Some of the drugs used in the study may make you unable to have children in the future. Your study doctor will discuss this with you. Interactions/Contraindications with Contraception Methods. If applicable, insert: [Known interactions or contraindications with specific contraception methods] Are there benefits from being in the study? State the direct benefits, or the possibility of direct benefits, that are likely for research participants. If there is no known clinical benefit, ensure this is stated. If there are no known direct benefits, state: No one knows whether or not you will benefit from this study. There may or may not be direct benefits to you from taking part in this study. Describe the generalizable or societal benefits and use a sentence such as: We hope that the information learned from this study can be used in the future to benefit other people with a similar disease and/or health condition. What are your responsibilities in this study? Identify participant responsibilities. Include, add to, or modify bullets below as applicable. Include only those relevant to your protocol. Here are some examples: If you choose to participate in this study, you will be expected to: Tell the study doctor about your current medical conditions; Tell the study doctor about all prescription and non-prescription medications and supplements, including vitamins and herbals, and check with the study doctor before starting, stopping or changing any of these. This is for your safety as these may interact with the intervention you receive on this study. Tell the study doctor if you are thinking about participating in another research study Return any unused study medication. Return any [specify e.g., diaries or questionnaires] that you take home to complete Tell the study doctor if you become pregnant or father a child while participating on this study Avoid drinking/eating specify what and for how long Stop taking name for specify washout period insert name of study intervention is for you alone, and must not be shared with others. If applicable, include: If someone accidentally takes insert name of study intervention, include instructions e.g., they should immediately go to the nearest emergency department. Do not eat for 12 hours before visits. Do not take medications before visits. Do not eat grapefruit or drink grapefruit juice during this study. Ask your study team about anything that worries you. Tell study staff anything about your health that has changed. Tell your study team if you change your mind about being in this study. Can I choose to leave the study?
Some of the drugs used in the study may make you unable to have children in the future. Your study doctor will discuss this with you. Interactions/Contraindications with Contraception Methods. If applicable, insert: [Known interactions or contraindications with specific contraception methods] Are there benefits from being in the study? State the direct benefits, or the possibility of direct benefits, that are likely for research participants. If there is no known clinical benefit, ensure this is stated. If there are no known direct benefits, state: No one knows whether or not you will benefit from this study. There may or may not be direct benefits to you from taking part in this study. Describe the generalizable or societal benefits and use a sentence such as: We hope that the information learned from this study can be used in the future to benefit other people with a similar disease and/or health condition. What are your responsibilities in this study? Identify participant responsibilities. Include, add to, or modify bullets below as applicable. Include only those relevant to your protocol. Here are some examples: If you choose to participate in this study, you will be expected to: Tell the study doctor about your current medical conditions; Tell the study doctor about all prescription and non-prescription medications and supplements, including vitamins and herbals, and check with the study doctor before starting, stopping or changing any of these. This is for your safety as these may interact with the intervention you receive on this study. Tell the study doctor if you are thinking about participating in another research study Return any unused study medication. Return any [specify e.g., diaries or questionnaires] that you take home to complete Tell the study doctor if you become pregnant or father a child while participating on this study Avoid drinking/eating specify what and for how long Stop taking name for specify washout period insert name of study intervention is for you alone, and must not be shared with others. If applicable, include: If someone accidentally takes insert name of study intervention, include instructions e.g., they should immediately go to the nearest emergency department. Do not eat for 12 hours before visits. Do not take medications before visits. Do not eat grapefruit or drink grapefruit juice during this study. Ask your study team about anything that worries you. Tell study staff anything about your health that has changed. Tell your study team if you change your mind about being in this study. Can I choose to leave the study?
73609-Interventional%20Consent%20Template%20-%20(Participant%20only)%20-%2019Sept2016.docx