REMINDER: We now use Cayuse as our protocol management software.
For information about Cayuse, please click here .
Welcome to the Arkansas State University Institutional Biosafety Committee homepage. The purpose of this site is to provide a simplified roadmap through the procedures required at Arkansas State for conducting research that utilizes recombinant DNA technology. The University has established a Biosafety Program to protect students, faculty, staff, and the public from potential adverse exposure to biological materials used in research and teaching activities at ASU, and to satisfy federal regulatory and containment requirements concerning the appropriate use of Biohazardous materials. The Institutional Biosafety Committee (IBC) has oversight responsibility for the program with specific responsibility for:
- Ensuring that it fulfills all administrative oversight, review, and reporting functions as described in the NIH Guidelines for Research Involving Recombinant DNA Molecules
- Registering the IBC with the NIH Office of Biotechnology Activities
- Filing annual reports to update committee rosters and biosketches
- Meeting as needed and maintaining a permanent record of IBC meetings and activities. All protocols that include the use of biohazardous materials must be submitted to the IBC for its review via Cayuse IRB software.
Please refer to the University's Governing Principles for Biosafety and to the Office of Research FAQs for additional information, or call Research and Technology Transfer at (870) 972-2694.
When to seek Program Approval
a. Determine whether your laboratory has a program approval.
All work that is conducted is done under recommended containment level, e.g., BL1 and facilities and practices have been reviewed and approved by the IBC and a registration number assigned.
b. Determine whether the proposed research is covered under the program approval for the laboratory.
Used to cover the recombinant DNA research activity of the Lab. PI agrees that all work with certain organisms will be conducted at recommended containment levels and certifies that the facilities and practices in the laboratory are available to achieve this containment.
If yes, no additional action is needed.
If no, complete the program approval form.
Steps to Obtain Program Approval
a. Determine where the work is to be conducted.
Used to determine which Guidelines/Regulations are applicable. Research contained inside a laboratory follows NIH guidelines for recombinant research.
For research involving planned introductions outside the laboratory, USDA or EPA regulations may apply. At present, the IBC alone cannot provide approvals, but can provide information.
b. Determine whether the organisms require special containment for handling, culturing, and other activities, and if so, what containment level is recommended.
To assure safety of laboratory workers and the environment.
Complete a comprehensive risk assessment analysis of the organism(s) to be used. See NIH Guidelines appendix G (or pages 10-13 of this user's guide) and CDC list of pathogens for containment description and recommended level.
All work with human pathogenic or potentially pathogenic material must also be registered with the NIH Biosafety Committee/ASU Safety Office.
All transgenic plants, animals, and other higher organisms must be registered and approved by the IBC.
Plant pathogens may require compliance with USDA/APHIS regulations.
c. Complete the IBC program approval form.
Registers the recombinant DNA activity with the IBC, which ascertains and notifies P.I as the type of oversight and containment levels recommended by the NIH guidelines that are necessary.
Recommendations/Requirements for Laboratory Experiments
a. Determine whether the cloning work you propose is exempt from the NIH Guidelines.
Answer question 6 on the program approval form as III-E if you meet conditions of NIH guidelines Section III-E (see page 9 of this User's Guide). File with IBC. No action other than registration is needed. BL1 containment is recommended.
b. If not exempt, determine the containment recommended by NIH guidelines and the approval needed. Contact the BAC for guidance, if needed.
Answer question 6 as III-D if you meet the conditions of NIH Guidelines Section III-D (see page 9 of this user's guide). Most experiments in this category can be done at BL1 (See NIH Guidelines, Appendix G or Page 10 of this guide), and registered simultaneously with initiation.
Answer question 6 as III-C if you meet the conditions of NIH Guidelines Section III-C. This approval level includes transgenic plants and animals or cloning DNA into risk group 2 or higher organisms. Containment with such microorganisms is at BL2 or above, or is determined by the IBC. Experimental protocol for containment and practices must be approved prior to installation or through a program approval.
Answer question as III-A or III-B if you meet the conditions of NIH Guidelines Sections III-A or III-B (see page 8 of this user's manual). These experiments must be reviewed by the NIH-RAC or NIH-ORDA, which then recommends the conditions under which the experiment should or should not be done.
Recommendations/Requirements for Experiments Outside the laboratory
a. Determine whether the activity proposed constitutes a planned introductions into the environment.
If yes, it is likely that a permit from a regulatory agency is needed.
b. Determine, for the organism or application, which guidelines or regulations apply. NOTE: Transfer or shipping of organisms from another laboratory may need special approval.
Contact the IBC for further guidance.
All IBC protocols must be registered with the committee via Cayuse, our protocol management software. Cayuse 424 users may use their login credentials to access this software. If you are a new user, please contact CayuseIRB@astate.edu to request login credentials.