Selecting IRB Document Types

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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
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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
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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
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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
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