Legal Name:

  City:                                             State:

  DHHS Institution Profile File (IPF) code, if known:

  Federal Entity Identification Number (EIN), if known:

  If this Assurance replaces an MPA or CPA, please provide the "M" or "T" number:

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.  The Institution should have available for review by the Office for Human Research Protections (OHRP) upon request a brief description and line diagram explaining the interrelationships among the Assurance Signatory Official, the Institutional Review Board (IRB), IRB support staff, and investigators in these various components.

NOTE: The Signatory Official signing this Assurance must be legally authorized to represent the Institution providing this Assurance and all components listed below.  Entities that the Signatory Official is not legally authorized to represent may not be listed here without the prior approval of OHRP.

                []   Please check here if there are no such components or alternate names.

3.  Statement of Principles

This Institution assures that all of its activities related to human subject research, regardless of funding source, will be guided by the ethical principles in the following document(s). (indicate below )

4.  Applicability

(a)  This institution assures that all of its activities related to federally-conducted or -supported human subject research will comply with the Terms of Assurance for Protection of Human Subjects for Institutions Within the United States.  NOTE:  The Terms of Assurance are contained in a separate document on the OHRP website.

(b)  Optional:  This institution elects to apply the following to all of its human subject research regardless of source of support:

5.  Designation of Institutional Review Boards (IRBs)

This institution designates the following IRB(s) for review of research under this Assurance (if the IRB is not previously registered with DHHS or has not provided a membership roster to DHHS, please attach the necessary materials available elsewhere on this website).

NOTE: Reliance on another institution's IRB or an independent IRB must be documented by a written agreement that is available for review by OHRP upon request.  OHRP’s sample IRB Authorization Agreement may be used for this purpose, or the institutions involved may develop their own agreement.  Future designation of other IRBs requires update of the FWA.

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

  First Name:                               Middle Initial:        Last Name:            

  Degrees or Suffix (e.g., MD, PhD):                        Institutional Title:

  Institution:

  Telephone:                            FAX:                E-Mail:

  Address:

  City:                                      State:             Zip Code:

7.  Signatory Official (i.e., Official Legally Authorized to Represent the Institution -- cannot be IRB Chairperson or IRB member)

I understand that the Assurance Training Modules on the OHRP website describe the responsibilities of the Signatory Official, the IRB Chair(s), and the Human Protections Administrator under this Assurance.   Additionally, I recognize that providing all research investigators, IRB members and staff, and other relevant personnel with appropriate initial and continuing education 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) designated above are to provide oversight for all research conducted under this Assurance. These IRB(s) will comply with the Terms of the Assurance and possess appropriate knowledge of the local context in which this Institution’s research will be conducted.  I understand that all collaborating institutions engaged in federally-conducted or -supported human subject research must submit their own Assurance.

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 ____________________________________________       Date: ________________

  First Name:                               Middle Initial:        Last Name:            

  Degrees or Suffix (e.g., MD, PhD):                        Institutional Title:

  Telephone:                            FAX:                E-Mail:

  Address:

  City:                                      State:             Zip Code:

NOTE:   Facilities operated by the U.S. Government may require Department or Agency clearance. Please contact the relevant Department or Agency Human Protections Officer before forwarding this Assurance to OHRP.

Assurance Number:                            Expiration Date:

Signature of DHHS Approving Official:                                                             Date: