Research Utilizing rDNA Technology
Written by Erica Kresovich and Bill Greer, ORP

Given that aspects of recombinant DNA (rDNA) technology are increasingly found in a majority of research activities conducted at Penn State University, individuals should be reminded that this research is regulated through the Office of Biotechnology Activities (OBA), at the National Institutes of Health. The NIH Guidelines for Research involving recombinant DNA Molecules (NIH Guidelines) govern rDNA research (http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html). Although the NIH Guidelines place the onus of compliance on the principal investigator (PI), they indicate the institution is responsible for ensuring rDNA research conforms to the NIH Guidelines. The NIH policy clearly states that deviation from the guidelines may result in the suspension and/or termination of Public Health Service funds supporting research that involves rDNA technology. In December 2004 OBA published a memo reminding institutions that rDNA research requires oversight from an Institutional Biosafety Committee (IBC). This memo can be accessed via the following link: http://www4.od.nih.gov/oba/IBC/rDNA_Compliance_Reminder.pdf (PDF).

The NIH Guidelines require institutions conducting rDNA research toestablish an IBC, which is responsible for the review and oversight ofrDNA research. Depending on the scope of the research a projectmay be exempt from the rDNA guidelines. Historically, Penn StateUniversity has placed the onus of determining the exemption status of a project on the PI. However, effective immediately, the IBC willshare the PI's responsibility of determining the exemption status oftheir rDNA research. Penn State University Policy SY-24, "Use of Biohazardous Materials in Research and Teaching" has been revised torequire each investigator utilizing rDNA technology to submit an application to the Office for Research Protections (ORP). Applications can be accessed on our website at: http://www.research.psu.edu/orp/areas/biohazardous/applications/IBC.rtf (RTF). If you determined your research to be exempt from guidelines, the application will validate your assessment and remain on file in our office documenting that rDNA techniques are occurring in your laboratory. ORP must have a completed application on file for every project involving rDNA technology (determined to be exempt or non-exempt) and being conducted at PSU.

If you have any questions about using rDNA at PSU, please contact the Office for Research Protections at 814.865.1775 or at orprotections@psu.edu.