**IMPORTANT: CONSULT OPRR BEFORE SUBMISSION.**

**OPRR CANNOT ACCEPT UNSOLICITED ASSURANCES.**

THIS IS A SAMPLE SINGLE PROJECT ASSURANCE (SPA) FOR AN

INSTITUTION WHICH CURRENTLY DOES NOT HAVE A MULTIPLE PROJECT

ASSURANCE (MPA) ON FILE WITH OPRR.

**[FULL IRB REVIEW REQUIRED OF IRB]{.underline}**

Using this Sample, type on Institutional Letterhead, supplying where
indicated, information specific to the proposed research activity and
your Institution, and include required certification on the endorsement
page.

**[(Name of Institution)]{.underline}**

Assurance of Compliance with DHHS regulations for

Protection of Human Research Subjects

**[(Name of Institution) ]{.underline}**, 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**

**I.** **Applicability**

Except for research exempted or waived under the DHHS regulations 45 CFR
46.101, Part 1 of this Assurance applies to all research involving human
subjects, and all other activities which even in part involve such
research, regardless of whether the research is otherwise subject to
federal regulation, if:

\(a\) the research is sponsored by this institution, [or]{.underline}

\(b\) the research is conducted by or under the direction of any
employee or agent of this institution in connection with institutional
responsibilities, [or]{.underline}

\(c\) the research is conducted by or under the direction of any
employee or agent of this institution using any property or facility of
this institution, [or]{.underline}

\(d\) the research involves the use of this institutions nonpublic
information to identify or contact human research subjects or
prospective subjects.

**II.** **Ethical Principles Governing Human Subjects Research**

This institution is guided by the ethical principles regarding all
research involving humans as subjects as set forth in the report of the
National Commission for the Protection of Human Subjects of Biomedical
and Behavioral Research entitled, [Ethical Principles and Guidelines for
the Protection of Human Subjects of Research]{.underline} (the Belmont
Report) and as specified below.

A. This institution recognizes the principles of respect for persons,
beneficence (including minimization of harms and maximization of
benefits), and justice as stated in the Belmont Report and will apply
these principles in all research covered by this Assurance.

B. This institution acknowledges and accepts its responsibilities for
protecting the rights and welfare of human research subjects.

**III. Policies**

A. This institution acknowledges that it and its investigations bear
full responsibility for the performance of all research covered by this
Assurance, including full responsibility for complying with Federal,
state and local laws as they may relate to such research.

B. This institution assures that before human subjects are involved in
research, proper consideration will be given to:

\(1\) the risks to the subjects,

\(2\) the anticipated benefits to the subjects and others,

\(3\) the importance of the knowledge that may reasonably by expected to
result,

\(4\) the informed consent process to be employed,

\(5\) the provisions to protect the privacy of subjects, and

\(6\) the additional safeguards for vulnerable populations.

C. This institution recognizes the need for appropriate additional
safeguards in research involving subjects who are likely to be
vulnerable to coercion or undue influence such as children, prisoners,
pregnant women, mentally disabled persons, or economically or
educationally disadvantaged persons.

D. This institution encourages and promotes constructive communication
among the institutional officials, research administrators, department
heads, research investigators, clinical care staff, human subjects, and
all other relevant parties as a means of maintaining a high level of
awareness regarding the safeguarding of the rights and welfare of the
subjects.

E. This institution will exercise appropriate administrative overview
carried out at least annually to assure that its practices and
procedures designed for the protection of the rights and welfare of
human subjects are being effectively applied.

**Part 2**

**IRB, Institution, and Investigator Compliance with 45 CFR 46**

**I. Applicability**

Part 2 of this Assurance applies to the following research project which
is conducted or sponsored by this institution and supported by the
Department of Health and Human Services (DHHS).

Project Title
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

DHHS Project Number
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Project Principal Investigator
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**II**. **Institutional Responsibilities**

A. This institution has complied and will continue to comply with the
requirements of 45 CFR 46 as specified below.

B. In accordance with the compositional and quorum requirements of 45
CFR 46.107 and 46.108, the Institutional Review Board (IRB) designated
in Part 3 and in the attached roster is responsible for the initial and
continuing review of this project.

