Regulations

The IBC is mandated to uphold specific regulations, guidelines and standards pertaining to scientific research. KUMC recognizes the below references as mandatory unless special circumstances arise, in which sound justification may warrant exemption.

NIHNIH Guidelines

The NIH Guidelines are regulations published by the National Institutes of Health (NIH) Office of Biotechnology Activities describing the standards for working with recombinant & synthetic DNA. The publication is  entitled: "NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules".

 

BMBLBiosafety in Microbiological and Biomedical Laboratories, 5th Edition (BMBL)

The BMBL is a nationally recognized joint publication by the Centers for Disease Control & Prevention (CDC) and NIH describing the standards for research practices. Although the publication is a guidance document (as a whole), many portions are mandatory by other regulatory documents. KUMC takes the disposition that the entire document is mandatory and will serve as the baseline for research practices unless a completed risk assessment shows sound justification to state otherwise.

 

CDCSelect Agent Regulations

The CDC within the US Department of Health and Human Services (HHS) regulates the possession, use and transfer of biological select agents & toxins. The federal law that governs this research is known as the Select Agent Regulations (42CFR73).

Last modified: Mar 21, 2014
ID=x7908