ALTERNATIVES TO PARTICIPATING IN THE STUDY. Since this study is for research only, the only other choice would be not to be in the study. CONFIDENTIALITY Your records of being in this study will be kept private except when ordered by law. The following people will have access to your study records: • The investigator(s) • Sponsor company or research institution [including monitor(s) and auditor(s)] • IntegReview IRB THIS IS AN IMPORTANT DOCUMENT - KEEP FOR FUTURE REFERENCE VERSION CONTROL MJ: 4/3/17 The Institutional Review Board (IRB), IntegReview, and accrediting agencies may inspect and copy your records, which may have your name on them. Therefore, total confidentiality cannot be guaranteed. If the study results are presented at meetings or printed in publications, your name will not be used. IN CASE OF STUDY RELATED INJURY No form of compensation is offered. Please be aware that some insurance plans may not pay for research-related injuries. You should contact your insurance company for more information. LEGAL RIGHTS You will not lose any of your legal rights by signing this consent form. CONTACT INFORMATION If you have questions, concerns, or complaints about this study or to report a study related injury, contact: Xxxxxx Xxxxxxxx, MD 000-000-0000 xxxxxxxxxxxxxxxx@xxxxx.xxx If you are unable to reach anyone at the number(s) listed above and you require immediate (life threatening) medical attention, please go to the nearest emergency room. If you do not want to talk to the investigator or study staff, if you have concerns or complaints about the research, or to ask questions about your rights as a study subject you may contact IntegReview. IntegReview’s policy indicates that all concerns/complaints are to be submitted in writing for review at a convened IRB meeting to: Mailing Address: OR Email Address: Chairperson IntegReview IRB 0000 X. Xxxxxxx xx Xxxxx Xxxxxxx Xxxxx 000 Xxxxxx, Xxxxx 00000 xxxxxxxxxxx@xxxxxxxxxxx.xxx If you are unable to provide your concerns/complaints in writing or if this is an emergency situation regarding subject safety, contact our office at: 000-000-0000 or toll free at 0-000-000-0000 between 8 a.m. and 5 p.m. Central Time IntegReview has approved the information in this consent form and has given approval for the investigator to do the study. This does not mean IntegReview has approved your being in the study. You must consider the information in this consent form for yourself and decide if you want to be in this study. PAYMENT FOR BEING IN THE STUDY You will not be...
ALTERNATIVES TO PARTICIPATING IN THE STUDY. This research study is not intended to diagnose, treat, or prevent any disease and is for research purposes only. The only alternative is to not participate in this study. NEW FINDINGS You will be told about any new information that might change your decision to be in this study. CONFIDENTIALITY AND DISCLOSURE AGREEMENT STATEMENT Your identity will be kept confidential as per the Health Insurance Portability and Accountability Act (HIPAA), except where disclosure is required by law. As part of this research, the study investigator will collect health data and the results of your study-related surveys and procedures. Health data may include: your age, gender, and a brief medical history. Your information may be used and shared with these people for the following purposes: • The study Investigator and study staff to conduct this research. • The sponsor, people who work with or for the sponsor and other researchers involved in this study. These people will use your information to review the study, and to check the safety and results of the study. • Others required by law to review the quality and safety of research, including the U.S. Food and Drug Administration (FDA), Department of Health and Human Services, Office for Human Research Protections, other government agencies in the United States and other countries to be sure applicable laws are being followed; and the Institutional Review Board (IRB) to protect the rights and safety of participants. After your information is shared with the people and companies listed above, the law may not require them to protect the privacy of your information. We cannot promise complete confidentiality. To maintain the integrity of this research, you might not have access to health information developed as part of this study until it is completed. At that point, you generally would have access to your health information. If the results of this study are published, your name or other personal information will not be included. You can cancel your authorization to use and share your information at any time by writing a letter to the study investigator at the address listed on the first page of this consent form. If you cancel your authorization, you will not be able to continue in the study and the study investigator and study staff will still be able to use and share your information that they have already collected. This authorization to use and share your information expires in 50 years or as applicable by local law. A des...
ALTERNATIVES TO PARTICIPATING IN THE STUDY. Since this study is for research only, the only other choice would be not to be in the study. CONFIDENTIALITY Your records of being in this study will be kept private except when ordered by law. The following people will have access to your study records: • The investigator • BARDA, High Point Clinical Trials Center, and Rho, Inc.; including monitors and auditors • The United States Food and Drug Administration (FDA) • Other state or federal regulatory agencies I • IRB Your information or bio-specimens will not be used or distributed for future research studies even if identifiers are removed. A description of this clinical trial will be available on xxxx://xxx.XxxxxxxxXxxxxx.xxx, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time. The Institutional Review Board (IRB), , and accrediting agencies may inspect and copy your records, which may have your name on them. Therefore, total confidentiality cannot be guaranteed. If the study results are presented at meetings or printed in publications, your name will not be used.