C. This institution has provided and will continue to provide both
meeting space for the IRB and sufficient staff to support the IRB\'s
review and record keeping duties.

D. In addition to the review and approval of the IRB, this institution
has reviewed and sponsors the project referenced above.

**III. IRB Review**

A. The IRB shall review, and have the authority to approve, require
modification in, or disapprove this research activity or proposed
changes in it before human subjects may be involved.

B. The convened IRB reviewed and approved the above project.

C. The IRB determined, in accordance with the criteria found at 45 CFR
46.111, and where applicable, 45 CFR 46 Subparts B, C, and D, that
protections for human subjects are adequate.

D. The IRB has the authority to suspend or terminate approval of the
above referenced research in accordance with 45 CFR 46.113 for (1)
non-compliance with 45 CFR 46, and this Assurance document or the IRB\'s
requirements, and (2) for elimination of unexpected serious harm to
subjects.

E. The IRB has determined that legally effective informed consent
**\[copy of document must be attached unless specified otherwise by
OPRR\]** will be obtained in a manner and method which meets the
requirements of 45 CFR 46.116 and 46.117.

F. Certification of IRB approval, at least annually shall be submitted
to the DHHS awards unit that issued the award, as a condition for
receipt of funds for a non-competing continuation and/or additional
involvement of human subjects.

G. Continuing reviews by the IRB shall be conducted at intervals
appropriate to the degree of risk, but not less that once per year. (45
CFR 46.109 \[e\]). The IRB may be called into an interim review session
by the Chairperson at the request of any IRB member or Institutional
Official to consider any matter concerned with the rights and welfare of
any subject.

H. The IRB shall prepare and maintain adequate documentation of its
activities in accordance with 45 CFR 46.115.

I. The IRB shall report promptly to institutional officials and the
Office for Protection from Research Risks (OPRR):

\(1\) any serious or continuing noncompliance by investigators with the
requirements of the IRB,

\(2\) any suspension or termination of IRB approval,

\(3\) any unanticipated problems or injuries involving risks to subjects
or others, and

\(4\) any changes in this research activity which are reviewed and
approved by the IRB.

J. Where appropriate, the IRB will determine that adequate additional
protections are ensured to fetuses, pregnant women, prisoners, and
children as required under Subparts B, C, and D of 45 CFR 46. The IRB
will notify OPRR promptly when IRB membership is modified to satisfy the
requirements at 45 CFR 46.304 and when the IRB fulfills its duties under
45 CFR 46.305 (c).

K. The IRB will comply fully with the requirements of all applicable
Federal policies and guidelines, including those concerning notification
of sero-positivity, counseling, and confidentiality of subjects.

**IV. Research Investigator Reporting Responsibilities**

A. Investigators acknowledge and accept their responsibility for
protecting the rights and welfare of human research subjects and for
complying with all applicable provisions of this Assurance and 45 CFR
46.

B. Research investigators shall reports promptly to the IRB proposed
changes in this research activity and the changes shall not be initiated
without IRB review and approval except where necessary to eliminate
apparent immediate hazards to the subjects.

C. Research investigators shall report promptly to the IRB any
unanticipated problems involving risks to subjects and others.

**Part 3**

**Certification of IRB Approval and Institutional Endorsement**

Project Title
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

DHHS Project Number
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Project Principal Investigator
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Date of IRB Approval \_\_\_\_\_\_\_\_\_\_\_\_ Date of Next Scheduled IRB
Review \_\_\_\_\_\_\_\_\_

**The officials signing below assure that the project referenced above
was approved by the IRB of 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 OPRR 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 OPRR requested and IRB approved Informed
Consent Documents to be used in this project unless the designated IRB
operates under an OPRR-approved Multiple Project Assurance (MPA) or
unless OPRR has indicated otherwise.

