On this page:
- About HHEAR
- Consultation, Laboratory, and Data Analysis Services
- Data Submission and Sharing Policies
- Application Submission and Review Process
- Post-Approval Process
What is HHEAR?
The Human Health Exposure Analysis Resource (HHEAR) is a centralized network of high quality exposure-assessment services and expertise available to extramural researchers who want to include or expand analyses of environmental exposures in their studies of human health. There is no cost to the investigator. Services include:
- Expert consultation on exposure analysis, study design, and data analysis and interpretation.
- State-of-the-art targeted and untargeted laboratory analysis of biological and environmental samples.
- Statistical and data analytical services including support for meta and pooled analyses.
HHEAR also supports a public data repository of de-identified epidemiologic and biomarker data from approved projects. The data is harmonized and, after an embargo period, it is shared with other researchers to promote secondary analysis of pooled environmental health data.
HHEAR was established to promote characterization of the exposome (the totality of human environmental exposures) and advance understanding of the influence of environment on human health over a lifetime.
How is HHEAR organized?
The HHEAR consortium has three components:
- The Network of Exposure Analysis Laboratories, comprised of six Lab Hubs, provides targeted and untargeted environmental exposure analyses in human and environmental samples.
- The Data Repository, Analysis, and Science Center (Data Center) provides statistical services and maintains a data repository.
- The Coordinating Center connects the research community to these exposure resources by facilitating communication between investigators, the Lab Hubs and the Data Center and assisting investigators with the proposal review and post –approval processes.
I'm budgeting for an NIH grant that may use HHEAR resources. How should I handle that?
We recommend that you include within your NIH grant budget the funds and laboratory support you will need for the exposure analyses that are central to the specific aims of your NIH grant. HHEAR does not currently plan to commit resources for pending grant applications nor to support analyses which are included within funded research.
However, in the future, your study may be eligible to expand the exposure analyses using HHEAR, but this cannot be guaranteed at the time of your grant application submission.
If you need resources to support your NIH grant, HHEAR Laboratory Hub and Data Center scientists may be available to collaborate as a researcher on your grant proposal or in a fee-for-service/cost recovery basis.
What will happen to my existing CHEAR project?
CHEAR has ended and isn’t accepting new applications. The program will complete laboratory analyses for already approved studies. Data from the studies will be made available to researchers in the Data Repository after an embargo period. Researchers with approved projects should continue to use their myCHEAR accounts to track the progress of their projects. CHEAR applicants whose projects were not approved and who meet the HHEAR eligibility requirements may submit proposals for HHEAR services.
Consultation, Laboratory, and Data Analysis Services
I am not an environmental epidemiologist but would like to add exposure analysis to my study. How can HHEAR help?
Contact the HHEAR Coordinating Center (HHEARHelp@westat.com) to schedule a pre-submission consultation with HHEAR scientists. We can advise you on how to add exposure analysis to your study. We can work with you to support the development of a proposal that is consistent with the goals of HHEAR and that maximizes the scientific value of your project.
What kinds of analyses will HHEAR provide?
The HHEAR National Exposure Assessment Laboratory Network (Lab Hubs) provides state-of-the-art services both targeted and untargeted exposure analyses of human biological samples and environmental samples. The Data Center provides statistical analyses, data integration, and interpretation services for investigators using HHEAR laboratory services.
What types of samples can I submit to HHEAR for analysis?
HHEAR will accept human biological samples (such as blood, serum, or urine) and environmental samples (such as dust, soil, water, or silicone wristbands). To find more information on the matrices that are most common for HHEAR analyses, go to the Sample Matrix table.
How can I find out if HHEAR can do the laboratory analyses I need?
Check our Lab Analysis Services, Targeted Analysis, and Untargeted Analysis of the Exposome webpages. You will find information on the difference between targeted and untargeted measures, the types of samples you can submit and quantities needed, HHEAR methods for analysis and quality assurance, and more. Our Sample Matrix table shows biological and environmental sample matrices most commonly analyzed by HHEAR and the minimum volume required for each.
We also encourage you to contact our Coordinating Center (HHEARHelp@westat.com) to schedule a pre-submission consultation with our Lab Hub scientists.
How can I find out how much sample is required for a lab analysis?
