/ The University of Toledo
Department for Human Research Protections
Social, Behavioral & Educational Institutional Review Board
Office of Research, Rm. 2300 University Hall
Mail Stop 944; Toledo, Ohio 43606-3390
Phone: 419-530-2844 Fax: 419-530-2841
Deviation/Violation/Participant Non-compliance Reporting Form

Directions: A new form must be completed and submitted to the SBE IRB for each incident of deviation or violation or participant non-compliance within 5 days of the P.I. becoming aware of the occurrence (see comment below regarding reporting participant non-compliance.

Filing of this form with the SBE IRB does not release the Principal Investigator from any other reporting requirements of the government, sponsor, external IRB or other regulatory agency. Please fill in all narratives on the computer. Additional supporting documents may be attached to this form.

Definitions:

Deviations are variances from the SBE IRB (and sponsor when one exists) approved protocol/protocol related materials that have not been pre-approved and 1) are within the researchers' control, 2) imposed no increase in risk to the participant and, 3) did not result in a negative consequence and it is not anticipated that it may result in a negative consequence in the future.

Violations are variances from the SBE IRB (and sponsor when one exists) approved protocol/protocol related materials that have not been pre-approved and 1) are not within the researchers' control, 2) imposed an increase in risk to the participant and/or, 3) may have resulted in a negative consequence already or may in the future.

Participant Non-Compliance refers to variances from the SBE IRB (and sponsor when one exists) approved protocol/protocol related materials that have not been pre-approved and are not in the control of the researcher. They may or may not have increased risk to the participant and/or result in a negative consequence.

Only those instances of participant non-compliance that increased risk to the participant and/or resulted in a negative consequence already or may in the future as determined by the principal investigator must be reported to the SBE IRB.

SBE IRB #: / IS THIS A: Violation Deviation Participant Non-Compliance
PROTOCOL TITLE:
IF THIS IS A SPONSORED PROJECT, PROVIDE NAME OF SPONSOR:
TOTAL APPROVED NUMBER OF HUMAN SUBJECTS:
TODAY'S DATE: / DATE OF OCCURRENCE:
1. / Describe the violation/deviation/participant non-compliance:
2. / Explain why this occurred.
3. / What steps were taken to resolve this particular occurrence?
4. / What is being done to prevent similar occurrences in the future?
5. / Did the occurrence result in an adverse event or a violation of the rights of a human subject (e.g. violation of privacy)?
Yes – Explain in Detail Below No
6. / Will the participant continue with the research?
Yes No – List Date Stopped:
7. / Will the research project itself continue?
Yes No – List Date Stopped:
8. / Was the study sponsor (if one exists) and/or all other required regulatory agencies notified of the occurrence within the required timeframe?
Yes – Please provide information below No – Go to signature line)
Agency Name / Contact / Phone Number / Date Contacted
Name of Principal Investigator
Principal Investigator (signature): / Date:

SBE Deviation Reporting Page 1 of 2 08/13/2007