1. General Information

Transcription

1 Edit: Protocol General Information 1. General Information 1.1. * Title of Study/Project: 1.2. Additional (UM/JHS/SCCC, etc.) identifying number for this study: (if applicable) 1.3. * Principal Investigator: Test PI Professional License # (if applicable): M NOTE: PI must be a UM Faculty. If a non-faculty member wishes to be PI of a study, approval must be received in advance from the Vice Provost of Human Subjects Research Department: (this field will be populated automatically based on PI's department once the page is saved) WEBRIDGE, INC. Major Sub-division: (if applicable) Research Center: (if applicable) 1.5. Co-Investigator(s): Add Last Name First Name Employer Department/Division Professional Lic. # (if applicable) There are no items to display 1.6. Faculty Advisor(s): Add Last Name First Name Employer Department/Division Professional Lic. # (if applicable)

2 There are no items to display NOTE: If this is student-initiated research, a faculty advisor must be selected. If a non-faculty member wishes to be PI of a study, approval must be received in advance from the Vice Provost of Human Subjects Research Study Contact(s): Add Last Name First Name Employer Department/Division Professional Lic. # (if applicable) There are no items to display NOTE: You may include as many individuals as you feel necessary to receive notifications regarding this protocol. If you do not indicate a Study Contact, only the PI will receive such notifications. Note: The Principal Investigator, Co-Investigators, Faculty Advisors, and Study Contacts will have editor access to this protocol Key Study Personnel: Add Last Name First Name Employer Role in Project Professional Lic. # (if applicable) There are no items to display NOTE: Individuals are considered to be "key personnel" if they have direct contact with subjects, subject data, subject records (including records-based research), protected health information or biological samples collected and/or tested for research purposes. The definition of key personnel includes individuals who may have direct responsibilities for data analysis or who contribute or collaborate in a substantive way to the scientific development of a project. Key personnel are also those listed as such on a DHHS-supported grant that is sponsoring the study. Students are considered key personnel if they meet any of these criteria. The definition of key personnel is not dependent upon whether or not the personnel receive compensation from the grant supporting the project. Pharmacists are considered key personnel and should be listed on the Form 1572 as a subinvestigator, if they will be compounding, labeling, monitoring and reporting test article compliance data. Appropriate licensure and/or certifications for study personnel are to be uploaded in section * Will this study be conducted in collaboration with a non-um or non-jhs faculty or staff member? 1.9.A. If yes, list all non-um/jhs collaborators: Add Name Institution Telephone

3 There are no items to display * Type of Research: Medical * Type of Review Requested: Select one Notes Expedited Review Exempt Review Full Board Review Emergency Use Facilitated Review External IRB Review Clear Study involves no more than minimal risk to human subjects and fits under one or more of the nine categories for expedited review. See UM IRB policy 8.2. Study involves very little, if any, risk to human subjects and fits within an exempt category listed under 45 CFR (b)(1)-(6). See UM IRB policy 8.1. Study does not meet the criteria for exemption or for expedited review. See UM IRB policy 8.3. See UM IRB policy Study reviewed and approved by NCI-CIRB/Pediatric CIRB. Requesting review by external IRB (e.g. Florida Department of Health IRB). NOTE: For a summary describing the types of review, please see IRB Review and Approval Process and Instructions for Review Categories A. If External IRB Review, select the proposed IRB of record for this study: Select one Florida Department of Health IRB Miami Children's Hospital IRB Clear - 1. General Information

4 Edit Research Personnel Key Study Personnel 1.8.A. * Select key study personnel: [None] 1.8.B. * Indicate the individual's role(s) in the project: Check all that apply Clinical interventions and/or therapy Data analysis and/or statistics Data management Interviews Lab testing Medical, social and/or behavioral assessment Pharmacist Screening/recruitment Study coordinator Responsible for consenting participants Sub-investigator Other 1.8.B.(i) If other, please specify: * Required OK OK and Add Another Cancel

5 Edit Research Personnel Non-UM/Jackson Health System Collaborators 1.9.A.(i) * Name of Collaborator: 1.9.A.(ii) * Collaborator's Institution 1.9.A.(iii) Telephone: * Required OK OK and Add Another Cancel

6 - 1a. Expedited Review Categories 1a. Expedited Review Categories Applicability for Expedited Review: Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR and 21 CFR The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects. The categories in this list apply regardless of the age of subjects, except as noted. The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal. The expedited review procedure may not be used for classified research involving human subjects A. * Under what category is expedited review being requested? Please check all that apply: Category Description Clinical studies of drugs and medical devices only when condition (a) or (b) is met: 1 (a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review). (b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: 2 (a) From healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or (b) From other adults and children, considering the age, weight, and health of subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week. Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat);

