Request to Conduct Research

PART I: Research and Development -- Request to Review

**VA Pittsburgh Healthcare System (VAPHS),**

**Pittsburgh, PA**

*To complete: Select All, Copy, Paste into a new word document, Protect
as Forms, Delete this Instruction Page and fill in information for pages
1-7. To access links, unprotect.*

***To be submitted to the Office of Research 3 weeks before the meeting
date of the appropriate subcommittee (IRB or IACUC); see
[calendar]{.underline} for schedule. Complete the New Submission
Checklist as you prepare your proposal and submit to the Research Office
with all other required materials.***

Note: [All]{.underline} Requests to Conduct Research must include this
form, Part I plus other forms and materials as determined by your
responses to queries herein.

If this is your first Research Proposal submitted through this VA
Medical Center, please request an appointment with Dr. Ali Sonel to
discuss your Request to Conduct Research. Contact the Research Office at
412-954-5386.

> [INSTRUCTIONS]{.underline}

**This Form and associated materials are required to initiate and
facilitate R&D Committee approval for your research project. You may not
begin any work described in the attached protocol until written approval
by the local R&D Committee is received.**

**STEPS**

1.  Complete this form, PART I, in its entirety, complete other required
    forms (including Part II, III, IV, or V, their ancillary materials,
    and the **New Submission Checklist** and submit to the Research
    Office.

2.  Attach a complete copy of your proposal. The narrative will
    generally include: Rationale, Background and Work Accomplished, Work
    Proposed, Resources, Collaboration, Publications, Literature
    References, and will depend on the agency to which you are
    submitting the proposal. To access guidelines for specific VA
    supported grants, **click here**. If you need further information on
    preparing your proposal, contact the Research Office at
    412-954-5381.

3.  Turn in entire packet to the VAPHS Office of Research located at
    7180 Highland Drive, Building 2, Room 2073W.

4.  Contact the Research Office 412-954-5380 with any questions or
    problems associated with your Submission.

Request to Conduct Research

PART I: Research and Development -- Request to Review

**VA Pittsburgh Healthcare System (VAPHS)**

**Pittsburgh, PA**

<table>
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<col style="width: 2%" />
<col style="width: 11%" />
</colgroup>
<tbody>
<tr class="odd">
<td><strong>1.</strong></td>
<td colspan="5"><strong>Principal Investigator/Program
Director:</strong></td>
<td colspan="2"><strong>Last</strong></td>
<td colspan="4"><strong>First</strong></td>
<td><strong>MI</strong></td>
<td colspan="2"><strong>Degree</strong></td>
</tr>
<tr class="even">
<td></td>
<td colspan="5"></td>
<td colspan="2"><strong>     </strong></td>
<td colspan="4"><strong>     </strong></td>
<td><strong>     </strong></td>
<td colspan="2"><strong>     </strong></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="2"></td>
<td colspan="3"><strong>Phone #:</strong></td>
<td><strong>     </strong></td>
<td colspan="2"><strong>Ext:</strong></td>
<td colspan="2"><strong>     </strong></td>
<td colspan="3"><strong>Mail Code:</strong></td>
<td><strong>     </strong></td>
</tr>
<tr class="even">
<td></td>
<td><strong>FAX#:</strong></td>
<td><strong>     </strong></td>
<td colspan="3"><strong>Pager#:</strong></td>
<td><strong>     </strong></td>
<td colspan="3"><strong>E-mail:</strong></td>
<td colspan="5"><strong>     </strong></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="3"></td>
<td colspan="11"></td>
</tr>
<tr class="even">
<td><strong>2.</strong></td>
<td colspan="4"><p><strong>VA Appointment <em>(Check
One)</em>:</strong></p>
<p><strong>Service:</strong> <u>     </u></p></td>
<td colspan="10"><p> <strong>Full-Time</strong>
<strong>Consultant</strong> <strong>Contract</strong></p>
<p> <strong>Part Time <u>     </u>/hrs wk</strong> <strong>Without
Compensation (WOC)</strong></p></td>
</tr>
</tbody>
</table>

