Annual Institutional Review of the IBC

1. Purpose
   • 1.1. This procedure refers to the IBC and biosafety program only.
   • 1.2. The purpose of this procedure is to describe the process for institutional review of the IBC and biosafety program by evaluators external to ORC and the IBC.
   • 1.3. The review is in the form of an annual report to the Institutional Official.

1. Key Word Definitions

   2.1. BSO: Biological Safety Officer
   2.2. ORC: Office of Research Compliance 2.3. IBC: Institutional Biosafety Committee 2.4. PI: Principal Investigator
   2.5. IO: Institutional Official

   2.5.1. The IO for Mississippi State University is the Vice President for Research and Economic Development.

2.6. VP-ORED: Vice President for Research and Economic Development 3. Responsibilities and Authorities

3.1. Biological Safety Officer
3.1.1. Writes annual report;
3.1.2. Organizes statistics and data.

3.2. IBC Chair
3.2.1. Assists in writing report.

3.3. IO: Reads report and provides feedback.

4. Items Needed
4.1. Annual Report Template

Section: Biosafety Effective Date: 8/18/10

STANDARD OPERATING PROCEDURE

5. Procedure
5.1. The BSO will gather and organize statistics for report;
5.2. The annual report will cover the calendar year from January through December;
5.3. The annual report will be submitted to the IO by January 31 of the next calendar year. 5.4. The BSO will write the annual report with assistance from the IBC Chair.
5.5. The annual report will consist of the following sections:

5.5.1. Section I: Overview of the IBC
5.5.1.1. function of the IBC;
5.5.1.2. membership roster including areas of expertise represented on the committee.

5.5.2. Section II: Performance/Year in Review

5.5.2.1. 5.5.2.2. 5.5.2.3. 5.5.2.4. 5.5.2.5. 5.5.2.6. 5.5.2.7. 5.5.2.8.

number of applications reviewed;
number of post-approval monitoring reviews performed; number of modifications/updates/completions received; number of laboratories and animal facilities reviewed; total number of BSL-2 labs both on and off campus; types of organisms/rDNA handled;
number of incidents reviewed;
results of annual PI survey;

5.5.2.8.1. documented PI complaints with resolution.

5.5.2.9. 5.5.2.10. 5.5.2.11.

5.5.3. Section III 5.5.3.1.

Effective Date: 8/18/10

number of policies and procedures approved/reviewed;
number and types of training given;
description of other activities performed by the IBC or biosafety program.

Goals for upcoming year

5.6. Comments from the IO will be shared with the IBC at the next scheduled meeting after receipt of IO response.

6. Associated SOPs 6.1. None

7. Associated Forms

7.1. Annual Report Form

8. References

   8.1. NIH OBA Tool for the Self-Assessment of the IBC and Program Oversight of Recombinant DNA Research

9. Revision History
   9.1. Revised 4/1/2013 and approved 5/15/2013 9.2. Revised 12/4/2014 and approved 2/18/2015 9.3. Revised 7/29/2015 and approved 9/16/2015