NOW, THEREFORE, it is mutually agreed that the National Institute of Mental Health
(NIMH) Human Genetics Initiative Distribution Agreement signed by NIMH, the center for
Genetic Studies, and _____________________________________ (PLEASE PRINT)
as the Receiving Institution is amended to include the following text in paragraph 14
under the section, Acknowledgement for Autism Biomaterials and Clinical Data:
Biomaterials and phenotypic data were obtained from the following projects that participated in the NIMH Autism Genetics Initiative; The collection data and biomaterials come from the Autism Genetic Resource Exchange (AGRE) collection. This program has been supported by a National Institute of Health (grants MH64547 and 1U24MH081810) and Autism Speaks, Inc. (formerly the Cure Autism Now Foundation). The Principal Investigator of grant MH64547 is Daniel H. Geschwind, M.D., Ph.D. (UCLA). The Co-Principal Investigators include Stanley F. Nelson, M.D., and Rita Cantor, Ph.D. (UCLA), Christa Lese Martin, Ph.D. (U. Chicago), T. Conrad Gilliam, Ph.D. (Columbia). Co-investigators include Maricela Alarcon, Ph.D., Kenneth Lange, Ph.D., Sarah J. Spence M.D., Ph.D. (UCLA), David H. Ledbetter Ph.D. (Emory) and Hank Juo, M.D., Ph.D. (Columbia). The Principal Investigator of grant 1U24MH081810 is Clara M. Lajonchere, Ph.D. (USC). The Co-Principal Investigators include Steven Moldin, Ph.D. (USC), Janet Miller, J.D., Ph.D. (Autism Speaks), Mark Urata, M.D. (CHLA), Constantinos Sioutas, Ph.D. (USC), David Amaral, Ph.D. (UC Davis), Curtis Deutsch, Ph.D. (UMASS). Scientific oversight of the AGRE program is provided by the AGRE steering committee: Dan Geschwind, M.D., Ph.D., UCLA; Maja Bucan, Ph.D., University of Pennsylvania; W. Ted Brown, M.D., Ph.D., F.A.C.M.G., N.Y.S. Institute for Basic Research in Developmental Disabilities; Rita M. Cantor, Ph.D., UCLA; John N. Constantino, M.D., Washington University School of Medicine, St. Louis; T. Conrad Gilliam, Ph.D., University of Chicago; Martha Herbert, M.D., Ph.D., Harvard Medical School; Clara Lajonchere, Ph.D., Autism Speaks; David H. Ledbetter, Ph.D., Emory University; Christa Lese-Martin, Ph.D., Emory University; Janet Miller, J.D., Ph.D., Autism Speaks; Stanley F. Nelson, M.D., UCLA; Gerard D. Schellenberg, Ph.D., University of Pennsylvania; Carol A. Samanago-Sprouse, Ed.D., George Washington University; Sarah Spence, M.D., Ph.D., NIMH; Matthew State, M.D., Ph.D., Yale University; Rudolph E. Tanzi, Ph.D., Massachusetts General Hospital. The collection of data and biomaterials in another project has been supported by National Institutes of Health grant MH55135 (“Collaborative Linkage Study of Autism”). The Principal Investigator was Susan E. Folstein, M.D. (Tufts University/New England Medical Center, Boston, MA), and her key Clinical and Phenotypic Coordinators were Brian Winklosky and Beth Rosen-Sheidley, M.S., C.G.C. Co-Investigators included James S. Sutcliffe, Ph.D., and Jonathan L. Haines, Ph.D. (Vanderbilt University, Nashville, TN). The collection of data and biomaterials in another project has been supported by National Institute of Health grant MH55284. The Principal Investigator and Co- Investigators were: University of North Carolina, Chapel Hill: Joseph Piven, M.D., University of Iowa, Iowa City: Val Sheffield, M.D., Ph.D., Veronica Vieland, Ph.D. and Thomas Wassink, M.D. The Shanghai-New Jersey Consortium is currently conducting a privately funded Autism Candidate Gene Study involving researchers at Rutgers University (Department of Genetics) and University of Dentistry and Medicine of New Jersey (UMDNJ) (Center for Advanced Biotechnology and Medicine), New Jersey and The Chinese National Human Genome Center at Shanghai, China. The principal Investigator involved is Jay A. Tischfield, Ph.D. and