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Bio Hazards

INSTITUTIONAL BIOSAFETY COMMITTEE

RECOMBINANT DNA PROCEDURES (updated 10/7/2009)

I.       PROCEDURES FOR PROCESSING RECOMBINANT DNA PROPOSALS

A.     The Office for Sponsored Programs and Research Activities (OSPRA) identifies a proposal involving Recombinant DNA or a Principal Investigator (PI) contacts the Institutional Biosafety Committee (IBC) or Institutional Biosafety Officer (IBO) with an inquiry.

B.      A Preliminary Review Form (PRF) and a copy of the Institutional Biosafety Committee Procedures is sent to the PI by the IBC-RDS Chair.

C.      Upon receipt of the completed Preliminary Review Form, the IBC-RDS Chair or an IBC Member evaluates the Preliminary Review to determine the status of the project.

D.     IF EXEMPT, the IBC-RDS Chair sends a letter of exemption status to the IBO and to the PI.

E.      IF NOT EXEMPT (MUA or notification letter required)

1.         The Preliminary Review results will be sent to the PI in the form of an official notice, with a copy to the IBO for file documentation, and a Memorandum of Understanding and Agreement (MUA) is requested from the PI.

2.         The IBC-RDS will make copies of the MUA and distribute them to the IBC members, who will convene to review the MUA within four months of the Preliminary Review. (Note: The IBC-RDS meets on an Ad-hoc basis. Every effort will be made to finish the review within thirty days.)

3.         If the IBC rules that modifications are necessary or special conditions must be met by the PI, the Chairperson will notify the PI and the IBO in writing of the necessary conditions for IBC approval.

4.         It is the desire of the IBC to aid the PI in obtaining IEC approval and expediting his or her research, but it is the PI's responsibility to comply with the NIH Guidelines. It is especially important to allow time (about one month) for the IBC to complete its study and approve facilities if any of the proposed experiments are not exempt.

II. PROCEDURES TO BE TAKEN TO MONITOR RECOMBINANT DNA RESEARCH AND ASSURE COMPLIANCE

Procedures to Assure Compliance in Case of Failure of Principal Investigator to Respond:

(The IBC may modify or accelerate the following process according to the degree of risk [or public perception of risk involved.)

A.      If the PI fails to respond to a request for a PRF or MUA within 30 days, a "No-Response Letter" is sent to the Principal Investigator.

B.      If still no response within an additional month (total of 60 days), the Principal Investigator is sent the "Procedures to be Taken to Monitor Recombinant DNA Research and Assure Compliance" and is requested to appear before the IBC to explain the lack of response. Copies of this correspondence are also sent to the PI's chairperson or supervisor.

C.      If refusal or unexplained failure to attend or if still no response (or MUA submission), a letter of concern will be sent along with the Procedures to be Taken to Monitor Recombinant DNA and Assure Compliance to the Principal Investigator and to the immediate superior (Department Chairperson and Dean or Provost)

D.      If still no response or no MUA submission, the Academic Vice President and Provost, and the President will be informed of the failure to cooperate and will be requested to advise the PI and appropriate chair/dean of the importance of compliance with institutional policies. This action may include suspension of unapproved laboratory research.

Please click here for a fillable copy of the Memorandum of Understanding and Agreement (MUA).

For additional information, please contact:

IBC RECOMBINANT DNA CHAIR                      
Dr. Stokes S. Baker
Biology Department
University of Detroit Mercy
101 Ford Life Science Building
PO Box 19900
Detroit, MI 48219-0900
Phone: (313)993-1142
Email: bakers@udmercy.edu

INSTITUTIONAL BIOSAFETY OFFICER
Dr. James F. Graves
Biology Department
University of Detroit Mercy
101 Ford Life Science Building
PO Box 19900
Detroit, MI 48219-0900
Phone: (313) 993-1162
Email: gravesjf@udmercy.edu