7 (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; 3 (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected aster saline mist nebulization. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical devices are not generally eligible for expedited review, including studies of cleared medical devices for new indications) Examples: 4 (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input or significant amounts of energy into the subject or an invasion of the subject s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual. Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (Note: Some research in this category may be exempt from the HHS regulations for the protection of human subjects, 45 CFR (b)(2) and (b)(3). This listing refers only to research that in not exempt. Collection of data from voice, video, digital, or image recordings made for research purposes. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (Note: Some research in this category may be exempt from the HHS regulations for the protection of human subjects, 45 CFR (b)(2) and (b)(3). This listing refers only to research that in not exempt) - 1a. Expedited Review Categories

8 - 1b. Exempt Review Categories 1b. Exempt Review Categories 1.11.B. Exempt Review Categories: Research activities in which the only involvement of human subjects will be in one or more of the following are exempt from federal regulations 45 CFR 46: * Under what category is exemption being requested? Please check all that apply: Category Description Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, or reputation. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public official or candidates of public office: or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Research and demonstration projects which are conducted or subject to the approval of Department or Agency heads, and which are designed to study, evaluate or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, the Food and Drug Administration or approved by he environmental protection Agency of the food Safety and inspection service of the U.S. Department of Agriculture. - 1b. Exempt Review Categories

9 - 1c. General Information (cont'd) 1c. General Information (cont'd) * Proposed Start Date: Anticipated Completion Date: Check here if completion date is uncertain CRIS To determine whether the UM CRIS Office (Clinical Research Initiation Service) must complete a Medicare Coverage Analysis (MCA) and/or a contract for this Study, please answer the following: 1.14 * Study Involves: Study Involves Chart review only Interview or survey activities only Limited data set only Observational only Testing a drug, device, or biologic, or performing procedures, lab tests (including blood draws) and/or interventions (standard of care and/or experimental) None of the above Clear 1.15 * Type of Study: Check all that apply Prospective Retrospective Description Collecting new data Looking only at data already collected 1.16 * Who initiated this study? 1.17 * Will you use the University of Miami's Velos eresearch system to track this study, its subjects, milestones, and/or related data collection? Yes No Clear If yes, the Velos eresearch system will be notified for your protocol. See for additional information on Velos A. If yes, will you require assistance to develop electronic versions of your finalized case report forms for data collection within Velos eresearch?

10 Yes No Clear If yes, notification will be sent to the Office of Research Information Management (ORIM) regarding the need for follow-up. It is recommended to discuss this with ORIM as early as possible in the CRF development process. NOTE: If Study involves testing a drug, device, or biologic, and/or if procedures, lab tests and/or interventions will be performed on a patient as part of the Study: 1. A coverage determination and/or contract are likely required from CRIS. 2. The study must comply with the UM's patient enrollment and tracking policy. UM's Clinical Research Revenue Cycle (CRRC) office must be notified of a consented subject no later than 24 hours after receiving a signed consent (including screening consents) and upon patient disenrollment. Notification can be submitted to CRRC automatically via Velos or manually via the CRIS website ( 3. eprost will notify the CRIS Office about this Study. The Study may not be initiated until CRIS and the IRB approve it. - 1c. General Information (cont'd)

11 - 1d. Methods & Procedures - Bio-Medical 1d. Methods & Procedures - Bio-Medical * Methods and Procedures: Does this research involve: Check all that apply Animal transplants into humans/xenotransplantation (specific Florida statutes apply) Audio-recordings/video recordings/photographs (specific informed consent forms required) Behavioral therapy Biohazardous materials/pathogens/toxins (see Environmental Health and Safety website for more information) Cadaveric organ and tissue procurement (specific Florida statutes apply - conveyance of bodies or parts of bodies into or out of the state for medical education or research purposes requires notification and approval from the anatomical board. Refer to cadaver policy on the Office of Research Administration website.) Cancer Changes in diet or exercise Cognitive/psychological assessments-eeg- SCID, etc. Cosmetics (specify below) Deceptive technique Deprivation of physiological requirements, such as nutrition or sleep Devices administered, implanted or applied to the subjects Double-blind trial Drugs, chemicals, or biological agents Experimentation on fetuses or live premature infants (specific Florida statutes apply to prohibit the use of any live fetus or live, premature infant for any type of scientific, research, laboratory or other kind of experimentation, except as necessary to protect or preserve the life and health of such fetus or premature infant) Focus groups Genetic research (specific informed consent forms required) (DNA analysis is confidential and Florida statutes require informed consent of subject) HIV testing (specific confidentiality rules apply and specific informed consent forms required, except in epidemiological research where identity of subject is not known and may not be retrieved by the researcher) Human toxicity/pharmacokinectic studies Interviews, surveys, questionnaires IV insertion(s) Manipulation of psychological or social variables Materials that subjects might consider offensive, threatening or degrading Medical tests - comparisons, evaluations

