US Military Academy at West Point USMA Research Project Submission Information All non-exempt protocols requiring review by the Keller Army Community Hospital Institutional Review Board (IRB) must be submitted to the SharePoint website at https://portal.dean.usma.edu/HRA/default.aspx All of the required templates are located in the “Static Documents” on the SharePoint site. Once you have initiated a new package submission in SharePoint, notify the HPA of your submissions! If you are unclear about what documents to submit, PLEASE CONTACT Dr Linda Mallory at (845) 938-7385 or via email at linda.mallory@usma.edu. Required documents for new Protocols CITI training certificate (within 3 years) and current CV (within 2 years) for Principal Investigator, Associate Investigators. CITI and CV must be uploaded under each member “User Profile” located on the upper right hand corner on the “My Projects” workspace (US Army specific modules can be found on www.citiprogram.org U.S. Army Medical Research and Materiel Command) CV for Principal Investigator and all Associate Investigators (as applicable). If this includes cadet research, cadets can submit their transcripts. Conflict of Interest Statement for Principal Investigator and all Associate Investigators (as applicable) USMA Research Protocol Application USMA Informed Consent Form (or a Request for a Waiver of Informed Consent) Scientific Review All pertinent study questionnaires, survey instruments, case report forms, data collection sheets Other Protocol Documents (as applicable to type of research study submitted) If your study is funded, upload Grant Application Proposal or the grant funding award letter If your study is a sponsored protocol, upload the original Sponsor Protocol If this is a multi-site study involving investigators listed on the protocol that are not affiliated with West Point, an Institutional Agreement for IRB Review (IAIR) or an Individual Investigator Agreement is required. Please contact the HPA for guidance on which agreement is required. If your study includes recruitment of study participants, upload advertisement flyers, e-mails, letters of support, information sheets, telephone scripts, and/or any study information that will be given to study participants. If your study involves a device, provide the device manual or as much information/documentation as possible. For any protocols which may be exempted, please use the “USMA Exempt Request Template” form. **Please use the document naming convention on page 2.** Version: JUL2015 Getting Started 1. All templates are located in the “Static Document” folder. 2. The place to upload protocol documents (file sharing) is in the “Shared Documents” folder. 3. Clearly label each document with the PI’s last name and the name of the document uploaded. For example, “MalloryConsent Form” or “Mallory-Protocol.” Save and label each subsequent version of documents. For example, “MalloryICD Waiver v2.” 4. All templates must be saved and completed on your computer’s hard drive. Naming Uploaded Documents When adding documents into the file share folder, a description of the document is required. Please use these document naming rules to help IRB members’ easily recognize the supporting documents for each submission. All documents from a primary investigator MUST begin with the investigator’s last name. All of the documents for your protocol should be labeled with your last name. If there are multiple versions of a document, include the version number in the file name (see #3 above). Document Document Name Amendment <PI Last Name>-Amendment# CITI Training Certificates <PI Last Name>-<Name of Investigator>-CITI Closure Report <PI Last Name>-Closure Report Conflict of Interest <PI Last Name>-<Name of Investigator>-Conflict of Interest Consent Form <PI Last Name>-Consent Form Continuing Review <PI Last Name>-Continuing Review Data Collection <PI Last Name>-Data Collection Exempt Determination <PI Last Name>-Exempt Determination Grant/Funding <PI Last Name>-<Name of grant or funding award> Handouts <PI Last Name>-Handouts Impact Statement <PI Last Name>-Impact Statement Individual Investigator Agreement <PI Last Name>-<Name of Investigator>-IIA Memo <PI Last Name>-Memo Memo <PI Last Name>-Memo Recruitment/Advertisement Flyer <PI Last Name>-Recruitment Research Protocol <PI Last Name>-Protocol Scientific Review <PI Last Name>-Scientific Review Survey/Interview Questions <PI Last Name>-Survey <PI Last Name>-Interview Questions Questions If you have any questions on how to upload documents, please contact the USMA HPA, Linda Mallory at 845-938-7385 or linda.mallory@usma.edu. Page 2 of 2