UMBC IBC Forms and Submission Procedures

 

Full committee
Designated member
Training requirements
NIH research classifications

The below information will assist investigators in the planning, development and submission of research protocols and teaching lab applications for review and approval by the IBC.

Training

Please review the requirement for biosafety training. The IBC requires that anyone performing activities involving biohazardous material, including infectious biological agents and recombinant or synthetic nucleic acid molecules. All principal investigators as well as research staff, and Lab Instructors involved in research in their laboratories are required to take this training so they understand the specific hazards associated with their work and know how to protect themselves from such hazards in the areas specific to the research. Training must be renewed every three years.

How to submit a research protocol or teaching lab application

Applications to the IBC may be submitted under two processes (please download the form in order to fill it out):

1) Submission of an IBC Research Application Form  or IBC Teaching Lab application form for consideration at a convened IBC meeting:

Application forms will describe the use of recombinant or synthetic nucleic acid molecule use in research and teaching labs at UMBC when such research or teaching falls under classification of the NIH Guidelines. A summary of these classifications are found at the bottom of this page. The use of biohazardous materials in research and teaching also requires input and approval of use from the IBC. The IBC meets quarterly or as required by the IBC Chair.  Submission of IBC applications to compliance@umbc.edu by the below deadlines will ensure a more efficient review of your application. The meeting schedule for the 2024-2025 academic year is as follows:

 The IBC will meet on:                             Applications must be submitted to ORPC no later than:  

January 17, 2024                                                      December 17th, 2024

April 17, 2024                                                          March 17th, 2024

July 17th, 2024                                                        June 17th, 2024

October 16th, 2024                                                 September 16th, 2024

January 15th, 2025                                                  December 15th, 2024

 

2) Submission of an IBC Research Application Form for using the IBC’s “Designated Review” (DR) process:

The DR may only be used by the IBC for projects including:

  • The purchase of commercially available materials (e.g. Addgene ) for a new faculty member “startup’ program.
  • The processing through the Office of Technology Development of material transfer agreements to obtain materials from a collaborator/colleague for the above situation. Consult the IBC’s Frequently Asked Questions regarding material transfer agreements.

The intent of DR projects must fall within the list of exempt recombinant or synthetic nucleic acid molecule experiments listed in the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (“NIH Guidelines”) Section III-F, Exempt Experiments and must be conducted under BL1 containment conditions. The DR process may not be used for work with transgenic animals or plants or for currently approved IBC registrations.

Using this process, the IBC Chair will appoint two committee members to review the project. These members are given 2 business days to either accept the DR request or call for full committee review. If a single committee member calls for a full committee review, then the project is reviewed by the full IBC at the next convened meeting. If no calls are received for full review and the designated reviewers have no questions or concerns, a letter of DR approval will be forwarded to the investigator. DR approvals are documented in the agenda of the next IBC meeting.

IBC Application and Pre-review Consultation

The ORPC staff is available to answer any questions regarding the IBC submission process and IBC review of research studies, and teaching lab applications. We also provide pre-review consultation to discuss all aspects of IBC review, from preparing the submission to completion of the study or teaching lab. We also offer in person review sessions on Wednesdays between 12:00 pm and 1:00 pm during the academic year. Please visit our registration page to arrange a time.   Please contact the office staff for more information.

Grant Congruency Review

Grant to protocol review is required when investigators seek or obtain funding to conduct research with animals, human subjects or biohazardous/recombinant DNA use. All research procedures outlined in a grant/contract submission must be covered in an approved protocol and all compliance committee approvals must be secured prior to the release of research funds.

Examples of information required for congruency review include:

  • Specific aims of the research
  • Animal/human/biohazardous material/recombinant DNA use research work scope
  • Procedures proposed in a grant application
  • Collaborations or subrecipients proposed in a grant
  • Revisions to grant due to grant reviewer comments
  • Modifications to protocol applications, performed at different times in a protocol time cycle
  • Co-investigators and/or research personnel

Congruency reviews are conducted by the ORPC. If questions arise during the congruency review, the ORPC will contact the PI for additional information, clarification of discrepancies or request that a protocol submission or modification be made to the appropriate compliance committee (e.g., IRB, IACUC, IBC). The Office of Sponsored Programs will be notified of the review. The PI is responsible for notifying OSP of new funding or amendments made to protocols.

