There will be no cost to you for any part of this study.
At the NIEHS Clinical Research Unit (CRU), you will be paid $20 for enrolling in the PEGS cohort, an additional $25 for completing the Health and Exposure Survey, and an additional $60 for completing the Exposome Surveys.
You will be contacted by the study recruiter, Nicole P. Edwards.
As a participant joining the Personalized Environment and Genes Study (PEGS), you will need to provide different types of information. You will be asked to give basic information such as age, weight, race, addresses lived, etc. You will be required to complete one or more surveys to answer questions about your health, diet, lifestyle, and environmental exposures. You will have the option to skip any questions that you do not want to answer. You will be requested to provide a urine sample and a blood sample for lab and genetic tests such as DNA genotyping and/or sequencing. You may be asked to provide access to your electronic health records. You will have the option to provide or decline consent to any of these requests. Your demographic information may be used to obtain environmental exposure data from publicly available geographic information systems databases. All information shared by you with PEGS will be stored in a secure location at NIEHS. All participant data will be de-identified before publication.
You may also be asked to donate other samples at an enrollment or follow-up visit, or by request via mail in a provided container/packet. Your consent to donate additional samples will be obtained prior to collection, and will be obtained at each visit. Your decision regarding whether to donate these samples will not affect your eligibility to participate in PEGS. Compensation for optional samples will be provided according to the guidelines outlined in the consent form.
Your samples will be de-identified and placed in the study’s biorepository. Scientists will perform various tests on your samples such as DNA genotyping, whole genome sequencing and tests for environmental toxins, to study the links between genes, environment, and diseases.
You will not personally benefit by joining this study. However, the data and biological samples that you provide will support new scientific discoveries that could improve the prevention and treatment of various diseases such as diabetes, heart disease, allergies, asthma, cancer and many others.
The only physical risk associated with this study is some bruising, swelling or redness that might occur at the venipuncture (blood draw) site. There is also a very small risk of loss of data privacy. If there is a data breach, there is a small chance that your information could be leaked and misused. We have taken several measures to protect your data and hence the chance of this is very small, but not zero. For this study, we have obtained a Certificate of Confidentiality which legally protects your personal information and study data from third parties, e.g., insurance companies, employers, and others. All data and biological samples provided by the participants to PEGS are stored in a secure location at NIEHS. All participant data is de-identified before publication.
No. We take your privacy very seriously. We make every effort to keep your participation data and results confidential. For this study, we have obtained a Certificate of Confidentiality which legally protects your personal information and study data from third parties, such as insurance companies, employers, and others. All data and biological samples provided by the participants to the Personalized Environment and Genes Study are stored in a secure location at the NIEHS. All participant data is de-identified before publication. In spite of these efforts, if there is a data breach, there is a small chance that your information could be leaked and misused.
Yes. You may participate in any number of other studies at the same time as long as you meet the requirements of that study.
No. You may be requested to participate in a future or follow-up study, but participation in future or follow-up studies is completely voluntary. If you are invited to a follow-up study, we do hope you will participate. Participants just like you are helping us improve the prevention and treatment of human diseases. If you do agree to participate, you would have the study explained to you and you will be asked to sign a consent form for the follow-up study.
By default, your enrollment into the Personalized Environment and Genes Study will last indefinitely. There is no limit on how long we will keep your data and biological and environmental samples. You have the right to withdraw from the study at any time and for any reason without any penalties.
Your participation in the Personalized Environment and Genes Study is completely voluntary. You may withdraw from the Personalized Environment and Genes Study at any time and for any reason without affecting your current or future participation in other NIEHS studies. To withdraw, contact 1-866-809-1261 or NIEHS PEGS. Upon withdrawal, study staff will ensure you are not contacted regarding future follow-up studies and will destroy your biological and environmental samples, unless you choose to allow continued use of your original sample(s) by researchers. If your data has already been used and analyzed, we will not be able to remove your data from those analyses or publications. However, going forward, unless you choose to allow continued use of your original data by researchers, we will remove your data from the PEGS database and future analyses, and we will no longer provide your data to other scientists for future follow-up studies. If your data have already been provided to follow-up study researchers/staff, we will contact those individuals and ask that your data be removed from any further analyses.
Results of research conducted using the PEGS data at the cohort level are published in scientific journals and a listing of these publications can be found on the NIEHS PEGS website. Study updates and newsletters are mailed directly to PEGS participants. All results generated from the Personalized Environment and Genes Study are strictly for research purposes only and cannot be directly used to diagnose, predict or treat a condition or disease. Your data and samples are tested and analyzed in a blinded manner, meaning they are tested anonymously. Scientists do not know your identity when they screen your samples or analyze your data and will not directly provide you with any results. However, if your sample is unblinded (de-coded) so a researcher can ask you to participate in a follow-up study, that researcher will explain why you have been selected, and will explain any results of your tests that are relevant to that study. Optionally, PEGS participants who have consented to receiving incidental findings from their DNA analysis may be informed of individual results through trained genetic counselors, if any of these results are clinically actionable.
When we conduct genetic tests on your DNA samples, we may discover genetic variations not related to the specific diseases we are studying. These are called incidental findings. Most genetic variations that we find during our research will be of uncertain clinical importance, so we will not routinely return your results to you. In rare cases where we find specific genetic variations that we think are significantly important to your health and you agree to be informed of these results, we will attempt to contact you after confirming the finding in a clinical laboratory. If you choose to be contacted regarding the results of your genetic tests, you will be able to speak with a genetic counselor who will explain the findings and what they mean to your health. The counselor may make recommendations for follow-up with your physician or with a specialist.
A brief description of the Personalized Environment and Genes Study (PEGS) can be found on the Learn More About PEGS webpage.