Tea with the IRB:“Tips When Submitting to the IRB”

Rocio Yong, M.P.H., C.I.P. 2/25/2020

Introductions

• Department / Division• Research Role• Submissions to HSPP• Previous role before you

joined CHLA

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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

• Describe what you want to do. For example:– We are seeking IRB approval for…– We are interested in…– This research will look at…

• 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)

• Reference the Study Protocol (e.g. See Section X of the Study Protocol) whenever possible

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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 mlevy@chla.usc.edu 1‐7031

Dongqing dli@chla.usc.edu 1‐6023

Maryann mgirgis@chla.usc.edu 1‐4010

Jeremiah jklashorst@chla.usc.edu 1‐4224

Linda lifox@chla.usc.edu 1‐8171

Deebra debsmith@chla.usc.edu 1‐2080

Rocio ryong@chla.usc.edu 1‐8317

Skyler srothganger@chla.usc.edu 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 irbreliance@chla.usc.edu

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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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QUESTIONSCOMMENTSSCENARIOS

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