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

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

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

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

Major Changes

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

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

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 email to irb@iu.edu

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

Reportable Events

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

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)

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

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

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

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

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

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

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)

Submitting via KC IRB

Submitting via KC IRB

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.

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

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

KC IRB Questionnaire Updates FEBRUARY RELEASE KC IRB Questionnaire Updates

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

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

Updating KC IRB Questionnaires

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

Questions?