1. the Issue of Noncompliance Involved

HUMAN SUBJECT RESEARCH Noncompliance Reporting Form

Noncompliance is defined as the failure (intentional or unintentional) of an Investigator, his/her designees, IRB members, RSPP staff members, or others involved in the conduct or review of research involving human subjects to adhere to: a) federal, state or local human subject protection laws, regulations, or policies: b) Aurora system policy on human subjects in research; c) Aurora Research Subject Protection Program (RSPP) standard operating procedures governing the review and conduct of human subject research; d) IRB determination; and/or e) IRB-approved protocols excluding changes made to eliminate apparent immediate hazard to subjects. Noncompliance may be related to studies reviewed by Aurora’s IRB as well as studies ceded to an external IRB. Noncompliance does not include failure by the study subject to follow protocol or investigator/study team instructions. For RSPP Use Only (Receipt Stamp) Must be reported no later than 10 working days of discovery.

Aurora IRB Protocol #: / Protocol Title: Principal Investigator: Contact person: Contact person’s E- Contact Person’s Phone #: mail:

Date of discovery: Subject Identifier: Date of occurrence:

1. The issue of noncompliance involved: Failure to obtain IRB approval prior to any protocol change, excluding Failure to follow study-specific IRB directives changes made to eliminate apparent immediate hazard to subjects Investigator/study team failure to follow protocol: Data sharing/data protection issues including Breaches of Privacy. out of window visits/item/service If a Privacy breach, you must notify the Aurora Privacy Office per dosing error Aurora system policy #198-HIPAA Privacy Breach Investigation and lab processing error Notification. Check here to document notification. specimen ordering/collection error inclusion/exclusion criteria error

 Failure to obtain or document informed consent/authorization or failure Failure to obtain IRB approval for human subject research to use the IRB approved consent/authorization form or other material Failure to follow Aurora system policies on human subject research or Other RSPP/Aurora IRB SOPs

2. Describe specifically what occurred and the events surrounding the Noncompliance. Check if you have attached supporting documentation. If a medical event, remember to include, as applicable:  specifics on hospitalization, life-threatening occurrence, surgical/medical intervention  whether the missed test/procedure or visit was required by the protocol for safety purposes or only a data point.

3. Briefly explain what caused the noncompliance to occur (e.g., inadequate training, inadequate process, intentional decision by investigator for subject safety purposes, etc.):

4. Explain why the Noncompliance would or would not significantly [defined per RSPP SOP 601 as: “In a way that is important enough to be worthy of attention or have an effect”] increase the potential risk of harm to future subject(s) should it recur:

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5. Explain why the noncompliance did or did not significantly compromise subject rights:

6. Explain why the Noncompliance did or did not significantly impact the integrity of the study/data:

7. What action was or will be taken to correct this issue of Noncompliance and on what date(s) was it or will it be taken:

8. What action was or will be taken to prevent this Noncompliance from recurring (consider/address what caused the Noncompliance to occur) and on what date(s) was it or will it be taken:

9. Is this study ceded to a non-Aurora IRB? YES/ NO If “YES,” was this issue of noncompliance reported to the non- Aurora IRB/IRB of Record? YES/ NO

______(Printed name of individual submitting report) (Date)

If Submitter is not the PI, Submitter certifies that PI has been notified of Noncompliance report.

If an email submission, attach a copy of the form to an email addressed to [email protected]. If a Cyber IRB submission, upload a copy of the completed form to Cyber.