Tulane University. Human Research Protection Program Application for Human Subjects Research, Part 1

Transcription

1 Tulane University Human Research Protection Program Application for Human Subjects Research, Part 1 Last edited by: Dominique Monlezun Continuing Review Biomedical/Clinical Last edited on: September 30, 2015 Social/Behavioral [click for checklist] [ ] Cooking for Health Optimization with Patients (CHOP) The data in this form are to be used for reporting purposes and must be kept accurate and up-to-date. Please update this form whenever new information is available or if any information should change, i.e., whenever Amendments or Continuing Reviews are submitted. If you have questions, please see the Tulane University HRPO website, us at irbmain@tulane.edu or call us at (504) Other I. Principal Investigator Name: Dominique Monlezun, M.P.H. dmonlezu@tulane.edu Status: Tulane Faculty/Staff - Internal Medicine II. Faculty Advisor te: A Faculty Advisor is required if the PI is a student. Name: Department: III. Study Coordinator Name: Generated on IRBNet

2 Department: IV. Key Personnel te: te: All changes in Key Personnel must be timely reported through the submission of an Amendment updating this Application Form. Name: Leah Sarris Name: Beau Saccoccia Name: Puneet Lakhmani Generated on IRBNet

3 Name: Kevin MacPherson Name: Glynis McGowan Name: Emily Landry Name: Brian Hilands Name: Laura Mitchell Generated on IRBNet

4 Name: McDaniel Lang Role: Clinical Coordinator Name: Seun Adebola Name: Christopher Carr Name: Isadore Budnick Generated on IRBNet

5 Name: Rachel Shepard Name: Nicole DeValle Name: Akash Desai Department: Newcomb-Tulane College Name: Francesca Cardello Generated on IRBNet

6 Name: Harish Sujan Name: Mita Sujan Name: Timothy Harlan Name: Darian Arman Name: Katie Pedroza Generated on IRBNet

7 Name: Austin Grant Name: Casey McGowan Name: Shakira Smith Name: David Tran Generated on IRBNet

8 V. Review Type Requested Review Type: Request for Human Subjects Research Determination Exempt [complete Application for Exemption] Expedited [If this is a new project - complete Application Part 2] Convened [If this is a new project - complete Application Part 2] Facilitated, Shared, or Other Alternative Review Model Eligibility for Expedited Review: Classified Research? Yes Risk to Subjects by Identification? Yes Minimal Risk? Yes Greater Than Minimal Risk? Yes Expedited categories which apply to this research: Category 1 Category 2 Category 3 Category 4 Category 5 Category 6 Category 7 Are there any research components, activities, or procedures that do not fit wholly into one or more of the above categories? Yes: VI. Funding Information Federally Funded? Yes [provide a copy of the grant application(s) with this submission] Industry Sponsored? Generated on IRBNet

9 Yes [complete Interdepartmental Order Form; submit IRB initial application fee] Sponsor Type: ne Sponsor Name: Sponsor Assigned ID #: Grant/Contract Title: Status: t Funded Tulane Account #: All Tulane Faculty, Staff, and students involved in the project must complete Parts A, Part B, and the Attestation of the COI Disclosure Forms found at The Forms are not to be submitted to the HRPO. Key Personnel are subject to disclosure requirements of the University's Conflict of Interest Policy. All non-tulane individuals listed as key personnel for the project must complete Part A, Part B, and the Attestation of the COI Disclosure Forms that are available at These Forms are not to be submitted to the HRPO. All COI questions and comments should be directed to the COI Committee's Administrative Compliance Specialist, Genean Mathieu at coi@tulane.edu (or by phone at ). Is there a protocol-specific Conflict of Interest? Yes [complete IRB Supplement N] VII. Project Information (Refer to the HRPO Website at: Investigator Initiated? Yes Multi-Center Study? Yes Tulane PI is Lead Investigator? Yes If yes, submit CV, 1572, wallet/emergency card Tulane is Lead Site? Yes Clinical trial? Yes Phase: Registered on clinicaltrials.gov? Yes clinicaltrials.gov #: VIII.Location Information Tulane University Affiliated Performance Sites: Tulane University Medical Center/Hospital Downtown Generated on IRBNet

