FOA Title: 
Notice Of Change to RFA-ES-16-004 Maintain and Enrich Resource Infrastructure for Existing Environmental Epidemiology Cohorts (R24)
Grant Type: 
NOT-ES-17-007
Primary IC: 
NIEHS
Release Date: 
Aug 11 2017
Expiration Date: 
N/A
AC Source: 
N/A
Purpose: 
Notice Change RFA-ES-16-004 Maintain Enrich Resource Infrastructure Existing Environmental Epidemiology Cohorts R24)” Notice Number: NOT-ES-17-007 Key Dates Release Date:   August 11, 2017 Related Announcements RFA-ES-16-004 Issued National Institute Environmental Health Sciences NIEHS) Purpose Notice to inform potential applicants changes RFA-ES-16-004, ldquo;Maintain Enrich Resource Infrastructure Existing Environmental Epidemiology Cohorts R24) Part 2. Section I.  Funding Opportunity Description Currently reads: Scope FOA resource grant expected focus activities will enable efficient planning operation cohorts preparation 1) maintain scientific integrity the resource community engagement; 2) prepare future scientific needs direction; 3) promote engagement new disciplines the field; 4) facilitate scientific collaborations across cohorts. are categories encouraged activities under program: 1) maintenance the cohort 2) enrichment resource infrastructure activities support data preparation in cohort, data linkage across collaborations. Examples activities can supported under FOA include, are limited the following: 1) Cohort maintenance activities: Ongoing recruitment retention the target study population; Expansion recruitment enroll special populations enhance breadth the science power the cohort; Maintain community engagement outreach activities; Continuation enhancement sample collection management existing biorepositories environmental sample repositories. includes ongoing quality control, sample curation inventory maintenance, implementation laboratory processes prepare samples future analyses. 2) Enrichment resource infrastructure activities: Data preparation in EEC: Development implementation improved quality control assurance activities across full data sample/specimen lifecycle, initial sample collection laboratory processing, preservation, storage retrieval future use/reuse. Development implementation biospecimen collection, processing preservation methods enhance efficiency, yield, reproducibility stability. Validation exposure or health outcome data.  example, assessing comparability self-reported data versus medical record biomarker information, the assessment how well biomarker measured through non-invasive means compares gold standard other target tissue other standards.  also include opportunity integrate validate emerging exposure response assessment technologies. includes is limited methods improve/enhance exposure classification short-lived chemicals, multiple chemicals nonchemical stressors, cumulative exposures exposure mixtures. example, repeated urinary sampling improve assessment short-lived compounds, testing biological questionnaire assessments enhance measure stress such cortisol teleomere length.  nbsp; Data preparation data linkage across cohort collaborations: nbsp;Development processes, policies infrastructure support broad sharing cohort data biospecimens. includes activities related making data findable, accessible, interoperable reusable such as: Linkage existing data specimens other extant data sources such health records environmental data sources. Development application processes, policies infrastructure support broad sharing cohort data biospecimens; includes activities related making data findable, accessible, interoperable reusable. Development application methods tools support interoperability data generated the parent cohorts other relevant data sets e.g. implementation common data metadata standards evaluation their utility support data integration); Development implementation web based platforms promote wider access/use data samples collaborative analyses be responsive this FOA applications seeking support cohort maintenance must also include enrichment resource infrastructure activities. EEC applications only seek support Enrichment Resource infrastructure activities also considered responsive this FOA. Modified read: Scope the FOA resource grant expected focus two categories activities: 1) maintenance resource infrastructure enrichment existing EECs 2) enrichment EEC data management sharing appropriate consistent achieving goals the program. Examples activities can supported under FOA include, are limited the following:   1) Maintenance resource infrastructure enrichment existing EECs: Cohort maintenance activities: Ongoing recruitment retention the target study population. Expansion recruitment enroll special populations enhance breadth the science power the cohort. Re-consenting participants broad data sharing appropriate consistent achieving goals the program. Continuation enhancement sample collection management existing biorepositories environmental sample repositories. Continuation enhancement community engagement outreach activities. Enrichment resource infrastructure within cohort: nbsp;Development implementation biospecimen collection, processing preservation methods enhance efficiency, yield, reproducibility stability. Validation exposure or health outcome data improve exposure disease classification.  example, assessing comparability self-reported data versus medical record biomarker information, the assessment how well biomarker measured through non-invasive means compares gold standard other target tissue other standards.  also include opportunity integrate validate emerging exposure exposure response technologies. Development testing new methods improve/enhance exposure classification short-lived chemicals, multiple chemicals, nonchemical stressors, cumulative exposures exposure mixtures. example, repeated urinary sampling improve assessment short-lived compounds, testing biological questionnaire assessments enhance measures stress such cortisol teleomere length.  