IACUC and Biosafety Committees

The IACUC is authorized to approve, require changes to, disapprove all proposed research activities involving vertebrate animals. In addition, the IACUC is authorized to suspend any research activities that are in violation of previously approved protocols. All research involving vertebrate animals is required to be reviewed and approved by the IACUC prior to initiating research.

In addition to the review of research protocols involving the use of non-human animals, the members of the IACUC also conduct an internal program review and facilities inspection once every 6 months.

You will need to complete a Study Protocol Form and submit to the IACUC Chair for review. Please make sure to have completed CITI Training requirements before completing an application as this will be an automatic return to you and your study staff. For assistance on obtaining a certificate, view CITI training tutorial.

Please complete the renewal/closure form, and return to the IACUC Chair.

Please complete the unanticipated or adverse event form, and return to the IACUC Chair.

• Approved Domestic Animal Assurance
• Guide - Care and Use of Lab Animals
• CU Occupational Health Program for Animal Care and Use
• IACUC Guidebook
• IACUC New Member Information
• IACUC Policy - PRP 3995

The IACUC committee members meet at least once every six months to review the University’s IACUC program and inspect all animal facilities, and provide a report to the Institutional Official.  The committee may also meet throughout the year, as needed, to review procedures, protocols, and/or concerns of non-compliance. 

Use the anonymous tip line link to promptly report concerns. This enables protection for any affected animals, and promotes a caring and ethical culture.

Reports should include (but are not limited to) instances of:

1. Significant adverse impact on the health or welfare of one or more animals
2. Significant threat of adverse impact to animal welfare (such as extended power outages, flooding, facility damage)
3. Significant or repeated noncompliance issues with regulatory (State of Pennsylvania, OLAW, USDA) or funding entity (NSF, NIH) requirements
4. Significant or repeated noncompliance issues with CU-Bloomsburg and Animal Care and Use Program Protocols, Policies, Assurances, and Agreements

• Dr. Eric Stouffer – Research Scientist
• Dr. William Coleman – Research Scientist
• Dr. Kevin Ball – Research Scientist
• Dr. Pamela Frenz – Veterinarian (Non CU-Bloomsburg)
• Dr. Candice Klingerman – IACUC Chair
• Dr. Kylie Jeffrey D.C. – Non CU-Bloomsburg Affiliated
• Dr. Clay Corbin – Research Scientist
• Dr. Scott Duncan – Non-Scientist

• Dr. Candice Klingerman
• Christine Orlando

The mission of the Institutional Biosafety Committee is:

To ensure that all recombinant DNA research activities at Commonwealth University of Pennsylvania comply with Department of Health and Human Services, National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines).

To ensure that protocols of all research at the University which uses or produces biohazardous organisms or materials requiring Biological Safety Level 2 or higher containment, including but not limited to recombinant DNA, are reviewed and found to protect personnel, environmental, and public safety.

To ensure that protocols of all research at the University, which use or produces genetically modified plants (through the use of recombinant DNA) are reviewed and found to protect personal, environmental, and public safety.

All research involving recombinant DNA, human and/or animal pathogens, and genetically modified plants must be approved by the CU IBC before research can be initiated. The CU IBC meets as needed to fulfill its mission. Membership of the CU IBC consists of both faculty and external reviewers with expertise covering recombinant DNA technology, molecular biology, microbiology, infectious disease, animal care, and botany.

• Dr. Henry Karl

Principal Investigator Responsibilities

Principle Investigators (PIs) are responsible for full compliance with the NIH Guidelines during the conduct of research involving recombinant or synthetic nucleic acid molecules.

