Office of Responsible Research Practices
The Ohio State University

Investigator Guidance

Registration Requirements

Investigators must register with the IBC if they are:

  1. Creating recombinant or synthetic nucleic acid molecules  (vector plus gene)
  2. Inserting recombinant or synthetic nucleic acid molecules into cell lines/tissue cultures, whole animals, humans, or plants
  3. Using or creating transgenic or knock-out animals
  4. Using a microorganism that is pathogenic to humans (including immunocompromised individuals), plants, or animals (based on wild-type organism)
  5. Using or collecting human or non-human primate materials (body fluids, tissues, cells and established cell lines, etc.)

For work with human subjects, the following specifically apply:

  1. Experiments involving the deliberate transfer of recombinant or synthetic nucleic acid molecules, or DNA or RNA derived from recombinant or synthetic nucleic acid molecules into one or more human subjects must be approved by The Ohio State University Institutional Biosafety Committee before final Institutional Review Board (IRB) approval may be granted.
  2. Experiments utilizing live, recombinant, and/or attenuated microorganisms for the purposes of vaccination of one or more human subjects must be approved by The Ohio State University Institutional Biosafety Committee before final IRB approval may be given.
  3. Other protocols, upon IRB request, may receive IBC review/approval.

For work with whole animals, the following specifically apply:

  1. Experiments involving the deliberate transfer of recombinant or synthetic nucleic acid molecules into whole animals must be registered (submitted) with The Ohio State University IBC before IACUC approval may be granted. The registration application must be approved before animals can be ordered.
  2. Experiments involving the deliberate transfer of any human, animal, or plant pathogen into whole animals must be registered (submitted) with The Ohio State University IBC before IACUC approval may be granted. The registration application must be approved before animals can be ordered.
  3. Other protocols, upon IACUC request, may receive IBC review/approval.

Registration Process and Forms

Investigators will register by submitting an application via the electronic system, eProtocol:  http://eprotocol.osu.edu/

Guidance on information to include in the eIBC protocol: IBC Guidance Document

Review Process

Pre-Review
The IBC Chairperson or the Institutional BioSafety Officer (IBO) will review applications and provide a preliminary recommendation for biosafety containment (BSL1, BSL2, BSL3.) and may request protocol modifications prior to full committee review.

Exempt Applications
The IBC Chairperson or designee will review applications for exemption to determine whether or not the application meets the criteria for exemption from the NIH Guidelines for Research with Recombinant or Synthetic Nucleic Acid Molecules. ORRP staff will inform the investigator that the work is exempt and that BSL1 containment applies. The IBC will be informed at the next convened meeting of any exempted applications received during the previous month via the minutes.  Changes in locations should be provided by logging a public comment in the e-protocol system on that protocol’s home page.

Designated Member Review
The application may be reviewed by a designated member of the IBC if one or more of the following occur:

  • If an application receives a preliminary recommendation as a BSL1 application
  • If the application involves only human or non-human primate materials under BSL2
  • If the application involves human source material (under BSL2) and exempt rDNA,

Should the application require BSL2 containment, the application will be brought to the full committee for review.  Otherwise, the designated member will approve the application at the approved BSL on behalf of the committee. All designated member reviews will be noted in the minutes of the IBC.

The designated member review process pertains to protocols in the categories listed above and may not be used for recombinant DNA research that is not exempt.

Facility Walk-Through
For applications requiring BSL2 and higher, the IBO and / or Office of Environmental Health and Safety staff will conduct a facility walk-through of the identified research area to determine if the recommended containment can be achieved. Any committee member can request a facility walk-through for any research area, regardless of the biosafety level assigned. Research staff are encouraged to conduct self-audits of their facilities using walkthrough checklists and narratives developed by the IBO and staff.

Full Committee Review at a Convened Meeting
In full committee review (recommended BSL2 and higher), the application and accompanying materials, as necessary, are available to the committee membership via the eProtocol website. The application is reviewed at the next convened meeting of the IBC. Primary and secondary reviewers are assigned to each protocol.  These reviewers present the application to the committee and provide an electronic review prior to the meeting. A simple majority of the committee represents quorum. Any committee action requires passage by a majority of quorum.

Approval
Approval letters are generated by the ORRP staff and sent to the PI. The approval letter indicates the biosafety level approved for the research in addition to any other conditions or stipulations assigned by the committee. The PI may appeal the decision of the IBC by providing, in writing, their objection and the rationale for the objection. The PI is referred to the appropriate biosafety level recommendations in the CDC/NIH publication, Biosafety in Microbiological and Biomedical Laboratories, 5th edition and the applicable appendices pertaining to containment in the NIH guidelines.

In cases where a protocol is approved with modifications, the PI must provide to the IBC a written response within 60 days or the proposal will be inactivated. If any withdrawn or terminated proposal is still needed, it will need to be resubmitted as a new request and go through the review process again.

Conditions of Approval

The approval is for only the materials, personnel, and facility specifically provided in the application. The IBC requires an annual review of protocols unless considered exempt for years 1-4 of the protocol.  Any protocol that has not submitted an annual review within 60 days of the anniversary date, will be terminated.

Continuing Approval/Updates

Changes in facilities as well as any significant modifications to methods or biological materials used must be reported to the IBC via an amendment application. The IBC Chair and / or IBO has been given the authority to approve on behalf of the IBC changes in an investigator’s protocol involving the same biological materials as previously submitted provided the new methods do not change the biosafety level that was previously assigned to the laboratory.

Beginning August 2015, a new protocol will need to be submitted every 5 years for protocols not considered exempt.  The PI will have the option to create a renewal of the previous protocol and update the information to only include the current work being conducted.  This renewal protocol will be reviewed as described above.

Changing Study Team Members

Study personnel changes no longer require an amendment or approval by the IBC. These changes can be completed by the Principal Investigator within eProtocol. However; if there is a change in the Principal Investigator, an amendment will need to be submitted.