+---+-------------------------------------------------------------------+
| * | **New Investigators must submit an [Investigator Data Sheet VA    |
| * | 10-5386]{.underline}. An Optional Personal Data Form may also be  |
| 3 | submitted. Co-Principal investigators who have not previously     |
| . | completed the Investigator Data Sheet must submit it as well.**   |
| * |                                                                   |
| * |                                                                   |
+---+-------------------------------------------------------------------+
|   |                                                                   |
+---+-------------------------------------------------------------------+
| * | **Project Contact Information: Is PI this project's contact       |
| * | person?** **Yes** **No\***                                        |
| 4 |                                                                   |
| . | \*If No, access, complete, and submit [Research Project Contact   |
| * | Information form]{.underline}.                                    |
| * |                                                                   |
+---+-------------------------------------------------------------------+

+---+------------+-----------------------------------------------------+
| * | **Project  | [     ]{.underline}                                 |
| * | Title:**   |                                                     |
| 5 |            |                                                     |
| . | ***(142    |                                                     |
| * | characters |                                                     |
| * | m          |                                                     |
|   | aximum)*** |                                                     |
+---+------------+-----------------------------------------------------+

+---+----------------+---+---+---+---------------------------------------+
| * | **Status of PI |   |   | * |                                       |
| * | in Proposal:** |   |   | * |                                       |
| 6 |                |   |   | A |                                       |
| . | ***(Check      |   |   | w |                                       |
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+---+----------------+---+---+---+---------------------------------------+
|   | **Does PI have |   |   |   |                                       |
|   | a dual         |   |   |   |                                       |
|   | appointment /  |   |   |   |                                       |
|   | University     |   |   |   |                                       |
|   | affiliation?** |   |   |   |                                       |
|   | **No** **Yes   |   |   |   |                                       |
|   | Where?**       |   |   |   |                                       |
|   |                |   |   |   |                                       |
|   | [              |   |   |   |                                       |
|   |  ]{.underline} |   |   |   |                                       |
+---+----------------+---+---+---+---------------------------------------+
|   |                |   |   |   |                                       |
+---+----------------+---+---+---+---------------------------------------+
| * | **Type of      |   |   |   | > **Competitive Renewal of Active     |
| * | Submission:**  | * |   |   | > Project**                           |
| 7 |                | * |   |   |                                       |
| . | ***(Check      | N |   |   |                                       |
| * | One)***        | e |   |   |                                       |
| * |                | w |   |   |                                       |
|   |                | * |   |   |                                       |
|   |                | * |   |   |                                       |
+---+----------------+---+---+---+---------------------------------------+
|   | ***If          |   |   |   |                                       |
|   | Competitive    |   |   |   |                                       |
|   | Renewal, has   |   |   |   |                                       |
|   | the title      |   |   |   |                                       |
|   | changed?***    |   |   |   |                                       |
|   | **No** **Yes** |   |   |   |                                       |
+---+----------------+---+---+---+---------------------------------------+

+---+---------------------------+---------------+---+---+----------------+
| * | **[For VA Grants          |               |   |   |                |
| * | only:]{.underline}        |               |   |   |                |
| 8 | Co-Principal              |               |   |   |                |
| . | Investigator(s): *(Enter  |               |   |   |                |
| * | only if project is        |               |   |   |                |
| * | funded; Must have a VA    |               |   |   |                |
|   | appointment and must be   |               |   |   |                |
|   | designated a Co-PI in     |               |   |   |                |
|   | application)***           |               |   |   |                |
+---+---------------------------+---------------+---+---+----------------+
|   | **NO CO-Principal         |               |   |   |                |
|   | Investigator**            |               |   |   |                |
+---+---------------------------+---------------+---+---+----------------+
|   | *Last name, first name,   |               | * |   |                |
|   | MI, Degree*               |               | C |   |                |
|   |                           |               | h |   |                |
|   |                           |               | e |   |                |
|   |                           |               | c |   |                |
|   |                           |               | k |   |                |
|   |                           |               | i |   |                |
|   |                           |               | f |   |                |
|   |                           |               | a |   |                |
|   |                           |               | t |   |                |
|   |                           |               | a |   |                |
|   |                           |               | n |   |                |
|   |                           |               | o |   |                |
|   |                           |               | t |   |                |
|   |                           |               | h |   |                |
|   |                           |               | e |   |                |
|   |                           |               | r |   |                |
|   |                           |               | V |   |                |
|   |                           |               | A |   |                |
|   |                           |               | M |   |                |
|   |                           |               | C |   |                |
|   |                           |               | * |   |                |
+---+---------------------------+---------------+---+---+----------------+
| a | [     ]{.underline}       |               |   |   |                |
| \ |                           |               |   |   |                |
| . |                           |               |   |   |                |
+---+---------------------------+---------------+---+---+----------------+
| b | [     ]{.underline}       |               |   |   |                |
| \ |                           |               |   |   |                |
| . |                           |               |   |   |                |
+---+---------------------------+---------------+---+---+----------------+
| c | [     ]{.underline}       |               |   |   |                |
| \ |                           |               |   |   |                |
| . |                           |               |   |   |                |
+---+---------------------------+---------------+---+---+----------------+
| # | **Anticipated Starting    |               |   |   |                |
| # | Date *(mo/day/year)*:     |               |   |   |                |
|   | [     ]{.underline}**     |               |   |   |                |
| 9 |                           |               |   |   |                |
| . |                           |               |   |   |                |
+---+---------------------------+---------------+---+---+----------------+

