FORM: Initial Review - University of Miami



Once completed, this form should be uploaded in initial eProst submission for HSRO approval. A copy of the signed form must be included with your submission to the reviewing IRB and uploaded to eProst submission. NOTE: no study activities may be initiated until external IRB oversight has been confirmed in eProst and the study is in the External IRB state.eProst Number: FORMTEXT ?????Protocol Name: FORMTEXT ?????Investigator: FORMTEXT ?????Primary Contact: FORMTEXT ?????Person completing the form(if different than the researcher)Name: FORMTEXT ?????Institution/Affiliation: FORMTEXT ?????Mailing address: FORMTEXT ?????Phone number: FORMTEXT ?????Email: FORMTEXT ?????Study Summary and Basic Information(1-3 sentences) FORMCHECKBOX Check this box if this is a multi-site trial. FORMTEXT ?????Statement of Justification for use of external IRB: FORMCHECKBOX Study is PHS-funded and external review is required per single IRB mandate FORMCHECKBOX Industry-funded multi-site study and sponsor is requiring single IRB review as a condition of participation. – Provide a statement from sponsor requiring external single IRB review. FORMCHECKBOX Other: FORMTEXT ?????Sponsor/Funding SourceFunding informationName of Funding Source: FORMTEXT ?????Mailing address: FORMTEXT ?????Contact Name: FORMTEXT ?????Phone number: FORMTEXT ?????Email: FORMTEXT ?????Reviewing IRB and Reliance Agreement External IRB informationName of IRB: FORMCHECKBOX Western IRB FORMCHECKBOX Advarra IRB FORMCHECKBOX Quorum Review FORMCHECKBOX IntegReview FORMCHECKBOX Alpha IRB FORMCHECKBOX Other FORMTEXT ?????IRB Contact Name: FORMTEXT ?????Phone number: FORMTEXT ?????Email: FORMTEXT ?????The UM and the External IRB must have a “Reliance Agreement” in place before the study can be approved. Agreements are in place with Western IRB, Advarra IRB, NCI CIRB and Quorum Review. If you are using a different external IRB, provide information about the agreement by choosing a selection on the right. FORMCHECKBOX SMART IRB Agreement FORMCHECKBOX The External IRB’s Template agreement (if checked, include the agreement in the eProst submission) FORMCHECKBOX Not sure – If checked send the UM Template agreement to the External IRB. Describe your site’s role in this research. Check all that apply FORMCHECKBOX UM is the Grant Recipient FORMCHECKBOX UM is the Data Coordinating Center FORMCHECKBOX UM faculty or staff will be interacting or intervening with subjects to obtain data about them or specimens from them. FORMCHECKBOX UM faculty or staff will be collecting information from subjects through surveys or interviews FORMCHECKBOX UM faculty or staff will be accessing private identifiable information for recruitment purposes – Note: If checked, HIPAA Authorization waiver is required. FORMCHECKBOX UM faculty or staff will be obtaining private, identifiable data about subjects through review of records or other information that was or will be collected for another purpose (EMR, student records, records from another study. Note: Do not check this box if the data received deidentified, coded and linked to the individual's identity when the UM researchers do not have access to the subjects' identities. FORMCHECKBOX UM faculty or staff will be obtaining private, identifiable data about subjects through review of records or other information that was or will be collected for this study. Note: Do not check this box if the data received is deidentified, coded and linked to the individual's identity when the UM researchers do not have access to the subjects' identities. FORMCHECKBOX UM faculty or staff will be obtaining anonymous or deidentified data about subjects that were collected for other purposes (e.g. a different research study, or a deidentified data base). Note: Check the box if the data you are receiving are in a Limited Data Set with a Data Use Agreement or when the data are coded and linked to the subjects' identity and the UM researchers will not have access to that link. FORMCHECKBOX UM faculty or staff will be obtaining identifiable human bio-specimens that were collected for another purpose. Note: Do not check the box if the bio-specimens are coded and linked to the subjects' identity when the UM researchers receive them and UM researchers will not have access to that link.Local Context/Institutional Requirements for Informed Consent(This section includes Institutionally-required language that must be included by the reviewing IRB) FORMCHECKBOX FORMCHECKBOX Unless consent is waived, the External IRB should approve a template consent document. You will need to obtain approval from the External IRB of a UM-formatted (or JHS) consent document that includes the language required by the University of Miami.Copy and paste the language from the template consent document to the appropriate Footer Template(s). The UHealth Footer is located HERE. The JHS Footer is located HERE. Then revise the language in the template to indicate where the research is being conducted (UHealth or JHS) and include the local contact information for the study team and PI. Then add the required language, which is located HERE. Study will be performed at Jackson Health System sites.Study will be performed at University of Miami / UHealth sites.-54610289560The UM requires a separate HIV consent when the study involves HIV testing. The UM and JHS require a HIPAA Authorization that is separate from the informed consent document. If the consent template includes HIPAA authorization language, remove it. You must submit a HIPAA Form B through eProst. 00The UM requires a separate HIV consent when the study involves HIV testing. The UM and JHS require a HIPAA Authorization that is separate from the informed consent document. If the consent template includes HIPAA authorization language, remove it. You must submit a HIPAA Form B through eProst. It is the study team responsibility to ensure that all language required by the University of Miami (UM) and the UM HSRO are included in the consent documents. When the consent form is complete, highlight the language required by the UM and the UM HSRO.? Then submit this copy as a comment.? Below is a copy of the language that must be included in the consent document.?. Include if research information will be added to University of Miami Medical RecordIf you are, or have been, a patient at a University of Miami facility, you will have a University of Miami medical record. We use an electronic medical record system known as UChart, which improves access to information important to your