nbsp; 2) Enrichment EEC data management sharing: Development infrastructure support broad sharing data, including activities related making data findable, accessible, interoperable reusable such as: Implementation an improved quality assurance quality control plan across full data lifecycle, including identification handling potentially erroneous missing values. Enabling data discovery integration through development utilization standard, unambiguous terminology. includes creation enhancement data dictionaries ontologies. use descriptive terms existing biomedical ontologies e.g. NCBO BioPortal, https://bioportal.bioontology.org) highly encouraged. Development application methodologies support interoperability EEC data other relevant data sets, including implementation common data metadata standards evaluation their utility support data integration. Formatting depositing individual-level de-identified data an existing repository. Development implementation a searchable web-based platform data sharing integration. Linkage integration multiple data sets different sources such health records environmental data sources. Development implementation techniques data visualization and/or big data analytics. Applicants encouraged bring new expertise areas including data architecture, database administration, information science, data science, data engineering.    be responsive this FOA, applications must include significant activities enrichment EEC data management sharing. Part 2. Section IV. Application Submission Information Currently reads: Research Strategy: Research Strategy must consist the following sections: Cohort Overview Overall description summary the proposed EEC. Summary describing EEC accomplishments related both infrastructure the supported research including clinical public health significance the research using cohort. Include summary the population, enrollment over time, data biological specimen collection, follow-up cohort since past project period. a data sharing plan implemented, include report describing any all data sharing activities. application should describe detail scientific rationale the need continue cohort the value opportunities the broader research agenda this cohort be designed support the immediate, intermediate, long-term time frame. Maintenance Research Infrastructure Plan Cohort Maintenance: application must clearly define catchment area sampling frame what activities necessary achieve goals the resource well justify new study questions, additional recruitment or sample/data enhancement. application must describe research team's plan resource enhancements aimed support validation data, improved exposure characterization, data preparation in cohort data preparation data linkage across cohort collaborations. Leadership the Administrative Core use the multiple PD/PI strongly encouraged. Since application includes strong methods component facilitate broad data sharing linked cohort infrastructure maintenance, type expertise should complement scientific oversight leadership. Please provide summary the types funding sources were used establish maintain EEC date. Resource Sharing Plan: Individuals required comply the instructions the Resource Sharing Plans provided the SF424 R&R) Application Guide, the following modification: applications, regardless the amount direct costs requested any year, must address Data Sharing Plan. plan should include following items: Statement the investigator's commitment share data; Description the data be produced; Standards be used collected data metadata; Mechanisms providing access to/sharing data; Description tools, including software, needed access and/or interpret data; Milestones timelines making data publicly accessible; Provisions reuse redistribution the data. Modified read: Research Strategy: Research Strategy must consist the following sections: Cohort Overview Overall description summary the proposed EEC. Summary describing EEC accomplishments related both infrastructure the supported research including clinical public health significance the research using cohort. Include summary the population, enrollment over time, data biological specimen collection, follow-up cohort since past project period. a data sharing plan implemented, include report describing any all data sharing activities. application should describe detail scientific rationale the need continue cohort the value opportunities the broader research agenda this cohort be designed support the immediate, intermediate, long-term time frame. Action Plan Cohort Maintenance Resource Infrastructure Enrichment Cohort Maintenance: application must clearly define catchment area sampling frame what activities necessary achieve goals the resource well justify new study questions, additional recruitment or sample/data enhancement. Resource Infrastructure: application must describe research team's plan resource infrastructure enhancements aimed support validation data, improved exposure characterization, data preparation in cohort data preparation data linkage across cohort collaborations. Action Plan Enrichment EEC Data Management Sharing application should describe the proposed enhancements facilitate broader sharing data the scientific community. application must clearly describe methods used make data findable, accessible, interoperable, reusable. appropriate, describe efforts harmonization alignment existing meta)data standards.   Description milestones timelines making data publicly available. Leadership the Administrative Core Leadership: use the multiple PD/PI strongly encouraged. Since application includes strong data infrastructure component, appropriate expertise should included complement scientific oversight leadership. Administrative Core: Describe administrative model the proposed activities, including responsibilities communication, decision making, oversight. Please provide summary the types funding sources were used establish maintain EEC date. Resource Sharing Plan: Individuals required comply the instructions the Resource Sharing Plans provided the SF424 R&R) Application Guide, the following modification: applications, regardless the amount direct costs requested any year, must address Data Sharing Plan. plan should include following items: Statement the investigator's commitment share data. Description the type amount digital data be managed over life the proposed project. Description the data be shared the rationale selecting those data sharing i.e. raw vs processed data, aggregate vs individual level data). Description data standards, including formats, data identifiers, metadata other data documentation be used collected data rationale their selection. Description mechanisms providing access or sharing data. of publicly accessible data repositories encouraged. Description tools, including software, needed access and/or interpret data. Delineation who be responsible data management, both during data collection analysis after completion the project, applicable. Provisions reuse redistribution the data. Description timelines metrics data sharing. other aspects the FOA remain same. Inquiries Please direct inquiries to: Kimberly Ann Gray, PhD National Institutes Environmental Health Sciences NIEHS) Telephone: 919-541-0293 Email: kimberly.gray@nih.gov