+---+--------------------+---------------------------------------------+
| # | #                  | ## LIST: Specific Program                   |
| # | # Funding Source:  | , Institute, Company, or Agency/Foundation: |
|   |                    |                                             |
| 1 |                    |                                             |
| 0 |                    |                                             |
| . |                    |                                             |
|   |                    |                                             |
| # |                    |                                             |
| # |                    |                                             |
|   |                    |                                             |
+---+--------------------+---------------------------------------------+
| # | ##  Dept o         | ##                                          |
| # | f Veterans Affairs |                                             |
|   |                    |                                             |
+---+--------------------+---------------------------------------------+
| # | ##                 | ##                                          |
| # |  National Institut |                                             |
|   | es of Health (NIH) |                                             |
+---+--------------------+---------------------------------------------+
| # | Other Federal      | ##                                          |
| # | Government Agency  |                                             |
|   |                    |                                             |
+---+--------------------+---------------------------------------------+
| # | Private            | ##                                          |
| # | Proprietary        |                                             |
|   | Company            |                                             |
+---+--------------------+---------------------------------------------+
| # | Voluntary          | ##                                          |
| # | Agency/Foundation  |                                             |
|   |                    |                                             |
+---+--------------------+---------------------------------------------+
| # | #                  | ##                                          |
| # | #  None/Intramural |                                             |
|   |                    |                                             |
+---+--------------------+---------------------------------------------+
| # |                    |                                             |
| # |                    |                                             |
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| e |                    |                                             |
| s |                    |                                             |
| e |                    |                                             |
| a |                    |                                             |
| r |                    |                                             |
| c |                    |                                             |
| h |                    |                                             |
|   |                    |                                             |
| P |                    |                                             |
| l |                    |                                             |
| a |                    |                                             |
| n |                    |                                             |
|   |                    |                                             |
| N |                    |                                             |
| a |                    |                                             |
| r |                    |                                             |
| r |                    |                                             |
| a |                    |                                             |
| t |                    |                                             |
| i |                    |                                             |
| v |                    |                                             |
| e |                    |                                             |
|   |                    |                                             |
| u |                    |                                             |
| n |                    |                                             |
| d |                    |                                             |
| e |                    |                                             |
| r |                    |                                             |
|   |                    |                                             |
| t |                    |                                             |
| h |                    |                                             |
| e |                    |                                             |
|   |                    |                                             |
| t |                    |                                             |
| o |                    |                                             |
| p |                    |                                             |
| i |                    |                                             |
| c |                    |                                             |
|   |                    |                                             |
| ' |                    |                                             |
| b |                    |                                             |
| u |                    |                                             |
| d |                    |                                             |
| g |                    |                                             |
| e |                    |                                             |
| t |                    |                                             |
| ' |                    |                                             |
| . |                    |                                             |
| * |                    |                                             |
+---+--------------------+---------------------------------------------+

  --------- -------------------------------------------------------------------
  **11.**   **Abstract: An abstract of \<500 words organized to include:
            *Hypotheses* *to be tested*, *Objectives*, *Research* *Plan*, and
            if basic science study, *Relevance* *to the VA*, must be attached
            to this form.**