12 Nutritional supplements (specify below) Open-label trial Pharmacogenetic studies Phenotyping Placebo control group Possible invasion of privacy of subject or subject's family Prospective human biological samples (specific informed consent forms required) Prospective records/data Radiation treatment Radioisotopes or other sources of ionizing radiation (including x-rays, CT-scans, PET-scans) Recombinant DNA/gene transfer/gene therapy (specific informed consent forms required; DNA analylsis is confidential and Florida statutes require informed consent of subject) Retrospective human biological samples Retrospective records Single-blind trial Standard treatment control Stem cell research Surgery/transplantation Surgical procedure Use of private records (medical or educational records) Venipuncture, blood drawing, marrow biopsy sampling, biopsy of other tissues, etc. Vulnerable populations Web-based research Other *** FOR REFERENCE PURPOSES ONLY *** 1.18.A. If other, please specify: 1.18.B. If cosmetics, please specify: 1.18.C. If nutritional supplements, please specify: - 1d. Methods & Procedures - Bio-Medical

13 - 1e. Methods & Procedures - Social/Behavioral 1e. Methods & Procedures - Social/Behavioral * Methods & Procedures: Check all that apply Audio-recordings/video recordings/photographs (specific informed consent forms required) Behavioral therapy Changes in diet or exercise Cognitive/psychological assessments - EEG, SCID, etc. Deceptive technique Deprivation of physiological requirements, such as nutrition or sleep Focus groups Interviews, surveys, questionnaires Manipulation of psychological or social variables Materials that subjects might consider offensive, threatening or degrading Medical tests - comparisons, evaluations Possible invasion of privacy of subject or subject's family Prospective records/data Retrospective records Use of private records (medical or educational records) Venipuncture, blood drawing, etc. Vulnerable populations Web-based research Other 1.19.A. If Other, please specify and explain: * Are there any medical procedures not checked above involved in this study? 1.20.A. If yes, please explain:

14 - 1e. Methods & Procedures - Social/Behavioral

15 2: Supplemental Information & Approvals 2. Supplemental Study Information - All Studies 2.1. * Will human biological samples be used in this research? 2.2. * Does the study involve genetic testing of subjects or their samples? 2.3. * Does this study involve cancer patients, diagnosis, therapy, or prevention? Yes No Clear NOTE: Approval from the Cancer Protocol Review Committee is required for all studies involving cancer patients, diagnosis, or therapy. 2: Supplemental Information & Approvals

16 Edit: Protocol a. Supplemental Study Information - Bio-Medical Studies 2a. Supplemental Study Information - Bio-Medical Studies 2.4. * Will investigational drug(s)/biologic(s) be used in this research? 2.5. * Will an investigational device be used in this research? 2.6. * Does this study involve recombinant DNA and/or gene transfer? If yes, approval from the Institutional Biosafety Committee (IBC) is required. See IBC website for additional information and forms * Does this study include any radiation ionizing procedure(s) for research? - 2a. Supplemental Study Information - Bio-Medical Studies

17 Edit: Protocol b. Ancillary Committee Approval Requirements 2b. Ancillary Committee Approval Requirements Does this research involve: * 2.8. facilities and/or support from the Clinical Research Center? (if yes, approval from the CRC is required) Yes No Clear * 2.9. biological agents, Biosafety Level 2 (BSL2) and higher, including, but not limited to, infectious and potentially infectious agents? (if yes, approval from the Office of Environmental Health and Safety, Biosafety officer, is required. See EHS website for the Biological Agents registration form) 2.9.A. If yes, upload the biological agents registration form: Add Yes No Clear Name There are no items to display Version * patient specimen collected at any UM/JHS patient care facility, archived tissues or slides, and/or Department of Pathology expertise or facilities? (if yes, approval from the Pathology Research Steering Committee is required. See HSRO website for additional information.) Yes No Clear * radioactive materials, radioisotopes, and/or radiation producing equipment (if yes, approval from the Radiation Safety Office is required. See HSRO website for additional information.) Yes No Clear * prospective interventions with participants who have cancer? (if yes, approval from the Protocol Review Committee is required. See PRC website for additional information.) 2.12.A. If yes, upload approval documentation if this study has already been approved by the Protocol Review Committee: Add Yes No Clear name There are no items to display version - 2b. Ancillary Committee Approval Requirements

