks. This paper would also contain extensions to STROBE statement that are specific to biobanks with examples and explanations from this field.
2. Because of the overlap of biobank projects with general human genome epidemiology studies, a more general “module” on standards for presenting human genome epidemiologic data within the STROBE framework.
3. A set of guidelines for documenting biobank structure, standards and procedures. It was also proposed that biobanks produce a separate statement outlining its structure, including intellectual property guidance, human subjects protection, and information technology standards. Such a report could be used as a reference document, to which each Biobank-based study could refer at the time of publication.
4. The P3G led knowledge base group will take the lead in developing online repository of tools (e.g. informed consent documents), and register of biobank studies.

 

CENTERS FOR DISEASE CONTROL & PREVENTION

INVITED PARTICIPANTS

Sara Bedrosian Consultant Office of Genomics and Disease Prevention CCHP, CDC Linda Bradley, PhD Geneticist Office of Genomics and Disease Prevention CCHP, CDC D. Joe Boone, PhD Associate Director for Science Division of Public Health Partnerships National Center for Health Marketing, CDC Bin Chen, PhD Health Scientist CCHIS, CDC Adolfo Correa, MD, PhD Supervisory Medical Officer Division of Birth Defects and Developmental Disabilities NCBDDD, CCHP, CDC Robert L. (Bob) Davis, MD, MPH Guest Scientist Office of Genomics and Disease Prevention CCHP, CDC W. Andrew Faucett , MS , CGC ORISE Fellow CCHIS, CDC Marta Gwinn, MD, MPH Associate Director for Science Office of Genomics and Disease Prevention, CCHP, CDC W. Harry Hannon, PhD Chief, Newborn Screening Branch Division of Laboratory Sciences National Center for Environmental Health, CCEH, CDC Susan Hariri, PhD, MPH Epidemic Intelligence Service Officer Office of Genomics and Disease Prevention CCHP, CDC Muin Khoury, MD, PhD Director Office of Genomics and Disease Prevention CCHP, CDC Bruce Lin, MPH HuGE Net Coordinator Office of Genomics and Disease Prevention CCHP, CDC Mary Lou Lindegren, MD Medical Epidemiologist Office of Genomics and Disease Prevention CCHP, CDC Shauna Lyn, MD Epidemic Intelligence Service Officer Office of Genomics and Disease Prevention CCHP, CDC Cynthia Moore, MD, PhD Medical Geneticist Office of Genomics and Disease Prevention CCHP, CDC Nadeem Qureshi, MBBS Harkness Fellow Office of Genomics and Disease Prevention CCHP, CDC Tom Savel, MD Public Health Informatics Fellow Office of the Director NCBDDD, CDC Leah Simpson, MBA Public Health Advisor Office of Genomics and Disease Prevention CCHP, CDC Karen K. Steinberg, PhD Acting Deputy Director Coordinating Center for Health Promotion, CDC Kathleen Szegda, MPH, MS Project Coordinator Office of Genomics and Disease Prevention CCHP, CDC Marshalyn Yeargin-Allsopp, MD Medical Epidemiologist Division of Birth Defects and Developmental Disabilities NCBDDD, CCHP, CDC

Virginia Barbour, MBBChir, DPhil Senior Editor, PLoS Medicine Public Library of Science European Bioinformatics Institute Genome Campus Mylene Deschenes, BCL, LLB, LLM Executive Director Centre de recherche en droit public Faculté de droit Université de Montréal Isabella Fortier, PhD, MS Director of Genetic Epidemiology McGill University and Genome Quebec Innovation Centre Julian Higgins, PhD MRC Biostatistics Unit Institute of Public Health Tom Hudson, PhD Associate Professor and Associate Physician Departments of Medicine and Human Genetics McGill University and Genome Quebec Innovation Centre John Ioannidis, MD Department of Hygiene and Epidemiology School of Medicine University of Ioannina Bartha Knoppers, PhD, LLD Canada Research Chair in Law and Medicine Centre de recherche en droit public Universite de Montreal C.P. 6128, succ. Centre-ville Julian Little, PhD Department of Epidemiology and Community Medicine University of Ottawa Jan-Eric Litton, PhD Biomedical Computing Technology Department of Medical Epidemiology and Biostatistics Karolinska Institutet Jack S. Mandel, PhD, MPH Rollins Professor of Epidemiology Chairman, Department of Epidemiology Rollins School of Public Health Emory University Teri Manolio, MD, PhD Director, Epidemiology and Biometry Program National Heart, Lung, and Blood Institute National Institutes of Health Catherine McCarty, PhD Senior Research Scientist and Director Center for Human Genetics Marshfield Clinic Research Foundation David Moher, PhD Director, Clinical Research Children's Hospital of Eastern Ontario Research Institute Prof. John Newton, FRCP, FFPH CEO UK Biobank Bill Ollier, PhD CIGMR Director Centre for Integrated Genomic Medical Research Catherine Schaefer, PhD Research Scientist / Epidemiologist Kaiser Permanente Division of Research Peter Scheidt, MD Director, Program Office National Children’s Study, Room 5C01C National Institute of Child Health and Human Development National Institutes of Health H-Erich Wichmann, MD, PhD GSF National Research Center for Environment and Health Institute for Epidemiology