ALTERNATIVES TO PARTICIPATING IN THE STUDY. Since this study is for research only, the only other choice would be not to be in the study. If you are not in this study you can still receive allergen immunotherapy or other treatments for your allergy symptoms. Allergen immunotherapy is proven to reduce the severity of allergies but takes 30 to 70 injections into your arm. This process takes at least 3 years, but benefits begin to show in 1 to 2 years. If you choose not to be in this study, you can still get treatments for your allergy symptoms, including: • An oral antihistamine, such as Zyrtec • A prescription for eye drops called olopatadine • A nasal corticosteroid, such as Flonase CONFIDENTIALITY Your records of being in this study will be kept private except when ordered by law. The following people will have access to your study records: • The sponsor-investigator, Xx. Xxxxxxxx • People appointed by Xx. Xxxxxxxx to monitor or audit the study data • Employees of Texan Allergy & Sinus Center • The United States Food and Drug Administration (FDA) • IntegReview IRB A description of this clinical trial will be available on xxxx://xxx.XxxxxxxxXxxxxx.xxx, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time. The Institutional Review Board (IRB), IntegReview, and accrediting agencies may inspect and copy your records, which may have your name on them. Therefore, total confidentiality cannot be guaranteed. If the study results are presented at meetings or printed in publications, your name will not be used.
ALTERNATIVES TO PARTICIPATING IN THE STUDY. Since this study is for research only, the only alternatives would be not to participate or to withdraw your participation in the study. CONFIDENTIALITY Your provided personal health information and data gathered during the study will be kept private except when ordered by law. The following people will have access to your study records: • The investigator • Sponsor company and/or research institution [including monitor(s) and auditor(s)] • State or federal regulatory agencies • Advarra Institutional Review Board The Institutional Review Board (IRB), Advarra, and accrediting agencies may inspect and copy your records, which may have your name on them. Therefore, total confidentiality cannot be guaranteed. If the study results are presented at meetings or printed in publications, your name will not be used. While every effort will be made to protect the confidentiality of your information, absolute confidentiality cannot be guaranteed. Identifiers might be removed from your identifiable private information or identifiable biospecimens collected during this study and could then be used for future research studies or distributed to another investigator for future research studies without additional informed consent. A description of this clinical trial will be available on xxxx://xxx.XxxxxxxxXxxxxx.xxx, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
ALTERNATIVES TO PARTICIPATING IN THE STUDY. Since this study is for research only, the only other choice would be not to be in the study. If you understand the information in this document, and agree to adhere to the requirements, and do not have any questions, and you feel this study is right for you, please electronically sign this document with your password below. What to do in a medical emergency. This study does not provide emergency medical services. Do not contact the study or study staff if you have a medical emergency. If you feel significant discomfort beyond normal everyday stress, for mental health issues you can call 0-000-000-0000 or Text HOME to 741741 from anywhere in the US, and get help from the National Suicide Prevention Hotline. In medical emergencies dial 911. How to Leave the Study You may contact xxxx@xxxxxxxxxx.xxx at any time if you wish to leave the study. We’ll ask you a couple of questions about why you want to leave which you may decline to answer and then immediately stop your participation.
ALTERNATIVES TO PARTICIPATING IN THE STUDY. Since this study is for research only, the only other choice would be not to be in the study. A study participant may opt-out at any time during the study. If a participant opts out of the study, Xx. Xxxx X Rippetoe, PT, DPT will obtain orders on the previous participant’s behalf to receive home health care at the previous participant’s home health care provider of choice. This is done to ensure that the previous participant receives the appropriate standard of care to ensure optimal outcomes following total knee replacement surgery, not as punishment for failing to complete the study. Any costs associated with receiving home health services will be billed directly to the participant or their insurance company. CONFIDENTIALITY Your records of being in this study will be kept private except when ordered by law. The following people will have access to your study records: • The investigator • Sponsor company or research institution [including monitor(s) and auditor(s)] • State or federal regulatory agencies • IntegReview IRB A description of this clinical trial will be available on xxxx://xxx.XxxxxxxxXxxxxx.xxx, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time. The Institutional Review Board (IRB), IntegReview, and accrediting agencies may inspect and copy your records, which may have your name on them. Therefore, total confidentiality cannot be guaranteed. If the study results are presented at meetings or printed in publications, your name will not be used.
ALTERNATIVES TO PARTICIPATING IN THE STUDY. Since this study is for research only, the only other choice would be not to be in the study.
