[OR] [For non-therapeutic trials, add the following paragraph:] If you decide to stop being part of the study, you should tell your study doctor, and any information that you have already provided will be kept in a confidential manner. [If applicable, add the following] You may ask that your identifiable samples be destroyed. 3. RISKS ASSOCIATED WITH PARTICIPATION: [In simple language and in simple bullet format (whenever possible), explain the possible risks and discomforts, including: Potential risks of investigational agents, devices, procedures, and treatments, as well as known risks of comparative agents, devices, procedures, and treatments used in the study; If applicable, psychological, social, or economic risks; and Only include the risks associated with procedures and/or treatments being performed solely because the subject is participating in this research study. Risks of standard of care procedures that would normally be performed even if the subject were not participating in this research study should not be included in the consent form. However, if randomizing to a standard of care treatment when other standard of care treatments/alternatives exist, the risks of the standard of care treatment should be included because the patient may not incur these risks outside of the study.]. [Start with the potential side effects of the experimental drugs and devices. To the extent possible, risks of harm or discomfort should be characterized as to their probabilities of occurrence, potential seriousness, duration, and reversibility. You may do this using 1 of the following 2 ways: If you can state the percentage of occurrence for each risk, the use of categories is not necessary. However, you should list the risks in bullet format, and in descending order with the most frequently occurring risks first and so on; OR You may use categories of risk: The current UTHSC guidelines for risk categories include Very Rare, less than 1%; Rare, 1 to 5%; Occasional, 6 – 20%; Common, 21 – 50%; and Very Common, 51 to 100%. One of these categories should be used for each potential risk with the corresponding range of percentages. For example:] All drugs can have side effects. Although not all or none of these side effects may occur, if they do occur, they may need medical attention. You must notify your study doctor about all symptoms, side effects, complaints, illnesses, or injuries which you experience during the course
[if research procedures are taking place at both Methodist and Le Bonheur, add] Methodist Le Bonheur Healthcare [if research procedures are taking place at Le Bonheur Children’s Hospital add] Le Bonheur Children’s Hospital [if research procedures are taking place at Methodist Hospitals, add] Methodist Hospitals [if research procedures are taking place at Regional One Health, add] Regional One Health [if research procedures are taking place at University Clinical Health, add] University Clinical Health [if research procedures are taking place at a UT Le Bonheur Pediatric Specialists facility, add] UT Le Bonheur Pediatric Specialists, Inc. [if your study has a sponsor, add] [name of sponsor], which sponsors and provides funds for this research [if applicable, add] [name of CRO], which has been hired by the sponsor to coordinate the study [if applicable, add] A Data and Safety Monitoring Board (DSMB) [If you included a sponsor, CRO, DSMB, or similar unaffiliated organization in the above bullet point list, you must add:] However, some of these organizations or institutions above do not have the same obligations to protect your PHI. Your PHI will only be used and/or given to others: To do the research To study the results To see if the research was done correctly [Provide an expiration date for the authorization by choosing one of the following 3 statements:] Your PHI will be used until the study is completed. [OR] [if the research is FDA-regulated, state] Your PHI will be used for as long as the sponsor reports study information to the FDA. [OR] [if the research is without a foreseeable end point, such as a repository or a registry, state] Your PHI will be used indefinitely.