IRB 7.2 IRB MEMBER TRAINING
Presented by:Joey Casanova, CIP
Associate Director for Educational InitiativesHuman Subject Research Office
LOCATING CHECKLISTS• Several worksheets and checklists are provided in the
system to guide your review process and document your decisions. – Worksheets are for the reviewer's benefit only.– Checklists must be completed and attached when
submitting your review comments to document your decisions.
• To locate the worksheets and checklists:– Click IRB then IRB library in upper left corner.– Click the Worksheets or Checklists tab.– Click a link to open or save the document.
IRB 7 NAVIGATION
“MY INBOX”
UNDERSTANDING YOUR INBOXYour Role In My Inbox Not In My
InboxState Explanation
IRBcommitteemember oroccasionalreviewer
Non-committee Review
You have been designated as the reviewer for this exempt or expedited study. You must submit your final review before the IRB decision can be communicated to the study team. If you request clarifications, the study comes back to you to finish the review after the clarifications are made.
Studiesassigned tootherreviewers
Committee Review
You may be part of the committee that will review this study. If so, review the study details in advance. You can request clarifications. Record your notes and recommendations in the system before the meeting as described in Preparing Comments for a Meeting.
Studiesassigned toothercommittees
THE STUDY WORKSPACE
IRB MEETING AGENDAS
LOCATING MEETING AGENDA ITEMS
• As a committee member, you can get a meeting agenda listing the studies and other submissions to be reviewed in an upcoming meeting. You can get the agenda in two forms:– As a web page with links to the studies– As a printable document
ACCESSING AGENDA FROM E-MAIL
• To access the meeting workspace web page containing links to the studies, click the link next to Link.
• To open or save the printable document, click the link next to Description.
Note: The most up-to-date agenda is in the web page format.
NAVIGATING TO THE AGENDA
• Click IRB and then IRB Meetings in the upper left corner.
• Click the name of the meeting to view.
• The meeting workspace displays the list of agenda items in the center of the page.
IRB COMMITTEE MEETING AGENDA
CHECKLISTS AND WORKSHEETS
LOCATING CHECKLISTS• Several worksheets and checklists are provided in the
system to guide your review process and document your decisions. – Worksheets are for the reviewer's benefit only.– Checklists must be completed and attached when
submitting your review comments to document your decisions.
• To locate the worksheets and checklists:– Click IRB then IRB library in upper left corner.– Click the Worksheets or Checklists tab.– Click a link to open or save the document.
KEY CHECKLISTS AND WORKSHEETS
Topic Checklists (use and attach) Worksheets (for reviewer's use)
Approval Criteria • Criteria for Approval and Additional Considerations (HRP-314)
• Additional Federal Criteria (HRP-318)
Type of Review • Pre-Review (HRP-308)• Review of Information
Items (HRP-321)• Scientific or Scholarly
Review (HRP-320)
Level of Review • Human Research (HRP-310)
• Engagement (HRP-311)• Exemption (HRP-312)• Expedited (HRP-313)
KEY CHECKLISTS AND WORKSHEETSTopic Checklists (use and attach) Worksheets (for
reviewer's use)
Consent /recruitment
• Waiver or Alteration of Consent (HRP-410)
• Waiver of Written Documentation of
• Consent (HRP-411)• Waiver of Consent for
Emergency Research (HRP-419)
• HIPAA Waiver of Authorization (HRP-441)
• Short Form of Consent (HRP-317)
• Advertisements (HRP-315)• Payments (HRP-316)
Special Populations • Pregnant Women (HRP-412)
• Non-Viable Neonates (HRP-413)
• Neonates of Uncertain Viability (HRP-414)
• Prisoners (HRP-415)• Children (HRP-416)• Cognitively Impaired Adults
(HRP-417)
KEY CHECKLISTS AND WORKSHEETS
Topic Checklists (use and attach) Worksheets (for reviewer's use)
Devices/Drugs • Non-Significant Risk Device (FDA) (HRP-418)
• Drugs (HRP-306)• Devices (HRP-307)• Criteria for HUD
Approval and• Additional
Considerations (HRP-323)
• Emergency Use (HRP-322)
Type of Review • HIPAA Waiver of Authorization (HRP-441)
• Additional Federal Criteria (HRP-318)
• HIPAA Authorization (HRP-330)
THE NEW STUDY APPLICATION
Title as listed in protocol
