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Institutional Biosafety Application

(Human Blood and Blood Products, Human Body

Fluids, and/or Human Tissue Teaching Protocol)

****** All Responses Must Be Typed ******
(Valid until 12/31/2016)

Complete the items in the form below using as much space as required for each entry. Submit this form electronically to The Office for Research Protections at . Transmit it as a Microsoft Word document or as a Rich Text Format (rtf) attachment from the Principal Investigator’s (PI) CAC account(i.e., ). If you are unable to submit this form electronically, it may be signed by the PI and mailed to the Office for Research Protections, The 330 Building, Suite 205, University Park, PA. Handwritten applications are not accepted.

This application is to assist instructors in determining whether the Institutional Biosafety Committee (IBC) needs to review their proposed use of biohazardous materials in the course of their classroom activities.

Will Human blood, blood products, human body fluids, and/or human tissue be utilized as part of the classroom activities (including individual autologous use)?

(If you answered Yes, please complete this application and submit it for review to the Institutional Biosafety Committee)

Course Title: / Course Number:
Campus: / Location of Class:
Principal Instructor: / Email:
Mailing Address:
University Status (For example: Faculty, Staff, Post-doc, Grad. Student): / Telephone:
Department: / College: / Campus:
Describe experience with biohazard to be used:
Describe training that individual will receive (if applicable):

NOTE:

  • As principal instructor, it is your responsibility to adequately train all individuals conducting procedures described in this protocol prior to using biohazardous material(s).
  • As Teaching Assistants are added, you must submit the IBC’s personnel additional form. The personnel additional form must be approved before personnel may begin work with biohazardous materials.

Teaching Assistant: / Email:
Mailing Address:
University Status (For example: Faculty, Staff, Post-doc, Grad. Student): / Telephone:
Department: / College: / Campus:
Describe experience with biohazard to be used:
Describe training that individual will receive (if applicable):
Teaching Assistant: / Email:
Mailing Address:
University Status (For example: Faculty, Staff, Post-doc, Grad. Student): / Telephone:
Department: / College: / Campus:
Describe experience with biohazard to be used:
Describe training that individual will receive (if applicable):
Teaching Assistant: / Email:
Mailing Address:
University Status (For example: Faculty, Staff, Post-doc, Grad. Student): / Telephone:
Department: / College: / Campus:
Describe experience with biohazard to be used:
Describe training that individual will receive (if applicable):

*** PLEASE LIST ADDITIONAL TEACHING ASSISTANTS NEAR THE END OF THE SUBMISSION (ALL MUST BE INCLUDED)***

  1. What is the duration of the course to be taught:

Start Date: / End Date:
  1. Have you considered alternatives to human blood/tissues/fluids?

(If yes, why are you still utilizing human derived agents?)

  1. Please complete the following table:

List type of biohazard
(Human blood, tissue or fluid) / Manufacturer, Supplier or Other (Individual)
  1. Describe how the biohazardous material will be used in the course of your instruction.
  1. How will you dispose of the materials once they are no longer needed?
  1. The Principal Instructor and all Teaching Assistants much complete Penn State’s Bloodborne Pathogen Training online atPenn State’s Bloodborne Pathogen (BBP) Training. This training is required to ensure that these individuals are aware of the potential hazards involved in handling these materials and use the proper precautions to protect themselves from bloodborne diseases. Have all of these individuals completed Penn State’s Bloodborne Pathogen (BBP) Training?

Yes No (Note: BBP training must be completed before this application can be approved.)

  1. What type of training and personal protective equipment will students receive prior to handling human blood tissue or fluid? Please provide a course syllabus, which demonstrates bloodborne pathogen training has been incorporated as part of the curriculum and provide the name and title of the individual(s) who will be providing training to the students.

PLEASE LIST ADDITIONAL TEACHING ASSISTANTS:

Teaching Assistant: / Email:
Mailing Address:
University Status (For example: Faculty, Staff, Post-doc, Grad. Student): / Telephone:
Department: / College: / Campus:
Describe experience with biohazard to be used:
Describe training that individual will receive (if applicable):
Teaching Assistant: / Email:
Mailing Address:
University Status (For example: Faculty, Staff, Post-doc, Grad. Student): / Telephone:
Department: / College: / Campus:
Describe experience with biohazard to be used:
Describe training that individual will receive (if applicable):
Teaching Assistant: / Email:
Mailing Address:
University Status (For example: Faculty, Staff, Post-doc, Grad. Student): / Telephone:
Department: / College: / Campus:
Describe experience with biohazard to be used:
Describe training that individual will receive (if applicable):
Teaching Assistant: / Email:
Mailing Address:
University Status (For example: Faculty, Staff, Post-doc, Grad. Student): / Telephone:
Department: / College: / Campus:
Describe experience with biohazard to be used:
Describe training that individual will receive (if applicable):

ASSURANCES FOR USE OF BIOHAZARDOUS MATERIALS

As the principal instructor for this class, I assure:

  1. the information provided on this form accurately summarizes the nature and extent of the proposed use of biohazardous material(s);
  1. All individuals (including students) handling the biohazardous agents described in this application are technically competent and have been properly trained;
  1. I will obtain approval from the IBC before initiating any changes to this application;
  1. I am familiar with and will comply with Penn State’s Policy SY-24, “Use of Biohazardous Material in Research and Instruction;”
  1. all applicable rules and regulations regarding human subjects, vertebrate animals and radiation protection, etc. have been addressed in the preparation of this application and the appropriate reviews have been initiated, and
  1. bloodborne pathogen protection procedures are included in the course syllabus.

E-MAIL TO ORP!

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