Skip to main content


IBC Main > IBC FAQs


IBC - FAQs

  1. What research/teaching activities require Institutional Biosafety Committee (IBC) Approval?
  2. Are immortal/established human cell lines covered by OSHA's Bloodborne Pathogens Standard?
  3. Are there activities that do not require IBC review?
  4. My work is Exempt from NIH Guidelines, does it require IBC review?
  5. What aspects of the activities are reviewed by the IBC? Does this include a Scientific review?
  6. Where can I access the NIH Guidelines for Research Involving Recombinant DNA Molecules?
  7. What do I need to do to apply for IBC review of my project?
  8. Who can be a Principal Investigator (PI) on an IBC Memorandum of Understanding and Agreement (MUA)?
  9. How do I file a Memorandum of Understanding and Agreement (MUA) describing my activities with rDNA or other biohazardous agents to the IBC?
  10. How long does it take to get a review and notification of the results?
  11. What is the review process after the electronic submission of an MUA?
  12. When and how do I amend an Existing Approved MUA?
  13. How long is an MUA approved for?
  14. What is the Continuing Annual Review and how should I submit my annual review?
  15. How do I submit an application for activities conducted at Biosafety Level 3 for review by the IBC?
  16. What is the review process for the BSL3 application?
  17. How do I make a change to an Existing Approved BSL3 application?
  18. Where can I find additional information concerning the IBC and Biosafety?
  19. Where can I find additional information concerning synthetic nucleic acids?



  1. What research/teaching activities require Institutional Biosafety Committee (IBC) Approval?

    The Institutional Biosafety Committee is charged under the NIH guidelines for Research Involving Recombinant or synthetic nucleic acid molecules (r/sNA) molecules and Cornell University Policy with additional oversight of all activities involving:

    • Recombinant and synthetic NA (and RNA) including purchase, creation or use of transgenic plants and animals
    • Biohazardous agents (e.g. bacteria, viruses, fungi, protozoa, prions)
    • human and non-human primate source material (e.g. blood, body secretions and tissues, primary and established cell lines)
    • Select agents and Biologically Derived Toxins (including strain and amounts exempted from the select agent regulation)
    • Any material requiring a CDC import license or a USDA permit
  2. Are immortal/established human cell lines covered by OSHA's Bloodborne Pathogens Standard?

    Yes. Research involving the use of human-derived substances (e.g. blood or blood components, tissues, cells, secretions) is subject to the OSHA "Bloodborne Pathogens" (BBP) Standard. It is impossible to test human cells, including established cell lines, for all BBP/adventitious agents. Therefore, ALL human tissues and cell lines (including established lines) fall under the BBP standard. Research experiments involving human-derived materials, including established human cell lines, require IBC review, and BSL2 practices and procedures must be followed while working with them. BBP training is required for all employees who can reasonably anticipate exposure to human blood or other potentially infections materials. This training is required both at the time of initial work assignment and at least every twelve months thereafter. Information about BBP training can be obtained at:  EH&S Training

  3. Are there activities that do not require IBC review?

    Yes the following activities do not require IBC review:

    • Activities using only commercially available deregulated transgenic crops.
    • Activities that involve only the in vitro use of nucleic acids (i.e., PCR, synthetic double stranded RNA) and does not involve the cloning and propagation of recombinant DNA in cells.
  4. My work is Exempt from NIH Guidelines, does it require IBC review?

    If your work is exempt from the NIH guidelines but does not fall under the categories listed in FAQ 3 it is still subject to IBC review. This includes exempt r/sNA activities under Section III-F of the NIH guidelines which must be reviewed and approved by the IBC. See FAQ 11 for review requirements for Exempt activities.

