Initial Review

The EHS Risk Assessment must be filled out prior to initiation of all research projects, basic or clinical, funded or not funded, except for HSC low risk exempt studies.  All information regarding hazards involved in any research project must be complete.   Submit a copy of the form and any necessary additional information to the Research Institute (RI), 6th floor Wescoe, along with your grant paperwork for new projects/renewals. For studies not managed through the RI, submit the form with the HSC or IACUC application.

The IRSC classifies research involving biohazards into three classes:

Class 1:  Research which, according to the current body of knowledge reasonably known to the scientific community, involves negligible risk to any organism other than organisms which are the subject of the research.

Class 2:  Research which, according to the current body of knowledge reasonably known to the scientific community, involves negligible risk to the community at large, but which may pose  a  risk  to KUMC  personnel,  patients  or  property.    Proposals  involving recombinant DNA activities that are exempt from NIH guidelines may be defined as Class 2. In these cases, a written statement must be submitted along with the appropriate IRSC form indicating that the proposal is exempt from the NIH guidelines and describing the recombinant DNA activities in sufficient detail to allow the Committee Chairman to make a determination that exemption is appropriate.

Class 3:  Research which poses a significant risk to the community at large such as posing the possibility  of  an  epidemic,  blight,  or  pervasive  cloud  of  dangerous  chemicals.    All recombinant DNA activities that are not exempt from NIH guidelines are defined as Class  3.  Additionally, certain activities involving highly toxic or infectious agents may also need to be defined as Class 3.

Each principal investigator needs to have on file with the Institutional Research and Safety Committee, a statement describing the research program conducted in his/her unit, the normal hazards associated with those research programs, and the normal safety precautions followed in such research.  The principal investigator shall also indicate which research programs of his/her unit pose Class 1, 2 and 3 hazards.  This statement should be submitted on the appropriate EHS Risk Assessment form as noted above and at the initiation of any new research.