Research Integrity Office 218 Ross Hall / 331, Reno, Nevada 89557 7753272368 / 7753272369 fax wwwunredu/research-integrity Selecting IRBNet Document (Attachment) Types For each document added to a project or package, IRBNet requires researchers to select a Document Type from a pre-determined list. The RIO suggests the following alignments. Document Types in IRBNet Drop-down List Instructions and Applicable Documents Abstract/Summary Adverse Event Report Not required Do not use; select Unanticipated Problem Report type instead Use to add recruitment materials (eg, flyers, scripts, letters) Use to add researcher form: Amendment / Modification Request Use to add researcher forms: Part II applications Other: exempt research; Consent Waivers; forms for populations or federal agencies; and requests for external IRB request, emergency use, and HUD device Not required Use to add assent scripts, sheets, or forms Use to add researcher form: Closure or Continuing Review (Renewal) when the latter is used to close a protocol Use to add third-party confidentiality or non-disclosure agreements (e.g., Data Use Agreements) Do not use Do not use Do not use Use to add the following: Consent forms and addendums Information sheets, scripts, and letters Video/photo release forms Use to add researcher form: Continuing Review (Renewal) Not required Do not use; instead add CVs to IRBNet User Profiles and link Project Team Credentials to Project Packages Use to add data collection logs or spreadsheets (e.g., for records reviews); observation sheets Use to add researcher form: HIPAA Authorization Use to add researcher form: HIPAA Waiver Request Use to add FDA 1572 or other PI agreement Use to add the following: Investigator’s brochure for investigational drugs Device manual for investigational devices Advertisement Amendment/Modification Application Form Budget Child Assent Closure/Final Report Confidentiality/Non-Disclosure Conflict of Interest – Declaration Conflict of Interest – Management Plan Conflict of Interest – Other Consent Form (NOTE: Separate categories exist for assent and parent permission forms) Continuing Review/Progress Report Cover Sheet CV/Resume Data Collection HIPAA Consent/Authorization HIPAA Waiver Investigator Agreement Investigator’s Brochure Page 1 of 2 Document1 Letter Other Parental Permission Form Proposal Protocol Protocol Deviation/Violation Report Publication Material Questionnaire/Survey Reportable Event (Non-AE) Study Plan Training/Certification Unanticipated Problem Report Page 2 of 2 Use to add the following: Permission letters or emails from research sites or other oversight bodies (e.g., school district) External IRB approval letters Use to add the following: VA PRS reports Responsible Official Attestation (note: electronic signature preferred) Oversight committee approvals (e.g., Biosafety) Study documents that don’t fit into another preexisting categories (use rarely) Use to add the following: Parent permission forms Parent information sheets Parent opt-out forms Use to add the following: Grant proposals and applications Statements of work and contracts Use to add sponsor clinical trial protocol Do not use; select Unanticipated Problem Report type instead Not required but may be used when abstracts or manuscripts based on study results are submitted for continuing review, closure, or annual report Use to add research instruments NOTE: Attach the versions that will be given to participants Do not use; select Unanticipated Problem Report type instead Not required Do not use; instead link CITI training to IRBNet User Profiles and Project Team Credentials to Project Packages Use to add Reporting Problems form when reporting possible noncompliance, complaints, problems, and local adverse events to the IRB Document1