grant

Core B: Clinical Translational Core

Organization UNIVERSITY OF IOWALocation IOWA CITY, UNITED STATESPosted 16 Jul 2021Deadline 31 May 2027
NIHUS FederalResearch GrantFY202512-20 years old21+ years oldASDAccelerationAddressAdolescenceAdultAdult HumanAffectAgeArchitectureAreaAutismAutistic DisorderBasic ResearchBasic ScienceBioinformaticsBiologyCare GiversCaregiversCaringCausalityClinicClinicalClinical DataClinical EvaluationClinical ResearchClinical StudyClinical TestingClinical TrialsCollaborationsConceptionsConsentControl GroupsCountryDataData MartDevelopmentDiagnosisDisability researchDisability studyDrugsEarly Infantile AutismEngineering / ArchitectureEtiologyFamilyFundingGenetic studyGeographyGestationHandHealth Care SystemsIDDRCIDDRPIndividualInfantile AutismInfrastructureInpatientsIntellectual and Developmental Disabilities Research CentersIntellectual disabilityIntellectual functioning disabilityIntellectual limitationInternationalInterventionInvestigatorsIowaKanner's SyndromeLaboratoriesLifeMRDD Research CenterMRDDRCMedicationMental Retardation and Developmental Disabilities Research CentersMental disordersMental health disordersMissionMolecularOrganization ChartsOutcomes ResearchParticipantPatient RecruitmentsPatientsPersonal SatisfactionPharmaceutical PreparationsPopulationPopulation HeterogeneityPregnancyPregnancy OutcomePreventionPrimary CareProviderPsychiatric DiseasePsychiatric DisorderPubertyRaceRacesResearchResearch InfrastructureResearch PersonnelResearch ResourcesResearch on disabilitiesResearchersResistanceResourcesRisk AssessmentRoleRuralRural PopulationRural groupRural peopleSchoolsServicesSiteSourceStudy on disabilitiesTestingTranslatingTranslational ResearchTranslational ScienceUnderserved PopulationUniversitiesWorkadolescence (12-20)adulthoodadverse pregnancy outcomeagesautism spectral disorderautism spectrum disorderautistic spectrum disorderbiobankbiorepositorycare servicescare systemscausationclinical practiceclinical testclinical translationclinically translatablecohortcost effectivecritical perioddata accessdatamartdesigndesigningdevelopmentaldisease causationdiverse populationsdrug/agente-ConsenteConsentelectronic consenthandsheterogeneous populationhuman subjectimprovedintellectual and developmental disabilitylife spanlifespanlimited intellectual functioningmanufacturemental illnessnovelorganizational structureparticipant recruitmentpatient populationperinatal periodperinatal phasepopulation diversityprenatalprospectivepsychiatric illnesspsychological disorderracialracial backgroundracial originrecruitresearch clinical testingresearch studyresistantrural arearural individualrural locationrural regionsocial rolesynergismtranslation researchtranslational investigationunbornunder served groupunder served individualunder served peopleunder served populationunderserved groupunderserved individualunderserved peopleurban areaurban locationurban regionwell-beingwellbeing
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Full Description

PROJECT SUMMARY: CLINICAL TRANSLATIONAL CORE (CTC)
The Clinical Translational Core (CTC) of the Hawk-IDDRC seeks to address the challenges faced by those

living with IDD at all life stages by providing investigators the resources to transition discoveries from the

laboratory into clinical practice, and enable an understanding of the biology underlying clinical observations, in

order to advance translational research. The CTC differentiates itself by providing infrastructure for recruiting

rural populations as well as participants at key transition points across the lifespan, including: the perinatal

period, puberty and adolescence, adulthood at varying levels of independence, and later adulthood as

professional caregivers assume a primary role. These transition points represent critical periods that influence

the long-term wellbeing of those living with IDD, yet our understanding of each is limited. Importantly, rural

populations 1) have decreased access to appropriate care, 2) have different potential IDD exposures that are

not well studied, and 3) lack research infrastructure. The Hawk-IDDRC CTC is poised to fill these needs and

will thus provide access to unique clinical data and biosamples from this understudied population by carrying

out the following aims: 1) Facilitate and accelerate the recruitment and clinical evaluation of IDD-affected

patients at all stages of life and from diverse areas to connect them and their families with clinical studies and

resources; 2) Provide IDD researchers with biobanking and bioinformatics services; 3) Facilitate and support

the design, development, and testing of novel IDD therapies by providing a successful architecture for clinical

trials and drug manufacturing services to IDD researchers. The expertise and resources of the CTC Co-

Directors (Mark Santillan and Alexander Bassuk) covers a broad spectrum of capabilities, ranging from

prenatal risk assessment, to human subject recruitment, and banking of clinical data and biosamples. Specific

assets of the University of Iowa (UI) that cover the lifespan include CoLab (Global Pregnancy Collaboration),

an international collaboration of 40 sites focused on pregnancy outcome research, sharing clinical data and

biosamples; a clinical recruitment center for SPARK, a nationwide genetic study of autism; UI-led statewide

networks of collaborating clinics, schools, and providers in rural and urban areas; and the Intellectual Disability-

Mental Illness (ID-MI) clinic, one of only a handful of inpatient units in the country that focuses on patients with

intellectual disability and a co-occurring mental illness. The CTC will serve as a central focal point for these

resources, streamlining access for investigators, and enabling its support of 31 federally funded projects

totaling $12.6 million per year. The access to a unified, harmonized source of clinical data, biosamples, and

clinical cohorts allows the CTC to work with all Cores to perform retrospective and prospective IDD studies.

The resources of the CTC will support the mission of the Hawk-IDDRC to provide an organizational structure

that integrates basic and clinical research across the lifespan—from conception to adulthood—focused on the

prevention, diagnosis, treatment and amelioration of IDDs, and tailored to a rural, underserved population.

Grant Number: 5P50HD103556-05
NIH Institute/Center: NIH

Principal Investigator: ALEXANDER BASSUK

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