IRB Submission Checklist - Office of the Institutional Review Board

 IRB Submission Checklist
The purpose of this document is to provide IRB submission guidance for UNM Investigators. All documents with signature
lines require a signature in the spaces provided. Please contact the Office of the IRB for assistance:
irb.unm.edu
|
505.277.2644
|
IRBMainCampus@unm.edu
Submission Type
Page
New Project (NP)
2
Amendment (AM)
3
Continuing Review (CR)
4
Reactivation (RA)
4
Closure (C)
5
Event Report (ER)
6
Response to Modifications Request (MODs)
7
IMPORTANT!
Submit actions separately, the OIRB will not accept combined submissions (Continuing Review + Amendment).
What to expect after submitting your IRB submission through IRBNet
or ) IRB submission package.
!
The OIRB Staff will assess the completeness of your ‘locked’ (
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OIRB Staff may ask for clarifications and unlock ( ) your IRBNet package, which will allow you to make changes
to your submission.
Your ‘locked’ ( ) IRB submission package will be reviewed by the IRB for a decision.
The IRB decision letter will be uploaded to the project’s ‘Reviews’ page and you will receive an email notification.
You may be asked for modifications (e.g. to revise documents or provide additional information); your response
will be in a new package (see Response to Modifications Request (MODs)).
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Tips for a “stellar” IRB submission
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Use this checklist to ensure a complete submission package.
Follow the naming conventions on this checklist for your documents and include version dates in the file name
before saving the document.
If you have questions before submitting, contact the OIRB.
Submit all documents as Word documents; use PDFs only if required (e.g. signature pages); and keep all
documents unprotected/unlocked.
PDFs containing more than one document are not accepted; attach documents separately.
For assistance with using IRBNet, please see the following guidance documents:
o IR
BNet_Submission_Instructions
o IRBNet_Investigator_CheatSheet
The first package in IRBNet for an already approved project
The OIRB is requesting the investigator (or shared project team member) attach all active and approved study documents
to establish a complete record in the IRBNet system (note that stamped consent(s) and previous approval letters should
not be uploaded). This is only required once to make consecutive submissions much easier, maintain IRB records, and
facilitate better communication between the board and the investigator. OIRB staff cannot upload documents on behalf of
the investigator, we can only provide guidance. If you are submitting a closure for a project that has never been in IRBNet,
please submit through email.
IRB Submission Checklist v04.21.15
UNM Office of the Institutional Review Board
Page 1 of 7
New Project Submission Checklist
NOTE: Documents required for a new project submission will depend on nature of the project. The minimum required CITI
training is Social & Behavioral Research - Basic/Refresher. If you have questions, please contact the OIRB.
Document Type
Document Description (Name)
Notes
These are documents that the researcher and IRB will see
Application Form
* Project Information.pdf
This form must be signed by the Principal
Investigator of Record
Other
* Department Review.pdf
This form must be signed by the
Department Chair or designee
Other
* Project Team Packet
Must include all investigators;
•
Project Team Form.doc
•
CITI Completion
Report(s).pdf
All investigators are required to complete
the UNM FCOI Survey:
http://researchcompliance.unm.edu/coi
Protocol
* Protocol.doc
This document is required for all projects;
use the OIRB’s template protocol
Other
** Other Supporting
Documents.doc/.pdf
Letters of Support, Other IRB Approvals,
Tribal Approvals, Data Transfer
Agreements, Certificates of Confidentiality
These are documents that the participant will see/hear
Consent Form
* Consent Form.doc
Child Assent
** Assent Document.doc
HIPAA
Consent/Authorization
** HIPAA Authorization.doc
Advertisement
** Recruitment Materials.doc
Flyers, Posters, Print Media, Audio/Video,
Online Content, Scripts
Data Collection
** Project Instruments.doc/.pdf
Questionnaire/Survey
**Questionnaires/Surveys.doc/.pdf
Surveys, Questionnaires, Data Collection
Tools, Interview Scripts/Questions
Other
** Other Participant
Documents.doc/.pdf
Appointment / Post Cards, Flair / Swag,
Translations of any document
Letter
Note: Consent is required for all projects
unless a wavier is requested and justified
in the protocol.