The Sample Matrix table provides information on the amounts needed for the matrices HHEAR most commonly analyzes. The information in the table is illustrative and not a complete picture of HHEAR’s analytical capabilities.
We also encourage you to contact the HHEAR Coordinating Center (HHEARHelp@westat.com) to schedule a pre-submission consultation with our Lab Hub scientists.
What is the minimum/maximum number of samples you will accept per study for laboratory analysis?
A project's eligibility for HHEAR services does not depend on a predetermined number of biological or environmental samples available for analysis. The number and characteristics of biological/environmental samples will be considerations for assessing the feasibility of the proposed laboratory analyses and the data analysis plan. These aspects influence both the power to test hypotheses and the workload of the HHEAR Lab Hubs.
If you have questions about how many samples you will need to achieve your project goals, contact our Coordinating Center (HHEARHelp@westat.com) to schedule a pre-submission consultation with HHEAR scientists. Our scientists can provide advice on environmental exposure analyses, biological and environmental samples, study design, power calculations, and data analysis.
How is my project assigned to a Lab Hub?
There are six Lab Hubs in the HHEAR National Exposure Assessment Laboratory Network. A HHEAR Lab Hub will be assigned to your project based on:
- Analytic requirements of your proposed project,
- The NIH Institute that funded the parent study,
- The expertise of the Lab Hub,
- Available capacity of the Lab Hubs, and
- Lab Hub’s interest in the proposed project.
Data Submission and Sharing Policies
What data am I required to share with HHEAR?
You are required to share your experimental design details and supporting data, including phenotypic data at the individual level, needed to achieve the aim(s) of your proposal. In addition, to promote collaboration and secondary analyses of data with the research community we request specific key variables:
- Common covariates, including sex, race/ethnicity, education, and other SES variables.
- The age (and/or date if birthdate) at which a measurement such as BMI or weight was taken.
- The age (or date if birthdate is provided) at which the questionnaire, if applicable, was completed.
- The age (or date if birthdate is provided) at which the anticipated sample was donated.
- Supporting variables. If your dataset contains derived variables, provide the variables used to create them. For example, if you provide BMI we would also require weight and height.
When will my data become publicly available?
HHEAR has a one year embargo period on publicly released data. During this period, only the study PI and Data Center members will have access to the data and work collaboratively. If the investigator did not request a statistical analysis, the embargo period ends one year after HHEAR has returned all laboratory analysis results to the investigator. Otherwise, it ends one year after HHEAR provides the first statistical analysis report. After the embargo, all project data will be de-identified (if any identifiers were provided) and made publicly available through the HHEAR Data Center website; however, if a manuscript is accepted for publication at any time during the embargo, then the embargo period ends.
Who can access shared HHEAR data?
Researchers interested in using HHEAR data must register on the HHEAR Data Center website, agree to the terms specified in the HHEAR Data Use Guide, and must be affiliated with an institution that has Federalwide Assurance for the Protection of Human Subjects, or the equivalent. After the embargo period, de-identified project data is publicly available to approved users through the HHEAR Data Center website.
Do I have any control over the use of my shared HHEAR data?
No. Once a user is authorized to use the HHEAR data repository, they will receive access to all publicly available data in the repository.
How do you keep study participants’ identities confidential?
HHEAR investigators are not required to submit any protected health information (PHI) to the Data Center. The HHEAR Data Center makes all efforts to ensure that the datasets are de-identified before it is made publicly available. However, we depend on the users to follow good practices in data use by agreeing to the terms specified in the HHEAR Data Use Guide. HHEAR has no control over the use of the data once it has been downloaded from the HHEAR Data Repository.
What IRB Approval is required to use HHEAR services?
You will need to submit an attestation letter from your institution’s IRB which must confirm that the consent provided by study participants is consistent with the use of their data and biological and environmental (if applicable) samples for “future unspecified research.” This includes the public sharing of their de-identified data. We strongly recommend you review the informed consent form used in your study before applying to HHEAR.
Many institutions’ IRBs have a person responsible for institutional certifications and familiar with providing attestation letters. Here is an example of an IRB attestation letter. For more information about the IRB attestation letter, read the HHEAR Policies for Access to Services.
Application Submission and Review Process
Who can use HHEAR?
