IMPORTANT: CONSULT OHRP BEFORE SUBMISSION.
OHRP CANNOT ACCEPT UNSOLICITED ASSURANCES.

(Name of Institution)

Assurance of Compliance with DHHS regulations for
Protection of Human Research Subjects

(Name of Institution)                                          , hereinafter known as the "institution", hereby gives assurance that it will comply with the Department of Health and Human Services (DHHS) regulations for the protection of human research subjects ( 45 CFR 46) as specified below.

PART 1

Ethical Principles and Institutional Policies Governing
Research Involving Human Subjects

Part 3

Certification of IRB Approval and Institutional Endorsement

Project Title ________________________________________________________________________

DHHS Project Number ________________________________________________________________

Project Principal Investigator ____________________________________________________________

Date of IRB Approval ______________(if any)  

Date of Next Scheduled IRB Review _______________

The officials signing below assure that the project referenced above was approved by the IRB on the date indicated and that the project will be conducted in accordance with the requirements of Part 46, Title 45 of the Code of Federal Regulations and this Assurance document. A dated roster listing the current membership of the designated IRB is attached.

As appropriate, the officials signing below further assure that for each protocol in this project for which IRB approval was not possible due to delayed onset of subject involvement, the IRB's institution will provide a copy of the IRB-approved protocol, IRB-approved consent language, and documentation of IRB certification (Optional Form 310), including the applicable Assurance number, to OHRP for approval prior to accrual of human subjects.

I.	Authorized Official of the Institution Providing this Assurance
	Signature ___________________________________ Date: ________________

Please type the following items.

Name and Title: Institution: Address:

Telephone:

Fax:

E-mail:

II.	Authorized Official of the Institution with the IRB (Include only if different from the institution above)
	This institution authorizes the designation of its IRB for review of the project referenced in this Assurance.

Signature: _________________________________________ Date: ________________

Please type the following items.

	Name and Title:
	Institution:
	Address:

Telephone:

Fax:

E-mail:

III.	IRB Chairperson (Must be completed in all cases [see IRB membership list])

Signature: _________________________________________ Date: ________________

Please type the following items.

	Name and Title:
	Institution:
	Address:

Telephone:

Fax:

E-mail:

MPA Number if applicable: __________________

IV.	Responsible Project Investigator at Institution Providing this Assurance

I have attached copies of all OHRP requested and IRB approved Informed Consent Documents to be used in this project unless the designated IRB operates under an OHRP-approved Multiple Project Assurance (MPA) or unless OHRP has indicated otherwise.

Signature: _______________________________________ Date: __________________

Please type the following items.

	Name:
	Title:
	Institution:
	Address:

Telephone:

Fax:

E-mail:

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- Space Below for DHHS -

 DHHS Approving Official

An application for new or competing support for continuation in which human subjects will be involved will require a new and separate Assurance, unless the activity is exempt under section 45 CFR 46.101 (b).

For the Institutional Review Board (IRB) Membership Roster see: Institutional Review Board Members

Policy and Assurances | OHRP Home Page

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Updated August 28, 2002