Notice Of Change to RFA-ES-16-004 “Maintain and Enrich Resource Infrastructure for 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 by
National Institute of Environmental Health Sciences (NIEHS)

Purpose

This Notice is to inform potential applicants of changes to RFA-ES-16-004, “Maintain and Enrich Resource Infrastructure for Existing Environmental Epidemiology Cohorts (R24)

Part 2. Section I.  Funding Opportunity Description

Currently reads:

Scope of FOA

Each resource grant is expected to focus on activities that will enable efficient planning and operation of cohorts in preparation to (1) maintain the scientific integrity of the resource and community engagement; (2) prepare for future scientific needs and direction; (3) promote engagement of new disciplines in the field; and (4) facilitate scientific collaborations across cohorts.

There are two categories of encouraged activities under this program: (1) maintenance of the cohort and (2) enrichment of resource infrastructure activities to support data preparation with in the cohort, for data linkage and across collaborations. Examples of activities that can be supported under this FOA include, but are not limited to the following:

(1) Cohort maintenance activities:

  • Ongoing recruitment and retention of the target study population;
  • Expansion of recruitment to enroll special populations to enhance the breadth of the science or power of the cohort;
  • Maintain community engagement and outreach activities;
  • Continuation and enhancement of sample collection and management of existing biorepositories and environmental sample repositories. This includes ongoing quality control, sample curation and inventory maintenance, implementation of laboratory processes to prepare samples for future analyses.

(2) Enrichment of resource infrastructure activities:

Data preparation with in the EEC:

  • Development and implementation of improved quality control and assurance activities across the full data and sample/specimen lifecycle, from initial sample collection to laboratory processing, preservation, storage and retrieval for future use/reuse.
  • Development and implementation of biospecimen collection, processing and preservation methods to enhance efficiency, yield, reproducibility and stability.
  • Validation of exposure and or health outcome data.  For example, assessing the comparability of self-reported data versus medical record or biomarker information, or the assessment of how well a biomarker measured through non-invasive means compares to gold standard or other target tissue or other standards.  This also may include an opportunity to integrate or validate emerging exposure or response assessment technologies.
  • This includes but is not limited to methods to improve/enhance exposure classification to short-lived chemicals, multiple chemicals and nonchemical stressors, cumulative exposures and exposure to mixtures. For example, repeated urinary sampling to improve assessment of short-lived compounds, testing other biological or questionnaire assessments to enhance measure of stress such as cortisol or teleomere length.   

Data preparation for data linkage and across cohort collaborations:  Development of processes, policies and infrastructure to support broad sharing of cohort data and biospecimens. This includes activities related to making data findable, accessible, interoperable and reusable such as:

  • Linkage of existing data and specimens to other extant data sources such as health records and environmental data sources.
  • Development and application of processes, policies and infrastructure to support broad sharing of cohort data and biospecimens; this includes activities related to making data findable, accessible, interoperable and reusable.
  • Development and application of methods or tools to support interoperability of data generated in the parent cohorts with other relevant data sets (e.g. implementation of common data and metadata standards and evaluation of their utility to support data integration);
  • Development and implementation of web based platforms to promote wider access/use of data samples and collaborative analyses

To be responsive to this FOA applications seeking support for cohort maintenance must also include some enrichment of resource infrastructure activities.

EEC applications that only seek support for Enrichment of Resource infrastructure activities will also be considered responsive to this FOA.

Modified to read:

Scope of the FOA

Each resource grant is expected to focus on two categories of activities: (1) maintenance and resource infrastructure enrichment for existing EECs and (2) enrichment of EEC data management and sharing as appropriate and consistent with achieving the goals of the program. Examples of activities that can be supported under this FOA include, but are not limited to the following:  

(1) Maintenance and resource infrastructure enrichment for existing EECs:

Cohort maintenance activities:

  • Ongoing recruitment and retention of the target study population.
  • Expansion of recruitment to enroll special populations to enhance the breadth of the science or power of the cohort.
  • Re-consenting of participants for broad data sharing as appropriate and consistent with achieving the goals of the program.

Continuation and enhancement of sample collection and management of existing biorepositories and environmental sample repositories. Continuation and enhancement of community engagement and outreach activities.

Enrichment of resource infrastructure within the cohort:

  •  Development and implementation of biospecimen collection, processing and preservation methods to enhance efficiency, yield, reproducibility and stability.
  • Validation of exposure and or health outcome data to improve exposure disease classification.  For example, assessing the comparability of self-reported data versus medical record or biomarker information, or the assessment of how well a biomarker measured through non-invasive means compares to gold standard or other target tissue or other standards.  This also may include an opportunity to integrate or validate emerging exposure or exposure response technologies.
  • Development and testing of new methods to improve/enhance exposure classification to short-lived chemicals, multiple chemicals, nonchemical stressors, cumulative exposures or exposure to mixtures. For example, repeated urinary sampling to improve assessment of short-lived compounds, testing other biological or questionnaire assessments to enhance measures of stress such as cortisol or teleomere length.   

