Institutional Review Board (IRB) Authorization Agreement

This agreement allows the University of Utah IRB to act as the IRB of record for an External Institution (Institution B). Both institutions have completed a Federal-wide Assurance (FWA). The University of Utah IRB must be designated on the OHRP-approved FWA for Institution B.

DIRECTIONS FOR USE OF THIS FORM:

·  This form must be signed by the signatory officials of both institutions.

·  Instructions and text red font should be replaced or deleted.

Name of Institution Providing IRB Review (Institution A):

University of Utah – Assurance: FWA00003745 – U Utah

Name of Institution Relying on the Designated IRB (Institution B):

<insert name of institution>
Assurance: / <insert FWA number>

The Officials signing below agree that <name of Institution B> may rely on the designated IRB for review and continuing oversight of its human subjects research described below.

This agreement is limited to the following specific protocol(s):

IRB Number: / <insert number>
Title of Study: / <insert title>
Principal Investigator: / <insert name>
Sponsor or Funding Agency: / <insert sponsor>

This agreement allows the University of Utah (Institution A) to act as the IRB of record for an External Institution (Institution B). Both institutions have completed an OHRP-approved FWA. The IRB at Institution A will follow written procedures for reporting its findings and actions to appropriate officials at Institution B. Relevant minutes of IRB meetings will be made available to Institution B upon request. Institution B remains responsible for ensuring compliance with the IRB’s determinations and with the Terms of its OHRP-approved FWA. This document must be kept on file by both parties and provided to OHRP upon request.

Signature of Signatory Official (Institution A - University of Utah):

______
Signature / ______
Date
______
Print Full Name / ______
Institutional Title

Signature of Signatory Official (Institution B):

______
Signature / ______
Date
______
Print Full Name / ______
Institutional Title

HIPAA ASSURANCE LETTER TEMPLATE

If applicable, the HIPAA Assurance Letter should be submitted with the IAA. This assurance confirms that the External Institution will comply with the University of Utah IRB’s determinations regarding authorization for use of protected health information (PHI). This letter should be used in instances when an External Institution’s covered entity, for research purposes, gives University of Utah researchers access to protected health information maintained by that entity

DIRECTIONS FOR USE OF THIS TEMPLATE:

·  This letter must be placed on the External Institution’s letter head.

·  This letter should be signed by the External Institution’s HIPAA privacy officer (if applicable) or the signatory official.

·  Instructions and text red font should be replaced or deleted.

<Date>

To the University of Utah IRB:

This letter confirms that we are willing to collaborate with the University of Utah researchers on the following research project:

IRB Number: / <insert number>
Title of Study: / <insert title>
Principal Investigator: / <insert name>
Sponsor or Funding Agency: / <insert sponsor>

We are aware that the procedures used in this project involve the use and/or disclosure of protected health information (PHI) for research purposes with / without> authorization from the patients at <insert name of institution>.

If the study is requesting a waiver of authorization, use the following language:

We have policies and procedures in place to document our Privacy Board’s acceptance of a waiver of authorization approved by the University of Utah IRB per 45 CFR 164.512, Uses and disclosures for which an authorization of opportunity to agree or object is not required, specifically 45 CFR 164.512(i), Uses and disclosures for research purposes.

We are also aware that we must provide to our patients, upon request, an accounting of disclosures of their PHI under a waiver of authorization per 45 CFR 164.528, Accounting of disclosures of protected health information.

This letter confirms that a waiver of authorization <will be / has been> approved by our Privacy Board for the project named above.

If the study is using a consent and authorization document, use the following language:

We have policies and procedures in place to document our Privacy Board’s acceptance of an authorization (and consent) document. The University of Utah IRB will ensure that this authorization satisfies the requirements of 45 CFR 164.508.

This letter confirms that an authorization (and consent) document <will be / has been> approved by our Privacy Board for the project named above.

Sincerely,

<Name of Privacy Officer or Signatory Official>

<Title of Privacy Office or Signatory Official>

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