**[Institutional Review Board (IRB)]{.smallcaps}**

**[Request for deferral of New Protocol]{.smallcaps}**

**[to another institutional IRB]{.smallcaps}**

**Date Rec=d in HSO: [\_\_\_\_\_\_\_\_\_\_\_\_\_]{.underline}**

+-----------------------------------+-----+---------------------------+
| **Instructions:** Use this form   |     |                           |
| when submitting a request for     |     |                           |
| deferral of a new protocol to     |     |                           |
| another institution's IRB. Please |     |                           |
| submit this form electronically   |     |                           |
| along with the protocol and any   |     |                           |
| supporting documents to your CIO  |     |                           |
| human subjects contact. However,  |     |                           |
| if submitting hard copies, please |     |                           |
| send the original request form    |     |                           |
| with one copy of all documents to |     |                           |
| the CIO designated staff          |     |                           |
| official. Consecutively number    |     |                           |
| **ALL** pages, beginning with the |     |                           |
| title page of the protocol,       |     |                           |
| followed by any consent form(s)   |     |                           |
| and ancillary documents. Complete |     |                           |
| all applicable items or the form  |     |                           |
| will be returned.                 |     |                           |
|                                   |     |                           |
| **OMB Reminder:** Please note     |     |                           |
| that you are responsible for      |     |                           |
| obtaining OMB clearance on        |     |                           |
| Federally sponsored information   |     |                           |
| collections. An IRB approval of   |     |                           |
| **or** an exemption from IRB      |     |                           |
| review is unrelated to            |     |                           |
| requirements for OMB clearance    |     |                           |
| under the Paperwork Reduction     |     |                           |
| Act. For more information on      |     |                           |
| whether there are legal           |     |                           |
| requirements for your study to go |     |                           |
| through the OMB clearance         |     |                           |
| process, please contact your      |     |                           |
| CIO\'s OMB coordinator or OPPE    |     |                           |
| clearance staff.                  |     |                           |
+-----------------------------------+-----+---------------------------+
| **Date Submitted by Investigator: |     | +----------------------+  |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**  |     | | **[Protocol          |  |
|                                   |     | | No]{.smallcaps}:     |  |
|                                   |     | | [\_\_\_              |  |
|                                   |     | | \_\_\_\_\_\          |  |
|                                   |     | | _\_\_]{.underline}** |  |
|                                   |     | |                      |  |
|                                   |     | | (For Human Subjects  |  |
|                                   |     | | Office Use)          |  |
|                                   |     | +----------------------+  |
+-----------------------------------+-----+---------------------------+
| **Title of Protocol:              |     |                           |
| \_\_                              |     |                           |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |     |                           |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_** |     |                           |
|                                   |     |                           |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\   |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |     |                           |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |     |                           |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |     |                           |
+-----------------------------------+-----+---------------------------+
| Proposed Dates for Project to     |     |                           |
| Begin: End:                       |     |                           |
| \_\_\_\                           |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |     |                           |
+-----------------------------------+-----+---------------------------+
| **Name of Primary CDC Contact     |     |                           |
| (PC) and Degrees:                 |     |                           |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_    |     |                           |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_** |     |                           |
+-----------------------------------+-----+---------------------------+
| *Scientific Ethics* Verification  | T   |                           |
| No.:                              | ele |                           |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_  | pho |                           |
|                                   | ne: |                           |
|                                   | F   |                           |
|                                   | ax: |                           |
|                                   | \   |                           |
|                                   | _\_ |                           |
|                                   | \_\ |                           |
|                                   | _\_ |                           |
|                                   | \_\ |                           |
|                                   | _\_ |                           |
|                                   | \_\ |                           |
|                                   | _\_ |                           |
|                                   | \_\ |                           |
|                                   | _\_ |                           |
|                                   | \_\ |                           |
|                                   | _\_ |                           |
+-----------------------------------+-----+---------------------------+
| **CIO**: **Division**: **MS**:    | U   |                           |
| [\_\_\_\_\_\_\_\_]{.underline}    | ser |                           |
|                                   | ID  |                           |
|                                   | (UI |                           |
|                                   | D): |                           |
|                                   | \_\ |                           |
|                                   | _\_ |                           |
|                                   | \_\ |                           |
|                                   | _\_ |                           |
|                                   | \_\ |                           |
|                                   | _\_ |                           |
|                                   | \_\ |                           |
|                                   | _\_ |                           |
|                                   | \_\ |                           |
|                                   | _\_ |                           |
|                                   | \_\ |                           |
|                                   | _\_ |                           |
|                                   | \_\ |                           |
|                                   | _\_ |                           |
|                                   | \_\ |                           |
|                                   | _\_ |                           |
|                                   | \_\ |                           |
|                                   | _\_ |                           |
|                                   | \_\ |                           |
|                                   | _\_ |                           |
|                                   | \_\ |                           |
|                                   | _\_ |                           |
+-----------------------------------+-----+---------------------------+
| List all CDC Co-investigators     |     |                           |
| below (list CDC Principal         |     |                           |
| Investigator (PI) in #1 if        |     |                           |
| different from the PC indicated   |     |                           |
| above). If PI is indicated her,   |     |                           |
| insert PI before name (use        |     |                           |
| supplemental page if number of    |     |                           |
| investigators is \> than 2):      |     |                           |
|                                   |     |                           |
| 1[.]{.underline} *Scientific      |     |                           |
| Ethics* Verification No.:         |     |                           |
| \_\_\_\                           |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |     |                           |
+-----------------------------------+-----+---------------------------+
| 2\. *Scientific Ethics*           |     |                           |
| Verification No.:                 |     |                           |
| \_\_\_\                           |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |     |                           |
+-----------------------------------+-----+---------------------------+
| 3\. *Scientific Ethics*           |     |                           |
| Verification No.:                 |     |                           |
| \_\_\_\                           |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |     |                           |
+-----------------------------------+-----+---------------------------+
| **Name, degrees, and affiliation  |     |                           |
| of Primary Contact (PC)/Principal |     |                           |
| Investigator (PI) with outside    |     |                           |
| institution:**                    |     |                           |
+-----------------------------------+-----+---------------------------+
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\   |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |     |                           |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |     |                           |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |     |                           |
|                                   |     |                           |
| Telephone:                        |     |                           |
| \_\_\                             |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |     |                           |
| Fax:                              |     |                           |
| \_\_\_\_\_\_\                     |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |     |                           |
| Email Address:                    |     |                           |
| \_\_\_\_\_\_\_\_\_\_\_\           |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |     |                           |
+-----------------------------------+-----+---------------------------+
| **Name of outside institution**:  |     |                           |
|                                   |     |                           |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_  |     |                           |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |     |                           |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |     |                           |
|                                   |     |                           |
| Institution protocol              |     |                           |
| Identification No.:               |     |                           |
| \_\_\_\_\_\_\_\_\_\_\_\_\_        |     |                           |
| (Provide title if different from  |     |                           |
| CDC title):                       |     |                           |
|                                   |     |                           |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_  |     |                           |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |     |                           |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |     |                           |
+-----------------------------------+-----+---------------------------+
| Name and degrees of the IRB       |     |                           |
| manager at institution with IRB   |     |                           |
| to contact regarding this         |     |                           |
| request:                          |     |                           |
|                                   |     |                           |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\     |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |     |                           |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |     |                           |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |     |                           |
|                                   |     |                           |
| Telephone:                        |     |                           |
| \_\_\                             |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |     |                           |
| Fax:                              |     |                           |
| \_\_\_\_\_\_\                     |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |     |                           |
| Email Address:                    |     |                           |
| \_\_\_\_\_\_\_\_\_\_\             |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |     |                           |
|                                   |     |                           |
| Complete Mailing Address for      |     |                           |
| institution:                      |     |                           |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\       |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |     |                           |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |     |                           |
|                                   |     |                           |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\     |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |     |                           |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |     |                           |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |     |                           |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |     |                           |
+-----------------------------------+-----+---------------------------+