18 Edit: Protocol c. Studies Involving Cancer Research 2c. Studies Involving Cancer Research NOTE: Approval from the Cancer Protocol Review Committee is required for all studies involving cancer patients, diagnosis, or therapy * Is identifiable data being accessed from the Florida Cancer Registry? 2.13.A. If yes, has Florida Department of Health IRB approval been sought? 2.13.A.(i) If yes in 2.13.A., please upload a copy of the approval letter: Add Name Description Version There are no items to display 2.14 SCCC Number: (if applicable) Cooperative Group Number: (if applicable) 2.15 * Is the study being funded by the Sylvester Cancer Center? 2.16 * Is this study being managed or supported by Clinical Research Services (CRS) at the Sylvester Cancer Center? 2.16.A. If yes, please indicate the CRS services being utilized: Check all that apply Regulatory management Data management Research nursing Business office Data Safety Monitoring Committee (DSMC) - 2c. Studies Involving Cancer Research

19 - 2d. Studies Involving Drugs and/or Devices - FDA Audit 2d. Studies Involving Drugs and/or Devices - Past FDA Audits * Have you ever been audited by the FDA? If yes, please answer the following questions: 2.17.A. When did the audit(s) occur? 2.17.B. Upload documentation related to the audit(s): Add Name Description Version There are no items to display - 2d. Studies Involving Drugs and/or Devices - FDA Audit

20 - 3. Research Locations 3. Research Location(s) 3.1. * Is this a multi-center study? (A multi-center study is one in which non-um PIs at different institutions are conducting the same study.) 3.1.A. If yes, is the University of Miami the coordinating center? Yes No Clear 3.2. * List all Performance Sites "engaged" in this research. NOTE: For multi-center studies, list performance sites only for the research being conducted by the UM principal investigator. Even if UM is the only site, it must be indicated here. An institution or performance site is "engaged in this research" when its employees or agents (i) intervene or interact with living individuals for these research purposes; (ii) obtain individually identifiable private information for these research purposes; or (iii) if the institution receives a direct federal award to support this research. This may apply when a UM investigator collaborates with a non-um investigator or institution, or when UM serves as a Coordinating Center. Each PI at each non-um performance site will require a letter of IRB approval from the site's IRB. If the site has an FWA, list below. See OHRP guidance at Also see UM IRB "Subcontracts for Non-UM Institutions or Individuals 'Engaged' in UM Research." Add Delete Name of Performance Site If Other, Site Name IRB Approval [Edit] University of Miami 3.3. * Are there any performance sites "involved" but NOT "engaged" in this research? NOTE: If a UM investigator will be conducting research at a non-um site or institution (e.g. when only recruiting subjects, collecting specimens, etc. at the site) and the employees or agents of the institution or performance site (i) do not intervene or interact with living individuals for these research purposes; or (ii) do not obtain individually identifiable private information for these research purposes; or (iii) if the institution does not receive a direct federal award to support this research, THEN the institution or performance site is considered "involved" but not "engaged" in the research. See UM IRB Policy "Agreement for Non-UM Institutions or Individuals 'Involved' in UM Research." 3.3.A. If yes, list all Performance Site(s) "involved" but NOT "engaged" in this research: Add Name of Performance Site IRB Approval Letter Letter of Cooperation There are no items to display

21 3.4. * Will you be conducting this study at any institutions other than UM or JHS? 3.4.A. If yes, a copy of the institution's IRB approval must be attached: Add Name Description Version There are no items to display 3.5. * Does this study involve UM related research activities conducted or coordinated at one or more sites outside of the United States? - 3. Research Locations

22 Edit PR_RESEARCH LOCATIONS - Performance Sites Engaged Performance Site "Engaged" in this Research 3.2.A. * Name of Performance Site: 3.2.A.(i) If Other, please specify: 3.2.A.(ii) If you selected University of Miami in 3.2.A. above, please indicate all UM sites at which the protocol team will engage in protocol activities: Check all that apply Description Gables University of Miami: Coral Gables Campus UMSM BPEI ABLE BPPB BPIP BPRC BCRI UOMH UMHC UMHC Deerfield DRI CRC IWH MCCD Miami Project RSMAS SCCC TRI LPLC UMKM CLRB DAYS PAC RMSB Other UM Site University of Miami Medical Campus Bascom Palmer Eye Institute Anne Bates Leach Bascom Palmer at Palm Beach Bascom Palmer at Plantation Bascom Palmer Retina Center in Naples Batchelor s Children Research Institute University of Miami Hospital University of Miami Hospital & Clinics University of Miami Hospital & Clinics at Deerfield Beach Diabetes Research Institute Clinical Research Center Institute for Women's Health Mailman Center for Child Development Miami Project to Cure Paralysis Rosenstiel School of Marine and Atmospheric Sciences Sylvester Comprehensive Cancer Center Touch Research Institute Lois Pope Life Center University of Miami Kendall Clinic Clinical Research Building Daystar UM Professional Arts Center Rosenstiel Medical Science Building Other University of Miami Site