the Co-Principal Investigators in New Jersey include Lei Yu, Ph.D., Linda M. Brzustowicz, M.D., Neda Gharani, Ph.D., James H. Millonig, Ph.D., Tara Matise, Ph.D., Derek Gordon, Ph.D., and in Shanghai Wei Huang, Ph.D., Ying Wang, Ph.D. NIDCD funded a program project grant (PO1/U19 DC 03610) that was conducted initially at the Eunice Kennedy Shriver Center in Waltham MA, and then transferred to Boston University School of Medicine (Department of Anatomy and Neurobiology). This program project was part of the NICHD/NIDCD funded Collaborative Program of Excellence in Autism (CPEA). The Principal Investigator was Helen Tager-Flusberg, Ph.D., with Susan Folstein as the co-PI. Clinical data were collected by Robert Joseph, Ph.D., Susan Bacalman, M.S.W., and a team of students and research assistants. As part of this program project, a supplement was awarded by NIDCD to collect blood samples from the children enrolled in the program project and their first degree relatives. The collection of the blood samples was coordinated by Nancy Shaffer, B.A. The University of Washington Autism Center research was funded by a grant from the National Institute of Child Health and Human Development (U19HD34565; Geraldine Dawson, Director), which is part of the NICHD Collaborative Program of Excellence in Autism. The CPEA program project is directed by Geraldine Dawson, Ph.D. (Department of Psychology), with Gerard D. Schellenberg, Ph.D. (Departments of Neurology, and Gerontology and Geriatric Medicine) as molecular biologist, and Ellen M. Wijsman, Ph.D. (Department of Biostatistics and Division of Medical Genetics) as statistical geneticist. The Director of the Data Management and Statistical Core is Robert Abbott, Ph.D. (Department of Educational Psychology) with Jeffery Munson, Ph.D. (UW Autism Center). Associate Director in charge of recruitment and diagnostic data collection is Annette M. Estes, Ph.D. (Department of Psychiatry and Behavioral Sciences, Division of Child Psychiatry). As part of an NIH supplementary project, Mount Sinai School of Medicine was funded from 2004-2005 to contact participants that previously participated in a family/genetic study of autism. Multiplex and simplex families were included. All participants were reconsented specifically to have their biomaterial and diagnostic assessment data contributed to NIMH repository. Any outstanding diagnostic and cognitive assessments were also collected. Blood samples were collected from affected and unaffected family members. For all affected family members, diagnostic assessments included the ADI-R, ADOS-G, Vineland Adaptive Behavior Scale, the PPVT-III and/or the Leiter International Performance Scale. The Principal Investigator was Dr. Alison McInnes, and Co-Investigators were Drs. Jeremy Silverman and Christopher J. Smith, who also supervised the data collection. The diagnostic data collection was performed by staff members at the Family Studies Research Center at MSSM who were trained and reliable raters on the ADI-R and ADOS-G. Data and biomaterials collected for the Indiana University Genetic Studies of Autism has been supported by National Institutes of Mental Health grant U10-MH)66766-02S1. The Principal Investigator was Christopher J. McDougle, M.D. (Indiana University) and the Co-Principal Investigator was John I. Nurnberger, Jr., M.D., Ph.D. (Indiana University). Co-Investigators included David Posey, M.D. (Indiana University), Carrie Smiley, R.N., as project coordinator, Sandi Barton and Kurt Williman as research interviewers. We acknowledge assistance form Naomi Swiezy, Ph.D., Kelly Ernsperger, LCSW, and Jennifer Wilerson, R.N. Data was also provided by Dr. Patricia Rodier and Dr. Christopher Stodgell at the University of Rochester. The collection of data and biomaterials for Study 41 was done by investigators in the STAART Network under an NIH Grant. The grant’s focus was the study of the treatment of affective disturbance in children with autism through experiments addressing three specific aims: 1. To determine if the serotonin reuptake inhibitor, citalopram, is effective in the treatment of behavioral disturbance in children with autism. 