+-----------------+--------------------------------+-----------+-----+---+
|                 |                                |           |     |   |
+-----------------+--------------------------------+-----------+-----+---+
| **FUNDING       | **[Location of                 |           |     |   |
| MECHANISM:**    | Research]{.smallcaps} (Use     |           |     |   |
|                 | additional sheets if           |           |     |   |
| **Insert        | necessary):**                  |           |     |   |
| appropriate     |                                |           |     |   |
| code from list  | **\[ \] U.S. or its            |           |     |   |
| below. If       | territories**                  |           |     |   |
| funded, include |                                |           |     |   |
| Procurement &   | **and/or**                     |           |     |   |
| Grants Office   |                                |           |     |   |
| funding No.**   | **\[ \] Foreign countries**    |           |     |   |
|                 |                                |           |     |   |
| **Grant = G**   |                                |           |     |   |
|                 |                                |           |     |   |
| **Cooperative   |                                |           |     |   |
| Agreemt = CA**  |                                |           |     |   |
|                 |                                |           |     |   |
| **Contract =    |                                |           |     |   |
| C**             |                                |           |     |   |
|                 |                                |           |     |   |
| **Purchase      |                                |           |     |   |
| Order = PO**    |                                |           |     |   |
|                 |                                |           |     |   |
| **Interagency   |                                |           |     |   |
| Agreemt = IAA** |                                |           |     |   |
|                 |                                |           |     |   |
| **Memorandum of |                                |           |     |   |
| Understanding = |                                |           |     |   |
| MOU**           |                                |           |     |   |
|                 |                                |           |     |   |
| **CDC only =    |                                |           |     |   |
| CDC**           |                                |           |     |   |
|                 |                                |           |     |   |
| **Collaborative |                                |           |     |   |
| = COL**         |                                |           |     |   |
+-----------------+--------------------------------+-----------+-----+---+
|                 | **List All Collaborating       | **OHRP    | **  |   |
|                 | Institutions by Full Name,     | Assurance | IRB |   |
|                 | City, State, and/or Country**  | No:**     | /IE |   |
|                 |                                |           | C** |   |
|                 |                                |           |     |   |
|                 |                                |           | **A |   |
|                 |                                |           | ppr |   |
|                 |                                |           | ova |   |
|                 |                                |           | l** |   |
|                 |                                |           |     |   |
|                 |                                |           | **  |   |
|                 |                                |           | att |   |
|                 |                                |           | ach |   |
|                 |                                |           | ed/ |   |
|                 |                                |           | pen |   |
|                 |                                |           | din |   |
|                 |                                |           | g** |   |
+-----------------+--------------------------------+-----------+-----+---+
| 1\.             |                                |           |     |   |
+-----------------+--------------------------------+-----------+-----+---+
| 2\.             |                                |           |     |   |
+-----------------+--------------------------------+-----------+-----+---+
| 3\.             |                                |           |     |   |
+-----------------+--------------------------------+-----------+-----+---+

