Institutional Biosafety Committee Questionnaire

A. PRINCIPAL INVESTIGATOR INFORMATION
Protocol #:
Provide name as you wish it to appear on issued documentation:
First Name: / Middle Initial: / Last Name: / Suffix:
B. PRIMARY CONTACT INFORMATION
Please indicate the primary contact for IBC related communication about this study. Official documentation will be provided via a Quorum OnQ Portal account (at no cost).
First Name: / Last Name: / Title:
Business Name:
Mailing Address:
City: / State: / Zip Code:
Phone: / Email:
C. ADDITIONAL CONTACT INFORMATION(if applicable)
First Name: / Last Name: / Title:
Business Name:
Mailing Address:
City: / State: / Zip Code:
Phone: / Email:
Please provide this contact with Quorum OnQ Portal access.
Quorum will use the contact’s e-mail address to establish a Quorum OnQ Portal account at no additional cost. Through the Portal, users can access approval documents and make secure electronic submissions.
D. STUDY INFORMATION
  1. Is this the first clinical trial site for this study?
Yes*
No
Unknown
*If yes, Quorum will provide a written RAC review determination from the IBC for protocol registration with NIH’s Office of Science Policy.
  1. Are you requesting that this protocol be considered for vaccine exemption under Appendix M-III-A?
Yes
No
  1. Has this protocol ever been disapproved by another IBC?
Yes, please explain:
No
E. RESEARCH LOCATION(S)
List all facilities where study product will be present and where subjects receive required post-dosing care.
The Main Facility Business Name will appear on all issued documentation.
Main Facility Business Name:
Address: / Suite #:
City: / State: / Zip Code:
Phone:
1. Type of facility: Outpatient medical office Hospital Other, please specify:
2. Please identify the facility’s Biosafety Level:
BL-1 (handles study products which do not cause disease in healthy humans)
BL-2 (handles study products with moderate potential hazard to personnel and the environment that may cause mild disease to humans, or are difficult to contract via aerosol in a lab setting)
BL-3 (handles study products involving various microbes which can be transmitted by aerosols and/or cause severe disease)
BL-4 (handles study products that are easily transmitted and can cause fatal disease)
3. What study activities will be done at this site? (check all that apply)
Biological product receiving or shipping
Biological product storage
Biological product preparation
Dosing
Specimen collection
Subject medical care or follow-up
Other, please specify:
4. Please describe or attach information about the facility environment which supports how the facility will contain or reduceexposure to the biological product. (check all that apply)
Facility floor plan
List of safety equipment (e.g., personal protective equipment, biosafety cabinets)
Please specify:
Facility design (e.g., hand washing station, autoclave, ventilation system, door locks)
Please specify:
Other, please describe:
5. How many people will have access to the biological product from the clinical trial at this facility?
Additional Facility Business Name:
Address: / Suite #:
City: / State: / Zip Code:
Phone:
1. Type of facility: Outpatient medical office Hospital Other, please specify:
2. Please identify the facility’s Biosafety Level:
BL-1 (handles study products which do not cause disease in healthy humans)
BL-2 (handles study products with moderate potential hazard to personnel and the environment that may cause mild disease to humans, or are difficult to contract via aerosol in a lab setting)
BL-3 (handles study products involving various microbes which can be transmitted by aerosols and/or cause severe disease)
BL-4 (handles study products that are easily transmitted and can cause fatal disease)
3. What study activities will be done at this site? (check all that apply)
Biological product receiving or shipping
Biological product storage
Biological product preparation
Dosing
Specimen collection
Subject medical care or follow-up
Other, please specify:
4. Please describe or attach information about the facility environment which supports how the facility contains or reduces exposure to the biological product. (check all that apply)
Facility floor plan
List of safety equipment (e.g., personal protective equipment, biosafety cabinets)
Please specify:
Facility design (e.g., hand washing station, autoclave, ventilation system, door locks)
Please specify:
Other, please describe:
5. How many people will have access to the biological product from the clinical trial at this facility?
F. TRAINING & RESOURCES
1. Are there policies in place to ensure that the research site is in compliance with the NIH Guidelines (i.e.,Waste Disposal, Spill Procedure, Serious Adverse Event Reporting)?
Yes
No*, please explain:
*Sample procedures are available on the OnQ Portal at
2. Has research personnel involved in this trial undergone training relative to the NIH Guidelines?
Yes
No, please explain:
4. Does the research site have a health surveillance program for laboratory workers conducting research with recombinant or synthetic nucleic acid molecules?
Yes
No, please explain:
G. PRINCIPAL INVESTIGATOR ACKNOWLEDGEMENT
By signing and/or submitting this form, I am confirming that the information is accurate and all required attachments have been included in the submission.I am also confirming that I am the Principal Investigator (PI) or the PI’s designee authorized to submit on behalf of the PI, and the PI is aware and responsible for the information contained in this submission.The PI acknowledges that they are responsible for understanding and complying with NIH Guidelines in the conduct of recombinant DNA research in addition to the conditions of Quorum Review:
  1. Not initiate or modify recombinant DNA research until all requirements of the NIH Guidelines are met.
  2. Submit all recombinant DNA research and any subsequent changes to the IBC for prior review and approval or disapproval.
  3. Evaluate, address, and comply with all aspects of the Appendix M, when applicable.
  4. Report any new information bearing on the NIH Guidelines to the IBC and to the NIH.
  5. Comply with all recombinant DNA reporting requirements, including prompt reporting to the IBC, NIH, and other appropriate authorities of serious adverse events, any significant problems, violations of the NIH Guidelines, or significant research-related accidents and illnesses.
  6. Ensure the integrity of the physical and biological containment of recombinant DNA materials.
  7. Inform the research staff of the reasons and provisions of potential biohazards and any precautionary medical practices advised or requested.
  8. Instruct, train, supervise, and oversee research staff in the biosafety practices and techniques required to ensure safe and appropriate handling of recombinant DNA materials.
  9. Adhere to IBC approved emergency plans for handling accidental spills and personnel contamination.
  10. Correct work errors and conditions that may result in the release of recombinant DNA materials.
  11. Comply with shipping requirements for recombinant DNA materials.
  12. Be adequately trained in good microbiological techniques.
  13. Remain in communication with the IBC throughout the conduct of research involving recombinant DNA.

Name of Person Completing this Form / Title
______
Signature of Person Completing this Form / ______
Date
______
Signature of Principal Investigator (if different than above) / ______
Date

F-209-001, Institution Biosafety Committee Questionnaire, 19Mar2018Page 1 of 4