(2) Enrichment of EEC data management and sharing:

Development of infrastructure to support broad sharing of data, including activities related to making data findable, accessible, interoperable and reusable such as:

  • Implementation of an improved quality assurance and quality control plan across the full data lifecycle, including the identification and handling of potentially erroneous or missing values.
  • Enabling data discovery and integration through development and utilization of standard, unambiguous terminology. This includes creation or enhancement of data dictionaries and ontologies. The use of descriptive terms from existing biomedical ontologies (e.g. NCBO BioPortal, https://bioportal.bioontology.org) is highly encouraged.
  • Development and application of methodologies to support interoperability of EEC data with other relevant data sets, including implementation of common data and metadata standards and evaluation of their utility to support data integration.
  • Formatting and depositing individual-level de-identified data in an existing repository.
  • Development and implementation of a searchable web-based platform for data sharing and integration.
  • Linkage and integration of multiple data sets from different sources such as health records and environmental data sources.
  • Development or implementation of techniques for data visualization and/or big data analytics.

Applicants are encouraged to bring in new expertise in areas including data architecture, database administration, information science, data science, and data engineering.   

To be responsive to this FOA, applications must include significant activities for enrichment of EEC data management and sharing.

Part 2. Section IV. Application and Submission Information

Currently reads:

Research Strategy: The Research Strategy must consist of the following sections:

Cohort Overview

  • Overall description and summary of the proposed EEC.
  • Summary describing the EEC accomplishments related to both the infrastructure and the supported research including clinical and public health significance of the research using this cohort. Include a summary of the population, enrollment over time, data and biological specimen collection, and follow-up of cohort since the past project period. If a data sharing plan was implemented, include a report describing any or all data sharing activities.
  • The application should describe in detail the scientific rationale for the need to continue this cohort and the value and opportunities to the broader research agenda that this cohort will be designed to support in the immediate, intermediate, and long-term time frame.

Maintenance and Research Infrastructure Plan

  • Cohort Maintenance: The application must clearly define catchment area or sampling frame and what activities are necessary to achieve the goals of the resource as well as justify the new study questions, additional recruitment and or sample/data enhancement.
  • The application must describe the research team's plan for resource enhancements aimed to support validation of data, improved exposure characterization, data preparation with in cohort and data preparation for data linkage and across cohort collaborations.

Leadership and the Administrative Core

  • The use of the multiple PD/PI is strongly encouraged. Since this application includes a strong methods component to facilitate broad data sharing to linked cohort infrastructure and maintenance, this type of expertise should complement the scientific oversight and leadership. Please provide a summary of the types and funding sources that were used to establish and maintain EEC to date.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan. The plan should include the following items:

  • Statement of the investigator's commitment to share data;
  • Description of the data to be produced;
  • Standards to be used for collected data and metadata;
  • Mechanisms for providing access to/sharing data;
  • Description of tools, including software, needed to access and/or interpret the data;
  • Milestones and timelines for making the data publicly accessible;
  • Provisions for reuse and redistribution of the data.

Modified to read:

Research Strategy: The Research Strategy must consist of the following sections:

Cohort Overview

  • Overall description and summary of the proposed EEC.
  • Summary describing the EEC accomplishments related to both the infrastructure and the supported research including clinical and public health significance of the research using this cohort. Include a summary of the population, enrollment over time, data and biological specimen collection, and follow-up of cohort since the past project period. If a data sharing plan was implemented, include a report describing any or all data sharing activities.
  • The application should describe in detail the scientific rationale for the need to continue this cohort and the value and opportunities to the broader research agenda that this cohort will be designed to support in the immediate, intermediate, and long-term time frame.

Action Plan for Cohort Maintenance and Resource Infrastructure Enrichment

  • Cohort Maintenance: The application must clearly define catchment area or sampling frame and what activities are necessary to achieve the goals of the resource as well as justify the new study questions, additional recruitment and or sample/data enhancement.
  • Resource Infrastructure: The application must describe the research team's plan for resource infrastructure enhancements aimed to support validation of data, improved exposure characterization, data preparation with in cohort and data preparation for data linkage and across cohort collaborations.

Action Plan for Enrichment of EEC Data Management and Sharing

  • The application should describe how the proposed enhancements will facilitate broader sharing of data with the scientific community.
  • The application must clearly describe the methods used to make data findable, accessible, interoperable, and reusable. As appropriate, describe efforts for harmonization and alignment with existing (meta)data standards.  
  • Description of milestones and timelines for making data publicly available.

Leadership and the Administrative Core

  • Leadership: The use of the multiple PD/PI is strongly encouraged. Since this application includes a strong data infrastructure component, appropriate expertise should be included to complement the scientific oversight and leadership.
  • Administrative Core: Describe the administrative model for the proposed activities, including responsibilities for communication, decision making, and oversight. Please provide a summary of the types and funding sources that were used to establish and maintain EEC to date.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan. The plan should include the following items:

  • Statement of the investigator's commitment to share data.
  • Description of the type and amount of digital data to be managed over the life of the proposed project.
  • Description of the data to be shared and the rationale for selecting those data for sharing (i.e. raw vs processed data, aggregate vs individual level data).
  • Description of data standards, including formats, data identifiers, metadata and other data documentation to be used for collected data and rationale for their selection.
  • Description of mechanisms for providing access to or sharing data. Use of publicly accessible data repositories is encouraged.
  • Description of tools, including software, needed to access and/or interpret the data.
  • Delineation of who will be responsible for data management, both during data collection and analysis and after the completion of the project, if applicable.
  • Provisions for reuse and redistribution of the data.
  • Description of timelines and metrics for data sharing.

All other aspects of the FOA remain the same.

Inquiries

Please direct all inquiries to:

Kimberly Ann Gray, PhD
National Institutes of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0293
Email: kimberly.gray@nih.gov