** Letter of Support.pdf
These documents can be attached in the Designer Page of a single project or your individual User Profile (requires
IRBNet account and linking the training & Credentials record to a project)
Training / Certification
* CITI Completion Report – Human
Subjects Research.pdf
Required for all investigators.
CV/Resume
* Curriculum Vitae.doc/.pdf
Required for Principal Investigator
* Required
** Required if applicable
IRB Submission Checklist v04.21.15
UNM Office of the Institutional Review Board
Page 2 of 7
Amendment Submission Checklist
NOTE: Documents required for an amendment submission depend on what is being changed. Please submit the trackedchanges version only, don’t submit “clean” copies.
Document Type
Document Description (Name)
Application Form
* Amendment Application.pdf
- OR -
Notes
Must be signed by Principal Investigator of
Record
* Amendment Application Project Team.pdf
See New Project Submission
Checklist for appropriate
document type
** Revised Documents with
tracked changes and new
version date.doc
Examples: Protocol, Consent/Assent
Document / Script, HIPAA Authorization,
Recruitment Materials, Project Instruments,
Other Participant Documents…
Other
** Revised Project Team
Packet.doc/.pdf
Updated Project Team Packet (project
team form & CITIs)
See New Project Submission
Checklist for appropriate
document type
** New documents requiring IRB
review and approval before
implementation.doc
Examples: Consent/Assent Document /
Script, HIPAA Authorization, Recruitment
Materials, Project Instruments, others…
* Required
** Required if applicable
Examples of Amendments
Scenario
1
2
3
Include in Application
Changes to Protocol
•
(increase recruitment,
adding/removing
instruments, changing
project procedures…)
Identify the documents being
changed
•
Include an itemized list of the
changes
Change the PI of record
Add / Remove / Update
project team
Supporting Documents
"
Revised protocol to reflect changes
(use tracked-changes) with new
version date
"
Revised consent form to reflect
protocol changes (use trackedchanges) with new version date
"
Copy of new instruments.
"
New PI’s CV
"
Revised project documents to reflect
new PI (use tracked-changes) with new
version dates
•
Changing the [old PI Name] to
[new PI Name].
•
Identify the documents that need
to be changed as a result
•
Include an itemized list of the
changes
"
Updated Project Team Form, & CITI
report
•
Identify by name the project team
members that are bring
added/removed/updated with
currently approved roles
"
Updated Project Team Packet (project
team form & CITIs)
IRB Submission Checklist v04.21.15
UNM Office of the Institutional Review Board
Page 3 of 7
Continuing Review / Reactivation Submission Checklist
NOTE: Once a project is in IRBNet, only submit CR related documents; do not submit any amendments or edited
documents.
Document Type
Document Description (Name)
Notes
Application Form
* Continuing Review
Application.pdf
Must be signed by Principal Investigator of
Record
Other
** Last Signed Consent.pdf
Applicable if signed consent is required
AND if consented in the last approval period
Participant Identifiers must be redacted
Abstract / Summary
** Abstracts.doc/.pdf
Project Findings, Interim Findings
Publication Materials
** Publications.doc/.pdf
Other
** Other Supporting
Documents.doc/.pdf
Related Event Report, DSMB Report,
Report(s) to Funders
Other
** Project Team Packet
You can update your project team with:
•
Project Team Form.doc
•
Removal of team members
•
CITI Completion
Report(s).pdf
•
Updated CITI reports that have
expired
Note: Addition of team members requires an
amendment and should uploaded
separately
* Required
** Required if applicable
IRB Submission Checklist v04.21.15
UNM Office of the Institutional Review Board
Page 4 of 7
Closure Submission Checklist
NOTE: Documents required for a Closure depend on progress and state of the project. If a project is being closed that has
not been uploaded into IRBNet, please submit through email.
