ࡱ>  Ebjbj ;}c}c<1;;;;;OOO8O:.L+ A A A !"d&#4_:a:a:a:a:a:a:$&=?:-;Z#!!Z#Z#:;;A A :@&@&@&Z#;A ;A _:@&Z#_:@&@&5m7A `['$m6K::0:6@$@(m7"@;7Z#Z#@&Z#Z#Z#Z#Z#::%Z#Z#Z#:Z#Z#Z#Z#@Z#Z#Z#Z#Z#Z#Z#Z#Z# : NCI CIRB SLU Boilerplate Language for Consent/Assent Forms and HIPAA Authorizations The Saint ֱοƵ University Research Team must incorporate the following content into the CIRB approved consent/assent templates, as applicable. Shaded items are instructional and are meant to be deleted (not incorporated). A link to the SLU HIPAA Authorization is at the end of the document; the authorization will need to be completed separately (rather than embedding content into the consent document). Please note that local decisions regarding assent forms will usually be decided during Administrative Review. This is mainly due to variability in the CIRB-approved assent requirements/materials. SLU Boilerplate Assent Form language was submitted to CIRB assuming that CIRB-approved assents would generally be in place. If that is the case, SLU investigators can include Boilerplate reproductive risk language (below) into the CIRB assent form and submit for SLU Administrative Review. If no CIRB-approved Assent Form exists, the study team can submit/reference what CIRB approved regarding assent, and local requirements/requests for revision, if any, will be determined during SLU Administrative Review and noted on Appendix B of the NCI CIRB Submission Authorization Form. Click links below for necessary language:  HYPERLINK \l "BoilerplateConsentLanguage" Boilerplate Consent Language  HYPERLINK \l "BoilerplateAssentLanguage" Boilerplate Assent Language  HYPERLINK \l "BoilerplateHIPAAlanguage" Boilerplate HIPAA Authorization Language  BOILERPLATE CONSENT LANGUAGE: SAINT LOUIS UNIVERSITY Research Study Consent Form STUDY TITLE: [Title from protocol]  This consent form contains important information to help you decide whether to participate in a research study. The study staff will explain this study to you. Ask questions about anything that is not clear at any time. You may take home an unsigned copy of this consent form to think about and discuss with family or friends. Being in a study is voluntary your choice. If you join this study, you can still stop at any time. No one can promise that a study will help you. Do not join this study unless all of your questions are answered. After reading and discussing the information in this consent form you should know: Why this research study is being done; What will happen during the study; Any possible benefits to you; The possible risks to you; Other options you could choose instead of being in this study; How your personal health information will be treated during the study and after the study is over; Whether being in this study could involve any cost to you; and What to do if you have problems or questions about this study. Please read this consent form carefully. RESEARCH STUDY CONSENT FORM Participant: IRB #:First Name / Last NamePrincipal Investigator (PI)Contact Phone #First Name / Last Name CredentialsTitle of Project:  [Reproductive Risks: Note: Because Saint ֱοƵ University is a Catholic institution, the following statement(s) should be used and specific methods of contraception should not be listed in the consent document. However, in some studies, the harmful effects of a research study drug (e.g., thalidomide, or drugs labeled as Category X) on a fetus can be quite severe. In such cases, the study sponsor (via the protocol) or the IRB may require that specific measures including abstinence are listed; if so the following phrase should be added, according to ones own conscience, after careful reflection.] Pregnancy/Childbearing Potential If you are a woman of childbearing potential, please read and sign below. Some research medications or procedures can cause severe birth defects, mental disability in an unborn baby, or loss of the unborn baby. If you take part in a research study that includes a drug or medical procedure, you must be willing to have a pregnancy test done before beginning your participation and you must avoid becoming pregnant while you take part in the research study. If you are pregnant or breast feeding a baby, you cannot take part in this research study. If you become pregnant during the study you will be removed from the study. If you are pregnant or think you are pregnant, or if you are nursing a baby, it is important for you to tell the study doctor immediately. If you are sexually active during your participation in the research, you must use effective measures (chosen in consultation with your health care provider) to avoid becoming pregnant. Your signature below indicates you agree to these requirements. & Check this box if you are not a woman of childbearing potential (no signature needed). Signature _______________________________________ Date ______________________ Sexually Active Male If you are a sexually active male, please read and sign below. There is a concern that