  5. What aspects of the activities are reviewed by the IBC? Does this include a Scientific review?

    The fundamental consideration for the IBC in reviewing projects using r/sNA, and other biohazardous materials, is that the activities meet standards of good biological safety practice emphasizing protection of personnel, the general public, and the environment.  The IBC is not responsible for the scientific review of the project, except in those cases where the scientific design of the studies contributes to or requires potentially unsafe or risky practices. In those cases, the IBC may require modifications that would reasonably mitigate the risk without impacting the research outcomes. Specifically the IBC reviews the following aspects of the study:

    • Appropriate Biosafety level for proposed research
    • Vectors and host systems used in the proposal
    • Use of appropriate biosafety practices
    • Potential for environmental release
    • Suitable facilities, procedures, practices and training of personnel
  6. Where can I access the NIH Guidelines for Research Involving Recombinant DNA Molecules?

    Click to Link to the NIH Guidelines
    Click for Link FAQ’s and other guidance at NIH

  7. What do I need to do to apply for IBC review of my project?

    If you are eligible to be a PI on an IBC application (See FAQ 8) you may register with the IBC by completing an online Memorandum of Understanding and Agreement (MUA) form available at: http://www.ibc.cornell.edu/

    On-line registration is used for exempt and non-exempt projects. See FAQ 11 for details.

  8. Who can be a Principal Investigator (PI) on an IBC Memorandum of Understanding and Agreement (MUA)?

    Full time members of the Faculty may serve as Principal Investigators/Project Directors on IBC MUAs. Individuals with certain other titles such as Research Associates, Extension Associates, Lecturers, or Senior Assistant Librarians may serve under special circumstances with the approval of the Office of the Vice Provost for Research. For more information, see the Office of Sponsored Program’s Principal Investigator Eligibility Policy.

  9. How do I file a Memorandum of Understanding and Agreement (MUA) describing my activities with rDNA or other biohazardous agents to the IBC?

    The e-MUA can be accessed at https://ibc.research.cornell.edu

    As the MUA is overarching of all your work involving rDNA and other biohazardous materials you will have only one active MUA.

    The e-MUA covers:

    • Exempt r/sNA conducted at Biosafety Level 1(BSL1)  for lab, plants and animals
    • Non-Exempt r/sNA or  other Biohazardous work at BSL2 for lab, plants and animals

    Work conducted at Biosafety Level 3 requires a separate form and review process.  Please see FAQ 15 and 16 concerning BSL3 work.

  10. How long does it take to get a review and notification of the results?

    The committee meets monthly to review and approve MUAs. Minimum review time is 4 weeks and based on when the application is submitted may be longer.  Please check the submission and review schedule below.  Most MUAs are completed in one review cycle; however, if follow-up with a PI is needed, a MUA may be deferred to the next meeting which would delay the MUA for approximately 4 more weeks. The PI is notified of the result following any IBC meeting in which the MUA is discussed.

    Please see the Submission Schedule for dates.

  11. What is the review process after the electronic submission of an MUA?

    When a Non – Exempt r/sNA or Biohazard MUA is submitted to the IBC:

    • IBC Administrator will ordinarily assign 3 IBC members to a sub-committee to pre-review the document.
    • The sub-committee will send an electronically generated message to the PI with any questions or requests for revisions. Sometimes a reviewer or the Biosafety officer may request a meeting to discuss details of the project so that there is a common understanding of the work that is being proposed.
    • Once the PI responds and the reviewers’ questions have been satisfactorily answered (this may take several iterations), the IBC Administrator will add the MUA to the agenda for the next convened full IBC meeting.
    • At the fully convened meeting the MUA will be discussed and the following actions can occur:
      • Approval
      • Approval conditional upon IBC directed changes (Usually made administratively with permission from the PI)
      • Returned to PI for further revisions. The IBC will decide if the nature of revisions is such that the MUA needs to come back to the full committee for a full review or if a subcommittee of the IBC could review the changes and approve the MUA.
      • The IBC Administrator will communicate the IBC’s decision to the PI and help with any additional steps that need to be taken.

    When an Exempt r/sNA MUA is submitted to the IBC:

    • Exempt MUA’s are reviewed and approved by the IBC Chair or the Biosafety Officer without the need of full IBC process.
  12. When and how do I amend an Existing Approved MUA?