2. To determine if physiological or genetic markers, measures of family function, or particular pretreatment symptoms are predictive of sensitivity and response to treatment with citalopram. 3. To better understand the response in clinical trials of children with autism by identifying factors influencing parent and clinician ratings of change and to develop new strategies by which to capture the response to therapeutic interventions. Blood samples were collected between April 1, 2004 and October 30, 2006 and sent to the Genetic Repository from children and their parents participating in the citalopram trial. The citalopram trial was a multi-site randomized controlled trial (RCT) of the selective serotonin reuptake inhibitor (SSRI), citalopram, for the treatment of 149 children ages 5 to 17 with Autistic Spectrum Disorders (ASD) and moderate to severe levels of repetitive behaviors. This work was funded by National Institutes of Health via the following STAART center contracts: Mount Sinai School of Medicine, New York, New York: U54-MH066673, Eric Hollander, MD, principal investigator (PI) 5/1/04-12/11/08), Joseph Buxbaum, PI (12/12/08-4/30/09); University of North Carolina at Chapel Hill: U54-MH066418, Joseph Piven, MD, PI; University of California at Los Angeles: U54-MH068172, Marian Sigman, PhD, PI; Yale University, New Haven, Connecticut: U54-MH066494, Fred Volkmar, MD, PI. Dartmouth Medical School, Hanover, New Hampshire, and Boston University, Boston, Massachusetts: U54-MH066398, Helen Tager-Flusberg, PhD, PI; and DM-STAT, Inc, Boston: U01-HD045023, Kimberly Dukes, PhD, PI.Representatives from NIH included Ann Wagner, Ph.D.; Deborah Hirtz, M.D.; and Louise Ritz, MBA.The principal investigators included Eric Hollander, M.D.; Linmarie Sikich, M.D.; James T. McCracken, M.D.; Lawrence Scahill, M.S.N., Ph.D.; Joel D. Bregman, M.D.; Craig L. Donnelly, M.D.; and Bryan H. King, M.D. The Data Coordinating Center was led by Kimberly Dukes, Ph.D. The RCT, NCT00086645, was registered at prior to onset and was conducted at the following 6 academic medical centers: Mount Sinai School of Medicine, New York, New York; North Shore–Long Island Jewish Health System, New York; University of North Carolina at Chapel Hill; University of California at Los Angeles; Yale University, New Haven, Connecticut; and Dartmouth Medical School, Hanover, New Hampshire. In addition to the submission of trio blood samples, the following baseline (prior to treatment administration) was collected: Aberrant Behavior Checklist (ABC), Autism Diagnostic Interview-Revised (ADI-R), Autism Diagnostic Observation Schedule (ADOS), Vocabulary (Comprehensive Test of Phonological Processing (CTOPP) and Peabody Picture Vocabulary Test (PPVT)), IQ (Leiter International Performance Scale-Revised (Leiter-R), Mullen Scales of Early Learning, Wechsler Intelligence Scale for Children (WISC – IV), Wechsler Abbreviated Scales of Intelligence (WASI) or Stanford-Binet Intelligence Scales – 5th addition) and Vineland Adaptive Behaviors. We extend our gratitude to the children and families who participated in the repository, and the STAART Psychopharmacology Network investigators for data collection. From 1997 to 2011, the NINDS (1997-2007; 5R01N736708) and the NIMH (2007-present; 5R01MH080647) funded an autism genetics study (“Molecular and Genetic Epidemiology of Autism”) that was conducted by the John P. Hussman