Who can be a principal investigator

UMBC personnel who carry out activities involving recombinant and synthetic DNA as well as biohazardous materials fall under the auspices  NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. The individual who has the primary responsibility for a project that includes the design and implementation of research involving recombinant and synthetic DNA and biohazardous materials  is known as the Principal Investigator (PI). The PI ensures that students, technicians and research staff be made aware and understand their individual and collective responsibilities for research related tasks as defined here as well as the UMBC IBC Charter. In terms of an IBC application, at PI is a full time faculty member in a department where these research activities are conducted and may also be defined by UMBC’s Policy on Principal Investigator Eligibility.

When will I hear from the IBC about my research study or teaching application?

The length of time a study will take to be approved and an approval letter received depends on the type or level of review required. The ORPC staff, working in concert with the IBC, will make every effort to work with investigators to process proposals promptly. If additional changes are needed, it can take longer depending on reviewer questions or protocol load. 

Classification of research per NIH Guidelines

Use the below to determine if your experiments require IBC review and indicate on the IBC Application Form the appropriate NIH “Section” below that accurately describes your experiment.  If you are unsure in which category your experiments fall, please contact the ORPC.

Note: For research with plant species or plant pests refer this table.  For classification of animal or insect experiments (e.g., mice, Drosophila spp., C.elegans) refer to this table.

Section III-A, B & C: Experiments that require NIH and IBC approval prior to initiation. This process is initiated by first submitting to Institutional Biosafety Committee (IBC) then to the NIH . The NIH may determine the level of containment. This process may take several months to complete. Examples include:

  • Deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally, if such acquisition could
  • compromise the use of the drug to control disease.
  • Cloning of toxin molecules with LD50 of less than 100 ng / kg body weight.
  • Transfer of recombinant or synthetic nucleic acid molecules to human research participants.
 Section III-D: Experiments require IBC review before procuring materials to initiate experiments at UMBC.Examples include:

  • Experiments using Risk Group 2, 3, or 4 agents as host-vector systems.
  • Experiments in which DNA from Risk Group 2, 3, or 4 agents is cloned into nonpathogenic prokaryotic or lower eukaryotic host-vector systems.
  • Experiments involving the use of recombinant, synthetic, or reassortant viruses in tissue culture systems; or defective recombinant  viruses in the presence of helper virus or packaging cells in tissue culture systems (this includes all eukaryotic viruses).
  • Experiments involving more than 10 liters of culture.
  • Experiments involving human influenza strains H2N2, 1918 H1N1, and/or highly pathogenic H5N1.
Section III-E: Experiments require IBC review before procuring materials to initiate experiments at UMBC. Examples include:

  • Introduction into cultured cells of any recombinant or synthetic nucleic acids including those containing greater than half but less than 2/3 of a eukaryotic viral genome (unless Risk Group 3 or 4 agents—see above).
  • Cloning in non-pathogenic prokaryotes and non-pathogenic lower eukaryotes.
  • Experiments not specified (e.g. for use with animals or plants/plant pests, see instructions above).
 Section III-F: Experiments that are exempt under the NIH Guidelines and do require IBC review before procuring materials to initiate experiments at UMBC. Examples include:

  • Cloning of all other recombinant or synthetic nucleic acids in E.coli K12, S. cerevisiae, and B. subtilis host-vector systems (unless Risk Group 3 or 4 Pathogens—see above).
  • Introduction into cultured cells of any recombinant or synthetic nucleic acids containing less than half of a eukaryotic viral genome (with the exception of Risk Group 3 or 4 pathogens—see above).
  • Breeding experiments to generate transgenic rodents that may be housed under BSL1.
Experiments that are exempt under the NIH Guidelines and do not require IBC review at UMBC include:

  • Any research involving recombinant or synthetic nucleic acid molecules that will be placed in a biological system (e.g., cells, organisms, or viruses)  ONLY if it contains the exact sequence of a nonchromosomal or viral DNA source (organism or virus) that exists contemporaneously in a natural (non-laboratory) setting, and not a pathogen or toxin to humans, animals, or plants.
  • Colony maintenance, purchase, or transfer of transgenic rodents that require BL1. (III-D-4-c)

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