Discomforts and Risks. The risks of participating in this study are minimal. The programs may not be effective in helping you lose weight. It is possible that you could feel some hunger if you reduce your food intake to try to lose weight, or could be injured from exercise during this program. You may also experience mild skin irritation from wearing the armband, although this is not typical.
Discomforts and Risks. The risks of participating in this study are minimal. The programs may not be effective in helping you lose weight. It is possible that you could feel some hunger if you reduce your food intake to try to lose weight, or could be injured from exercise during this program. Lifespan - Rhode Island Hospital IRB 1 IRBNet ID: 1102103-22 Approved: August 17, 2021 Expiration: August 16, 2022 Study Volunteer Initials There are also some risks associated with exercising after a cardiovascular event. These risks are no greater than the risks you accept when you sign up to attend cardiac rehabilitation. To protect you, a cardiologist (Xx. Xx, the CR’s Medical Director) will review your medical record to determine that it is safe for you to participate in this program. The staff you will interact with are CPR-certified and know what to do in the event of a health emergency. You should always adhere to your healthcare provider’s recommendations, and in the unlikely event that the study member or a member of the study staff recommends a practice that contradicts the advice of your healthcare provider, please follow your healthcare provider’s advice and contact the research team immediately to notify us of this discrepancy.
Discomforts and Risks. Mindfulness training is safe. Only patients having current severe depression or psychosis may sometimes experience psychological distress during sessions. Some psychological discomfort, usually mild and transitory, may rarely happen in subjects that do not have these problems. A member of the study staff will contact you weekly to ask you about any problem or discomfort you might be experiencing during and between the training sessions. These phone calls should take no more than 5 minutes. • No side effects have been signaled with the performance of the walk test. • Some questions in the study questionnaires may make you uncomfortable. You may refuse to answer any of those questions and you make take a break at any time when completing those questionnaires. • Another risk of being in this study is a loss of your personal information. This is very unlikely to happen, and we will do everything to make sure that your information is protected.
Discomforts and Risks. Some of the questions from the interviews and questionnaires may be upsetting to you or your child. You can refuse to answer any questions you wish, ask to have the evaluation stopped at any time, or contact the investigator or research staff at (000) 000-0000 for further assistance. This study is neither designed nor intended to detect health problems in your child. The MRI scans that your child will undergo do not substitute for an appropriate medical examination by a qualified health care provider. If you suspect that your child might be suffering from injury or illness, including any injury involving the head or brain, you should not rely on this study as a way to determine whether or not your child is well. The investigators for this project are not trained to perform radiological diagnosis, and the MRI scans performed in this study are not designed to find abnormalities. The investigators and Brown University are not responsible for failure to find existing abnormalities in your child MRI scans. However, on occasion the investigator may notice an MRI image that seems abnormal. When this occurs, the investigator will inform you and recommend that you consult with your child’s primary care physician. The decision whether to proceed with further examination or treatment lies solely with you and your physician. The investigators and Brown University are not responsible for any examination or treatment that you undertake based upon these findings. Because the images collected in this study do not comprise a proper clinical MRI study, these images will not be made available for diagnostic purposes. Other possible risks include the remote possibility that the information would be released outside of the research setting, which could be upsetting for you. However, strong measures are taken to ensure that all information remains confidential. Specifically, all participants will be identified only by code number which will appear on documents used for evaluation for statistical analyses. All records and information will be kept locked in the clinical research facilities. Publications of this research will not identify individual participants. If any mental health related problem is detected, such as suicidality, intent to harm others, or drug abuse, or if previously unreported abuse is discovered, you and/or your child will be further evaluated and steps will be taken to ensure their safety (e.g., creating a safety plan, providing referrals). Reports of physic...
Discomforts and Risks. The BAN device is an FDA approved device to deliver nebulizer treatments. It is not being used in any way differently than what the BAN is approved for by the FDA. Being in this study will not change or influence any treatment you receive, what nebulizer medication is given to you through the nebulizer device or how often you receive nebulizer treatments. The only possible risk to you by participating in this study would be breach of confidentiality. The likelihood of this happening is very small. Data collection methods and practices are in place to protect your identity. Your name will be replaced with a non-identifying subject number so that your name is not kept with the medical record data we collected. This consent form will be kept separate from your study data as well under double lock according to Lifespan policy.
Discomforts and Risks. The parties agree and acknowledge that the following are some of the risks and discomforts associated with the aforementioned various medical procedures:
Discomforts and Risks. The questions you will be asked are from standard questionnaires used in sleep and psychology research. Certain questions may be mildly upsetting as they may probe sensitive psychological areas and others inquire about family history of medical and psychological illness. Additionally, certain questions ask about your use of drugs and alcohol. If you provide blood samples there is a risk that minor bruising or infection may occur at the site of the blood draw. You will be instructed to look for these minor bruises and infection following the procedure. Universal precautions including the use of gloves and disposable needles will be used. A risk of this study is that this information could be disclosed in the event that a legal authority subpoenas our records. If this were to happen, we would do all that we reasonably could to protect the records against release, including consulting with our legal representatives. No subpoenas have ever been issued to our lab in over 20 years of research at Lifespan
Discomforts and Risks. The risks in this study are considered minimal. The types of text messages we are sending to your child are common in standard care and do not pose any greater risk than other teens may receive in the community. Your child may experience some emotional discomfort in taking part in this study, but most children do not. Your child does not need to reply to any text message that makes him/her uncomfortable. Also, we will make sure that your child’s participation in this study remains confidential. It is very important that you understand that NO ONE is monitoring the text messages at any particular time. If your child needs immediate help at any time, please call 911, or one of the crisis numbers we will provide to you, or your child’s doctor.
Discomforts and Risks. The risks of participating in this study are minimal. It is possible that you may experience some soreness due to exercise participation or it is possible that you could injure yourself while exercising. You may also experience mild skin irritation from wearing the armband, although this is not typical.
Discomforts and Risks. The risks of participating in this study are minimal. The programs may not be effective in helping you lose weight. It is possible that you could feel some hunger if you reduce your food intake to try to lose weight, or could be injured from exercise during this program. There are also some risks associated with exercising after a cardiovascular event. These risks are no greater than the risks you accept when you sign up to attend cardiac rehabilitation. To protect you, a cardiologist (Xx. Xx, the CR’s Medical Director) will review your medical record to determine that it is safe for you to participate in this program. The staff you will interact with are CPR-certified and know what to do in the event of a health emergency. You should always adhere to your healthcare provider’s recommendations, and in the unlikely event that the study member or a member of the study staff recommends a practice that contradicts the advice of your healthcare provider, please follow your healthcare provider’s advice and contact the research team immediately to notify us of this discrepancy.