Institute for Human Genomics at the University of Miami Miller School of Medicine and Vanderbilt University. The Principal Investigator is Margaret A. Pericak-Vance, Ph.D. Jonathan L. Haines, Ph.D., of Vanderbilt University Center for Human Genetics Research, is a subcontract Principal Investigator. Co-Investigators are Michael Cuccaro, Ph.D., John R. Gilbert, Ph.D., and Eden R. Martin, Ph.D. Utah Autism Genetics Project. From 2005 to 2011, the NIMH (R01 MH069359) to study genetics of autism and related phenotypes using nuclear families and extended pedigrees. Principal Investigator was Hilary Coon. We ascertained a total of ~360 trios and small nuclear multiplex families and over 100 multi-generation, multiplex families. These extended pedigrees were identified or confirmed using the Utah Population Database (UPDB), a computerized genealogy database ( Information regarding close relative relationships is contained in the repository. More extended pedigree relationship data may be obtained from the PI. For linkage, genotyping services were provided by the Center for Inherited Disease Research (CIDR) using the 6K Illumina SNP Linkage Panel 12. The AGP Simplex Collection (TASC) was funded by an award from Autism Speaks and by funding support to the repository development by the NIMH. The principal investigator and co-investigators on this study were Louise Gallagher, Trinity College Dublin; Astrid Vicente, Instituto Gulbenkian de Ciencia, Oeiras; Joseph Buxbaum, Mount Sinai School of Medicine; Peter Szatmari, McMaster University; William McMahon, University of Utah; Michael Cuccaro, University of Miami; James Sutcliffe, Vanderbilt University; Christine Freitag, Klinikum der Johann-Wolfgang Goethe-Universität, Frankfurt/Main; Sabine Klauck, Deutsches Krebsforschungszentrum (DKFZ), Heidelberg; Veronica Vieland (DCC Director), Research Institute at Nationwide Children’s Hospital, Ohio; Dan Geschwind, AGRE/UCLA, John Nurnberger, University of Indiana; Ed Cook, University of Illinois at Chicago; Raphael Bernier, University of Washington/CPEA. Study 79 – The collection of data and biomaterials comes from the Phenotypic and Genetic Factors in Autism Spectrum Disorders Study. Since 2008, this project has been supported by the Autism Consortium and by NIMH grants (1R01MH085143-Principal Investigator Louis M. Kunkel, Ph.D. and 1R01MH083565-Principal Investigator Christopher Walsh, M.D., Ph.D.). The study was conducted through a collaborative network of five hospitals [Boston Children’s Hospital (BCH), the Lurie Family Autism Center at Massachusetts General Hospital (MGH), The Floating Hospital for Children at Tufts Medical Center, Boston Medical Center (BMC), and UMass Medical Center]. The Principal Investigators are Christopher Walsh, M.D., Ph.D. and Louis M. Kunkel, Ph.D. at BCH and Susan Santangelo, Sc.D. at MGH. Co-Investigators at the participating sites include: Ingrid A. Holm, M.D., MPH, Leonard Rappaport, M.D., MS and Ellen Hanson, Ph.D. (BCH), Elizabeth Caronna, M.D. and Marilyn Augustyn, M.D. (BMC), Ann Neumeyer, M.D. and Patricia Davis, M.D. (MGH), Karen Miller, M.D. and Laurie Demmer, M.D. (Tufts), and Jean Frazier, M.D. (UMass). Most importantly, we thank the families who have participated in and contributed to these studies. AMENDMENT FOR DISTRIBUTION 11.0--AUTISM
Principal Investigator, PLEASE PRINT
Signature and Date, Principal Investigator
Signature and Date, Receiving Institution’s Authorized Representative
Signature and Date, NIMH Center for Genetic Studies’ Authorized Representative
Washington University in St. Louis
Signature and Date, NIMH Center for Genetic Studies’ Authorized Representative
Rutgers University
Signature and Date, NIMH’s Authorized Representative


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