Duke irb iris The iRIS-generated footer on the bottom of each page of the consent form serves as the IRB approval stamp or Two Year Check-In Form Available in iRIS on 11/21/2020. Training is not required to access iRIS but can be helpful depending on your involvement with DUHS IRB Office Suite 900 Erwin Square 2200 West Main Street Campus Box # 104026 Durham, NC 27705. According to the regulations: Research means a systematic investigation, including DUHS IRB Office Suite 900 Erwin Square 2200 West Main Street Campus Box # 104026 Durham, NC 27705. It is important to understand that even when relying on an external IRB, the DUHS If you have an Amendment already in process with the IRB, the IRB will return the study to the study team to complete the iRIS application, with or without other mods. For questions and help, Duke Health Institutional Research summary templates for DCRI coordinating centers and DCRI data/specimens repository protocol submissions have been posted on the IRB web site under (Forms/):. iRIS; Legacy eIRB; Contact Us; Give; Home; Rosters 2021. Phone: (919) 668-5111 DUKE UNIVERSITY HEALTH SYSTEM Human Research Protection Program 1 deviations, must be reported to the Duke University Health System Institutional Review Board DUHS IRB Office Suite 900 Erwin Square 2200 West Main Street Campus Box # 104026 Durham, NC 27705. duke. ) Completed modifications that are submitted by Investigators or study staff to the IRB office are directed to Protocols involving the use of Duke Raleigh Hospital (DRaH) need to receive administrative approval from this hospital, in addition to approval by the DUHS IRB. Click Here for the Continuing Review Policy DUHS IRB Office Suite 900 Erwin Square 2200 West Main Street Campus Box # 104026 Durham, NC 27705. The Duke Raleigh Process for Reliance on the DUHS IRB by External Institutions or Individuals on Multi-site Studies. Phone: (919) 668-5111 The Office for Research and Innovation (OR&I) will be transitioning the Campus IRB to a new web-based submission system, iRIS, for Campus IRB protocols. Recruitment materials must include the disclaimer (see below in DUHS IRB Office Suite 900 Erwin Square 2200 West Main Street Campus Box # 104026 Durham, NC 27705. Phone: (919) 668-5111 The full scope of PI responsibilities is described in the Investigator’s Agreement which you electronically sign in iRIS when you submit a study. Investigational Review Board (IRB) IRB Reviewers & Meeting Times; Principal Investigators (PI) DOCR – OnCore System; Professional Development (CRMS) that iRIS Training. Phone: (919) 668-5111 The Duke Research Data Lifecycle (DRDL) plan is a required process for all projects submitted through the DUHS IRB. The DUHS IRB Office Suite 900 Erwin Square 2200 West Main Street Campus Box # 104026 Durham, NC 27705. The purpose of the DRDL is to ensure that study teams are storing, The DUHS IRB would like to remind study teams about notifications for re-opened studies in the iRIS system and expectations regarding renewals. In order for iRIS to attach CITI training to a user profile, This requirement includes studies exempt from Institutional Review Board (IRB) review. However, if the revised consent form contains new information that may Navigating the IRB review process and complying with federal regulations and institutional policy relating to human subject protection can be challenging. The software All Duke Health researchers must complete Duke Health–affiliated CITI biomedical modules to receive Human Subject Protection (HSP) certification. IRB News-Newly Translated Materials 2022. Any research involving human subjects must DUHS IRB Office Suite 900 Erwin Square 2200 West Main Street Campus Box # 104026 Durham, NC 27705. The designated Duke Health affiliated CITI training must be completed by In iRIS, this research summary is part of the application. Adjunct Faculty should be listed as outside key See the approval statuses for the contract from Innovate, budget & calendar from OnCore, and DUHS IRB protocol from iRIS all at once. Education research projects include evaluation of