23 3.2.A.(ii)(a) If Other UM Site, please specify: 3.2.B. * IRB of Record: Check all that apply UM (this includes Jackson Health System) Other If Other was selected for IRB of Record, please answer the following questions: 3.2.B.(i) If Other, please specify: 3.2.B.(ii) Does the site have an FWA (Federalwide Assurance)? 3.2.B.(ii)(a) If yes, enter name of FWA Holding Institution: UM 3.2.B.(ii)(b) If yes, enter FWA Number: 3.2.B.(iii) IRB Approval: 3.2.B.(iii)(a) If attached, please upload IRB approval letter or Research Collaboration agreement: None 3.2.B.(iv) Briefly describe activities at this site: * Required OK OK and Add Another Cancel

24 Edit PR_RESEARCH LOCATIONS - Performance Sites Involved Performance Site "Involved" in this Research 3.3.A. * Name of Performance Site: 3.3.B. * IRB of Record: Check all that apply UM (This includes Jackson Health System) Other If Other was selected for IRB of Record, please answer the following questions: 3.3.B.(i) If other, please specify: 3.3.B.(ii) Does the site have an FWA (Federalwide Assurance)? 3.3.B.(ii)(a) If yes, enter name of FWA Holding Institution: 3.3.B.(ii)(b) If yes, enter FWA Number: 3.3.C. If the Performance Site has an IRB, a copy of the IRB Approval Letter is required. Select status of IRB Approval Letter: 3.3.C.(i) Upload IRB Approval Letter: None 3.3.D. If the Performance Site does NOT have an IRB, documentation outlining the arrangement (i.e., a letter of cooperation or Use of Outside Facility agreement ) is required. Select status of site approval documentation: 3.3.D.(i) Upload site approval documentation: None 3.3.E. * Briefly describe activities at this site:

25 * Required OK OK and Add Another Cancel

26 - 3a. Non-US Sites 3a. Non-U.S. Sites 3.5.A. * List all non-u.s. countries where University of Miami research activities will be conducted or coordinated. Add Name There are no items to display 3.5.B. * Did a duly authorized foreign IRB, foreign governmental agency and/or local research ethics committee review this study? (See OHRP website for guidance on international research) 3.5.B.(i) If yes, please attach the approving correspondence: Add Name Description Version There are no items to display 3.5.C. * Describe the study team's knowledge of the local culture and community at each foreign site: 3.5.D. * Describe any additional local or customary permissions required in order to contact subjects and/or conduct this research at each foreign site (e.g. tribal counsel, etc.) 3.5.E. * Describe any regulations that relate directly to privacy/data protection, human biological materials, and genetic research (if applicable) in the foreign country: (see OHRP website for

27 guidance on international research) *** FOR REFERENCE PURPOSES ONLY *** - 3a. Non-US Sites

28 - 3b. Other UM or JHS Protocols & JHS Activities 3b. Other UM or Jackson Health System Protocols & JHS Activities 3.6. * Is this research part of a larger grant that includes other UM or Jackson Health System protocols? 3.6.A. If yes, please define Protocol(s) by ID, title, and Principal Investigator: Add Protocol ID Title Principal Investigator There are no items to display 3.7. * Are any study-related activities performed at a JHS site? - 3b. Other UM or JHS Protocols & JHS Activities

