ࡱ>  LKbjbj L}c}cB} " " " " """"8U"$y#"E$:$"$$$%&d)'4$G "'%%'' " "$$4ɭ*+*+*+'^ "$ "$*+'*+*+F>$ c>B(Tz߭06$)" "ƞ]'q'*+' 'Y]']']'**]']']''''']']']']']']']']']' :  SAINT LOUIS UNIVERSITY Pregnancy Follow-Up Research Consent and HIPAA Authorization Form STUDY TITLE:[Title from protocol] This 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/your baby; The possible risks to you/your baby; Other options you/your baby could choose instead of being in this study; How your/your babys 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/your baby have problems or questions about this study. Please read this consent form carefully. PREGNANCY FOLLOW-UP Research Consent and HIPAA Authorization Form Participant: IRB #:First Name / Last NamePrincipal Investigator (PI)Contact Phone #First Name / Last Name CredentialsTitle of Project: You are being asked to take part in a research study conducted by [name of principal investigator] and colleagues because you became pregnant while you were, or your male partner (the biological father of your baby) was, taking part in a clinical research study. This consent document may contain words that you do not understand. Please ask the research study doctor or research staff to explain anything that you do not understand. You may take home an unsigned copy of this form to think about or discuss with family or friends before making your decision about the collection and use of information about your pregnancy and the birth and health of your baby. WHY IS THIS RESEARCH STUDY BEING DONE? You are being asked to participate because you became pregnant while you were, or your male partner (the biological father of your baby) was, taking part in a clinical research study. The purpose of this research study is [insert main study purpose]. As part of this study, you/your partner received, [name of study drug], an investigational drug (a drug not approved by the Food and Drug Administration) and we want to see if the drug has any effect on your pregnancy or the health of your baby. The purpose of this follow-up is to provide information about your pregnancy to the study sponsor, [name of sponsor], who provided the investigational drug. There is not a lot of human data about the possible risk to you/your baby. Because the drug is investigational, researchers do not know its effects on male sperm, female eggs, the growth and development of an embryo, fetus, or newborn, or breast milk. The sponsor of the research study is asking for your permission to collect and use medical information about your pregnancy, its outcome, and if appropriate, the birth and health of your baby. We want to follow your pregnancy and try to find out if the investigational drug has any effect on your pregnancy and the health of your baby. For placebo-controlled, the following statement must be included: In this research study, some individuals received the investigational drug and others received only a placebo. A placebo looks the same as the investigational drug and is given the same way, but it has no active ingredient(s) in it. You/your partner and the study staff will not know which drug you/your partner received until the study is over (but they can find out in the case of a medical emergency). WHAT AM I BEING ASKED TO DO? Your participation in this pregnancy follow-up is limited to allowing the study sponsor to collect and use medical information about your pregnancy, its outcome, and if appropriate, the birth and health of your baby. Identifiers might be removed from your/your babys data collected in this research, and used for future research studies or distributed to other researchers for future research studies without your additional permission. 3. HOW LONG WILL I BE IN THE RESEARCH STUDY? We may collect information throughout the course of your pregnancy and for up to [amount of time] after your baby is born. WHAT ARE THE RISKS? As this study involves the use of your/your babys personal information, there is a chance that a loss of confidentiality will occur. The researchers have procedures in place to lessen the possibility of this happening, as described in section 7 of this form. The research team is willing to discuss any questions you might have. ARE THERE BENEFITS TO BEING IN THIS RESEARCH STUDY? You/your baby will not benefit directly from allowing the study team to collect and use information about your pregnancy and the health of your baby. Even though you/your baby may not receive any benefit, other women and babies who are exposed to this drug may benefit in the future because of what the researchers learn from this research study. WHAT OTHER OPTIONS ARE THERE? You may choose not to be in this research study. If you do not wish to provide any information, this will not prevent your/your partners ability to continue to participate in the research study. WILL MY INFORMATION BE KEPT PRIVATE? The results of the research study may be published but your/your babys name or identity will not be revealed and your/your babys record will remain private. In order to protect your/your babys information, the study team will [describe measures taken to protect privacy and confidentiality]. The Ƶ Institutional Review Board (the Board that is