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. There may be risks to taking part in this study. Below are the known risks of DHEA and the study procedures. There may be other risks that are unknown at this time.
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.
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. 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. We do not expect the stop smoking counseling to cause you discomfort. It is possible, but unlikely, that filling out surveys about your smoking and psychiatric symptoms or talking to a counselor would make you feel uncomfortable. All research staff are professionals and all information will be kept confidential. The discomforts of quitting smoking include withdrawal symptoms such as mood swings, anxiety, irritability, decreased concentration, restlessness, excessive hunger, and trouble sleeping. These symptoms not dangerous and usually only last about one to two weeks after quitting Use of the nicotine patch may result in side effects. The most common side effects of nicotine patch are skin irritation at the site on which the patch is applied, trouble sleeping, disturbed or vivid dreams, and nausea. In rare cases, you could experience an allergic reaction to the patch. Allergic reactions could consist of rash, hives, and/or swelling of the mouth/face/lips/tongue. If you experience any side effects that concern you, discontinue using these products and contact your primary care physician. Visit a local emergency room (ER) or call 911 if you are experiencing a medical emergency and need immediate treatment. It is possible that when you stop smoking, the doses of your psychiatric medicine will need to be adjusted. To participate in this study, you must agree to allow study staff to inform your primary care provider and your psychiatric providers about your intention to stop smoking and that you have been given the nicotine patch. You have my permission to contact my partial hospital psychiatrist and inform him/her of my study participation: Psychiatrist name Participant signature You have my permission to contact my primary care provider and inform him/her of my study participation. Primary care provider name Participant signature □Not applicable, I do not have a primary care provider You have my permission to contact my outpatient psychiatrist and inform him/her of my study participation. Psychiatrist name Participant signature □Not applicable, I do not have an outpatient psychiatrist If you report to our study staff that you are considering harming yourself or someone else, we have a duty to keep you and others safe. If we believe you are at risk of harming yourself or others, you will receive a call from the study principal investigator, Xxxxxxxxx Xxxxxxxx, Ph.D., or a covering mental health provider. If the risk is severe, we may inform your psychiatric p...
Discomforts and Risks. The risks of study participation are considered very minimal given that the investigation is observational in nature. Any risks typically associated with data transmission via smartphone will be minimized via electronic safeguards such as secure servers and encryption of data as described below. Your child may run the risk of interrupting their routines or activities when attempting to complete cognitive tasks and record eating episodes on their smartphone device, but will be instructed not to complete recordings when doing so would be detrimental to safety (e.g., while crossing the street). 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. 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 physical or sexual abuse will be reported to state authorities as mandated by law. Information obtained could be subject to subpoena, as questionnaires will assess underage drinking and alcohol use. There may be other risks that could arise which are not reasonably foreseeable. If new information becomes available which could influence your willingness to continue, this new information will be discussed with you.
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...
