ࡱ> ^a] /bjbj[[ ;N99'0F F 8L843l42333333$)57$3$39322./PRCv.2O303.88(//80$3$3G|38F f: 91Ů SITE SPECIFIC CONSENT LANGUAGE When using a non-91Ů IRB as a Reviewing IRB, 91Ů template consent language should still be used in consent materials unless an exception was granted (email  HYPERLINK "mailto:irb@slu.edu" irb@slu.edu with exceptions). For non-partner central IRB use, the 91Ů research team is responsible for inserting this required language. To do so, please follow the instructions shaded, and in italics, below. Track the insertions/revisions being made to the study consent using the track changes feature in Word to redline, and submit the tracked consent materials with your 91Ů Central IRB Submission Authorization Form for 91Ů Administrative Review. NOTE: Print Consent on 91Ů Letterhead when possible or add 91Ů Logo when possible REPRODUCTIVE RISKS Note: Because 91Ů is a Catholic institution, the following sections should be used IN THE PLACE OF the reproductive risk language in the template study consent. 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 or the IRB may require that specific measures are listed. In those cases, measures can be included in the language below, abstinence should be included, and 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 an unborn baby. If you take part in this research study, 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. [Specify duration if longer (e.g., for two months after last dose)] 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.  FORMCHECKBOX  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 and/or mental retardation to 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. [Specify duration if longer (e.g., for two months after last dose). Can also include language about following pregnancy should one occur.] 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. [Add if study involves payment from 91Ů at any amount. Not applicable if using gift cards.] To receive payment, you will be asked to provide your home address and social security number. If you receive $600 or more from 91Ů 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. [Add if study involves payment via 91Ů ClinCard 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. CONFIDENTIALITY 91Ů [and SSM Health] officials may review your research study records. [Include if any research information will be kept in the Medical Record] Some information about your participation in this study will be kept in your medical record. Authorized 91Ů 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. NOTE: HIPAA Authorization should be drafted as a stand-alone document using the 91Ů template, and will be separate from the consent document. All HIPAA language should be removed from the consent(s) unless an exception was granted. SUBJECT INJURY Replace injury language in the consent with the language below, based on level of risk. NOTE: 91Ů does not allow modifications to this language without approval from the Office of the General Counsel. If sponsors request deviations, expect review delays. If you believe that you are injured as a result of your participation in the research study, please contact the research study doctor. For studies that are more than minimal risk, also add the following paragraph.  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 91Ů 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 91Ů General Counsel's office at HYPERLINK "tel:314-977-5767" \t "_blank" 314-977-5767. CONTACT/QUESTIONS If you have questions about your rights as a research subject you may also contact 91Ů Institutional Review Board at 314-977-7744. CHILD ASSENT SITE SPECIFIC LANGUAGE Reproductive Risks (Replace reproductive risks in the assents with the language below, if applicable.) Reproductive Risks Option 1: 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. Option 2: 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. Option 3: Use for studies involving drugs with known teratogenic effects (i.e. Category x). This template is used at 91Ů for ages 10 and greater. We know that [insert study drug name] can cause miscarriages (loss of a pregnancy) 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. If at any time you think you might be pregnant, you must tell your study doctor right away.     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