Keeping Up with NIH Requirements for Recombinant DNA
by Paul Rubock
The NIH’s recombinant DNA Guidelines, first published almost thirty-four years ago, originated from an unprecedented instance of self-regulation. Following the Asilomar Conference in 1975, scientists declared a moratorium on research in this “new” area and then promulgated a consensus set of risk assessment and response actions that laid the groundwork for the current Guidelines. The direst possibilities entertained in the 1970’s now seem very remote, but the Guidelines have always had to adapt to technological advances. For instance, synthetic nucleic acids were, within the past year, formally deemed to be the equivalent of naturally occurring sequences in terms of risk assessment and associated notification and containment requirements. Earlier this year, the NIH also raised the bar on when recombinant DNA molecules can be deemed replication deficient. The latter change was based at least partially on the potential for using synthetic DNA to mimic functional genomes with decreasing amounts genetic material.
All laboratories must describe their use of rDNA in a submission to the University’s Institutional Biosafety Committee. This can be easily accomplished by selecting Appendix A from the RASCAL Hazardous Materials Menu. Keep in mind that “Guidelines” does NOT mean optional-they apply to all rDNA activities at an institution receiving any NIH funds for rDNA activities.
In addition to in vitro and in vivo (animal) applications, human gene transfer represents the third major rDNA activity in academic research. The review of such proposals is the joint responsibility of the IBC and the Institutional Review Board (IRB). Frequently, the personnel involved in the early, administrative aspects of reviewing such a proposal are most familiar with the IRB aspects of the approval process, including the protection of human research subjects. Reviewers may not recognize that even though this is yet another investigational product, the genetic manipulations designed to produce a therapeutic outcome call for IBC review in accordance with the Guidelines. EH&S recently hosted a webinar attended by CUMC IRB and HICCC personnel where the submittal requirements, along with how to distinguish a human gene transfer protocol from a ‘typical’ IRB submittal were discussed.
If you have any questions about your responsibilities under the Guidelines or how to identify a human gene transfer proposal, email them to: firstname.lastname@example.org.
Catching Up With ChemTracker by Jean Lee
In February 2006 the University deployed ChemTracker, a barcode and scanner-based system to manage chemical inventories on the Morningside Campus. The system has come a long way since then -
- There are currently49,664 chemical containers in the system.
- As of May 2010, we have added 29,793 retro barcodes to existing chemical containers.
- Random chemical audits performed this spring indicate that 96.24% of the campus’ chemical inventory has been captured, and the missing 3.76% of items have been subsequently added into the system.