Transcript
Page 1: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

IRB 7.2 IRB MEMBER TRAINING

Presented by:Joey Casanova, CIP

Associate Director for Educational InitiativesHuman Subject Research Office

Page 2: IRB 7.2 IRB M EMBER T RAINING 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.

Page 3: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

IRB 7 NAVIGATION

Page 4: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

“MY INBOX”

Page 5: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

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

Page 6: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

THE STUDY WORKSPACE

Page 7: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

IRB MEETING AGENDAS

Page 8: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

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

Page 9: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

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.

Page 10: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

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.

Page 11: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

IRB COMMITTEE MEETING AGENDA

Page 12: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

CHECKLISTS AND WORKSHEETS

Page 13: IRB 7.2 IRB M EMBER T RAINING 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.

Page 14: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

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)

Page 15: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

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)

Page 16: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

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)

Page 17: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

THE NEW STUDY APPLICATION

Page 18: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

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

Page 19: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

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

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Answer “yes” only if the UM PI is responsible for the conduct of this study at external sites

Used for branching

Used for branching

Page 21: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

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

Page 22: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

*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

Page 23: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

Upload ICF and other documents to be used during consent process

Upload advertisements, flyers, patient letters and other documents to be used for recruitment

Page 24: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

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.

Page 25: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

THE MODIFICATION/ CONTINUING REVIEW FORM

Page 26: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

Select type of submission

NOTE: This question will not appear if “Continuing Review” is selected above

Page 27: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

Numbers reported here must be consistent withprior reports and, if applicable, Velos

Indicate current state of the study

Page 28: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

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.

Page 29: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

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)”

Page 30: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

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.

Page 31: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

THE REPORTABLE NEW INFORMATION FORM

Page 32: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

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.

Page 33: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

Summary of RNI

Page 34: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

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

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COMPLETING YOUR REVIEW

Page 36: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

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

Page 37: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

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.

Page 38: IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office

THANK YOU!

Joey Casanova, CIPAssociate Director for Educational Initiatives

[email protected]


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