Transcript IRB72 IRB memberTraining - Human Subject Research Office

IRB 7.2 IRB MEMBER
TRAINING
Presented by:
Joey Casanova, CIP
Associate Director for Educational Initiatives
Human 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 INBOX
Your Role
IRB
committee
member or
occasional
reviewer
In My Inbox
Not In My
Inbox
State
Explanation
Noncommittee
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.
Studies
assigned to
other
reviewers
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.
Studies
assigned to
other
committees
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 (HRP314)
• 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 (HRP310)
• Engagement (HRP-311)
• Exemption (HRP-312)
• Expedited (HRP-313)
K
EY CHECKLISTS AND WORKSHEETS
Topic
Checklists (use and attach) Worksheets (for reviewer's
use)
Consent /
recruitment
•
•
•
•
•
Special Populations
•
•
•
•
•
•
Waiver or Alteration of
Consent (HRP-410)
Waiver of Written
Documentation of
Consent (HRP-411)
Waiver of Consent for
Emergency Research (HRP419)
HIPAA Waiver of
Authorization (HRP-441)
Pregnant Women (HRP412)
Non-Viable Neonates (HRP413)
Neonates of Uncertain
Viability (HRP-414)
Prisoners (HRP-415)
Children (HRP-416)
Cognitively Impaired Adults
(HRP-417)
•
•
•
Short Form of Consent
(HRP-317)
Advertisements (HRP-315)
Payments (HRP-316)
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 (HRP323)
• Emergency Use (HRP322)
Type of Review
• HIPAA Waiver of
• Additional Federal
Authorization (HRP-441)
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 template
to 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 here
are 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 studied
Investigator Brochures should be included here as well
Check yes if appropriate
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
List devices to be studied
Any 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
*This page will only appear if “yes” is selected
in question 3 on the Study Scope page
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 study
link. 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 with
prior 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 UMspecific
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 under
the “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, CIP
Associate Director for Educational Initiatives
[email protected]
305-243-9232