“top 10 tips when submitting to the irb” · #2 istar application –answer all questions •...
TRANSCRIPT
Tea with the IRB:
“Top 10 Tips When Submitting to the IRB”Rocio Yong, M.P.H., C.I.P. 10/30/2019
Introductions
• Department / Division
• Research Role
• Submissions to HSPP
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#1 Obtain Human Subjects Certification
• Step 1
– Complete one or both of the CITI Program Human Research Basic
Courses (Biomedical or Social/Behavioral)
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#1 Obtain Human Subjects Certification
• If research is considered more than minimal risk, also complete
Basic Good Clinical Practice (GCP) Courses (GCP and GCP - Social
and Behavioral Research Best Practices for Clinical Research)
• Access CITI at www.citiprogram.org
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#2 iStar Application – Answer All Questions
• Reference the Study Protocol (e.g. See Section X of the Study
Protocol) whenever possible
• In #12.1 - Include a description of the research procedures and
the routine clinical care procedures
– To evaluate risks and benefits, the IRB needs to consider those risks
and benefits that may result from the research (as distinguished
from risks and benefits of therapies subjects would receive even if
not participating in the research)
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#2 iStar Application – Answer All Questions
• If not applicable #22d.4 (study instructions) and #22d.5
(instruments) may be left blank
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#2 iStar Application – Answer All Questions
• If the research does not involve greater than minimal risk skip
#25.3 or click “Other” and enter “Not applicable” in #25.3.1
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#3 iStar Application – Upload Study Documents
• Submit
– Study Protocol
– CRFs, REDCap Forms, Data Collection Forms
– Instruments, Surveys
– Focus Group Guides
– Recruitment Materials
– Consent and Assent Forms
• Submit translated Consent and Assent Forms only
• Use a template Study Protocol from the HSPP website (new –
coming soon)
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#3 iStar Application – Upload Study Documents
• Submit FDA regulatory status of drug or device
– Documentation that includes IND#
• Sponsor protocol imprinted with the IND#
• Written documentation from the sponsor documenting IND#
• Written communication from the FDA documenting the IND#
(required if the investigator holds the IND)
– Revised Investigator Brochure (IB) must be submitted by the
investigator
• Submit IDE
– Documentation that includes IDE#
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#3 iStar Application – Upload Study Documents
• Submit device information
– Premarket Approval (PMA) (https://www.fda.gov/home)
– 510(k) (https://www.fda.gov/home)
– Non Significant Risk – PI Documentation
– Device Brochure
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#3 iStar Application – Upload Study Documents
• Premarket Approval (PMA) Database
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#3 iStar Application – Upload Study Documents
• 510(k) Premarket Notification Database
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#3 iStar Application – Upload Study Documents
• Non Significant Risk – PI Documentation
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#4 Submit to IRB
• Applications in Pre Submission and an APP# have not been
received by the HSPP
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#5 Contact the iStar Helpdesk
• If your application is in Department or Division review for
extended amounts of time
• If you have not received an “Agree to Participate” notice
• If you receive an error message
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#6 Answer Communications
• Address comments requesting
clarifications, reconciling of
discrepancies, requests for
additional information
• Review edits and acknowledge
these (if accurate)
• If edits are not accurate revise
these and provide an
explanation
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#7 Not Sure How to Address Something
IRB Administrator Email Ext #
Mara [email protected] 1-7031
Dongqing [email protected] 1-6023
Maryann [email protected] 1-4010
Jeremiah [email protected] 1-4224
Linda [email protected] 1-8171
Deebra [email protected] 1-2080
Rocio [email protected] 1-8317
Skyler [email protected] 1-7627
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#8 Amendments
• Provide description and rationale for proposed changes
• Avoid emailing documents to IRB Administrators to review
• “Upload Revision” function has become “…”
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#8 Continuing Review
• Submit continuing review applications with sufficient time for
review. The recommended (per the IRB approval memo) is at
least 8 weeks before the expiration date
• Do not let research expire
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#10 Ceded Submissions
• For Ceded review access the “Investigator Guidance” section in
the Human Subjects Protection Program intranet space
• For IRB reliance agreement questions email
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A Few More Things
• Edit Personnel function should only be used when consenting
privileges do not need to be designated.
• Edit Personnel function can be used to remove study personnel
(except Principal Investigator)
• Review the Approval Letter
• Close the study once the research is completed
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QUESTIONS?
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