375 lines
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375 lines
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<div><ul><li><a href="#cost">What is the cost of participation?</a></li><li><a href="#paid">Will I be paid for participating in this study?</a></li><li><a href="#contact">How will I be contacted?</a></li><li><a href="#samples">What information and samples will I be asked to provide?</a></li><li><a href="#sample">How will my samples be used?</a></li><li><a href="#benefits">What are the benefits of participating?</a></li><li><a href="#risks">What are the possible risks of participating?</a></li><li><a href="#sharing">Will my information be shared with third parties such as insurance companies, employers, etc.?</a></li><li><a href="#another">Can I participate in another study at the same time?</a></li><li><a href="#followup">Will I have to participate in future or follow-up studies?</a></li><li><a href="#withdraw">How do I withdraw from the study?</a></li><li><a href="#time">How long will my participation last?</a></li><li><a href="#results">Will I receive any results from this study?</a></li><li><a href="#incidental">What are incidental findings?</a></li><li><a href="#learn">How can I learn more about PEGS?</a></li></ul><h3 id="cost">What is the cost of participation?</h3><p>There will be no cost to you for any part of this study.</p><h3 id="paid">Will I be paid for participating in this study?</h3><p>You will receive $35 for blood collection, $15 for urine collection, $25 for completing the Health and Exposure Survey, and $60 for completing the Exposome Survey. We might invite you to complete other study-related activities that offer additional compensation.</p><h3 id="contact" novalidate="novalidate">How will I be contacted?</h3><p>You will be contacted by a study recruiter via email at <a href="mailto:myniehs@nih.gov">myniehs@nih.gov</a> or by phone.</p><h3 id="samples">What information and samples will I be asked to provide?</h3><p>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.</p><p>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.</p><h3 id="sample">How will my samples be used?</h3><p>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.</p><h3 id="benefits">What are the benefits of participating?</h3><p>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.</p><h3 id="risks">What are the possible risks of participating?</h3><p>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.</p><h3 id="sharing">Will my information be shared with third parties such as insurance companies, employers, etc.?</h3><p>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. Your data will not be shared with third party repositories unless you provide consent. All data and biological samples provided by the participants to the Personalized Environment and Genes Study are stored in a secure location at 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.</p><h3 id="another">Can I participate in another study at the same time?</h3><p>Yes. You may participate in any number of other studies at the same time as long as you meet the requirements of that study.</p><h3 id="followup">Will I have to participate in future or follow-up studies?</h3><p>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.</p><h3 id="withdraw">How do I withdraw from the study?</h3><p>Your participation in the Personalized Environment and Genes Study (PEGS) is completely voluntary. You may withdraw from PEGS at any time and for any reason without affecting your current or future participation in other NIEHS studies. Withdrawing from PEGS means that we will stop contacting you and scientists will not contact you about follow-up studies. If you withdraw, we will keep your information indefinitely, but will ask if we can keep using the samples you donated. If you say yes, we will keep using your samples. If you say no, we will destroy the samples. Please note that if we have already shared your samples and data with researchers, we cannot call them back. Contact <a href="mailto:niehs-pegs-info@nih.gov"><span>PEGS study staff</span></a> or call 866-809-1261 to withdraw.</p><h3 id="time">How long will my participation last?</h3><p>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.</p><h3 id="results">Will I receive any results from this study?</h3><p>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 <a href="https://www.niehs.nih.gov/research/atniehs/labs/crb/studies/pegs" media_library="Media Library" target="_blank" title="News & Updates">NIEHS PEGS website</a>. 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. If you opt into the NIH Clinical Center’s patient portal, you will be able to view the results of some of your research tests performed under the study protocol. A research clinician will notify you by telephone and mail of any out-of-range results that are of “clinical significance.”</p><h3 id="incidental">What are incidental findings?</h3><p>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.</p><h3 id="learn">How can I learn more about PEGS?</h3><p>A brief description of the Personalized Environment and Genes Study (PEGS) can be found on the <a href="/studies/pegs/learn" title="Learn More About PEGS">Learn More About PEGS</a> webpage.</p></div>
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