+-----------------+-----------------------------------------------------+
| **STUDY         |                                                     |
| POPULATION**    |                                                     |
| (If an          |                                                     |
| international   |                                                     |
| study, provide  |                                                     |
| race/ethnicity  |                                                     |
| of subjects by  |                                                     |
| estimated       |                                                     |
| percentages):   |                                                     |
+-----------------+-----------------------------------------------------+
| Estimated       | Race/Ethnicity Distribution for Domestic Studies:   |
| Number of       |                                                     |
| Subjects:\_\_\  | \% American Indian or Alaskan Native                |
| _\_\_\_\_\_\_\_ |                                                     |
|                 | \% Asian or Pacific Islander:                       |
|                 |                                                     |
|                 | \% Black or African American; not of Hispanic       |
|                 | Origin                                              |
|                 |                                                     |
|                 | \% Hispanic                                         |
|                 |                                                     |
|                 | \% White, not of Hispanic Origin                    |
+-----------------+-----------------------------------------------------+
| Gender          |                                                     |
| Distribution:   |                                                     |
|                 |                                                     |
| \% Male         |                                                     |
|                 |                                                     |
| \% Female       |                                                     |
+-----------------+-----------------------------------------------------+
| \[ \] Study     |                                                     |
| includes        |                                                     |
| members of      |                                                     |
| Vulnerable      |                                                     |
| Populations     |                                                     |
| (Check all that |                                                     |
| apply):         |                                                     |
+-----------------+-----------------------------------------------------+
| \[ \] Pregnant  |                                                     |
| women and/or    |                                                     |
| fetuses as      |                                                     |
| SPECIFIC        |                                                     |
| targets group   |                                                     |
| (Ref: 45CFR46,  |                                                     |
| Subpart B)      |                                                     |
+-----------------+-----------------------------------------------------+
| \[ \] Children  |                                                     |
| 17 years of age |                                                     |
| or under(Ref:   |                                                     |
| 45CFR46,        |                                                     |
| Subpart D)      |                                                     |
|                 |                                                     |
| \[ \]           |                                                     |
| Requesting      |                                                     |
| waiver of       |                                                     |
| parental        |                                                     |
| permission      |                                                     |
+-----------------+-----------------------------------------------------+
| \[ \] Mentally  |                                                     |
| disabled        |                                                     |
+-----------------+-----------------------------------------------------+
| \[ \]           |                                                     |
| Economically or |                                                     |
| educationally   |                                                     |
| disadvantaged   |                                                     |
+-----------------+-----------------------------------------------------+
| \[ \] Prisoners |                                                     |
| (Ref: 45CFR46,  |                                                     |
| Subpart C)      |                                                     |
+-----------------+-----------------------------------------------------+

