Disclosure Submission

Disclosure submission

The Institutional Biosafety Commitee (IBC) meets monthly throughout the year. Upcoming meeting dates and submission deadlines are listed below. Unless otherwise indicated, meetings are held in conference room 312.05 of Centerpoint Building A at 660 South Mill Avenue in Tempe at 1:30 p.m. IBC disclosures submitted after the submission deadline will be reviewed at the next month’s meeting. 

Meeting Date Submission Deadline

July 11, 2019

June 20, 2019

August 8, 2019

July 18, 2019

September 12, 2019

August 22, 2019

October 10, 2019

September 19, 2019

November 14, 2019

October 24, 2019

December 12, 2019

November 21, 2019

January 9, 2020

December 19, 2019

February 13, 2020

January 23, 2020

March 19, 2020

February 27, 2020

April 9, 2020

March 19, 2020

May 14, 2020

April 23, 2020

June 11, 2020

May 21, 2020

 

What requires IBC review?

 

Research that requires IBC review includes, but is not limited to, the possession, storage, or use of the following materials:

  • human or nonhuman primate cell lines, tissues, blood (or blood products), feces, saliva or bodily fluids
  • biological toxins, bioactive derivatives or subunits of toxins
  • human etiologic agents
  • select agents or toxins
  • transgenic animals or plants
  • animal or plant etiologic agents
  • biohazards
  • recombinant or synthetic nucleic acid molecules
Decision tree:  When to file an IBC disclosure for synthetic or recombinant nucleic acids
  1. Do the recombinant or synthetic nucleic acids code for any portion of a toxin or select agent?
  2. Do the recombinant or synthetic nucleic acids have the potential to replicate in a cell or integrate into the cell’s DNA?
  3. Will the recombinant or synthetic nucleic acids be modified to make them capable of penetrating a cell membrane?
  4. Are you working with a genetically modified organism?

If the answer is yes to any of the above questions, an IBC disclosure is required.

  1. Will the recombinant or synthetic nucleic acids be inserted into a cell?
  2. If the recombinant or synthetic nucleic acids will be inserted into cells, are they exclusively siRNA or shRNA (not encoded by a gene)?

If the answer is yes to 5 and no to 6, then an IBC disclosure is required.

 

What must be submitted to the IBC?

You must complete all disclosures using the current disclosure forms and submit them in .doc or .docx format to IBC@asu.edu. The type of disclosure form that needs to be filed will depend on the type of work being performed. You can find all forms on the Forms page.

If the work is funded, list the ASU proposal or award number on the disclosure form. In the absence of that information, attach a copy of the proposal or grant. In addition, you may need to file the following forms with the disclosure form:

Is there help available to assist me in preparing my submission?

Templates to aid in the completion of the safety sections and a sample disclosure are available on the Forms page. For assistance with preparing SOPs or questions on laboratory safety procedures, contact biosafety@asu.edu. For assistance with the disclosure submission process, contact the IBC Coordinator at IBC@asu.edu.

 What happens when a disclosure has been submitted?

Upon submission, the disclosure will receive pre-reviews by the IBC Coordinator and Biosafety Officer. principal investigators (PIs) will receive comments from the pre-review as applicable. You must promptly return a revised version of the disclosure that addresses all of the comments to the reviewers. Revisions should be made on the copy received from the reviewer and leave the reviewer’s comments in place for tracking purposes.  Since the reviewers may require multiple revisions by the PI, prompt responses back to the reviewers are necessary to keep the process moving.     

What happens when the pre-review is complete?

When the pre-review is complete, the IBC will determine the committee review process for the disclosure. The IBC requires most disclosures to be reviewed at a fully-convened IBC meeting. You can find more information on review processes in the IBC Policies and Procedures Manual. 

If the disclosure is assigned for full committee review, the IBC will assign the disclosure a primary reviewer from the IBC and placed on the next IBC meeting agenda. The primary reviewer will review the disclosure and, if necessary, submit any questions or comments to the investigator to address before the IBC meets. As with the pre-review process, you must promptly respond to the primary reviewer comments. The primary reviewer will provide a final copy of the disclosure to the IBC office for the committee to review during their convened meeting.   

Does the PI need to attend the IBC meeting?

Yes, the PI, or an approved representative thoroughly familiar with the disclosure submission, must attend the IBC meeting to participate in the review process. If the PI is located on a campus other than Tempe, remote attendance can be arranged by contacting the IBC Coordinator. When the disclosure is placed on the IBC agenda, the IBC Coordinator will send an Outlook calendar invite to the PI with the meeting details and agenda order.

Is there anything else that must be done prior to disclosure approval?

Depending on the research and the biosafety level, we may require training and laboratory inspection. For more information on training requirements, see Biosafety Training Information. If training is required for the disclosure, you must complete the training prior to approval. Laboratory inspections must be performed prior to approval for initial submissions. After initial submission, biosafety level 1 laboratories must be inspected every three (3) years and biosafety level 2 or 3 laboratories must be inspected at least every (1) year.

What happens after the disclosure is approved?

Once the IBC has approved the disclosure, the IBC Coordinator will process the formal approval letter and send it to the PI within three (3) business days. The approval letter will also indicate the length of the approval period and any additional requirements such as training frequency or committee stipulations.

What if there are changes to the research after the disclosure is approved?

Changes to any aspect of the project require submission of a Modification form. The IBC must approve the modification request before you can implement the changes. The type and level of the change will determine the level of review required for the change.

How do I close my disclosure?

Disclosures may not be closed until all materials have been disposed of properly and a close out inspection is performed by Environmental Health and Safety (EH&S). Once the inspection is complete, send an email to the IBC Coordinator requesting closure and confirming the disposition of materials. 

What if I want to save the material for a future project?

If you do not wish to dispose of materials, but will not be actively working with them, you will need to submit a Storage form in order to obtain approval to store the materials. The material may not be used in research or teaching until a new disclosure is submitted and approved by the IBC.

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