29 - 3c. Jackson Health Systems 3c. Jackson Health Systems 3.7.A. * The activities performed at Jackson Health Systems consist of: Check all that apply Recruitment of subjects Facilities use Retrospective analysis of charts/records Subject interventions such as tests, measurements, drug administration, surgery, consenting subjects, etc. 3.7.B. * List all Jackson Health System sites involved in this research: Check All That Apply Group Jackson Memorial Hospital JHS-1 JHS Hospitals Jackson North Medical Center JHS-1 JHS Hospitals Holtz Children's Hospital JHS-1 JHS Hospitals Jackson Rehabilitation Hospital JHS-1 JHS Hospitals Jackson South Community Hospital JHS-1 JHS Hospitals Jackson Memorial Long-Term Care Center JHS-2 JHS Long-Term Care Centers Jackson Memorial Perdue Medical Center JHS-2 JHS Long-Term Care Centers CHI Martin Luther King, Jr. Clinica Campesina JHS-3 JHS Primary Care Centers and Clinics Community Health of South Dade JHS-3 JHS Primary Care Centers and Clinics Dr. Rafael Peñalver Clinic JHS-3 JHS Primary Care Centers and Clinics Jackson Care-A-Van JHS-3 JHS Primary Care Centers and Clinics Jackson North Specialty and Diagnostic Center JHS-3 JHS Primary Care Centers and Clinics Jefferson Reaves Sr. Health Center JHS-3 JHS Primary Care Centers and Clinics Juanita Mann Health Center JHS-3 JHS Primary Care Centers and Clinics Liberty City Health Services Center JHS-3 JHS Primary Care Centers and Clinics North Dade Health Center JHS-3 JHS Primary Care Centers and Clinics North Miami Health Center JHS-3 JHS Primary Care Centers and Clinics P.E.T. Center JHS-3 JHS Primary Care Centers and Clinics Rosie Lee Wesley Health Center JHS-3 JHS Primary Care Centers and Clinics Other 3.7.B.(i) If other in 3.7.B, please specify:

30 3.8. * Does the study require use of Jackson resources? 3.8.A. If yes, describe activities requiring use of Jackson resources: 3.9. * Will the Jackson Health System incur any expenses as a result of this research? 3.9.A. If yes, please indicate the type of expense(s) that the Jackson Health System will incur: Add Type of Expense There are no items to display Estimated Amount * Upload completed and signed JHS CRRC forms: Add Name Description Version There are no items to display NOTE: The Jackson Clinical Trials Office Application Form is available from the Jackson Clinical Research Review Committee page. - 3c. Jackson Health Systems

31 4: Description of Study 4. Description of Study Study Protocol 4.1. * Abstract and Specific Aims Include a brief summary of the significance, purpose or research question, specific aims, and risks/benefits. Specific aims include hypotheses you will investigate * Research Background Provide background and previous studies supporting the study rationale. Include a brief summary of existing knowledge relevant to the research. Explain how the research may contribute to the advancement of knowledge If you have cited references above, please attach a bibliography, including title, full author list, journal, date and pages. This bibliography should include only those articles referenced above. Add Name Description Version There are no items to display 4: Description of Study

32 - 4a. Description of Study 4a. Description of Study (cont'd) Rationale and Methodology 4.4. * In non-technical, lay language, describe the study design and all study procedures, in order of sequence and timing. Include length of subject participation, what tasks are involved in the study, what tests or procedures subjects will be asked to complete or undergo, specific measures to be used, etc. If applicable, include frequency of visits, duration of visits, and study procedure calendar. 4.4.A. Standard Measures: Click the "Add" button to open the search window, the click the "Find" button to browse and select measures. Add Name of Measure Brief Description Type of Measure There are no items to display NOTE: A copy of the first page of each standard measure is provided in the Library of Standard Measures for verification. Ensure that the version being used in this study is the same as the version that has been selected. Upload any questionnaires and/or assessment tools to be used that are not listed above: Add Name Description Version There are no items to display 4.5. Identify and distinguish between those procedures that are standard treatment versus those that are experimental/research-specific. Not applicable

33 4.6. Describe any therapeutic alternatives that may exist for the study population. Not applicable - 4a. Description of Study

34 - 4b. Description of Study 4b. Description of Study (cont'd) Risk/Benefit Assessment 4.7. * Describe the nature, degree, and if available, expected frequency of all potential economic/financial, legal, physical, psychological, social or other risks to which research participants may be exposed as a result of their participation in this research. If applicable, please describe the risk of investigational agents or devices (side effects) * Are there potential direct benefits of this research to the subjects? Yes No Clear 4.8.A. If yes, provide a description of the potential direct benefits and indicate if all, or only some, of the subject groups may derive this potential benefit * Are there potential benefits of this research to society? 4.9.A. * Please explain: * Explain why the risk/benefit ratio supports conducting this research.