responsible for protecting the welfare of persons who take part in research), SSM Health officials, and other University officials may review your/your babys research study records. The Food and Drug Administration (FDA) or Sponsor [list name] may also review your/your babys research study records and medical records. State laws or court orders may also require that information from your/your babys research records be released. For  HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/nih_clinical_trial_definition.docx" applicable clinical trials, the following statement must be included: A description of this study and study results will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This website will not include information that can identify you/your baby. You can search this website at any time. Authorization to Use and Disclose Protected Health Information State and Federal privacy laws protect the use and release of your/your babys health information. Ƶ requires that private information about you/your baby be protected. This is especially true for your/your babys personal health information. Protected Health Information (PHI) is any health information that can identify you/your baby. To take part in this research study, you must give the research team permission to access your/your babys health information and to use and share your/your babys PHI. The research team will only use and/or share your/your babys information as described below and in the research consent form. What Health Information about me may be used or shared for this research study? Only include the PHI you will be using/sharing; this should be consistent with section 15.2 of the BIO eIRB Protocol (or section 11.2 of the BSS eIRB Protocol). The PHI that may be used or shared for this study will include: names, medical record numbers, person-specific dates (birthdates, admission dates, etc.), addresses, telephone numbers, fax numbers, email addresses, social security numbers, health plan beneficiary (insurance) numbers, account numbers, certificate or license numbers, vehicle identifiers and serial numbers, including license plate numbers, device identifiers and serial numbers, web universe resource locators (URLs) or internet protocol (IP) addresses, biometric identifiers (including finger and voice prints), full-face photographs and any comparable images, any other unique identifying number, characteristic, or code. Only include the sources from which you will be obtaining PHI; this should be consistent with section 15.3 of the BIO eIRB Protocol (or section 11.3 of the BSS eIRB Protocol). The PHI that may be used or shared for this study will be collected from the following sources: hospital medical records, physician or clinic records, laboratory, pathology and/or radiology reports, biological samples, interviews or questionnaires/health histories, data previously collected for research purposes obtained from [complete]; other [explain]. Who will my/my babys information be shared with? Your/your babys PHI will be maintained by Ƶ researchers and they will only share the information as described below. The researchers may use or share your/your babys health information with: (if applicable) The [central IRB name] and representatives, in order to provide research oversight The Ƶ Institutional Review Board and other University personnel, in order to provide research oversight Federal or state government representatives, when required by law Physicians who have access to your/your babys medical record when required for your/your babys medical care SSM Health representatives, in order to provide research oversight The study sponsor, [name of sponsor], who provided the investigational study drug (if applicable) List any collaborators, outside laboratories, sponsor, etc. and for each listed, what PHI are shared and why (if applicable) List any other groups with whom information may be shared, what is shared and why (if applicable) Include a statement that primary physician will be contacted if researcher during the study learns of a medical condition that needs immediate attention If applicable, the following statement must be included: The sponsor of this study is not covered by HIPAA. This means that the sponsor does not have to follow the same rules to protect your/your babys privacy. The researcher will send information to the sponsor. This information will contain PHI as listed above. In addition, the sponsor or its agents will review your/your babys research file and medical record in order to verify data that are provided to them. The researchers at Ƶ agree to protect your/your babys health information by using and/or disclosing it only as you authorize. However, if your/your babys PHI is shared with someone outside of the Ƶ research team and/or if you choose to share this information with others outside of this study, your/your babys health information may no longer be protected by HIPAA. Am I required to sign this document? Your decision to sign or not sign this form will not affect your/your babys standard medical treatment, payment or enrollment in any health plans or affect your/your babys eligibility for benefits. However, if you choose not to sign this