Frequently Asked Questions
When conducting research or teaching activities involving material(s) included by any of the categories defined in Penn State Policy SY24 - Use of Regulated and Biohazardous Materials in Research and Instruction.
IBC Application Forms are online here.
I conduct research that involves recombinant DNA molecules. Does my research require review and approval by Penn State University’s Institutional Biosafety Committee (IBC)?
The Office of Biotechnology Activities (OBA) is the governing body, which oversees research activities that involve recombinant DNA molecules. OBA’s directive is to ensure an institution's Biosafety program satisfies the standards outlined in the federal policy; “National Institutes of Health Guidelines (NIH) for Research Involving Recombinant DNA Molecules”. Consequently, each institution is required to establish an IBC, which reviews and approves the use of rDNA molecules for research, and reports to OBA at least annually.
Some research practices (even if ancillary to the experimental goal) involving strands and/or segments of DNA or RNA must conform to the NIH Guidelines for Research Involving Recombinant DNA Molecules. Recombinant DNA molecules have been defined as either: (i) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or (ii) molecules that result from the replication of those described in (i) above. Nucleic acids that are not and cannot be replicated inside organisms, cells, or viruses are not considered rDNA. Some examples of commonly encountered synthetic DNA not considered to be rDNA are simple Polymerase Chain Reaction (PCR) products, synthetic oligonucleotides/primers, and complementary DNA (cDNA) obtained by reverse transcription of RNA.
Scientists conducting research activities that involve rDNA molecules, as defined above, must submit the details of their project to Penn State University’s IBC for review and approval before the work is initiated. Projects involving rDNA molecules that have not been reviewed and approved by the IBC may not comply with federal policy, nor can they be supported through grants from Public Health Service Organizations (e.g. National Institutes of Health, Food and Drug Administration, and the Center for Disease Control).
Information on the Penn State University’s Biosafety Program can be found on the Office for Research Protections website. In addition, protocol forms, submission instructions, and contact information for staff who can assist you with the submission can also be found on the website.
When should a protocol modification be submitted to the IBC and how do I request changes (including personnel additions)?
All changes to how biohazardous/regulated materials, as defined in Penn State Policy SY24, will be used in the course of your activities must be submitted to the IBC for review and approval prior to the changes being implemented or the new materials being used. In addition, all new laboratory personnel who will work with biohazardous/regulated materials must be approved on the appropriate IBC protocol(s) prior to beginning this work. To add personnel only to an IBC-approved protocol, complete and submit the IBC’s Addition of personnel to an Approved IBC Protocol Form. For other changes, complete and submit the IBC’s Modification Request Form.
I have a new grant, doing many of the same things with a similar research objective – how do I get IBC approval for my new grant?
First, carefully review your new grant and existing approved protocol(s) to ensure that all procedures listed in the grant are covered by the existing approved protocol(s). If all of the new grant’s procedures are not included, complete and submit the IBC's Modification Request Form. If all of the procedures are included, please email ORP-Biosafety@psu.edu with a request to add the grant/funding agency to the appropriate IBC protocol(s). Please note that if your new grant has very different procedures or research objective(s), you’ll want to submit a new application.
An MTA is required when:
- Penn State owned tangible research materials including, but not limited to, animals, reagents, cell lines, devices, software and data are being sent to another academic institution, research institution or company.
- A Penn State researcher will receive tangible research materials including, but not limited to, animals, reagents, cell lines, devices, software and data from another academic institution, research institution or company. If the materials are being shipped to Penn State, Penn State often uses the company/institution’s agreement.
For all University locations other than the Hershey Medical Center/College of Medicine
Penn State’s Office of Technology Management (OTM) processes all MTAs for materials being shipped from Penn State and materials being shipped to Penn State from another academic institution, research institution or company.
Many of Penn State’s Colleges also have their own checklist completion requirements and/or other approval requirements for MTAs. Researchers should consult with their College’s Research Office regarding any additional MTA requirements or may contact the OTM for additional information.
If biological materials are being sent or received, the Uniform Biological Materials Transfer Agreement (UBMTA) can be used if the other institution/company has signed the Master UBMTA. You can check the list of entities that have signed the Master UBMTA as well as download the UBMTA for completing. The UBMTA should still be sent through the OTM for execution on behalf of Penn State.
The OTM coordinates with Penn State's Office for Research Protections (ORP) to verify that all necessary research oversight committee (i.e. IRB, IACUC, IBC and UIC) approvals are in place for all materials listed on the MTA. If materials are being received from or shipped outside of the United States, the OTM also completes an export review to ensure that there is no export control on the materials.
The OTM will prepare and forward the MTA for appropriate signatures by the other company/institution and/or PSU. Once the agreement is fully executed, a signed copy will be sent to the other institution/company and the OTM will notify the Penn State researcher and the College so that arrangements can be made to send/receive the materials. (Please note: All incoming and outgoing animal shipments must be coordinated through Penn State’s Animal Resource Program. When shipping hazardous materials, researchers must adhere to Penn State Policy SY34, Hazardous Material Shipping.)
The MTA execution process can sometimes take one to two weeks to complete.