IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

L OCATING C HECKLISTS 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

“M Y I NBOX ”

U NDERSTANDING Y OUR I NBOX Your RoleIn My InboxNot In My Inbox StateExplanation IRB committee member or occasional reviewer 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. 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

T HE S TUDY W ORKSPACE

IRB MEETING AGENDAS

L OCATING M EETING A GENDA I TEMS 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

A CCESSING A GENDA 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.

N AVIGATING TO THE A GENDA 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 C OMMITTEE M EETING A GENDA

CHECKLISTS AND WORKSHEETS

L OCATING C HECKLISTS 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.

K EY C HECKLISTS AND W ORKSHEETS TopicChecklists (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)

K EY C HECKLISTS AND W ORKSHEETS TopicChecklists (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)

K EY C HECKLISTS AND W ORKSHEETS TopicChecklists (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 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

List drugs, combinations, etc., to be studied Investigator 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 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

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 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 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

T O 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

T O 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.

T HANK Y OU ! Joey Casanova, CIP Associate Director for Educational Initiatives