[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, You may ask that your identifiable samples be destroyed. add the following] 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
[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