Signature:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**Please type the following items.**

Name:

Title:

Institution:

Address:

Telephone: Fax: E-mail:

\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*

All parts of this Assurance are in compliance with the requirements of
Part 46, Title 45, of the Code of Federal Regulations.

**DHHS Approving Official**

Signature:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Date: \_\_\_\_\_\_\_\_\_\_\_

Name:

Address: Assurance Coordinator, Division of Human Subject Protections

Office for Protection From Research Risks - NIH MSC 7507

6100 Executive Boulevard, Suite 3B01

Rockville, Maryland 20892-7507 \[Courier only: 20852\]

Telephone #: 301-496-7041

Fax #: 301-402-0527

E-mail address:

**ASSURANCE NUMBER S- \_\_\_\_\_\_\_\_\_\_**

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).

INSTITUTIONAL REVIEW BOARD MEMBERS

**\[to be revised and submitted to OPRR as changes occur\]**

**DATE:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

**NAME OF INSTITUTION PROVIDING THIS ASSURANCE: ASSURANCE NUMBER:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

**NAME OF INSTITUTION PROVIDING IRB REVIEW\* (if different from above):
ASSURANCE NUMBER:** \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

+-------------+-------------+-------------+-------------+-------------+
| **NAME **   | **HIGHEST   | **PRIMARY   | **          | **A         |
|             | DEGREE **   | SCIENTIFIC  | AFFILIATION | TTESTATIONS |
| **(voting   |             | ORNO        | WITH        | OF IRB**    |
| members     | **EARNED**  | NSCIENTIFIC | INS         |             |
| o           |             | SPECIALTY** | TITUTION(S) | **CH        |
| nly^)2,3^** |             |             | ABOVE**     | AIRPERSON** |
|             |             |             |             |             |
| **Last,     |             |             | **(YES/NO;  |             |
| First**     |             |             | **          |             |
|             |             |             |             |             |
|             |             |             | **IF YES,   |             |
|             |             |             | WHICH       |             |
|             |             |             | ONE)**      |             |
+-------------+-------------+-------------+-------------+-------------+
| \*          |             |             |             | **FOR ALL   |
|             |             |             |             | RESEARCH    |
| \*\*        |             |             |             | CONDUCTED   |
|             |             |             |             | UNDER THIS  |
|             |             |             |             | ASSURANCE,  |
|             |             |             |             | THE IRB     |
|             |             |             |             | CHAIRPERSON |
|             |             |             |             | HEREBY      |
|             |             |             |             | ATTESTS     |
|             |             |             |             | THAT,       |
|             |             |             |             | EXCEPT      |
|             |             |             |             | WHERE       |
|             |             |             |             | S           |
|             |             |             |             | PECIFICALLY |
|             |             |             |             | WAIVED OR   |
|             |             |             |             | ALTERED BY  |
|             |             |             |             | THE IRB     |
|             |             |             |             | UNDER 45    |
|             |             |             |             | CFR         |
|             |             |             |             | 46.116(c),  |
|             |             |             |             | 46.116(d),  |
|             |             |             |             | 46.117(c),  |
|             |             |             |             | THE IRB     |
|             |             |             |             | WILL UPHOLD |
|             |             |             |             | THE         |
|             |             |             |             | R           |
|             |             |             |             | EQUIREMENTS |
|             |             |             |             | OF 45 CFR   |
|             |             |             |             | 46 FOR      |
|             |             |             |             | WRITTEN     |
|             |             |             |             | INFORMED    |
|             |             |             |             | CONSENT, IN |
|             |             |             |             | NON         |
|             |             |             |             | EXCULPATORY |
|             |             |             |             | LANGUAGE    |
|             |             |             |             | UND         |
|             |             |             |             | ERSTANDABLE |
|             |             |             |             | TO THE      |
|             |             |             |             | SUBJECT (OR |
|             |             |             |             | THE         |
|             |             |             |             | SUBJECT\'S  |
|             |             |             |             | LEGALLY     |
|             |             |             |             | AUTHORIZED  |
|             |             |             |             | REPRE       |
|             |             |             |             | SENTATIVE), |
|             |             |             |             | INCLUDING   |
|             |             |             |             | THE         |
|             |             |             |             | FOLLOWING   |
|             |             |             |             | BASIC       |
|             |             |             |             | ELEMENTS    |
|             |             |             |             | PER 45 CFR  |
|             |             |             |             | 46.         |
|             |             |             |             | 116(a/b):** |
|             |             |             |             |             |
|             |             |             |             | **(1)       |
|             |             |             |             | IDE         |
|             |             |             |             | NTIFICATION |
|             |             |             |             | AS          |
|             |             |             |             | RESEARCH;   |
|             |             |             |             | PURPOSES,   |
|             |             |             |             | DURATION,   |
|             |             |             |             | AND         |
|             |             |             |             | PROCEDURES; |
|             |             |             |             | PROCEDURES  |
|             |             |             |             | WHICH ARE   |
|             |             |             |             | EX          |
|             |             |             |             | PERIMENTAL; |
|             |             |             |             | **          |
|             |             |             |             |             |
|             |             |             |             | **(2)       |
|             |             |             |             | REASONABLY  |
|             |             |             |             | FORESEEABLE |
|             |             |             |             | RISKS OR    |
|             |             |             |             | DIS         |
|             |             |             |             | COMFORTS;** |
|             |             |             |             |             |
|             |             |             |             | **(3)       |
|             |             |             |             | EXPECTED    |
|             |             |             |             | BENEFITS TO |
