Loyola University Chicago

1. All faculty currently conducting recombinant DNA research or teaching courses involving recombinant DNA techniques will submit descriptions of their procedures to the IBC for review within 60 days following October 16, 2006. The IBC has announced it will formally begin reviewing recombinant DNA research on this date.
2. Ongoing research that has been submitted for review by the IBC will be initially evaluated by the IBC (IBC Chair or Chair designate) as to whether the research is exempt or must undergo full committee review.
3. Research that is declared exempt by the IBC Chair or Chair's designate may continue without further oversight by the IBC unless changes are made to the protocol which would require further IBC review.
4. Investigators that have submitted ongoing research that requires full IBC review will have 90 days to address any contingencies that have been identified by the IBC. Research will be permitted to proceed during the 90 days. Ongoing research may continue during the actual review of the research by the IBC.
5.  After the initial submission of the protocol to the IBC, laboratory surveys must be completed by IBC Chair or BSO prior to action by the IBC on individual faculty applications. Surveys will be performed once the IBC Chair or Biosafety Officer assigns an appropriate Biosafety Level to the research program.

Initial protocol submissions to the IBC will be classified as:

1. Exempt Submissions - The IBC Chair will review all Exempt submissions to make a determination of Exemption. The outcomes of this review will be one of the following:
   1. Approval
   2. Conditional Approval - conditions must be satisfied in order for the protocol to be approved as Exempt.
   3. Not Exempt - The protocol is determined to not qualify for Exempt status and will be referred to the full IBC for review.
2. Full IBC Review Submissions - Submissions requiring full committee review will have one of the following outcomes:
   1. Approval - The committee has determined that the protocol adheres to the NIH Guidelines on Recombinant DNA Research and the research may proceed.
   2. Conditional Approval - Conditions must be satisfied in order for the protocol to be approved.
   3. Disapproval - The committee has determined that the protocol does not conform to the NIH Guidelines on Recombinant DNA Research and is therefore unacceptable. The investigator will be informed of the reasons for disapproval.
   
   Periodic Review - All approved protocols will be subject to review every three years. Investigators will be required to submit a renewal/update form for active procedures. When work has ceased on a protocol, investigators will be required to submit a "Request to Terminate a Protocol" form. If the NIH guidelines on Recombinant DNA Research change, amendments to existing protocols may be required.

The IBC recognizes the level of effort necessary for an investigator to submit a new grant application, and wants to assure timely review of procedures for biosafety compliance. To this end, the following policies have been established:

1. Some funding agencies require prior IBC approval before they will review a grant application.  For applications to such agencies, investigators must submit their protocols early enough that IBC has time to review and approve the protocols before the grant submission deadlines.  For applications to such agencies, the following IBC deadlines apply:
   1. For those protocols requiring Full Committee Review, the submission deadline to the IBC will be a minimum of 30 days before the submission deadline for the grant itself.  This time period is necessary for the processing and review of the protocol by the IBC and to allow the investigator to satisfy any conditions the committee may impose.
   2. For those protocols requiring Exempt Review, the submission deadline to the IBC will be a minimum of 21 days before the submission deadline for that grant itself.  This time period will allow for the processing of the application, review by the IBC Chair, and for the investigator to satisfy any conditions the IBC Chair may impose.
2. For applications to agencies that do not require prior IBC approval before they will review a grant application (those following "just in time" procedures, e.g., N.S.F., N.I.H.), the following IBC deadlines apply:
1. For those protocols requiring Full Committee Review, the submission deadline to the IBC will be a minimum of 30 days before funding begins.  This time period is necessary for the processing and review of the protocol by the IBC and to allow the investigator to satisfy any conditions the committee may impose.
2. For those protocols requiring Exempt Review, the submission deadline to the IBC will be a minimum of 21 days before funding begins.  This time period will allow for the processing of the application, review by the IBC Chair, and for the investigator to satisfy any conditions the IBC Chair may impose.

Investigators should consult the IBC Meeting Schedule on the Loyola IBC Website for dates of meetings and submission deadlines to ensure that timely review of protocols will be possible.

Proper laboratory safety procedures use personal protective equipment (PPE) as a protective barrier between laboratory personnel and hazardous agents with which they may come into contact.

Therefore, it is mandatory that all laboratory personnel will use appropriate PPE when working with hazardous chemicals, DNA, or micro-organisms.  PPE will not be worn by laboratory personnel outside the hazardous areas of the laboratory.

Principal Investigators will use their discretion in determining the use of PPE at times other than when laboratory personnel are working with the above agents.