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The document introduces study eligibility and identifies key contact information for the study PI. It explains that participation is voluntary, that participants may withdraw at any time without losing entitled benefits, and that the study team will discuss details before enrollment. It also defines roles when an individual cannot provide consent and provides the study’s purpose comparing specific treatment regimens for multiply relapsed HCL and HCLv.",{"@graph":63,"@context":119},[64,80,102],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":41,"@type":70,"position":76},"https://docshare.wps.com/template/letters/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/medical-record-consent-to-participate-in-an-nih-clinical-research-study/191494/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/medical-record-consent-to-participate-in-an-nih-clinical-research-study/191494.png","ImageObject",442,249,{"name":88,"@type":89},"Emma Mercer","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-04","2026-09-03",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",6,{"@type":103,"mainEntity":104},"FAQPage",[105,111,115],{"name":106,"@type":107,"acceptedAnswer":108},"Who can you contact about the study?","Question",{"text":109,"@type":110},"The document lists the study PI, Robert J. 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Kreitman, M.D\u003Cbr>Phone: 301-480-6187\u003Cbr>Email: [kreitmar@mail.nih.gov](kreitmar@mail.nih.gov) |\n| This consent form describes a research study and is designed to help you decide if you would like to be a part of the research study.\u003Cbr>The remaining document will now describe the research study in more detail. This information should be considered before you make your choice. Members of the study team will talk with you about the information in this document. Some people have personal, religious, or ethical beliefs that may limit the kinds of medical or research interventions in which they would want to participate. Take the time you need to ask any questions and discuss this study with NIH staff, and with your family, friends, and personal health care providers.\u003Cbr>If the individual being asked to participate in this research study is not able to give consent to bein this study, you are being asked to give permission for this person as their decision-maker. The term “you” refers to you as the decision-maker and/or the individual being asked to participate in this research, throughout the remainder of this document.\u003Cbr>IT IS YOUR CHOICE TO TAKE PART IN THE STUDY\u003Cbr>You may choose not to take part in this study for any reason. If you join this study, you may change your mind and stop participating in the study at any time and for any reason. In either case, you will not lose any benefits to which you are otherwise entitled. However, to be seen at the NIH, you must be taking part in a study or are being considered for a study. If you do choose to leave the study, please inform your study team to ensure a safe withdrawal from the research.\u003Cbr>WHY IS THIS STUDY BEING DONE?\u003Cbr>This consent form is to determine your eligibility for our study involving treatment with pentostatin plus rituximab versus bendamustine plus rituximab for multiply relapsed Hairy Cell Leukemia (HCL) and Hairy Cell Leukemia variant (HCLv) . |\n\n| MEDICAL RECORD | CONSENT TO PARTICIPATE IN AN NIH CLINICAL RESEARCH STUDY |\n| --- | --- |\n\n| MEDICAL RECORD | CONSENT TO PARTICIPATE IN AN NIH CLINICAL RESEARCH STUDY |\n| --- | --- |\n\n| MEDICAL RECORD | CONSENT TO PARTICIPATE IN AN NIH CLINICAL RESEARCH STUDY |\n| --- | --- |\n\n| MEDICAL RECORD | CONSENT TO PARTICIPATE IN AN NIH CLINICAL RESEARCH STUDY |\n| --- | --- |\n\n| MEDICAL RECORD | CONSENT TO PARTICIPATE IN AN NIH CLINICAL RESEARCH STUDY |\n| --- | --- |\n\n| MEDICAL RECORD | CONSENT TO PARTICIPATE IN AN NIH CLINICAL RESEARCH STUDY |\n| --- | --- |\n\n| MEDICAL RECORD | CONSENT TO PARTICIPATE IN AN NIH CLINICAL RESEARCH STUDY |\n| --- | --- |","cbCaigIfdjqFHxOo","https://ap.wps.com/l/cbCaigIfdjqFHxOo","pdf",167465,8,"English","# Consent to Participate in an NIH Clinical Research Study\n## Contact Information\n## Study Information and Decision-Making\n## Voluntary Participation and Withdrawal\n## Purpose of the Study","[{\"question\":\"Who can you contact about the study?\",\"answer\":\"The document lists the study PI, Robert J. Kreitman, M.D, with a phone number and email address for questions about the study.\"},{\"question\":\"Is participation in the study voluntary?\",\"answer\":\"Yes. The document states it is your choice to take part, you may refuse for any reason, and you may change your mind and stop participating at any time.\"},{\"question\":\"What happens if the person cannot give consent?\",\"answer\":\"If the individual asked to participate cannot consent, the decision-maker is asked to give permission on that person’s behalf. The term “you” refers to the decision-maker and/or the individual throughout the document.\"}]","Medical Record - Consent to Participate in an NIH Clinical Research Study | PDF"]