1. Reportable Events & Other IRB Updates February 2017
Human Subjects Office
Reportable Events & Other IRB Updates February 2017
OFFICE OF RESEARCH COMPLIANCE

2. IRB Updates & Changes Recommendations from working groups
Regulatory Affairs Committee
Consent Capacity Working Group
Feedback from ORC staff, investigators, accreditation site visitors, and auditors (FDA and VA)
Ongoing improvement of KC IRB

3. IRB Updates & Changes
Updated processes & submission requirements: amendments, study closure, reportable events
Minor revisions to KC IRB Questionnaires for consistency, clarification, and efficiency
New guidance:
Reportable Events
Research with Individuals Lacking Consent Capacity
Research with Prisoners

4. IRB Updates & Changes
Updated website to reflect new processes, update language, and provide clarifications
Revised SOPs to reflect new processes, update language, and provide clarifications
See ORC News announcement for details
Revised ICS template with updated HSO contact information
No revision to currently-approved ICS needed

5. Major Changes

6. Individuals Lacking Consent Capacity
As a result of recent working group:
Language change
New guidance
KC IRB questionnaire revisions
Cognitively/ decisionally impaired
Individuals Lacking Consent Capacity

7. Amendments
All amendments updating risks, benefits, or study procedures must be submitted within 60 days of receipt by the study team
Revised KC IRB questionnaire to collect better information
Personnel updates
Notification of changes to subjects

8. Study Closure
Required for greater than minimal risk research and FDA-regulated research
Review by an IRB member via expedited process
Reported to convened IRB via agenda
Optional for all other research
Send Study Closure Report via to

9. Study Closure – After Submission
Reviewed by an IRB member via expedited process
Notification of approval via as usual
Obtain approval documents as usual
Signed Study Closure Report
Study closure letter

10. Reportable Events

11. Process Changes Revised list of promptly reportable events
Noncompliance reporting now limited
Revised guidance for investigators
Retirement of the Prompt Reporting and Noncompliance Forms
New KC IRB questionnaire: smart form with customized questions

12. Overview
Promptly reportable events: must be reported to the IRB within 5 days of discovery
Events which are not promptly reportable should be reported at time of next renewal (or study closure, if no renewal)

13. Promptly Reportable Events
Conduct of human subjects research without IRB approval, including:
Failure to submit to IRB or beginning research prior to final approval
Initiation of substantive changes without IRB approval
Inclusion of vulnerable subjects without IRB approval
Conduct of research after expiration, during suspension, or after termination
Participation by investigators who have not completed appropriate investigator requirements

14. Promptly Reportable Events
Adverse event assessed by PI as (1) unexpected, AND (2) related or possibly related to study participation, AND (3) suggests that the research places subjects or others at a greater risk of harm than was previously known
Unanticipated adverse device effect

15. Promptly Reportable Events
Major protocol deviations/protocol noncompliance that may, in the opinion of the PI, (1) impact subject safety and/or (2) affect the integrity of the data, such as:
Dosing errors
Enrolling a subject who does not meet eligibility criteria
Study visits outside the protocol-specified timeline or missed study visits

16. Promptly Reportable Events
Consent and/or authorization issues, including:
Failure to obtain consent/authorization
Failure to obtain signature prior to beginning procedures
Enrolling subjects using a consent which does not include all known risks, or continuation of subject participation without notification of newly-identified risks
Other major deficiencies in informed consent or HIPAA authorization process
Minor deficiencies affecting 10 or more subjects

17. Promptly Reportable Events
Subject complaints that indicate unexpected risk and/or affect the rights and welfare of subjects
Study suspension or holds related to risk, safety, or compliance issues
Incident that may compromise information security, subject privacy, and/or confidentiality
Local audit reports

18. Promptly Reportable Events
Follow-up information for a previous reportable event
Failure to submit amendments which update risks, benefits, or procedures within 60 days of receipt
Failure to promptly report events when required per IU IRB SOPs

19. Promptly Reportable Events - VA
Local research deaths which are unanticipated and related to the research
Local serious adverse events (SAEs) or serious problems which are unanticipated and related to the research
Any event constituting apparent serious or continuing noncompliance (see ORO Guidance)

20. Submitting via KC IRB

21. Submitting via KC IRB

22. Submitting via KC IRB
Additional questions based on the type of event being reported
Be prepared to provide:
Details about the event: what happened, when and how it was discovered, etc.
Corrective measures to resolve the issue
Preventive measures to prevent recurrence
Plan for notifying sponsors, subjects, etc.

23. After Submission Promptly reportable events reviewed by convened IRB
Notification of approval via as usual
Obtain approval documents as usual
Signed Protocol Summary Report + FYI questionnaire
Approval letter, including IRB determinations

24. After Submission Mandatory reporting by HSO:
Federally-regulated research (federal funding, FDA, VA) +
IRB determines event represents Unanticipated Problem Involving Risks to Subjects or Others (UPIRTSO) or Serious and/or Continuing Noncompliance

25. KC IRB Questionnaire Updates
FEBRUARY RELEASE
KC IRB Questionnaire Updates

26. KC IRB Questionnaire Updates
Summary of Changes
B – Lay Summary & Research Design
New OnCore question
G2 – Individuals Lacking Consent Capacity
Revise language to Individuals Lacking Consent Capacity; revised questions per Consent Capacity Working Group
H – Informed Consent Process
M – ClinicalTrials.gov
Revise definitions and follow-up question
Amendment
Renewal: Changes & Amendments
Revise personnel update information; facilitate IB updates (with other changes); collect more details regarding subject notification
Renewal
Revise language for understandabiltiy; revise DSM questions
Reportable Events
NEW QUESTIONNAIRE
Deferral Questionnaire

27. Impact of Questionnaire Updates
All revised questionnaires need to be updated/completed with:
New submissions Submitted to IRB on or after 2/23/2017
Any submission previously Submitted to IRB and pushed back into an editable status (e.g. Return to PI, Tabled, Provisionally Approved, Withdrawn)
HSO staff will make the update for you, to the best of their ability
Any amendment which affects the revised questionnaire

28. Updating KC IRB Questionnaires

29. Stay tuned…
NIH Policy on the Use of a Single IRB for Multi-Site Research (effective September 25, 2017)
Revised Common Rule released January 19, 2017

30. Questions?