|             |             |             |             | THE SUBJECT |
|             |             |             |             | OR          |
|             |             |             |             | OTHERS;**   |
|             |             |             |             |             |
|             |             |             |             | **(4)       |
|             |             |             |             | ALTERNATIVE |
|             |             |             |             | PROCEDURES  |
|             |             |             |             | OR          |
|             |             |             |             | TREATMENTS; |
|             |             |             |             | **          |
|             |             |             |             |             |
|             |             |             |             | **(5)       |
|             |             |             |             | EXTENT OF   |
|             |             |             |             | CONF        |
|             |             |             |             | IDENTIALITY |
|             |             |             |             | TO BE       |
|             |             |             |             | MA          |
|             |             |             |             | INTAINED;** |
|             |             |             |             |             |
|             |             |             |             | **(6)       |
|             |             |             |             | WHETHER     |
|             |             |             |             | C           |
|             |             |             |             | OMPENSATION |
|             |             |             |             | OR MEDICAL  |
|             |             |             |             | TREATMENT   |
|             |             |             |             | ARE         |
|             |             |             |             | AVAILABLE   |
|             |             |             |             | IF INJURY   |
|             |             |             |             | OCCURS (IF  |
|             |             |             |             | MORE THAN   |
|             |             |             |             | MINIMAL     |
|             |             |             |             | RISK); **   |
|             |             |             |             |             |
|             |             |             |             | **(7) WHOM  |
|             |             |             |             | TO CONTACT  |
|             |             |             |             | FOR ANSWERS |
|             |             |             |             | TO          |
|             |             |             |             | QUESTIONS   |
|             |             |             |             | ABOUT THE   |
|             |             |             |             | RESEARCH,   |
|             |             |             |             | SUBJECT\'S  |
|             |             |             |             | RIGHTS, AND |
|             |             |             |             | RESEA       |
|             |             |             |             | RCH-RELATED |
|             |             |             |             | INJURY;**   |
|             |             |             |             |             |
|             |             |             |             | **(8)       |
|             |             |             |             | PA          |
|             |             |             |             | RTICIPATION |
|             |             |             |             | IS          |
|             |             |             |             | VOLUNTARY;  |
|             |             |             |             | REFUSAL TO  |
|             |             |             |             | PARTICIPATE |
|             |             |             |             | WILL        |
|             |             |             |             | INVOLVE NO  |
|             |             |             |             | PENALTY OR  |
|             |             |             |             | LOSS OF     |
|             |             |             |             | BENEFITS TO |
|             |             |             |             | WHICH       |
|             |             |             |             | SUBJECT IS  |
|             |             |             |             | ENTITLED;   |
|             |             |             |             | SUBJECT MAY |
|             |             |             |             | DISCONTINUE |
|             |             |             |             | AT ANY TIME |
|             |             |             |             | WITHOUT     |
|             |             |             |             | PENALTY OR  |
|             |             |             |             | LOSS OF     |
|             |             |             |             | BENEFITS TO |
|             |             |             |             | WHICH       |
|             |             |             |             | SUBJECT IS  |
|             |             |             |             | ENTITLED;   |
|             |             |             |             | **          |
|             |             |             |             |             |
|             |             |             |             | **(9) WHEN  |
|             |             |             |             | A           |
|             |             |             |             | PPROPRIATE, |
|             |             |             |             | ADDITIONAL  |
|             |             |             |             | ELEMENTS    |
|             |             |             |             | PER 45 CFR  |
|             |             |             |             | 46.116(b).  |
|             |             |             |             | **          |
|             |             |             |             |             |
|             |             |             |             | **AS IRB    |
|             |             |             |             | C           |
|             |             |             |             | HAIRPERSON, |
|             |             |             |             | I HEREBY SO |
|             |             |             |             | ATTEST.**   |
|             |             |             |             |             |
|             |             |             |             | *           |
|             |             |             |             | *SIGNATURE: |
|             |             |             |             | \_\_\_\_\_\ |
|             |             |             |             | _\_\_\_\_\_ |
|             |             |             |             | \_\_\_\_\_\ |
|             |             |             |             | _\_\_\_\_\_ |
|             |             |             |             | \_\_\_\_\_\ |
|             |             |             |             | _\_\_\_\_\_ |
|             |             |             |             | \_\_\_\_\_\ |
|             |             |             |             | _\_\_\_\_\_ |
|             |             |             |             | \_\_\_\_\_\ |
|             |             |             |             | _\_\_\_\_\_ |
|             |             |             |             | \_\_\_\_\_\ |
|             |             |             |             | _\_\_\_\_\_ |
|             |             |             |             | **          |
|             |             |             |             |             |
|             |             |             |             | **DATE:**   |
|             |             |             |             |             |
|             |             |             |             | **PHONE:    |
|             |             |             |             | E-MAIL:**   |
|             |             |             |             |             |
|             |             |             |             | **ADDRESS:  |
|             |             |             |             | **          |
+-------------+-------------+-------------+-------------+-------------+