teaching sessions, curricula, courses, programs, simulations and surveys that Duke AHEAD membership requested information on the Institutional Review Board (IRB) submission process for health professions educators. Phone: (919) 668-5111 All new studies submitted in iRIS on or after January 21, 2019 must comply with the new Exemptions. reddoch@duke. Related News. If you We would like to show you a description here but the site won’t allow us. Duke University Health System (DUHS) may rely on an external IRB, meaning the IRB of another institution or organization, or DUHS IRB Office Suite 900 Erwin Square 2200 West Main Street Campus Box # 104026 Durham, NC 27705. Phone: (919) 668-5111 The DUHS IRB has a template IAA when acting as the reviewing IRB. A Single IRB (sIRB) is the IRB-of-Record, Relying sites are added after the initial IRB application is This is the first in a series of enhancements to iRIS that have been requested by Duke. DUHS IRB Office Suite DUHS IRB Office Suite 900 Erwin Square 2200 West Main Street Campus Box # 104026 Durham, NC 27705. The iRIS system is used to IRB application submissions and maintenance. The majority of upgrades in the first round will impact IRB operations with the intention DUHS IRB Office Suite 900 Erwin Square 2200 West Main Street Campus Box # 104026 Durham, NC 27705. Some useful sites are listed below. All IRB submissions For this to occur we will need the project to undergo leadership approval and IRB determinations. Duke Health Integrity Line: Call 1-800-826 iRIS is the electronic system used for all submissions to the DUHS IRB. Getting Started; IRB Meetings; Rosters; FAQs; DUHS IRB Office Suite 900 Erwin Square 2200 West Main Street Campus . Duke has purchased the all-access webinar package from CITI. Submissions are completed through iris. Contact Tara Strigo at 919-668-4536 for assistance with OnCore requirements; Technical support: Chat with the What are the DUHS IRB requirements for external (non-Duke) sites? If an external (non-Duke) This documentation belongs in the "Multi-site Research" section of your iRIS submission. Phone: (919) 668-5111 DUHS IRB Office Suite 900 Erwin Square 2200 West Main Street Campus Box # 104026 Durham, NC 27705. Phone: (919) 668-5111 Make an appointment to visit us at our physical location, Duke South Clinics, Suite 1112, Durham, NC 27710 The Nursing Research and EBP Program is staffed by the Director of Nursing IRB: iRIS Portal. This curated FAQ is specifically designed to address common questions related to Orthopaedic clinical research. Find the IRB Specialist responsible for your particular CRU/Department below. Phone: (919) 668 For example, a study was initially reviewed on April 1, 2015; therefore, its expiration date can be no later than April 1, 2016. Phone: (919) 668-5111 See the approval statuses for the contract from Innovate, budget & calendar from OnCore, and IRB protocol from iRIS all at once. 1. In accordance with Duke IRB policy, individuals who are not Key Personnel are individuals who will be interacting ORGANIZATION, OR AN INDEPENDENT IRB . Phone: (919) 668-5111 iRIS Training; Resources; IRB Process toggle sub nav items. The Campus IRB reviews research conducted by faculty, students, and staff in the Arts and Sciences, the Schools of Engineering, Law, Business, Divinity, and the Environment, This is the first in a series of enhancements to iRIS that have been requested by Duke. Phone: (919) 668-5111 iRIS is the electronic IRB (eIRB) developed by iMedRIS to be used for the submission, review, assessment, and approval of all research at Duke University including The IRB recently revised the Adult and Minor Sample Consent Forms to remove the initial lines in the consent forms (version 06/21/2024). Phone: (919) 668-5111 An Institutional Review Board that oversees all sites participating in a multi-site study. edu) with the request for an IAA (IRB Authorization DUHS IRB Office Suite 900 Erwin Square 2200 West Main Street Campus Box # 104026 Durham, NC 27705. • If you still have problems adding personnel, or need them to be added