Check the eligibility criteria on the Are You Eligible for HHEAR Services webpage. If you have additional questions, please contact the Coordinating Center at HHEARHelp@westat.com To learn more about how HHEAR works, read the HHEAR Policies for Access to Services.
How do I apply for HHEAR services?
See the How to Apply webpage on the HHEAR website. If you have more questions, please contact the Coordinating Center at HHEARHelp@westat.com. To learn about how HHEAR works and our policies that you must comply with, read the HHEAR Policies for Access to Services before you apply.
When will I be able to apply to HHEAR?
You can submit applications to HHEAR at any time. HHEAR review applications on a rolling basis approximately four times per year. See our application submission and review schedule.
How long does it take to complete the HHEAR application review process?
The application process for services involves multiple steps. From initial application submission to final decision takes about 8 months. Avoid delays in the review process by reading the HHEAR Policies for Access to Services before you apply.
Where can I find information about studies supported by CHEAR and HHEAR?
Information about all approved CHEAR and HHEAR studies can be found on the Studies webpage of the HHEAR Data Center website.
How do I submit a HHEAR application on behalf of someone else?
When you create a myHHEAR account for the project, use the parent study’s Principal Investigator’s contact information. This information will pre-fill on the Initial Application.
I have collected some of my samples but not all. Can I secure HHEAR support for samples not yet collected?
No. Only existing samples are eligible for HHEAR. All of the biological and/or environmental samples and data you need to complete your HHEAR project must be in storage before you submit a HHEAR Final Application. In addition, we strongly encourage that you confirm the numbers and volumes of samples available before submitting applications as sample availability issues have led to significant delays and in some cases termination of previously approved studies.
Do I have to submit the IRB attestation letter, executed MTA, and signed DSA and DSP before my project is approved?
No; however, you must submit these documents within eight weeks after your Final application is approved. HHEAR requires that you indicate your agreement to HHEAR policies, which includes submission of these documents, on the Initial Application. We strongly recommend that you review HHEAR Policies for Access to Services and consider your ability and willingness to comply with all HHEAR policies before applying to HHEAR. Non-compliance with policies will cause a delay in the review of an application or in the analysis of samples and can result in the termination of your previously approved project.
I plan to use biological samples and/or data that were collected by cohorts/institutions other than my own. Where do I provide this information?
In your HHEAR Initial Application, under Step 2, Other Investigator, provide the contact information for the individual(s) who have the authority to transfer samples and data.
What are the elements of a successful HHEAR application?
First, understand what you are applying for. You are not applying for a grant. The HHEAR Program provides access to laboratory and data analysis services for investigators who want to add environmental exposures to their studies of human health. Your HHEAR application allows us to evaluate your eligibility and your project’s feasibility and consistency with HHEAR research priorities. Successful applications include the following elements:
- An explanation of how the project is consistent with HHEAR research priorities, adds or expands environmental exposure analyses for the parent study and advances the understanding of the role of environmental exposures in human health.
- A justification for each requested lab analysis which includes a description of how you will use the lab analysis results to assess the relationship between the exposure and health outcome for each specific aim.
- Accurate information on the number of participants and biological or environmental samples to be included for each specific aim. If you are requesting analyses of samples collected from participants at multiple time points, clearly state the exact number of participants for whom you have samples at each time point.
- A power calculation for each aim to demonstrate that the proposed sample size is sufficient to achieve that aim. Primary factors that affect power are significance level (alpha), sample size, variability in the measured response variable, and magnitude of the effect of the variable as well as correction for confounders and multi-variable comparisons.
For more ideas on what goes into a high-quality application see an example of an approved application annotated with additional guidance.
Should I expect that only experts in my field will be reviewing my application?
No. HHEAR review groups will include people with broad expertise in environmental epidemiology and exposure science but who may not have deep expertise in your field. Write your specific aims, significance, and research strategy (study design, methods, and procedures used to collect and analyze the data) so that other scientists can evaluate your application.
What should be included in the statistical analysis plan?
Clearly define your statistical methods. Include a description of variables or covariates that will be used in analyses. Consider if any aspects of the data could present problems for the analysis. For example, look at your sample size, number of covariates, incomplete repeated measures, missing data, and high dimensionality.
