ECHO Program Protocol

ECHO’s expert researchers, who work across many areas of child health research, worked together for more than two years to create a protocol for the Program. This protocol is referred to as the ECHO-wide Cohort Data Collection Protocol, or the ECHO Protocol for short. This protocol joins ECHO cohorts together to create a standard collection of information, including samples, from participants across the United States as a nationwide research data and specimen resource.

Current Use: 

View or download the ECHO-wide Cohort Data Collection Protocol.

Anticipated Use:

ECHO Cohort Data and Biospecimen Collection Protocol, v3.0, sIRB-approved June 14, 2023 NOT IN USE currently; intended for use beginning January 2024.

DRAFT ECHO Cohort Data and Biospecimen Collection Protocol NOT IN USE currently but anticipated for use in the next phase.

ECHO Data Quality Plan

View or download the ECHO Data Quality Plan

Manual of Operating Procedures (MOP)

The ECHO Program’s Manual of Operating Procedures (MOP) provides instruction for principal investigators and research staff in protocol implementation and data collection across participants and study sites to facilitate consistency.

• Introduction
  
• Chapter 1 Regulatory Requirements
  
• Chapter 1 Appendix A: Consenting Guidance and Best Practices
  
• Chapter 1 Appendix B: ECHO-wide Protocol eConsent Best Practices 
  
• Chapter 2 Training Requirements
  
• Chapter 3 Study Measurements and Procedures
  
• Chapter 4: Data Management (not yet published)
• Chapter 5: Laboratory Manual
  
• Appendices (not yet published)
  

ECHO Program Slides

• ECHO Program Slides

ECHO Program Policies

The ECHO Individual Return of Results Policy aims to outline the principles and framework for returning individual research results to ECHO participants who wish to receive them. This document applies to data collected by or generated from the conduct of the ECHO‐wide Cohort Data Collection Protocol but does not apply to summary research results or research results produced by the IDeA States Pediatric Clinical Trials Network.

The ECHO Return of Summary Research Results Policy aims to promote wide and timely dissemination of summary research results with ECHO participants, ECHO staff, and the broader community. This document applies to all ECHO Cohort Investigators and non-ECHO investigators who use ECHO data or generate data from ECHO biospecimen analyses but does not apply to individual research results or research results produced by the IDeA States Pediatric Clinical Trials Network.

Publications are critical to sharing ECHO science. The Publications Policy directs the development and review of research products derived from ECHO awardees that may use ECHO-wide Cohort data, include ECHO-wide Cohort analyses, represent ECHO, or be supported by ECHO-wide funds.

ECHO's Ancillary Study Policy encourages Program Investigators to propose ancillary studies to advance the program’s mission. ECHO-wide Cohort Ancillary studies (“ancillary studies”), using non-ECHO funding, will expand the efforts already underway through the ECHO program. Address questions to the ECHO Coordinating Center: echocc-ancillarystudy@duke.edu.

Accomplishing ECHO’s mission requires assuring public trust in the scientific process and in the credibility and rigor of the program’s research. The ECHO Program recognizes that conflicts of interest (COIs) arise from the research enterprise. The ECHO Conflict of Interest Policy aims to identify and manage COIs to preserve transparency, independent decision-making, protection of research participants, and the integrity of ECHO research.

The ECHO Biospecimen Utilization Policy directs the utilization and management of ECHO biospecimens collected by all ECHO Cohorts. This policy balances two important goals: to facilitate investigations of the impacts of a broad range of early environmental exposures on pediatric health and, at the same time, to respect and protect the participants whose biospecimens have been contributed by the ECHO Cohorts to the ECHO Program.

The ECHO Biospecimens Collection Processing and Storage Policy facilitates the standardization of and provides quality control for collection, processing, and storage of biospecimens collected by all ECHO Cohorts. The intent is to ensure that the cohorts carry out processes in a consistent manner across all research sites.

The ECHO-wide Biospecimen (Type C) Use and Reserve Policy directs the use and reserve of the ECHO-wide Type C biospecimens and establishment of processes and systems. The goal of this policy is to maximize the scientific and public health impact of ECHO by balancing commencement of Type C biomarker assays while ensuring availability of biospecimens for future analyses.

The ECHO-wide Data Sharing Policy aims to promote wide and timely dissemination of data within the ECHO Consortium and the broader scientific community to ensure their maximum utility and impact.