medical care. UChart will show that you are in a research study and a copy of this signed consent form will be included. To provide as complete a record as possible, some or all of your study-related research information may also be placed in UChart. This specifically includes investigational drugs, devices, biologics, or anything else that may, separately or together with other substances or activities, interfere with your clinical treatment or place you at greater risk of harm. Other information from the research study may be included as well. Including this information in the electronic medical record system is intended only to give information to caregivers providing treatment for you while you are on this study.This information will be available to University of Miami doctors, nurses and other authorized staff who may not be part of the research team but who are involved in providing you medical care, or who are otherwise allowed to access your information. The confidentiality of the results and other documents in UChart will be governed by laws, such as HIPAA, that concern medical records.?We suggest that you tell any non-University of Miami doctors that you are in a research study and that more information may be made available to them at your request. The research team may use your information to notify you of appointments, send you appointment reminders, or schedule additional appointments. FORMCHECKBOX If the research collects specimens include:Your information and samples (both identifiable and de-identified) may be used to create products or to deliver services, including some that may be sold and/or make money for others. If this happens, there are no plans [or replace with plans when using identifiable information/samples] to tell you, or to pay you, or to give any compensation to you or your family. Any blood, urine, tissue, or other biological specimens obtained for the purposes of this study become the exclusive property of the University of Miami [or other institution, please specify.]The University of Miami [or other institution, please specify] may retain, preserve, or dispose of these specimens and may use these specimens for research which may result in commercial applications. You will not receive money for donating blood, urine or tissue samples nor will you receive money from any future proceeds as a result of this research project. FORMCHECKBOX Select one of the following options for Compensation for Injury language based on funding type: FORMCHECKBOX [Non-Sponsored studies that involve greater than minimal risks:] If you are hurt or get sick as a result of being in this study, treatment will be available in most cases. If you have insurance, your insurance company may or may not pay for these costs. If you do not have insurance, or if your insurance company refuses to pay, you will be expected to pay. Funds to compensate you for pain, expenses, lost wages, and other damages caused by injury are not available. This policy does not prevent you from trying to obtain compensation through the legal system. FORMCHECKBOX [Sponsored studies that involve greater than minimal risks:] If you are hurt or get sick due to being in this study, treatment will be usually be available. If you are hurt because of [Chose one: a correctly done study procedure or because you took the study drug as you were told, OR. the device you received or because of a correctly done study procedure,] the Sponsor will pay for the cost of treating the injury. The University of Miami and the sponsor are not planning to pay for pain, lost wages, and other costs you incur because you were hurt. You do not give up any of your legal rights to obtain payment for an injury if you sign this consent document. [Include if applicable, otherwise delete.] If the sponsor pays any of your medical expenses, we may be required to give the sponsor your name, date of birth, and Medicare ID or social security number. FORMCHECKBOX Study involves payment to subjects exceeding $600 per calendar yearIf you receive $600 or more during a calendar year from the University for participating in research, you may receive a 1099 for tax reporting purposes. Reimbursements for travel and other expenses are not included in this amount. FORMCHECKBOX Study involves investigational devices approved under Category BYou or your insurance company will only be billed what the University will pay to obtain the device from the manufacturer. FORMCHECKBOX Include for a clinical trial. The sponsor, monitors, auditors, the IRB, the Food and Drug Administration will be granted direct access to your medical records to conduct and oversee the research. By signing this document you are authorizing this access. FORMCHECKBOX Include if the study involves HIV, hepatitis B, or hepatitis C testing with subjects who have not already been diagnosed with those conditions: As part of the study you will be tested for _______. Florida regulations require health care providers/laboratories to report new cases of HIV, AIDS, hepatitis infection and some STD to the county health department. If you test positive for ______, by law we have to report the personal identifiers such as name, sex, date of birth, address and phone number, and other identifying information. Information about these new infections is used to track these diseases statewide and nationwide. Other than this required reporting, your results will be kept confidential to the extent permissible under the law. The health department may contact you with resources for counseling and medical care, if you need them and want them. Check the Consents/Authorizations to be used FORMCHECKBOX Recruitment will require access to UM / JHS medical records. (Excluding PI/study team patient population)If yes, HIPAA waiver authorization determination will be granted by: FORMCHECKBOX External IRB. FORMCHECKBOX UM FORMCHECKBOX Assent Form FORMCHECKBOX 7-12 Years Old, FORMCHECKBOX 13-17 Years Old, FORMCHECKBOX Other FORMCHECKBOX HIPAA Form B (UM standard HIPAA Authorization) FORMCHECKBOX HIV Consent Form A separate HIV consent form is required when HIV is being tested FORMCHECKBOX Audio/Video/Photo Consent Form FORMCHECKBOX Genetic Consent Form FORMCHECKBOX Unlinked, FORMCHECKBOX Linked/no recontact, FORMCHECKBOX Linked/recontact FORMCHECKBOX Separate Pregnant Partner consent FORMCHECKBOX Other: FORMTEXT ?????Institutional Sign-Off From HSRO FORMTEXT ?????Signature FORMTEXT ?????Printed Name FORMTEXT ?????Title FORMTEXT ?????Date ................
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