IBC Frequently Asked Questions

General Issues

1. What is the Office of Research and Economic Development’s contact information?

Florida International University
Modesto A. Maidique Campus
11200 S.W. 8 Street, MARC 430
Miami, FL 33199-0001
Phone: (305) 348-2494
Fax: (305) 348-4117

2. Where can I find the official ORED policies?

All University policies and procedures are located in one central on-line location in the University Policies and Procedures Library maintained by the University Compliance Office at http://policies.fiu.edu/. All of the policies and procedures of the Office of Research and Economic Development may be reviewed on that database which is arranged by Pre-Award and Award, Post-Award, Office of Research Integrity and Office of Technology Management and Commercialization. Additionally, users may search the database using key words and all policies and procedures containing the key words will be listed, regardless of the University unit to which they pertain. This is particularly useful for sponsored research matters as administration of projects routinely involves other University units such as Purchasing, Travel, Risk Management and Environmental Health and Safety and many other units. Thus, the ability to search the Policies and Procedures Library using key words provides users with an expedient way to ensure that all relevant policies and procedures are accessed. The on-line policies and procedures also list the appropriate University contacts so that users may know whom they can call if they have any questions on the policies or procedures. Needed forms and background information are also included in the policies and procedures.

3. I need a confidentiality agreement, teaming agreement, material transfer agreement or memorandum of understanding executed on behalf of the University. Can I process that through the Office of Research and Economic Development, and if so, how?

See Office of Research and Economic Development Policy #2320.055, Negotiation and Execution of Sponsored Project Awards and Agreements at http://policies.fiu.edu/files/257.pdf.

Pre-Award may execute agreements that are not related to an existing proposal or sponsored project, but which are related to research or to potential future sponsored research projects or related to University intellectual property as follows.
Examples of these types of agreements are:

  • Memoranda of Understanding setting forth that the parties will work together to determine if a research project may be pursued in the future;
  • Confidentiality Agreements where documentation is to be exchanged for the purpose of determining if the parties may be able to pursue a future research project or related to University intellectual property review. An approved form confidentiality agreement is on the Pre-Award website at http://www.research.fiu.edu/forms/administrative/nonDisclosureAgreement.doc;
  • Material Transfer Agreements where biological material is being transferred for research purposes;
  • Teaming Agreements for a proposal effort

To request that Pre-Award execute an agreement other than an award document, the PI must provide to Pre-Award:

  1. The completed Agreement Request form
  2. A draft of the proposed agreement, if the PI has a draft (e.g., the form FIU confidentiality agreement with the blanks filled in)

Pre-Award will determine if the agreement is appropriate for execution by Pre-Award and if needed, will negotiate the agreement with the entity with which the agreement will be executed. The negotiation will be done in consultation with the PI and other FIU units, as necessary (e.g., Office of the General Counsel, Office of Technology Management and Commercialization). When the agreement is signed by all parties, Pre-Award will send a copy to the PI.

Special Considerations relating to Material Transfer Agreements

If a Material Transfer Agreement (MTA) seeks to transfer any Special Hazards Material (as defined in policy #125.405, Security in Laboratories with Special Hazards), the PI must obtain the approval from Environmental Health & Safety (EH&S) before the MTA may be signed by Pre-Award. Policy #125.405 defines Special Hazards Materials as including, but being not limited to, ?radioactive materials, Drug Enforcement Administration (DEA) controlled substances, select agents, carcinogenic and explosive materials, infectious materials, and laser devices, and any other hazardous materials, the purchase, handling, storage or transfer and disposal of which is regulated by federal, state, or local laws.?

The PI must provide to Pre-Award, the appropriate EH&S Research Clearance Form (found on the Pre-Award website at http://www2.fiu.edu/~ehs/dsrt/index.htm) with EH&S? approval of the transfer of the materials.

If the MTA is for the transfer of animals, the PI must work with the Laboratory Animal Research to ensure the Facility is prepared for the transfer and the care of the animals. Any IRB, IBC or IACUC approvals must also be in place, as applicable, before beginning to use the material transferred in any research project. See Office of Research and Economic Development Policy #2350.060, Purchase or Receipt of Items Requiring EH&S Prior Approval.

4. Why do I have to register my protocol?

Per federal and state regulations, Florida International University, Institutional Biosafety Committee (IBC) is required to review, approve, and maintain documentation on all protocols involving recombinant DNA.

5. What type of research must be registered with the IBC?

  • Experiments that Require Institutional Biosafety Committee Approval, RAC Review, and NIH Director Approval Before Initiation (See Section IV-C-1-b-(1), Major Actions).
  • Experiments Involving the Cloning of Toxin Molecules with LD50 of Less than 100 Nanograms per Kilogram Body Weight
  • Experiments that have been Approved (under Section III-A-1-a) as Major Actions under the NIH Guidelines
  • Experiments that Require Institutional Biosafety Committee and Institutional Review Board Approvals and RAC Review Before Research Participant Enrollment
  • 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 Research Participants
  • Experiments that Require Institutional Biosafety Committee Approval Before Initiation
  • Experiments Using Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents as Host-Vector Systems (See Section II-A, Risk Assessment)
  • Experiments in Which DNA From Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents is Cloned into Nonpathogenic Prokaryotic or Lower Eukaryotic Host-Vector Systems
  • Experiments Involving the Use of Infectious DNA or RNA Viruses or Defective DNA or RNA Viruses in the Presence of Helper Virus in Tissue Culture Systems
  • Experiments Involving Whole Animals
  • Experiments Involving Whole Plants
  • Experiments Involving More than 10 Liters of Culture
  • Experiments Involving Influenza Viruses
  • Experiments that Require Institutional Biosafety Committee Notice Simultaneous with Initiation
  • Experiments Involving the Formation of Recombinant or Synthetic Nucleic Acid Molecules Containing No More than Two-Thirds of the Genome of any Eukaryotic Virus
  • Experiments Involving Whole Plants
  • Experiments Involving Transgenic Rodents
  • Exempt Experiments