Successful applications will provide a power calculation for each aim to demonstrate that the proposed sample size is sufficient to achieve that aim. Primary factors that affect power are significance level (alpha), sample size, variability in the measured response variable, and magnitude of the effect of the variable.
What happens after my project is approved?
For information on what to do after your project is approved see the Post-Approval Process webpage. If you have more questions, contact the Coordinating Center at HHEARHelp@westat.com. To learn more about how HHEAR works, please read the HHEAR Policies for Access to Services (PDF).
When do I have to submit the IRB attestation letter, executed MTA, and signed DSA and DSP?
Submit these documents within eight weeks after your final application is approved. If you are unable to meet this deadline, you may request an extension. For more information on post-approval activities and deadlines, please read the HHEAR Policies for Access to Services (PDF). Non-compliance with deadlines could cause a delay in the analysis of samples.
How soon after my application is approved can I ship my samples to the Lab Hub for analysis?
Be prepared to ship your samples within four to five months after your final application is approved. That time frame includes deadlines for all post-approval activities that you, the Lab Hub, and the Data Center must meet before you may ship samples to the Lab Hub. Find out more about post-approval activities and deadlines in the HHEAR Policies for Access to Services (PDF).
Will I be provided with instructions on how to prepare and ship my samples to the Lab Hub?
After your Final Application is approved, the Coordinating Center will send you instructions for the next steps. One of the first activities is working with the Lab Hub to complete a lab analysis plan for each approved analysis. The plan will provide preliminary instructions for how to aliquot, label, package, and ship samples to the Lab Hub. In addition, when the Lab Hub is ready to receive samples, the Coordinating Center will set up a conference call with you and the Lab Hub to discuss the final procedures for preparing and shipping samples. For more information on post-approval activities, see the HHEAR Policies for Access to Services (PDF).
My samples are located in a biorepository that charges a fee to relabel them. Can I ship my samples without relabeling them?
HHEAR requires that you label your samples with the HHEAR sample ID (SID) label before shipping to a Lab Hub. The Coordinating Center will provide the barcoded labels and the Lab Hub will provide instructions for labeling. However, you may request a waiver from the requirement if all of the following criteria are met:
- All samples are labeled in a standard format with a barcode and eye-readable text.
- Labels do not contain protected information, such as the participant’s name, ID number, age, or gender, or the date the sample was collected.
- Each sample vial is labeled with a unique ID.
- Samples do not require aliquoting before shipping to a HHEAR Lab Hub or by a Lab Hub before shipping to another Lab Hub.
- You include a photograph of the original sample ID label with the Waiver Request Form.
A Lab Hub may request that you provide a sample vial and label to ensure the label is suitable. The Coordinating Center, Lab Hub, and Data Center will together determine if your request can be approved. Find out more about sample labeling in the HHEAR Policies for Access to Services (PDF).
The samples I will be submitting for analysis are stored in two different repositories. One repository is ready to ship, but the other can’t ship for three months. Will HHEAR analyze one set of samples now and the second set later?
HHEAR needs to analyze all of your samples at the same time. If the samples aren’t ready and you will miss your shipment deadline, submit an Extension Request Form to the HHEAR Coordinating Center. Extending deadlines will result in delayed services. In some instances, due to capacity issues and project queues, HHEAR may not be able to provide all requested laboratory and/or statistical analysis services. Find out more about extending deadlines in the HHEAR Policies for Access to Services (PDF).
Will my samples be returned to me after the laboratory analysis is done?
You may request that the Lab Hub return any residual samples to you. You should discuss this directly with the Lab Hub and be prepared to pay for the return shipment.
I am using the results from my HHEAR project in a publication. How should I recognize HHEAR support?
HHEAR resources are made possible by NIH funding and must be properly acknowledged in manuscripts. Review the HHEAR Publications Policy (PDF) for instructions on how to recognize HHEAR support. Contact the HHEAR Coordinating Center (HHEARHelp@westat.com) and/or lab hubs for additional help.
At what point in the manuscript preparation and publication process do I need to notify HHEAR?
Once a manuscript is ready for submission and has been approved by all named authors, the manuscript must be registered with HHEAR. This can be done through your myHHEAR account. If your manuscript is accepted for publication at any time during the embargo period, then the embargo period ends and the data becomes publicly available in the HHEAR data repository.