form, you may not take part in this research study. Does my permission expire? This permission to release your/your babys PHI expires when the research study is over and all required study monitoring has ended. If you choose to sign this form: You can change your mind and not allow the researcher to use and/or share your/your babys PHI (revoke your authorization). If you revoke your authorization, you must send a written letter to: [insert PIs name and mailing address] to inform [him/her/them] of your decision. If you revoke your authorization, researchers may only use and/or share your/your babys PHI already collected and used for this research study. If you revoke your authorization, your/your babys PHI may still be used and/or shared should you have an adverse event (a bad effect). If you withdraw your authorization, you may not be allowed to continue in the study. If you have questions or concerns regarding your/your babys privacy and the use of your/your babys personal health information, please contact the University Privacy Officer at (314) 977-5545. The Notice of Privacy Practices can be reviewed electronically at  HYPERLINK "https://www.slucare.edu/patient-information/legal-notices/notice-of-privacy-practices.php" https://www.slucare.edu/patient-information/legal-notices/notice-of-privacy-practices.php or if you prefer a paper copy, please request one at this time. WHAT ARE THE COSTS AND PAYMENTS? There will be no additional costs to you for allowing us to collect and use this health information. You will not be paid for participation. The regular medical care costs related to your pregnancy and the birth and care of your baby will be billed to you and/or your/your babys health insurance in the usual way. WHAT HAPPENS IF I AM, OR MY BABY IS, INJURED BECAUSE I TOOK PART IN THIS RESEARCH STUDY? If you believe that you/your baby are injured as a result of your participation in the research study, please contact the research study doctor and/or the Chairperson of the Institutional Review Board as stated in section 10. WHO CAN I CALL IF I HAVE QUESTIONS? If you have any 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 P] at [insert PIs phone number]. If you have questions, concerns or complaints about your/your babys rights as a research participant and would like to talk to someone not on the research team, please contact the Ƶ Institutional Review Board (IRB) at 314-977-7744 or  HYPERLINK "mailto:irb@slu.edu" irb@slu.edu. WHAT ARE MY RIGHTS AND WHAT ELSE SHOULD I KNOW AS A RESEARCH STUDY VOLUNTEER? Your decision to allow the collection and use of information about your pregnancy and the birth and health of your baby is voluntary. You may choose not to be a part of this research. There will be no penalty to you if you choose not to take part. You may leave the research study at any time. Your decision to allow the collection and use of information about your pregnancy and the birth and health of your baby will also have no effect on your/your partners participation in the study. The research study doctor or research study staff will let you know of any new information that may affect whether you want to continue to take part in the research study. Ƶ is receiving financial support from [sponsor name] to assist in the conduct of this research study. The amount of payment is enough to cover the research study doctors and/or institutions expenses to perform the research study. 12. AM I SURE THAT I UNDERSTAND? I have read this consent and HIPAA authorization form and have been able to ask questions and state any concerns. I have been asked if I wish to speak directly to the researcher or research study doctor responsible for this research study. The research team has responded to my questions and concerns. I believe I understand the research study, how protected health information (PHI) will be used, and the potential benefits and risks that are involved. Statement of Consent and HIPAA Authorization I give my informed and voluntary consent to take part in and agree to the use and disclosure of my protected health information (PHI) for this research study. I will be given a copy of this consent and authorization document for my records. I have received the Notice of Privacy Practices either electronically or as a hard copy. _____________________________________ Print Name of Pregnant Participant/Pregnant Partner _____________________________________ ________________ Signature of Pregnant Participant/Pregnant Partner Date SAINT LOUIS UNIVERSITY INSTITUTIONAL REVIEW BOARD APPROVAL STAMP This form is valid only if the IRBs approval stamp is shown below.  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. Signature of Consenting Research Team MemberDate First Name / Last Name CredentialsPrinted Name of Consenting Research Team Member NOTE: The Principal Investigator or Research Team Member that signs here must be authorized in the IRB-approved protocol to obtain informed consent and must sign at the SAME time on the same day as the above signatures are obtained. Failure to obtain HIPAA Authorization for the use and disclosure of PHI could result in the loss of research data.     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