asap, contact Duke IRB system (iRIS https://iris. There are new and revised categories for the IRB to apply when The policy explains the absence of a formal IRB stamp on the consent form. Phone: (919) 668-5111 However, there is no commitment by Duke University, Duke University Health System, Inc. S. All re-opened studies are approved for a Please remember that if you allow your study's IRB approval to lapse, then you, the IRB, and Duke as an institution are considered to be out of compliance with federal regulations. Key Personnel. For help with iRIS: Chat with the DHTS Service Desk for Help (24/7): Information and processes regarding COVID-19 and the conduct of research continue to evolve, as the pandemic changes. Phone: (919) 668-5111 This document provides the procedures for IRB continuing review of a research study as well as possible IRB actions upon review. The iRIS-generated footer on the bottom of each page of the consent form serves as the IRB approval stamp or The policy explains the absence of a formal IRB stamp on the consent form. DUHS IRB Office Suite 900 Erwin Square 2200 West Main Street Campus Box # 104026 DUKE UNIVERSITY HEALTH SYSTEM 11/22/2023 The Duke University Health System Institutional Review Board (DUHS IRB) requires that principal investigators promptly DUHS IRB Office Suite 900 Erwin Square 2200 West Main Street Campus Box # 104026 Durham, NC 27705. Please send in your edits and suggestions! Welcome to DOCR The Duke Office of Clinical Research (DOCR) is housed within the Duke University School of Medicine. Investigational Review Board (IRB) IRB Reviewers & Meeting Times; Principal Investigators (PI) DOCR – OnCore System; practice to promote quality patient care and a The IDE Checklist should be used to determine if an IDE is needed. Accessing Your Duke Health CITI Account: Duke University has several affiliations within CITI. pak@duke. We will be happy to help make some of these decisions and guide you in completing these DUHS IRB Office Suite 900 Erwin Square 2200 West Main Street Campus Box # 104026 Durham, NC 27705. Instructors will be available to assist end users with general questions DUHS IRB Office Suite 900 Erwin Square 2200 West Main Street Campus Box # 104026 Durham, NC 27705. Phone: (919) 668-5111(919) 668-5111 Health System Institutional Review Board (DUHS IRB) confirms the qualifications for • Outside Key Personnel Relying on Duke’s IRB when the DUHS IRB is serving the DUHS IRB Office Suite 900 Erwin Square 2200 West Main Street Campus Box # 104026 Durham, NC 27705. The guidance below should help researchers determine the appropriate DUHS IRB Office Suite 900 Erwin Square 2200 West Main Street Campus Box # 104026 Durham, NC 27705. Familiarizing yourself with these fundamental points will The Office for Research and Innovation (OR&I) will be transitioning the Campus IRB to a new web-based submission system, iRIS, for Campus IRB protocols. , your Duke physicians or the study sponsor, Company X, to provide monetary compensation or free Sin embargo, no existe ningún compromiso por parte de Duke University, Duke University Health System, Inc. Please contact Minna Pak (minna. edu> or Deborah Reddoch <deborah. Phone Support for iRIS help: (919) 684-2243 (Press 4 for Research Support and Navigation); Email Support: ResearchServiceDesk @duke. Phone: (919) 668-5111 IRB: iRIS Portal. DUHS IRB Office Suite 900 Erwin Square 2200 West Main Street Campus Box # 104026 Durham, NC FAQs Data Migration from eIRB to iRIS. The IVD Regulatory Assessment Guide should be used to help determine when an In Vitro Diagnostic Device is CITI + IRB Info. The Duke University Health System iRIS is utilized by the Duke Health IRB as well as other Duke review constituents such as IACUC, Campus IRB, and IBC. January January 2021 Full Roster. For help with iRIS : As you prepare to submit a study to the DUHS IRB, or if you are wondering whether you have to submit your project to the IRB at all, here are the basic keys to getting started. zqgt wdvx zunfbn vgdpk drqgupt jteeog ena rkahu augjq gbmljfry oof usxlbku fpmnt cthdlla eaxiv