午夜AV

Please Complete the Following Steps With Each Research Protocol You Wish to Submit.

1. Self-classify your research protocol lab exercise as Exempt or Non-Exempt using the NIH rDNA Categories and Full Guidelines.
2. If you feel your research is exempt, complete the Exemption Application and submit it for IBC Chair/BSO approval.
3. If it is clear to you that your research is non-exempt, complete the Full Protocol Submission Form.
4. If you wish to make a change to your approved protocol, please complete the Amendment Form.

• Office of Biotechnology Activities

• NIH Guidelines for Research Involving Recombinant DNA Molecules

•  (see Appendix A for information on Primary Containment for Biohazards)

IBC Policy for Initial Review of Ongoing Recombinant DNA Research by Faculty

• 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.
• 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.
• 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.
• 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.
•  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.

Review Policies and Outcomes for Submitted Proposals

• Initial protocol submissions to the IBC will be classified as:

1. 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.

Policy for Submission of IBC Protocols for New Grant Applications

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. 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.
      • 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 午夜AV IBC Website for dates of meetings and submission deadlines to ensure that timely review of protocols will be possible.

• Policy for the Use of Personal Protective Equipment in the Research Laboratory
  
  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.

All principal investigators, with an approved IBC protocol, should fill out the “Biosafety Laboratory Personnel Form” located on this webpage. This form should be filled out and sent to the Assistant Director for Research Compliance. The form should then be submitted to the Assistant Director for Research Compliance yearly thereafter.

The completion of this form is important so that the IBC may update its training records with the appropriate personnel present in each laboratory.

• For a protocol to be put on the meeting agenda for Full IBC review, it must be submitted to the IBC a minimum of 2 weeks before the scheduled meeting date. Protocols submitted for Full IBC review after the 2 week deadline will be reviewed at the next scheduled IBC meeting.
• In accordance with the IBC review policy for Ongoing Faculty Research, the 60 day deadline in this policy refers to the submission of the protocol to the IBC Office located in the Office of Research Services.
• Investigators are reminded to consider the dates of convened IBC meetings for Full IBC review of protocols when complying with the submission deadlines mentioned in the "Policy for Submission of IBC Protocols for New Grant Applications."

Biosafety training is an important part of the 午夜AV Biosafety Program.  The IBC has established two online training courses that must be completed to certify that laboratory personnel, working with recombinant DNA or biohazardous organisms, are appropriately trained for this type of work. One training course covers general biosafety practices and the other covers the proper uses and handling of UV radiation for sterilization purposes.   All investigators and laboratory personnel must complete these courses as a requirement of IBC approval of research protocols.  This policy took effect on January 1, 2007.

Please contact the ORS Director for Research Compliance for information on how to access the online training courses and take the quizzes.

A passing grade of 80% must be obtained in order to obtain certification for these courses.  The final quizzes may be attempted until a grade of 80% is obtained and submitted to the IBC in the Office of Research Services.

The online course that will be used for general biosafety practices has been prepared for a clinical lab setting but the practices and principles that are taught in this course apply to research laboratories performing recombinant DNA research or research with biohazardous organisms at 午夜AV. When viewing this online course, please disregard the one section that is specific for phlebotomists.