35 - 4b. Description of Study

36 - 4c. Description of Study 4c. Description of Study (cont'd) Data * Describe follow-up, data storage methods, data security, authorized access to records and record retention, including site name and address * Support the study validity by describing the statistical design, including quantitative and qualitative methods used to analyze data. Privacy/Confidentiality Agreements Describe any privacy agreements or certificates of confidentiality, if applicable. - 4c. Description of Study

37 - 4d. Description of Study 4d. Description of Study (cont'd) Deception * Is the use of deception part of the study design? If yes, please answer the following 3 questions: 4.14.A. Describe in detail the nature of the deception and explain why this is necessary for the research B. State how, when, and by whom the research subjects will be debriefed C. Upload a copy of the debriefing script. None - 4d. Description of Study

38 - 4e. Description of Study 4e. Description of Study (cont'd) Retrospective Studies 4.15.A. Maximum number of retrospective samples to be collected: (Do not enter commas, decimal points or special characters) 4.15.B. Maximum number of retrospective records to be reviewed: (Do not enter commas, decimal points ot special characters) 4.15.C. * Timeframe of the retrospective samples or records to be reviewed: (For example:01/01/2000 to 01/01/2005) Note: "Samples or records to be reviewed must be in existence (on the shelf) prior to submission of this application." 4.15.D. * Upload a copy of the data collection sheet (i.e. all variables that will be collected from retrospective records): Add Name Description Version There are no items to display - 4e. Description of Study

39 - 5. Study Participants 5. Study Participants Per 45 CFR 46, human subjects (participants) means a living individual about whom an investigator (whether professional or student) conducting research obtains: 1. data through intervention or interaction with the individual; or 2. identifiable private information (i.e. pathological specimens, medical records, etc.) 5.1. * Participant Age: Check all that apply Notes 0-6 Parent Permission/Consent required for each participant 7-17 Parent Permission/Consent & Child Assent required for each participant Consent required for each participant unless a waiver of consent is approved by the IRB Consent required for each participant unless a waiver of consent is approved by the IRB 5.2. For the following questions, please use integers for your responses. For any question that is not applicable, please enter the number 0. (Do not enter commas, decimal points or special characters) 5.2.A. * Maximum number of subjects in the Protocol to be screened at all sites (regardless of PI): 5.2.B. * Total number of subjects in the Protocol to be studied at all sites(regardless of PI): University of Miami 5.2.C. * Maximum number of subjects to be screened by this PI at UM: * Maximum number of subjects to be enrolled by this PI at UM: * From the above, how many are expected to complete this study (participate in the study beyond initial enrollment? Jackson Health Systems 5.2.D. * Maximum number of subjects to be screened by this PI at Jackson Health Systems (JHS): * Maximum number of subjects to be enrolled by this PI at Jackson Health Systems (JHS):

40 * From the above, how many are expected to complete this study (participate in the study beyond initial enrollment)? Miami VA Medical Center 5.2.E. * Maximum number of subjects to be screened by this PI at Miami VA Medical Center: * Maximum number of subjects to be enrolled by this PI at Miami VA Medical Center: * From the above, how many are expected to complete this study (participate in the study beyond initial enrollment)? - 5. Study Participants

41 - 5a. Study Populations 5a. Study Populations 5.3. * Study populations to be included in this study where PI will be conducting research and those sites where the UM IRB will have oversight responsibility: Check all that apply Notes Normal, healthy volunteers Children/minors (under 18 years of age) Cognitively impaired Comatose/traumatized Decedents Nursing home residents Poor/uninsured Elderly/aged Females of childbearing potential, if the study involves drugs or devices Jackson Health System (JHS) Residents/Fellows Specific Florida statutes apply to prohibit the use of any live fetus or live, premature infant for any type of scientific, research, laboratory Pregnant women/fetuses or other kind of experimentation except as necessary to protect or preserve the life and health of such fetus or premature infant. Specific Florida statutes apply to prohibit the use of any live fetus or live, premature infant for any type of scientific, research, laboratory Neonates or other kind of experimentation except as necessary to protect or preserve the life and health of such fetus or premature infant. Placenta, dead fetuses or fetal material Florida Dept of Corrections and/or Dept. of Juvenile Justice and/or Prisoners Miami-Dade county jails procedures must be complied with Illiterate/educationally disadvantaged Military personnel Approval from the Miami VA/West Palm Beach VA IRB is required Veterans prior to conducting research at these facilities. Hospitalized (inpatients) Outpatients Subordinates/employees Terminally ill participants UM students/trainees Teachers, day care workers Emergency/Trauma Specific Florida statutes apply to prohibit the enrollment of a

42 Wards of the state Other minor/adult, for whom a guardian has been appointed by the court, in a research study without first acquiring the approval of the court having jurisdiction of the ward. 5.3.A. If other, please specify: 5.3.B. Describe below any additional safeguards that have been included to protect vulnerable subjects: - 5a. Study Populations