10 Tulane University Medical Center/Hospital Lakeside Tulane University Health Sciences Center The Goldring Center for Culinary Medicine at Tulane University 300 rth Broad Street New Orleans, LA Tulane University Uptown Campus Tulane Cancer Center Ruth Fertel Clinic Hematology and Oncology Clinic, LLP (Baton Rouge) ne Other Performance Sites: Charity Hospital and Medical Center of LA, Interim LSU Public Hospital, Managed by: The University Medical Center Management Corp (UMCMC) HIV Out-Patient Clinic (UMCMC) Louisiana Cancer Research Consortium (LCRC) Clinical Translational Unit (CTU) Children's Hospital New Orleans Ochsner NO/AIDS Task Force Veteran's Administration Hospital (VA) Generated on IRBNet

11 Schools: Prisons/Jails: Other: Facility Name: Approval? Yes Physical Address: Description of Facility: ne International Study? Yes [complete Supplement E; provide proof of approval from site(s), translated documents, and certificate of translation] IX. Subject Information Targeted Populations: rmal Adult/Healthy Subjects Hospital Patients or Outpatients Tulane Students/Employees Children (under 18 years of age) [complete Supplement A] Prisoners [complete Supplement B] Pregnant Women, Fetuses, or Neonates [complete Supplement C] Cognitively Impaired [complete Supplement D] n-english Speakers/International Research [complete Supplement E] X. Research Procedures Research Procedures: The Internet [complete Supplement F] Deception [complete Supplement L] Generated on IRBNet

12 Questionnaires/Surveys [provide questionnaire(s)/survey(s)] Interviews/Focus Groups [provide interview or focus group guide] Stored Data and/or Specimens for Future Use [complete Supplement G] Physiological Processes [complete Supplement I] Placebo [complete Supplement M] ne Biohazard Materials (rdna, infectious agents, biological toxins) Yes [contact the Institutional Biosafety Committee; IBC approval is required] Radiation: Yes [contact the Radiation Safety Committee; RSC approval is required] Study of an FDA-regulated product? Yes XI. Drugs and Biologics Drugs or biologics to be used for research purposes? Yes [complete Supplement J] Trade Name: Generic: IND #: IND Holder: Status: New investigational drug or biologic Approved drug or biologic being used in accordance with its FDA-approved labeling Investigational use of approved drug or biologic Generated on IRBNet

13 XII. Medical Devices Study of the safety and effectiveness of a medical device? Yes [complete Supplement K] Trade Name: Generic: IDE #: IDE Holder: Status: New investigational device Approved device being used in accordance with its FDA-approved labeling Investigational use of approved device Are you using a Humanitarian Device? Yes [complete Supplement K] XIII.Consent and Authorization Method of Obtaining Consent: Informed Consent will be obtained from subjects and documented with a signed, written Consent Form [provide consent document; see Consent Template in IRBNet Forms and Templates Library] Informed Consent will be obtained from subjects, but no signed/documented Consent Form will be used. This includes oral or electronic consent (e.g., completing an online survey). Requesting a Waiver of Informed Consent. [complete Supplement H] Fully Informed Consent will not be obtained from all subjects. This includes deception, withholding information, etc. Requesting a Waiver of Informed Consent. [complete Supplement H] HIPAA: Collection of Protected Health Information? Yes, a waiver or alteration of HIPAA Authorization will be requested [complete Supplement O] Yes, subject's authorization will be obtained [provide HIPAA Form; see HIPAA Template in IRBNet Forms and Templates Library] XIV.Dissemination of Knowledge/Results of Research Investigator Initiated and Internally Sponsored Projects: Meeting presentation National Regional Local Generated on IRBNet

14 Journal publication Peer-reviewed Other: Other: This project is not investigator-initiated or internally sponsored. Externally Sponsored Projects: Marketing application Clinicaltrials.gov Journal publications Other: This project is not externally sponsored. Tulane University to Author or Collaborate: Yes This project is not externally sponsored. TRAINING REQUIREMENTS Key personnel conducting human subjects research must complete the mandatory CITI Training course online at Key personnel is defined by NIH as individuals who contribute to the scientific development or execution of a project in a substantive, measureable way, whether or not salaries are requested. Key personnel must devote measurable effort to the project. Key personnel are required to be listed in the grant application, progress report or any other report submitted to the federal funding agency by the institution. CITI completion reports are valid for 4 years. If your CITI Certification has expired or if you have not yet completed the Certification, please access the CITI website and complete either Group 1 for "Biomedical Research Investigators and Key Personnel," or Group 2 for "Social Behavioral Researcher Investigators and Key Personnel." Key personnel are also required to complete the Conflict of Interest (COI) CITI Training module. COI completion reports are valid for 4 years. If your CITI Certification has expired or if you have not yet completed the Certification, please access the CITI website and complete Group? Conflict of Interest Stage 1. More information regarding CITI Training can be found on our website, Please see the CITI Training Guidance Document for instructions on submitting your CITI Certification(s). Once the necessary CITI training is complete, each researcher (key research personnel) must submit their Certification for administrative review via the IRBNet system. ELECTRONIC SIGNATURES The Tulane HRPO Policy regarding signatures is as follows: Generated on IRBNet