As part of this general responsibility, the PI should:

• Be adequately trained in good microbiological techniques.
• Provide laboratory research staff with protocols describing potential biohazards and necessary precautions.
• Instruct and train laboratory staff in (i) the practices and techniques required to ensure safety, and (ii) the procedures for dealing with accidents.
• Inform the laboratory staff of the reasons and provisions for any precautionary medical practices advised or requested (e.g., vaccinations or serum collection).
• Supervise laboratory staff to ensure that the required safety practices and techniques are employed.
• Correct work errors and conditions that may result in the release of recombinant or synthetic nucleic acid materials.
• Ensure the integrity of physical containment (e.g., biological safety cabinets) and biological containment (e.g., host-vector systems that preclude survival of the agent outside the laboratory).
• Comply with permit and shipping requirements for recombinant or synthetic nucleic acid molecules.
• Adhere to the IBC-approved emergency plans for handling accidental spills and personnel containment.

Before initiating research subject to the NIH Guidelines, the PI must:

• Determine whether the research is subject to Section III-A, III-B, III-C, III-D, or III-E of the NIH Guidelines.
• Propose physical and biological containment levels in accordance with the NIH Guidelines when registering research with the IBC.
• Propose appropriate microbiological practices and laboratory techniques to be used for the research.
• Submit a research protocol to the IBC for review and approval.
• Seek NIH OBA’s determination regarding containment for experiments that require case-by-case review.
• Petition NIH OBA, with notice to the IBC, for proposed exemptions from the NIH Guidelines.
• Obtain IBC approval before initiating research subject to the NIH Guidelines.
• Seek NIH approval, in addition to the IBC approval, to conduct experiments specified in Sections III-A and III-B of the NIH Guidelines.

While conducting research subject to the NIH Guidelines, the PI must:

• Determine the need for IBC review before modifying recombinant or synthetic nucleic acid research already approved by the IBC.
• Submit any subsequent changes (e.g., changes in the source of DNA or host-vector system) to the IBC for review and approval or disapproval.
• Remain in communication with the IBC throughout the duration of the project
• Report any significant problems pertaining to the operation and implementation of containment practices and procedures, violations of the NIH Guidelines, or any significant research-related accidents and illnesses to the IBC, NIH OBA, and, as applicable, the Biological Safety Officer, and other appropriate authorities.

PIs conducting human gene transfer research subject to Section III-C of the NIH Guidelines must:

• Ensure that all aspects of Appendix M have been appropriately addressed prior to submission of a human gene transfer experiment to NIH OBA for review by the NIH Recombinant DNA Advisory Committee (RAC).
• Provide a letter signed by the PI(s) on institutional letterhead acknowledging that the documentation being submitted to NIH OBA complies with the requirements set forth in Appendix M.
• Not enroll research participants in a human gene transfer clinical trial until the RAC review process has been completed; IBC approval (from the clinical trial site) has been obtained; Institutional Review Board approval has been obtained; and all applicable regulatory authorization(s) have been obtained.
• Comply with reporting requirements for human gene transfer experiments (Appendix M-I-C of NIH Guidelines).

• Faculty Questionnaire

What are the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules?

The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) detail procedures and practices from the containment and safe conduct of various forms of research involving recombinant and synthetic nucleic acid molecules, including research involving genetically modified plants and animals, and human gene transfer research.

Who must comply with the NIH Guidelines?

All institutions that receive NIH funding for research involving recombinant or synthetic nucleic acid molecules must comply with the NIH Guidelines. Researchers at institutions that are subject to the NIH Guidelines must comply with the requirements even if their own project are not funded by NIH.

What is an Institutional Biosafety Committee?

Institutional Biosafety Committees (IBCs) provide local review and oversight of nearly all forms of research utilizing recombinant or synthetic nucleic acid molecules. They ensure that recombinant and synthetic nucleic acid research conducted at or sponsored by the institution is in compliance with the NIH Guidelines.

What is the NIH Office of Biotechnology Activities?

The NIH Office of Biotechnology Activities (OBA) promotes science, safety, and ethics in biotechnology through the advancement of knowledge, enhancement of public understanding, and development of sound public policies. A core responsibility of OBA is to foster awareness of, and adherence to, the standards and practices set forth in the NIH Guidelines.

To receive updates on current initiatives, policies, and news from OBA, subscribe to their listserv, "OBA News" by sending a message to: listserve@list.nih.gov with the message "subscribe OBA_NEWS"