Federalwide Assurance

#FWA00020736                 

  • OMB No. 0990-0278
  • Institution: Texas Tech University Health Sciences Center El Paso
  • Approved for use through August, 31, 2017
  • Expires: 10/12/2021

FWA for the Protection of Human Subjects

1. Institution Filing Assurance

  • Legal Name: Texas Tech University Health Sciences Center El Paso
  • City: El Paso                 
  • State/Province: TX                                   
  • Country: USA

2. Institutional Components

List below all components over which the Institution has legal authority that operate under a different name. Also list with an asterisk (*) any alternate names under which the Institution operates.

NOTE: The Signatory Official signing this Assurance must be legally authorized to represent the Institution providing this Assurance and all components listed below.

Name of Component or 
Alternate Names Used

City

State
(or Country if Outside U.S.)

 
Paul L. Foster School of Medicine El Paso TX

A

Gayle Greve Hunt School of Nursing El Paso TX

A

Graduate School of Biomedical Sciences El Paso TX

A

3. Statement of Principles

This Institution assures that all of its activities related to human subjects research, regardless of the source of support,  will be guided by the following statement of principles governing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution. (indicate below)

  • The Belmont Report

4. Applicability

  1. This Assurance applies whenever this Institution becomes engaged in human subjects research conducted or supported by any S. federal department or agency that has adopted the U.S. Federal Policy for the Protection of Human Subjects (also known as the Common Rule), unless the research is otherwise exempt from the requirements of the Common Rule or the department or agency conducting or supporting the research determines that the research shall be conducted under a separate assurance.

  2. Optional: This Institution elects to apply the following to all of its human subjects research regardless of the source of support, except for research that is covered by a separate assurance:

5. Assurance of Compliance with the Terms of the Federalwide Assurance

  1.  This Institution assures that whenever it engages in research to which this Assurance applies, it will comply with the terms of the Federalwide Assurance (contained in a separate document on the Office for Human Research Protections (OHRP) website).

6. Designation of Institutional Review Boards (IRBs)

This Institution assures that it will rely upon only IRBs registered with OHRP for review of research to which this FWA applies. This institution (a) designates the following internal IRB(s) for review of research under this Assurance; or (b) does not have an internal IRB and designates the following external IRB for review of all research to which this FWA applies or, if multiple external IRBs are relied upon, the following external IRB that reviews the largest percentage of research to which this FWA applies.

NOTE: Institutions designating internal IRBs do not need to designate any of the external IRBs upon which it relies.

HHS IRB

Registration

Number

 

Name of IRB as Registered with HHS

Is the IRB Internal or

External to the Institution?

IRB00009945 Texas Tech University Health Sciences Center El Paso IRB #1 I
IRB00009946 Texas Tech University Health Sciences Center El Paso IRB #2 I
IRB00004296  National Cancer Inst Central IRB #2 (Pediatric)
E

7. Human Protections Administrator (e.g., Human Subjects Administrator or Human Subjects Contact Person)

  • First Name: Myrna        Middle Initial: L         Last Name: Arvizo
  • Degrees or Suffix: BMS                                    
  • Institutional Title: Director
  • Institution: Texas Tech University Health Sciences Center El Paso
  • Telephone: (915) 215-4162  FAX: (915) 783-5223      Email: myrna.arvizo@ttuhsc.edu
  • Address: 5001 El Paso Drive MSB #1255
  • City: El Paso       State/Province: TX        Country: USA

8. Signatory Official (i.e., Official Legally Authorized to Represent the Institution)

I have read and agree to the Terms of the Federalwide Assurance.

I recognize that providing research investigators, IRB members and staff, and other relevant personnel with appropriate initial and continuing education and training about human subject protections will help ensure that the requirements of this Assurance are satisfied.

Acting officially in an authorized capacity on behalf of this Institution and with an understanding of the Institution’s responsibilities under this Assurance, I assure protections for human subjects as specified above. The IRB(s) that this institution relies upon will comply with the Terms of the Federalwide Assurance when reviewing research covered by this Assurance and possess appropriate knowledge of the local context in which this Institution’s research will be conducted.

All information provided with this Assurance is up-to-date and accurate. I am aware that false statements could be cause for invalidating this Assurance and may lead to other administrative or legal action.

  • Signature: Peter Rotwein M.D.
  • Date: 06/01/2016
  • First Name: Peter              Middle Initial:               Last Name: Rotwein
  • Degrees or Suffix: M.D.  
  • Institutional Title: Vice President for Research
  • Institution: Texas Tech University Health Sciences Center El Paso
  • Telephone: 915-215-4158     FAX: (915) 783-5223      
  • Email: peter.rotwein@ttuhsc.edu
  • Address: 5001 El Paso Drive  #1010H
  • City: El Paso        State/Province: TX      Country: USA

9. FWA Approval

The Federalwide Assurance for the Protection of Human Subjects for Institutions Within the United States submitted to HHS by the above Institution is hereby approved.

  • Assurance Number: FWA00020736                                                          
  • Expiration Date: 06/01/2021
  • Signature of HHS Approving Official: Christina Lindsay          
  • Date: 10/12/2016

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