IN CASE OF STUDY RELATED INJURY. If you experience a serious allergic reaction during the study, the study doctor and his team will provide necessary medical treatments up to transferring you by ambulance to a hospital. These treatments may include: • One or more shots of epinephrine into your thigh • Oxygen given by a mask • A breathing tube to ensure that your airway is clear • Other medicines to help you breathe • If you faint, medicines to help support your blood pressure • Other medicines to help control the allergic reaction • You may receive emergency treatments, if your heart or breathing stop If you are injured or experience a side effect during this study, no other form of compensation is offered aside from the listed medical treatments. If you are transferred by ambulance to a hospital, you may be responsible for the ambulance and hospital costs. 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: Dr. Xxxxxxxxxxx Xxxxxxxx (000) 000-0000 (day time) (000) 000-0000 (after hours) If you are unable to reach anyone at the number(s) listed above and you require immediate (life threatening) medical attention, please call 911 or 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 THIS IS AN IMPORTANT DOCUMENT - KEEP FOR FUTURE REFERENCE VERSION CONTROL jnb/9-10-18 mjc/12-24-18 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 ...
IN CASE OF STUDY RELATED INJURY. Please take a moment and consider whether this study is right for you by reviewing the following information. As always, if you are at all unsure, consult with a medical professional before joining this study. 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.
IN CASE OF STUDY RELATED INJURY. In the event of physical injury resulting from your participation in this research, you will be directed to receive the necessary medical treatment. Costs not covered by your health care insurer will be your responsibility. Also, it is your responsibility to determine the extent of your health care coverage. There is no program in place for other monetary compensation for such injuries. However, you are not giving up any legal rights or benefits to which you are otherwise entitled. If you are participating in research that is not conducted at a medical facility, you will be responsible for seeking medical care and for the expenses associated with any care received. 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.