  --------- -------------------------------------------------------------------

+---+----------------------+-------------------+----------------------+
| # | ## Project focus:    |                   |                      |
| # |                      |                   |                      |
|   | ##                   |                   |                      |
| 1 |                      |                   |                      |
| 2 | ##                   |                   |                      |
| . |                      |                   |                      |
+---+----------------------+-------------------+----------------------+
| # |                      | Females: Yes No   | Prisoners of War:    |
| # |                      |                   | Yes No               |
|   |                      |                   |                      |
|   |                      |                   |                      |
| A |                      |                   |                      |
| g |                      |                   |                      |
| e |                      |                   |                      |
| n |                      |                   |                      |
| t |                      |                   |                      |
|   |                      |                   |                      |
| O |                      |                   |                      |
| r |                      |                   |                      |
| a |                      |                   |                      |
| n |                      |                   |                      |
| g |                      |                   |                      |
| e |                      |                   |                      |
| : |                      |                   |                      |
|   |                      |                   |                      |
|   |                      |                   |                      |
| Y |                      |                   |                      |
| e |                      |                   |                      |
| s |                      |                   |                      |
|   |                      |                   |                      |
|   |                      |                   |                      |
| N |                      |                   |                      |
| o |                      |                   |                      |
+---+----------------------+-------------------+----------------------+

+---+----------------------+----------------------+--------------------+
| # | ## Keywor            |                      |                    |
| # | ds: *(Minimum 3, max |                      |                    |
|   | imum 6. Use MeSH ter |                      |                    |
| 1 | ms only. Enter one t |                      |                    |
| 3 | erm per line. Listin |                      |                    |
| . | g is available in VA |                      |                    |
|   | PHS Research Office* |                      |                    |
|   |                      |                      |                    |
| # |                      |                      |                    |
| # |                      |                      |                    |
|   |                      |                      |                    |
+---+----------------------+----------------------+--------------------+
|   | ## a.                | ## b.                | ## c. [            |
|   |  [     ]{.underline} | [     ]{.underline}  |      ]{.underline} |
+---+----------------------+----------------------+--------------------+
|   | ## d.                | ## e                 | ## f.[             |
|   |  [     ]{.underline} | .[     ]{.underline} |     ]{.underline}  |
+---+----------------------+----------------------+--------------------+

  --------- -------------------------------------------------------------------
  **14.**   **CONFLICT OF INTEREST:** The potential for conflict of interest
            exists when an individual's personal or private interests might
            lead an independent observer to reasonably question whether or not
            actions or decisions were made for personal or financial interests.
            The PI and Researchers who contribute 5% or more effort to this
            project must complete and sign a **Conflict of Interest** form and
            submit it to the Office of Research with this packet.

  --------- -------------------------------------------------------------------

+---+-------------------------------------------------------------------+
| * | **Do you currently have the resources necessary (e.g.,            |
| * | coordinator, physical space, information technology) to protect   |
| 1 | the safety of participants and the confidentiality of their data  |
| 5 | during the conduct of this study?**                               |
| . |                                                                   |
| * | Yes No If no, please explain how the resources will be obtained   |
| * | before the study is initiated:                                    |
+---+-------------------------------------------------------------------+

+---+-------------------------------------------------------------------+
| * | **Use of off-site- ancillary service facilities (e.g. radiology   |
| * | services, CORE labs.):** Yes No                                   |
| 1 |                                                                   |
| 6 | If yes, please provide the following information:                 |
| . |                                                                   |
| * | Location (institution, building, room#):                          |
| * |                                                                   |
|   | Brief description of the project activities at this site:         |
+---+-------------------------------------------------------------------+
| * | **Utilizing off-site storage of biological specimens**            |
| * |                                                                   |
| a |                                                                   |
| . |                                                                   |
| * |                                                                   |
| * |                                                                   |
+---+-------------------------------------------------------------------+
| * | > 1\) Will sample(s) be stored off site at a **for-profit**       |
| * | > organization for \> 90 days? Yes No                             |
| b | >                                                                 |
| . | > 2\) Will sample(s) be used for any purpose other than to        |
| * | > monitor subject safety? Yes No                                  |
| * | >                                                                 |
|   | > 3\) Will sample(s) be stored at a **non-profit** organization   |
|   | > for \> than 5 years? Yes No                                     |
|   | >                                                                 |
|   | > **If the answer is yes to any of the above questions, you must  |
|   | > have ORD tissue banking approval.**                             |
|   | >                                                                 |
|   | > **Are you banking specimens for future use?** Yes No            |
|   | >                                                                 |
|   | > (*Biological specimens collected and stored for future research |
|   | > purposes that are beyond the scope of work described in the     |
|   | > original protocol.)*                                            |
|   | >                                                                 |
|   | > *For additional guidance on tissue banking, please contact      |
|   | > **vhapthresearchcompliance@va.gov.***                           |
+---+-------------------------------------------------------------------+
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+---+-------------------------------------------------------------------+
|   |                                                                   |
+---+-------------------------------------------------------------------+
|   |                                                                   |
+---+-------------------------------------------------------------------+