43 - 5b. Inclusions/Exclusions 5b. Inclusions/Exclusions 5.4. * Is the population being enrolled in this study at high risk for incarceration? 5.4.A. If yes, will the subjects be withdrawn from the study once they are incarcerated? Yes No Clear 5.4.A.(i) If the above answer (question 5.4.A.) is no, describe how re-contacting/reconsenting, treatment, and/or follow-up will occur: NOTE: If a subject becomes incarcerated while enrolled in a study, all research interactions and interventions with that subject, and the obtaining of identifiable private information about the subject, must cease until the requirements of subpart C have been satisfied with respect to the relevant protocol. If notified that a previously enrolled research subject has become a prisoner, the principal investigator must promptly seek IRB re-review of the protocol in accordance with the requirements of subpart C if the principal investigator wishes to have the prisoner-subject continue to participate in the research. In special circumstances in which the principal investigator asserts that it is in the best interests of the subject to remain in the research study while incarcerated, the IRB Chairperson may determine that the subject may continue to participate in the research until the requirements of subpart C are satisfied * What are the criteria for exclusion of participants from the research? 5.6. * Will any population be systematically excluded in this study? 5.6.A. If yes, provide rationale/justification for this exclusion:

44 5.7. * What are the criteria for inclusion of participants in the research? 5.8. * Will only one group of individuals be systematically selected and recruited for this study (e.g., welfare patients, racial and/or ethnic minorities, persons confined to institutions or persons determined to be incapacitated)? Yes No Clear 5.8.A. If yes, please state how this participant group will benefit from the results of the research and provide the reasons and justifications to target this group: - 5b. Inclusions/Exclusions

45 - 5c. Research Involving Pregnant Women or Fetuses 5c. Research Involving Pregnant Women or Fetuses Pregnant woman or fetuses may be involved in research if ALL of the following conditions are met (all items must be justified): (a) Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies, including studies on nonpregnant women, have been conducted and provide data for assessing potential risks to pregnant women and fetuses. * Justification: (b) The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means. * Justification: (c) Any risk is the least possible for achieving the objectives of the research. * Justification:

46 (d) If the research holds out the prospect of direct benefit to the pregnant woman, the prospect of a direct benefit both to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus when risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means, her consent is obtained in accord with the informed consent provisions of subpart A of this part. * Justification: (e) If the research holds out the prospect of direct benefit solely to the fetus then the consent of the pregnant woman and the father is obtained in accord with the informed consent provisions of subpart A of this part, except that the father's consent need not be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest. * Justification: (f) Each individual providing consent under paragraph (d) or (e) of this section is fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate. * Justification:

47 (g) For children as defined in (a) who are pregnant, assent and permission are obtained in accord with the provisions of subpart D of this part. * Justification: (h) No inducements, monetary or otherwise, will be offered to terminate a pregnancy. * Justification: (i) Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy. * Justification:

48 (j) Individuals engaged in the research will have no part in determining the viability of a neonate. * Justification: - 5c. Research Involving Pregnant Women or Fetuses

49 - 5d. Research Involving Neonates and/or Fetal Tissue 5d. Research Involving Neonates and/or Fetal Tissue (a) * This research involves: Check all that apply Neonates of uncertain viability Nonviable neonates Viable neonates (Note: Please fill out the section requesting approval for the inclusion of minors in research) Fetal tissue - 5d. Research Involving Neonates and/or Fetal Tissue

50 - 5d(i). Research Involving Neonates 5d(i). Research Involving Neonates For the purpose of human subject protection regulations, newborns are considered neonates until they are determined to be viable. The regulations applicable to pediatric subjects would then apply. This section applies to neonates of uncertain viability and nonviable neonates. (a) (b) (c) * When appropriate, have preclinical and clinical studies been conducted and have they provided data for assessing potential risks to neonates? * The PI agrees that individuals engaged in the research will have no part in determining the viability of the neonate: * The consent form contains information regarding the reasonably foreseeable impact of the research on the neonate: - 5d(i). Research Involving Neonates

51 - 5d(ii). Research Involving Neonates of Uncertain Viability 5d(ii). Research Involving Neonates of Uncertain Viability (a) * To be approved, either of the conditions below must be met: Select one The research must hold out the prospect of enhancing the probability of survival of the neonate to the point of viability and any risk is the least possible for achieving that objective. The purpose of the research is the development of important biomedical knowledge which cannot be obtained by other means and there will be no added risk to the neonate resulting from the research. Clear (b) * Please justify the above selection: NOTE: Consent of either parent of the neonate of uncertain viability is required, or, if neither is able to consent, of the legally authorized representative of either parent. Consent of the father or his representative is not required if the pregnancy resulted from rape or incest. - 5d(ii). Research Involving Neonates of Uncertain Viability