**\*DENOTES CHAIRPERSON **

** \*\*DENOTES ALTERNATES (IF ANY, DENOTE MEMBER FOR WHOM ALTERNATE WILL
SERVE)**

** (1) WHERE REVIEW IS CONDUCTED BY ANOTHER INSTITUTION\'S IRB, THE IRB
MUST ENSURE ADEQUATE KNOWLEDGE OF LOCAL CONDITIONS, INCLUDING COMMUNITY
ATTITUDES, RELEVANT CULTURAL SENSITIVITIES, INSTITUTIONAL POLICIES/
COMMITMENTS, APPLICABLE LAW, AND STANDARDS OF PROFESSIONAL
CONDUCT/PRACTICE. **

** (2) NO IRB MEMBER MAY PARTICIPATE IN THE REVIEW OF ANY PROJECT IN
WHICH THE MEMBER HAS A CONFLICTING INTEREST. **

** (3) IRBs MUST BE CONSTITUTED SO AS TO ENSURE APPROPRIATE REVIEW AND
ADDITIONAL SAFEGUARDS FOR RESEARCH INVOLVING VULNERABLE CATEGORIES OF
SUBJECTS. **

** (4) AFFILIATION MAY TAKE THE FORM OF EMPLOYMENT, MEMBER OF GOVERNING
BOARD, STOCKHOLDER, OR PAID/UNPAID CONSULTANT (FOR PURPOSES OTHER THAN
IRB FUNCTIONS). **

**(5) SEE OPRR TIPS FOR INFORMED CONSENT AT:
http://www.nih.gov/grants/oprr/humansubjects/guidance/ictips.htm**