+---+-------------------------------------------------------------------+
| 1 |                                                                   |
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+---+-------------------------------------------------------------------+
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| . |                                                                   |
+---+-------------------------------------------------------------------+
|   |                                                                   |
+---+-------------------------------------------------------------------+
|   |                                                                   |
+---+-------------------------------------------------------------------+
|   |                                                                   |
+---+-------------------------------------------------------------------+
|   |                                                                   |
+---+-------------------------------------------------------------------+
| * | **Use of VA personnel, patients, facilities or other resources:** |
| * |                                                                   |
| 1 |                                                                   |
| 8 |                                                                   |
| . |                                                                   |
| * |                                                                   |
| * |                                                                   |
+---+-------------------------------------------------------------------+
| a | Does the project involve use of VA-funded personnel effort? Yes   |
| \ | No                                                                |
| . |                                                                   |
+---+-------------------------------------------------------------------+
| b | Are VA patients or VA patients' private health information        |
| \ | included in the study? Yes No                                     |
| . |                                                                   |
+---+-------------------------------------------------------------------+
| c | Are VA space or facilities used for the study? Yes No             |
| \ |                                                                   |
| . | If Yes: Existing VA location(s) (Bldg, Rm #(s):                   |
|   | [     ]{.underline}                                               |
|   |                                                                   |
|   | Requesting new VA Space? Yes No                                   |
|   |                                                                   |
|   | If Yes: How Much: [     ]{.underline}                             |
+---+-------------------------------------------------------------------+
| d | Are other VA resources used for the project (e.g., data bases,    |
| \ | human specimens, etc)? Yes No                                     |
| . |                                                                   |
+---+-------------------------------------------------------------------+
| I |                                                                   |
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| * |                                                                   |
| * |                                                                   |
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| * |                                                                   |
| * |                                                                   |
| , |                                                                   |
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+---+-------------------------------------------------------------------+

+----------------------+---------+------------+-----------------------+
| > **19.              |         |            |                       |
| > Institutional      |         |            |                       |
| > Support: (Mark     |         |            |                       |
| > each item. \*If    |         |            |                       |
| > 'Yes', letters of  |         |            |                       |
| > S                  |         |            |                       |
| upport/collaboration |         |            |                       |
| > must be            |         |            |                       |
| > attached).**       |         |            |                       |
+----------------------+---------+------------+-----------------------+
| > Laboratory Yes No  | M       |            | Pharmacy Yes No       |
|                      | edicine |            |                       |
|                      | Yes No  |            |                       |
+----------------------+---------+------------+-----------------------+
| > Radiology Yes No   | Nuclear |            | Nursing Yes No        |
|                      | Med.    |            |                       |
|                      | Yes No  |            |                       |
+----------------------+---------+------------+-----------------------+
| > Psychiatry Yes No  | Out     |            | Surgery Yes No        |
|                      | patient |            |                       |
|                      | Yes No  |            |                       |
+----------------------+---------+------------+-----------------------+
|                      |         |            |                       |
+----------------------+---------+------------+-----------------------+
| > Lab Space Yes No   |         | If Yes,    |                       |
|                      |         | Bldg and   |                       |
|                      |         | Room       |                       |
|                      |         | :[     ]{. |                       |
|                      |         | underline} |                       |
+----------------------+---------+------------+-----------------------+
| > Research Registry  |         | If Yes,    |                       |
| > Yes No             |         | Specify    |                       |
|                      |         | Admi       |                       |
|                      |         | nistrator: |                       |
|                      |         | [     ]{.  |                       |
|                      |         | underline} |                       |
+----------------------+---------+------------+-----------------------+
| > Other Yes No       |         | If Yes,    |                       |
|                      |         | Specify:   |                       |
|                      |         | [     ]{.  |                       |
|                      |         | underline} |                       |
+----------------------+---------+------------+-----------------------+