15 The PI must electronically sign all submissions for review including New Projects/Initial Submissions. For New Projects/Initial Submissions, if the PI is a student, a Faculty Advisor must be appointed and he/ she must electronically sign the package. For New Projects/Initial Submissions, if the PI is a Faculty or Staff member, the Department Head must sign the submission electronically. If the PI is the Department Head, then the Dean of the School must provide an electronic signature. You must share this project electronically within IRBNet with any applicable individuals so they may view and electronically sign/approve the submission. TULANE UNIVERSITY POLICY ATTESTATION Principal Investigator Assurance Statement: By my electronic signature as Principal Investigator on this research application, I certify the following: I certify that the information provided in this application is complete and correct. I understand that as Principal Investigator, I have the responsibility for the conduct of the study, the ethical performance of the project, and protection of the rights and welfare of human participants. I agree to comply and assure that all affiliated personnel comply with all Tulane HRPO policies and procedures, as well as with all applicable federal, state, and local laws regarding the protection of human participants in research. I assure that this study is performed by qualified personnel adhering to the Tulane IRB approved protocol. I assure that no modification to the approved protocol and consent materials will be made without first submitting for review and approval by the Tulane IRB an amendment to the approved protocol and revising this Application Form. I agree to obtain legally effective informed consent from the research participants as applicable to this research and as prescribed in the approved protocol. I will promptly report unanticipated problems to the Tulane IRB by using the appropriate form. I will adhere to all requirements for continuing review. I will advise the Tulane IRB of any change of address or contact information as long as this protocol remains active. I will revise this Application to update my contact information as needed throughout the course of the study. I assure that I have obtained all necessary approvals from entities other than Tulane IRB that are necessary to conduct this research. By my electronic signature on this study/package, I certify that I am knowledgeable about the regulations and policies governing research with human subjects and have sufficient training and experience to conduct this particular study in accordance with the research protocol. Faculty Advisor's Assurance: By my electronic signature as a Faculty Advisor on this research application, I certify that the student is knowledgeable about the regulations and policies governing research with human subjects and has sufficient training and experience to conduct this particular study in accordance with the research protocol. Additionally: I hereby confirm that I have thoroughly reviewed this IRB application, including the protocol narrative, and verify that it is complete and the research is appropriate in design. I agree to meet with the investigator on a regular basis to monitor study progress. I assure that the investigator will promptly report unanticipated problems to the IRB and will adhere to all requirements for continuing review Generated on IRBNet

16 If I will be unavailable (e.g. sabbatical leave, vacation or resignation), I will arrange for an alternate faculty sponsor to assume responsibility during my absence, and I will advise the Tulane IRB, in writing, of such changes. If the student leaves the university, I will provide all the necessary documents for terminating the study or continuing review. Department Head/Dean Assurance: By my electronic signature on this study/package, I certify that this protocol has been reviewed and approved for submission to the Institutional Review Board for Human Subjects Research. I have reviewed the project and believe that the benefits outweigh the potential risks. I consider it a suitable research project for my Department. If I become aware of any information regarding the suitability of this research project, I will immediately notify the HRPO. INSTRUCTIONS TO RESEARCHERS Review the contents of this form for accuracy and completeness before proceeding. Continue to construct your submission using the IRBNet Users Guide found in the Library. Submissions to the HRPO that do not include this Application Part 1 and all other required materials including the required electronic signatures will be considered incomplete and will not be Forwarded for review or action. Based on your responses, the following additional documentation must be included with this package before submission. Upload the following additional documentation in the Designer: Human Subjects CITI Training Certificates for all key personnel (uploaded into each individual's User Profile) COI CITI Training Certificates for all key personnel responsible for the design, conduct, or reporting of the research (uploaded into each individual's User Profile) A Research Protocol is required for all research studies. If the study is sponsored and a protocol was provided, this must be submitted. If this study is investigator initiated, a protocol is to be developed. See Tips for Writing a Protocol Document/Protocol Template within IRBNet for assistance. All recruitment materials must be submitted. Application Part 2 Complete Supplement H Include questionnaire(s)/survey(s) Provide consent document (see Consent Template in IRBNet Forms and Templates Library) [top] Generated on IRBNet