some research medications or procedures may cause severe birth defects, mental disability in an unborn baby, or loss of an unborn baby. If you take part in a research study that includes a drug or procedure, you and your partner must be willing to use effective measures (chosen in consultation with your health care provider) to avoid pregnancy. Signature _______________________________________ Date ______________________ [Include if appropriate to the research] A positive pregnancy test result for a minor will be reported to the parent(s) and/or legal guardian(s) of the minor. Include if standard of care billed to insurance] Because this research provides standard treatment and follow-up tests for the disease or condition being studied, insurance carriers ordinarily cover the costs. You should check with your insurance company to verify that they cover standard of care procedures. You will be responsible for any costs not covered by your health insurance company including any co-payments and/or deductibles. [Include if financial counseling is available] Financial counseling is available to you, which includes meeting with a licensed social worker and/or financial counselor. This social worker/financial counselor will assist you as needed in providing medical information to your insurance company. [Add if study involves payment] Payments for taking part in this research study will be put onto a ClinCard. ClinCard is managed by a company named Greenphire. Your personal information, such as your name, date of birth and social security number will be shared with Greenphire in order to put study payments onto the ClinCard. While the ClinCard is not a credit card, Greenphire may use your information like a credit card company would. You should review the terms and conditions of ClinCard when deciding whether to take part in this study. To receive payment for participation in this study, you will be asked to provide your home address and social security number. If you receive $600 or more from Saint ֱοƵ University for participation in this research study (or a combination of studies) in one tax year, you will be sent an IRS Form 1099 for tax purposes. CONFIDENTIALITY Saint ֱοƵ University and/or SSM Cardinal Glennon Childrens Medical Center officials may review your research study records. Some information about your participation in this study will be kept in your medical record. Authorized Saint ֱοƵ University and Hospital staff have access to this information. Systems are in place to keep medical record information confidential. It is possible this information could be shared with insurance or healthcare providers who are authorized to have your medical records. [Include if doing HIV testing as part of the study] You will receive an HIV test as part of this research. The result of your test may or may not become part of your medical record, depending on where testing takes place. At your request, the results of the HIV testing will be forwarded to your physician. As a volunteer in an approved research study, a confirmed positive HIV result will be reported to the Missouri Department of Health but your identity will not be revealed. SUBJECT INJURY LANGUAGE You will receive necessary medical treatment in the event that an injury results because of your participation in this research. The University will have the right to determine whether an injury is related to your participation in this study or happened because of your medical condition or other reasons which are not related to this study. If the injury is due to participation in the research, you will not have to pay for the cost of this treatment unless your injury is due to your own failure to follow the study doctors instructions. There are no plans for Saint ֱοƵ University to pay for the costs of any additional care. You have not waived your legal rights by signing this form. If you have questions, please call the Saint ֱοƵ University General Counsel's office at 314-977-5767. CONTACT/QUESTIONS If you have questions or concerns about this research study, or if you have any problems that occur from taking part in this research study, you may call (insert name of PI/designated physician) at (insert PI/physicians phone number). For questions after hours, you may call (insert name of PI/designated physician) at (insert PI/physicians phone number). If you have questions, concerns or complaints about your rights as a research participant and would like to talk to someone not on the research team, please contact the Saint ֱοƵ University Institutional Review Board (IRB) at 314-977-7744 or irb@slu.edu. CONSENT/SIGNATURES Consent and Assent Instructions: Consent: Capable subjects 18 years and older must sign on the research participant line below. Consent is provided by the Legally Authorized Representative for adult subjects unable to consent. For subjects under 18, consent is provided by the parent or guardian. Assent: Is not required for subjects 6 years and younger