Abbreviated title for easy identification
Summary of study
Select PI from a list of IRB7 users
Disclosures should be consistent with disclosures in DPS
Unless prior permission is granted, answer should be “No”
Sponsor’s protocol should be uploaded here. For investigator-initiated research, use the protocol templateto develop protocol
A list of known funding sources/sponsors will be available. Contact the HSRO if a new source needs to be added.Upload grant application or draft CTA as appropriate
Standard study teams may be associated with a PI. Please review to ensure that the study team members listed hereare accurate
Answer “yes” only if the UM PI is responsible for the conduct of this study at external sites
Used for branching
Used for branching
List drugs, combinations, etc., to be studiedInvestigator Brochures should be included here as well
List as appropriate
Upload IND letter or other correspondence from the FDA
*This page will only appear if “yes” is selected in question 2 on the Study Scope page
Check yes if appropriate
*This page will only appear if “yes” is selected in question 3 on the Study Scope page
List devices to be studiedAny documentation, instructions, etc. associated with the use of the device would be uploaded here as well
Check appropriate radio button
List as appropriate
Upload IDE letter or other correspondence from the FDA
Upload ICF and other documents to be used during consent process
Upload advertisements, flyers, patient letters and other documents to be used for recruitment
Upload any other documents not already included
NOTE: Clicking “Finish” does not submit the study.The PI must log in and click on the submit studylink. NOTE: Only the PI may submit the study.
THE MODIFICATION/ CONTINUING REVIEW FORM
Select type of submission
NOTE: This question will not appear if “Continuing Review” is selected above
Numbers reported here must be consistent withprior reports and, if applicable, Velos
Indicate current state of the study
If a COI was disclosed at initial submission, or there are no COIs, select “No”
Select all that apply
Examples: enrollment summaries, summaries of AEs not requiring immediate reporting, summaries of deviations not requiring immediate reporting, DSMB reports, grant progress reports, sponsor letters re: enrollment, etc.
Indicate current state of study
Indicate whether PI intends to notify subjects
List any changes that are UM-specific
Study-wide modifications that are described in a sponsor’s amendment do not need to be included here. Study teams may simply state “Refer to sponsor’s summary of changes (or other appropriate document)”
NOTE: Clicking “Finish” does not submit the continuing review/modification. The PI must log in and click on the submit link. NOTE: Only the PI may submit the continuing review/modification.
THE REPORTABLE NEW INFORMATION FORM
When viewing items in your Inbox or on the IRB Workspace, RNI Short Title will show up underthe “Name” column
List date study team became aware of the RNI
RNI includes unanticipated problems, newly identified risks, adverse events (unexpected and probably related), deviations and violations, audit or monitoring results, etc.
RNIs do not include expected or unrelated AEs, IND Safety Reports, Translations, Sponsor Letters without impact on risks, etc.
Summary of RNI
Select Yes or No based on PI’s review of the RNI
You will be able to list as many studies as are affected. (E.g. PI is involved in multiple studies involving the same drug.)
Upload documents as appropriate
COMPLETING YOUR REVIEW
TO COMPLETE A DESIGNATED (OR NON-COMMITTEE) REVIEW:1. Click Submit Designated Review
2. If true, check the box to indicate that you do not have a conflicting interest
3. Answer the relevant questions, paying special attention to each required question marked with a red asterisk (*).
4. (Optional) Add comments and attach documents related to the review
TO COMPLETE A COMMITTEE REVIEW:
• Click Submit Committee Review
• Answer the relevant questions, paying special attention to each required question marked with a red asterisk (*).
• (Optional) Add notes and attach documents related to the committee's review.
• Click OK.
THANK YOU!
Joey Casanova, CIPAssociate Director for Educational Initiatives