    PIs must submit to the IBC for review and approval any changes to their MUA. Unless specified otherwise, the proposed changes must not be implemented until the PI receives a written approval notice from the IBC. The types of changes that require an amendment to the MUA are:

    • Addition or deletion of individuals on the MUA
    • Change in facility or use of facility
    • Additional objectives to the project
    • New sources of nucleic acids (including DNA and RNA)
    • New vectors
    • Recipient organisms
    • New biohazardous materials (infectious agents, toxins, viral vectors)
    • Change in procedures involving biohazardous materials

    The Amendment is an electronic document.  Click to Submit an Amendment:

    Click on the title of the approved MUA for which you are filing an amendment.
    Next to Continuation Forms: Click on "Create an Amendment"
    Complete the form and submit to the IBC

    The review and approval can occur outside full committee by the Chair or Biosafety Officer or designated committee member.  If there are major changes to the work they may request that the amendment go to full committee for review or a new MUA application completed.

    The PI will receive electronic notification of revisions requested or notification of approval.

    e-MUA Help line - 607-255-7219

  13. How long is an MUA approved for?

    IBC approval of MUAs involving the use of Non-Exempt r/sNA or Biohazards is valid for a period of three years subject to annual reviews (see FAQ 14).  In order to maintain continuity of approval PIs must submit a new MUA for IBC review and approval before the three year approval lapses.

    Since the IBC conducts a de novo review of the renewal application at a scheduled IBC meeting, the review process will take a minimum of 45 days. At least 90 days prior to expiration the IBC office will contact the PI to remind them of the upcoming expiration date and provide a link to the e-MUA application to start work on the renewal.

    Exempt MUA’s are approved for the life of the project as long as no changes are made that would change the classification of the work.  A continuing annual review is required for Exempt work.

  14. What is the Continuing Annual Review and how should I submit my annual review?

    All approved MUAs are subject to an annual review.   The goal of continuing review is to reexamine all IBC approved work or any new work if not covered in an amendment and to confirm that work is being performed at appropriate containment levels.  Changes in personnel may be updated at this time.

    The Annual Review is an electronic document.  Click to Submit an Annual Review:

    Click on the title of the approved MUA for which you are filing an annual Review.
    Next to Continuation Forms: Click on "Questionnaire”
    Complete the form and submit to the IBC

    The review will occur outside full committee by the Chair or Biosafety Officer or designated committee member.  If there are major changes to the work they may request that a new MUA be filed. (ex. adding r/sNA work to a Biohazard only MUA)

    The PI will receive electronic notification of requested actions or notification of approval.

  15. How do I submit an application for activities conducted at Biosafety Level 3 for review by the IBC?

    Contact dad3@cornell.edu for instructions to file a BSL3 Application

    Please submit the application to the IBC Administrator at dad3@cornell.edu

  16. What is the review process for the BSL3 application?

    For complete overview see: BSL3 program document

    Upon receipt of the BSL3 application:

    The IBC Administrator will pass the application to the Biosafety Level 3 Advisory Committee (BAC) which is composed of the Biosafety Officer, Biosafety engineer, two IBC members, Occupational Physician (and a Veterinarian and IACUC member if animal work is involved)

    • The BAC will review and through the IBC administrator return requests for additional information to the PI
    • Upon receipt of the revisions the IBC administrator will contact the BAC to reconvene and review the changes
    • The BAC will then take the document along with recommendation to the IBC. At the fully convened meeting the BSL3 Application will be discussed and the following actions can occur:
      • Approval
      • Approval conditional upon IBC directed changes (Usually made administratively with permission from the PI)
      • Returned to PI for further revisions, will need to come back to full committee
  17. How do I make a change to an Existing Approved BSL3 application?

    Please contact the IBC Administrator at dad3@cornell.edu or 255-7219

  18. Where can I find additional information concerning the IBC and Biosafety?

    Contact the IBC administrator at dad3@cornell.edu or 255-7219.

    The IBC website can be accessed at:  http://www.ibc.cornell.edu/

    The Environmental Health and Safety (EH&S) Biosafety Site can be accessed at: http://sp.ehs.cornell.edu/lab-research-safety/bios/Pages/default.aspx

  19. Where can I find additional information concerning synthetic nucleic acids?

    FAQs for NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules

IBC Main > IBC FAQs