Assent should be obtained from minors ages 7-17, unless otherwise decided by the IRB. Parent/guardian attestation signature should be obtained in studies requiring assent. Signature lines/information in blue, below, can be deleted if not relevant to the study. The individual obtaining consent/assent must be authorized (according to the IRB-approved protocol) to do so, and should sign at the same date/time in which research participant signatures are obtained. ___________________________________ Print Name of Participant __________________________________ ________________ Consent Signature of Research Participant Date ___________________________________ ________________ Print Name of Parent/Guardian/Legal Representative Date ___________________________________ ________________ Signature of Parent/Guardian/Legal Representative Date ___________________________________ Description of Relationship to Participant ASSENT SECTION: Statement of Parent or Guardian: My child appears to understand the research to the best of his or her ability and has agreed to participate. ________________________________________ __________________ Signature of Parent or Guardian Date SAINT LOUIS UNIVERSITY INSTITUTIONAL REVIEW BOARD APPROVAL STAMP This form is valid only if the IRBs approval stamp is shown below.  Note: local approval stamp will be applied after CIRB approves our sites study specific worksheet. I certify that I have explained to the above individual(s) the nature and purpose of the research study and the possible benefit and risks associated with participation. I have answered any questions that have been raised and the subject/patient has received a copy of this signed consent document. If this study involves participants who are minors: I have explained all aspects of the research to the minor to the best of his or her ability to understand. I have answered all the questions of the minor relating to this research. The minor agrees to be in the research. I believe the minors decision to enroll is voluntary. The research study doctor and study staff agree to respect the minors physical or emotional dissent at any time during this research when that dissent pertains to anything being done solely for the purpose of this research. Signature of Consenting Research Team MemberDate First Name / Last Name CredentialsPrinted Name of Consenting Research Team Member Child Assent Boilerplate Language: Reproductive Risks (Use if applicable to research) Use for studies involving drugs without known teratogenic effects (ages 15-17). The effects of (insert study drug/device/procedure) during pregnancy have not been fully studied. There might be unknown risks to the unborn child if you (your partner if you are male) become pregnant during this study. Due to these risks you must not be in this study if you become pregnant, plan to become pregnant during the research study, or are breast-feeding a child. You/your partner must not get pregnant during the study. If you are having sex, you must talk to your parents and doctor about how to make sure you/your partner do not get pregnant. Pregnancy testing will be done during the study. If your pregnancy test shows that you are pregnant, your parents or legal guardians will be told. Use for studies involving drugs without known teratogenic effects (ages 7-14). If you are a girl and have started your periods, pregnancy testing will be done. If your pregnancy test shows that you are pregnant, your parents or legal guardians will be told. You must not get pregnant during the study. If you are a boy, it is very important that your partner does not get pregnant. If you are having sex, you must talk to your parents and doctor about how to make sure you/your partner do not get pregnant. This is because (insert study drug name) could cause bad birth defects in babies. You must not take part in this study if you become pregnant. If at any time you think you might be pregnant, you must tell your study doctor right away. Use for studies involving drugs with known teratogenic effects. This language should be used for ages 10 and greater. We know that (insert study drug name) can cause miscarriages or bad birth defects in babies. If you are a girl, it is VERY IMPORTANT that you do not get pregnant during the study (also include if time period after last dose). If you are a boy, it is VERY IMPORTANT that your partner does not get pregnant. You must use a condom (include other required barrier method details) if you have sex while you are in this study. The study doctor will talk to you about what other type(s) of birth control to use. Ask your parents or the study doctor if you have any questions about pregnancy risks. If you are a girl and have started your periods, pregnancy testing will be done. If your pregnancy test shows that you are pregnant, your parents or legal guardians will be told. You must not take part in this study if you become pregnant. 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