Support Documents

The following documents are supporting materials for the HHEAR application process, including several agreements that an investigator will be asked to sign once their project is approved for HHEAR Services.

Data Sharing Plan for the HHEAR Data Repository (DSP)

This document includes descriptions of: data types; data repositories to which data will be submitted; the timeline for data submission and release; as well as the appropriate uses of the data. It must be reviewed and signed by investigators approved for HHEAR services to indicate their agreement to abide by the Data Sharing Plan.

Example IRB Attestation Letter for HHEAR Data Submission

After a project is approved for HHEAR services, the PI will need to provide evidence of approval by their institutional IRB to deposit their data into the HHEAR Data Center repository. This approval will indicate that data submission and subsequent data sharing for research purposes are consistent with the informed consent of study participants from whom the data were obtained.

Example Population Characteristics Table

Question 8b of the HHEAR Initial Application requests that investigators provide frequency table(s) for key covariates and outcomes for the proposed HHEAR project. This document provides an example of the type of information to include in the frequency table(s).

HHEAR Application Web Example

This application template is provided for informational purposes only; all HHEAR applications must be submitted online at myhhear.hhearprogram.org.

HHEAR Data Repository Data Submission Agreement (DSA)

This document outlines the agreement between HHEAR and an investigator regarding submission of data to the HHEAR Data Repository; it must be reviewed and signed by investigators approved for HHEAR services to indicate their agreement to abide by the Data Submission Agreement.

HHEAR Environmental Material Transfer Agreement (E-MTA)

The HHEAR Human Material Transfer Agreement (H-MTA) is used for transfer of human biological materials with or without accompanying data between an academic or research (provider) institution and a HHEAR Laboratory Hub. It should be reviewed and signed by the provider investigator and authorized official for the provider and by the Lab Hub investigator and the authorized official for the Lab Hub.

HHEAR Extension Request Form

The HHEAR Extension Request Form is used when an investigator is unable to meet project deadlines. The form must be completed by the investigator and submitted to the Coordinating Center. The HHEAR Executive Committee will review the request for project extension.

HHEAR Human Material Transfer Agreement (H-MTA)

The HHEAR Human Material Transfer Agreement (H-MTA) is used for transfer of human biological materials with or without accompanying data between an academic or research (provider) institution and a HHEAR Laboratory Hub. It should be reviewed and signed by the provider investigator and authorized official for the provider and by the Lab Hub investigator and the authorized official for the Lab Hub.

HHEAR Project Change Request Form

The HHEAR Project Change Request Form is used when an investigator needs to change any element of an approved laboratory or data analysis. The form must be completed by the investigator and submitted to the Coordinating Center. The HHEAR Lab Hub(s) and Data Center will review the project change request in consultation with the HHEAR Executive Committee.

HHEAR Waiver Request Form

The HHEAR Waiver Request Form is used when an investigator wishes to be exempt from HHEAR policies for eligibility, data submission and sharing, execution of a Material Transfer Agreement, and/or sample labeling. The form must be completed by the investigator and submitted to the Coordinating Center. Depending on the type of request, the HHEAR Executive Committee, Coordinating Center, Data Center, and/or Lab Hub(s) may review the request.

myHHEAR User Guide

This User Guide contains instructions on how to register for an account on myHHEAR.