Closure Submissions through IRBNet for projects already established in IRBNet:
Document Type
Document Description (Name)
Notes
Application Form
* Closure Application.pdf
Must be signed by Principal Investigator of
Record
Other
** Last Signed Consent.pdf
Applicable if signed consent is required
AND if consented in the last approval period
Participant Identifiers must be redacted
Abstract / Summary
** Abstracts.doc/.pdf
Publication Materials
** Publications.doc/.pdf
Other
** Other Supporting
Documents.doc/.pdf
* Required
Project Findings, Interim Findings
Related Event Report, DSMB Report,
Report(s) to Funders
** Required if applicable
Closure Submissions for projects not in IRBNet; submit through email:
Document Type
Document Description (Name)
Notes
Application Form
* Closure Application.pdf
Must be signed by Principal Investigator of
Record
Other
* Project Team.doc
Must list all currently approved project
team members
Protocol
* Protocol.doc
Must submit the most recently IRB
approved protocol
Other
** Last Signed Consent.pdf
Applicable if signed consent is required
AND if consented in the last approval
period
Participant Identifiers must be redacted
Abstract / Summary
** Abstracts.doc/.pdf
Publication Materials
** Publications.doc/.pdf
Other
** Other Supporting
Documents.doc/.pdf
* Required
Project Findings, Interim Findings
Related Event Report, DSMB Report,
Report(s) to Funders
** Required if applicable
IRB Submission Checklist v04.21.15
UNM Office of the Institutional Review Board
Page 5 of 7
Event Report Submission Checklist
NOTE: Documents required for an Event Report depend on the nature of the event.
Document
Document Name (file name)
Notes
Application Form
* Event Report.pdf
Must be signed by Principal Investigator of
Record
Other
[Title of Document]_v[mmddyy].doc/.pdf
Sponsor Memo for Events, Corrective Action
Plan
Sponsor_Memo_021714.pdf
* Required
** Required if applicable
Examples of Events
Scenario
1
Include in Report
Protocol Deviation
Supporting Documents
"
(over-recruitment)
2
3
4
Consent Process Deviation
•
Describe what happened
(used expired consent form)
•
Provide a corrective action plan
Change to Protocol without
prior IRB Approval
•
List any specific requests:
Participant unexpected
harm
o
request permission to use
data
o
continue with project
Amendment Request to increase target
enrollment
o
Revised protocol to reflect changes
(use tracked-changes) with new
version date
o
Revised consent form to reflect
protocol changes (use trackedchanges) with new version date
"
Corrective action plan
"
Amendment Application to
change/update protocol
"
Request permission to use data
collected as a result of the changes
"
Detailed plan of how to prevent this
from happening in the future
"
Plan to inform participants of event
(participant shocked by
project equipment)
5
Breach of Confidentiality
(PI laptop with project data
was stolen)
IRB Submission Checklist v04.21.15
UNM Office of the Institutional Review Board
Page 6 of 7
Response to Modification Request Checklist
After your submission (NP, AM, CR, RA, C, ER) has been reviewed, you may be contacted at the IRB reviewer’s request
to provide additional
• Information
• Clarification
• Documentation
In response to a Modifications Requested Letter, please submit the following:
Document
Document Name (file name)
Notes
* Point – by – Point
Response
Modification_Response_[mmddyy].pdf
** Revised
Documents with
tracked changes
and new version
date
[Title of Document]_v[mmddyy].doc
Protocol_v021714.doc
Protocol, Consent Documents, Recruitment
Materials, Project Instruments, Other
Participant Documents, etc.
** Additional
Documents
[Title of Document]_[mmddyy].doc/.pdf
If reviewer requests additional documents
* Required
Modification_Response_110713.pdf
Provide a letter containing a point-by-point
response to the requested changes
Recruitment_Email_110613.doc
** Required if applicable
Note: You will receive a Modifications Requested Letter. This is not an approval letter - you cannot start project activities
until after the IRB has accepted your response.
IRB Submission Checklist v04.21.15
UNM Office of the Institutional Review Board
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