Additional information can be found at the following link: http://osp.od.nih.gov/sites/default/files/NIH_Guidelines.html#_Toc351276228

6. Will my laboratory be audited or inspected?

Yes. The Biosafety Officer (BSO) is responsible for conducting periodic laboratory inspections. The BSO or designee visits each laboratory each time a protocol is submitted to verify compliance. In addition, university laboratories are subject to inspection by federal, state, and local regulatory agencies as well as funding and accrediting agencies.

7. In what order should I submit my IACUC and IBC applications?

There is no prescribed requirement for the order in which IACUC and IBC applications are submitted; however, IACUC final approval will not be granted until IBC approval has been received. It is advisable to submit your IBC proposal either before or at the same time as when you submit your IACUC proposal to avoid delays.

8. I receive no external funding. Do I have to register my protocol?

Yes. Registration with the IBC is based on the biological materials used in your experiments, not on funding.

9. What should I do if the email address associated with my TOPAZ is no longer used and needs to be updated?

Please send an email address to topaz-help@fiu.edu along with your full name, your panther ID, your old email address, and your new email address. It is strongly advised to keep your email address in the TOPAZ system up to date to ensure you are receiving all applicable email notices from the TOPAZ system.

TOPAZ Online Protocols

1. How can I learn more about submitting a protocol through the online TOPAZ Electronic Protocol Submission System?

Investigators should first review the “Obtaining Approval” page for an overview of the approval process. Investigators should then proceed to review the “TOPAZ information” page, which includes information on training sessions, user guides, and other helpful information on accessing the TOPAZ system.

2. What are some of the primary differences between the old paper-based IBC process and the new TOPAZ system IBC process?

Investigators no longer need to email their application directly to the IBC Coordinator or IBC Chairperson. The system will submit the protocol directly to the Coordinator..

3. How do I do an Amendment or a Renewal to an existing paper-based IBC approved protocol in the new TOPAZ system?

Investigators are required to submit their existing project through the TOPAZ system as a new original protocol submission when the time comes for the investigator to do his/her first amendment or renewal of the paper-based protocol (this is a one-time requirement).

4. Who should I contact if I have a technical question about using the TOPAZ system?

Investigators should send an email to topaz-help@fiu.edu. A response will normally be provided within 24 hours during the normal business hours of 9 AM ? 5 PM, Monday-Friday. In rare cases, the response time might be longer than 24 hours if there are a large number of inquiries.

5. What should I do if I am unable to log into the TOPAZ system?

Please ensure that you are using your Panther ID as your username. The system will only accept your numerical Panther ID (it will not accept an alias login name).
All investigators with active IBC paper-based protocols should be able to login to the TOPAZ system. If you are unable to access the system, then you will need to follow the ?System Access Request? instructions below, so we can create a TOPAZ account for you.

  • TOPAZ System Access Request for FIU Personnel: If you are FIU Personnel (i.e., individuals with existing Panther IDs) and unable to login, please fill out and submit the following form to have a TOPAZ account created: Personnel Access Request Form.
    You should expect to receive an email confirming that your account has been created within 1-2 business days of submitting the request.
  • TOPAZ System Access Request for Non FIU Personnel: If you are Non FIU Personnel (i.e., individuals without existing Panther IDs) and are unable to login to Topaz, please have the Principal Investigator fill out the Person of Interest form referenced on the Division of Human Resources website here.
    Per the HR website: “A POI form can be completed either by the Manager or the Person of Interest. The POI form can be found under the Recruitment forms in the Manager Self Service or Employee Self Service within PantherSoft Human Resources. Once completed, print form and both the supervisor and the person of interest must sign.

    If you have any questions regarding this form, please contact HR directly at: (305) 348-2181.

    After you have submitted this form and received a Panther ID, please proceed to filling out the Personnel Access Request Form to have a TOPAZ account created.
    You should expect to receive an email confirming that your account has been created within 1-2 business days of submitting the request.

6. What is the difference between a ?Co-Investigator? role and a ?Key Associate? role?

Individuals that are designated in the application as Co-Investigators will have the ability to “view and edit” this application.

Individuals that are designated in the application as Key Associates will only receive TOPAZ system email notices.

7. What type of naming convention should I use when attaching files to my electronic application submission in TOPAZ?

Make the file name sufficiently descriptive and clear. Avoid using certain special characters in a file name (& * ? < # : ) as they may cause problems and you most likely won't be able to save the document. A dash (-) or underscore (_) may be used. File names should use consistent date formatting. For example, a file modified on March 24, 2011 should include 24MAR2011 in the file name. Use version numbers to manage the revisions of attachments (e.g., V1, V2, V3) Consider including the document file name and version in small font in the footer of the document. If you do this, remember to update the footer each time the document is revised.