UW Oshkosh

Office of Sponsored Programs and Faculty Development

INSTITUTIONAL BIOSAFETY COMMITTEE

ANNUAL CONTINUING REVIEW FORM YEAR 1 & 2 NON-EXEMPT PROTOCOLS

Note: IBC Registrations and Exempt status activities do not have expiration dates assigned. Annual continuing review is not required for these activities, however, if modifications to your registration or Exempt status project are requested please complete the IBC Modification Request Form, found at www.uwosh.edu/grants/forms

Date: Year: Year 1 Year 2 / Expiration Date: / ______
Principal Investigator: / ______
Protocol #: / ______
Project Title: / ______

The protocol specified above is due for annual continuing review by the IBC as required by the NIH Guidelines and terms outlined in the UW Oshkosh Office of Biosafety Activities (OBA) registration. To maintain approval status, return this form electronically to using your UW Oshkosh user account for verification. This form must be completed and returned prior to the anniversary date of the project. Please allow 2 weeks for the IACUC to complete the annual continuing review.

Note: Review your protocol application closely as you complete this form. Non-Exempt protocols and all IBC forms can be downloaded from TitanFiles or the Grants & Faculty Development website at: www.uwosh.edu/grants/forms

Please select one of the following:

Study is completed. Please close the file. (Answer questions below, sign form, attach any publications resulting from the project activities)
Study was never conducted. Please close the file. (Sign form)
Study is still in operation and will be used with no revisions. (Answer questions below and sign form)
Study is still in operation but modifications to the protocol are requested.
Please complete the IBC Modification Request Form if a modification to your protocol is requested. Include the Modification Request Form with this Annual Continuing Review Form and submit to
1.  During the past year, have there been incidents to report to the IBC or OBA? / Yes / No
If yes, please explain.
Note: Incidents involving your protocol should be reported to the IBC within 72 hours

Self Audit of Approved IBC Protocol

PROTOCOL AND PERSONNEL
1.  Do the PI and personnel all have access to the most recent version of this protocol and (any) modifications? / Yes / No / N/A
2.  Do the PI and personnel have accurate knowledge of the protocol / Yes / No / N/A
3.  Are all personnel who handle rDNA, synthetic nucleic acid molecules, biological agents/toxins, or other biohazardous materials listed on the protocol? / Yes / No / N/A
4.  Have all personnel received and completed training appropriate to their job duties? (Note: The PI is ultimately responsible for ensuring all research personnel and students are trained). / Yes / No / N/A
STUDY PROCEDURES
5.  Are the procedures used the same as those described in the protocol? / Yes / No / N/A
6.  Are the types of biohazardous materials used on the research or teaching activities consistent with those listed in the approved protocol? / Yes / No / N/A
7.  Have amendments been submitted for any changes in procedure? / Yes / No / N/A
8.  Are personnel wearing protective clothing (e.g. gloves, lab coat, etc.) appropriate for the biohazardous or biological materials in use and for subsequent procedures? / Yes / No / N/A
RISK ASSESSMENT
9.  Have new or additional risks been identified since IBC approval/last continuing review? / Yes / No / N/A
10.  Has the research design, procedures or methods of your protocol changed? / Yes / No / N/A
11.  Has the study organism, host, vector or donor species listed in the protocol changed? / Yes / No / N/A
12.  Has there been a change in DNA segment, selected gene, insert, or protein?
13.  Has the source(s) of biohazardous materials changed?
14.  Has there been a change in the type of PPE used?
15.  Has there been a change in source(s) of biohazardous materials listed in the protocol?
16.  Has the type of PPE used for the project activities changed?
17.  Has there been an increase in Risk Group of Biosafety Level Containment? / Yes
Yes
Yes
Yes
Yes
Yes / No
No
No
No
No
No / N/A
N/A
N/A
N/A
N/A
N/A
If you answered “Yes” to any of these questions please use the space below to provide an explanation.
18. Please provide an explanation to the changes listed in Questions 9-17
By checking this box and printing my name below, I agree to conduct the project in accordance with the PHS Policy, USDA regulations, Federal Animal Welfare Act, the Guide for the Care and Use of Laboratory Animals, and all relevant institutional regulations and policies regarding animal care and use at the University of Wisconsin Oshkosh.
Signature of PI: / ______/ Date:

IBC Use Only Below This Line

Status: / Ongoing without Revisions / Closed / Protocol Modification Requested (submit IBC Modification Request form with this form)
Signature of IBC Chair or Designee: / ______/ Date: / ______
Comments:

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