+-----------------------------------------------------------------------+
| **[1. Criteria for Reliance on another IRB]{.smallcaps}** (check and  |
| provide justification for all that apply)                             |
|                                                                       |
| Deferring institution's role is limited to the following:             |
+-----------------------------------------------------------------------+
| **\[ \]** The principal investigator is not an employee, contractor,  |
| visiting scientist or fellow of deferring institution. This policy    |
| does not apply to an employee who is assigned to another agency and   |
| who functions as an employee of that agency and lists his/her         |
| affiliation with the agency being deferred to:                        |
|                                                                       |
| **Provide title/position of principal investigator:**                 |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                        |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
+-----------------------------------------------------------------------+
| **\[ \]** Investigator(s) from deferring institution does not have    |
| any direct interaction with study participants or possess or have     |
| access to any identifiable data from the study.                       |
|                                                                       |
| **Explain how investigator from deferring institution meets this      |
| criteria:**                                                           |
|                                                                       |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                      |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
+-----------------------------------------------------------------------+
| **\[ \]** The study is being deferred to an outside organization that |
| has an OHRP approved FederalWide or Multiple Project Assurance (FWA   |
| or MPA) and that institution's IRB has reviewed and approved the      |
| study and their institution is responsible for participant            |
| recruitment.                                                          |
|                                                                       |
| **How will participants be recruited**:                               |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\             |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
|                                                                       |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                    |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
+-----------------------------------------------------------------------+
| **\[ \]** The study involves no more than minimal risk and does not   |
| address a controversial topic. Minimal risk means that the            |
| probability and magnitude of harm or discomfort anticipated in the    |
| research are not greater in and of themselves than those ordinarily   |
| encountered in daily life or during the performance of routine        |
| physical or psychological examinations or tests. Controversial topic  |
| means a sensitive topic such as illegal behaviors, sexual behavior    |
| practices, or psychiatric illness; involves a vulnerable population   |
| as defined in 45 CFR 46; or is of particular interest to the DHHS or  |
| Congress.                                                             |
|                                                                       |
| **Study is minimal risk because:**                                    |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\     |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
+-----------------------------------------------------------------------+
| **\[ \]** The study has not yet begun. Meaning no involvement with    |
| the human subjects or any personal identifiable information has       |
| begun.                                                                |
|                                                                       |
| **Explain status of the study (i.e. study is still in the planning    |
| and/or preparation phase):** \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_   |
|                                                                       |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                        |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **2. DESCRIBE CDC=S ROLE IN THE STUDY, INCLUDING PROTOCOL             |
| DEVELOPMENT:**                                                        |
|                                                                       |
| **\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                  |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_** |
|                                                                       |
| **\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                  |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_** |
|                                                                       |
| **\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                  |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_** |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **3. COPIES OF ALL OF THE FOLLOWING ITEMS ARE REQUIRED TO BE          |
| SUBMITTED WITH THE REQUEST FOR DEFERRAL. COPIES MUST BE RECEIVED BY   |
| HUMAN SUBJECTS ACTIVITY BEFORE REQUEST WILL BE APPROVED** (check mark |
| all that are attached and give written explanation for any item not   |
| attached)**:**                                                        |
|                                                                       |
| **\[ \]** IRB approved Protocol                                       |
|                                                                       |
| **\[ \]** IRB approved consent forms                                  |
|                                                                       |
| **\[ \]** IRB approval letter/report                                  |
|                                                                       |
| **\[ \]** IRB minutes pertaining to this protocol                     |
+-----------------------------------------------------------------------+

  ------------------------------------- ----- ---- --------- ----- ------------
  [**Data Confidentiality Information**                            
  (Circle)                                                         
  **Reference(s):**]{.smallcaps}                                   

  Is there an Assurance of              YES   NO   Applied   N/A   \' 308(d)
  Confidentiality to cover this project            For             PHS Act
  by the institution with the IRB?                                 

  Does the local site(s) have a         YES   NO   Applied   N/A   \'301(d) PHS
  Certificate of Confidentiality to                For             Act
  cover this project?                                              
  ------------------------------------- ----- ---- --------- ----- ------------

  --------------------------------------- ----------- -------------------------
  **Approvals** (Signature and Position   **Date:**   **Remarks:**
  Title):                                             

  Branch Chief:                                       

  Division Director:                                  

  CIO Human Subjects Contact:                         
  --------------------------------------- ----------- -------------------------