##  

+---+-------------------------------------------------------------------+
| * | ## All Personnel listed on the Project Protocol:                  |
| * |  *Co-Investigators, Collaborators, Nurses, Researchers, Support S |
| 2 | taff- anyone who will be accessing patient or other data involved |
| 0 |  with this research study-* must be listed in the following Form. |
| . |                                                                   |
| * |                                                                   |
| * |                                                                   |
+---+-------------------------------------------------------------------+

# 

# VA Pittsburgh Healthcare System (VAPHS): Research Project Staff Form

\*[VAPHS Research Staff Training
Requirements](../../../VAPHS_Research_Staff_Training_Requirements_(Final).doc)\*

Personnel subject to requirements for Training, Credentialing,
Privileging, Education verification, and Authorization to engage in
research at VAPHS:

1.  Fill in the following table and follow these instructions for
    research personnel who participate in research [At
    VAPHS]{.underline}. (Certain research personnel who do not come to
    VAPHS are exempt from VAPHS credentialing, privileging, and
    Authorization; list them in [Section II]{.underline}).

```{=html}
<!-- -->
```
1.  All personnel working at VAPHS must have a VA appointment, either
    paid or working without compensation (WOC). New personnel must apply
    for an appointment with the Research office.

2.  If the individual is new to VAPHS, [FORM 1: Application for
    Authorization to Conduct Research at VAPHS]{.underline} and
    associated materials must be completed.

3.  Current Research personnel who have completed [FORM 1]{.underline}
    need not resubmit; If the researcher's duties and responsibilities
    for the project OR the supervising PI has changed, a new [Function
    Statement]{.underline} or new Research Addendum to Scope of Practice
    must be submitted.

#### 

#### I. VAPHS Research Personnel 

+---+--------------+-----+----------+--------+-----+----+---+---------+
|   | ###          | **R | ##       | ###    | **% | \  | * | ###     |
|   | # Researcher | ole | # E-mail | Phone  | Eff | ## | * | Human S |
|   |              | in  |  address | Number | ort | ** | L | ubject  |
|   |              | P   |          |        | in  | An | a |         |
|   |              | roj |          |        | Pro | im | b | ### Re  |
|   |              | ect |          |        | jec | al | R | search  |
|   |              | \*\ |          |        | t** | Re | e |         |
|   |              | *** |          |        |     | se | s |         |
|   |              |     |          |        |     | ar | . |         |
|   |              |     |          |        |     | ch | * |         |
|   |              |     |          |        |     | ** | * |         |
+---+--------------+-----+----------+--------+-----+----+---+---------+
| * |              | A   |          |        |     |    | Y | Yes     |
| * |              | (   |          |        |     | Y  | e |         |
| 1 |              | PI) |          |        |     | es | s |         |
| * |              |     |          |        |     |    |   |         |
| * |              |     |          |        |     |    |   |         |
+---+--------------+-----+----------+--------+-----+----+---+---------+
| * |              |     |          |        |     |    | Y | Yes     |
| * |              |     |          |        |     | Y  | e |         |
| 2 |              |     |          |        |     | es | s |         |
| * |              |     |          |        |     |    |   |         |
| * |              |     |          |        |     |    |   |         |
+---+--------------+-----+----------+--------+-----+----+---+---------+
| * |              |     |          |        |     |    | Y | Yes     |
| * |              |     |          |        |     | Y  | e |         |
| 3 |              |     |          |        |     | es | s |         |
| * |              |     |          |        |     |    |   |         |
| * |              |     |          |        |     |    |   |         |
+---+--------------+-----+----------+--------+-----+----+---+---------+
| * |              |     |          |        |     |    | Y | Yes     |
| * |              |     |          |        |     | Y  | e |         |
| 4 |              |     |          |        |     | es | s |         |
| * |              |     |          |        |     |    |   |         |
| * |              |     |          |        |     |    |   |         |
+---+--------------+-----+----------+--------+-----+----+---+---------+
| * |              |     |          |        |     |    | Y | Yes     |
| * |              |     |          |        |     | Y  | e |         |
| 5 |              |     |          |        |     | es | s |         |
| * |              |     |          |        |     |    |   |         |
| * |              |     |          |        |     |    |   |         |
+---+--------------+-----+----------+--------+-----+----+---+---------+
| * |              |     |          |        |     |    | Y | Yes     |
| * |              |     |          |        |     | Y  | e |         |
| 6 |              |     |          |        |     | es | s |         |
| * |              |     |          |        |     |    |   |         |
| * |              |     |          |        |     |    |   |         |
+---+--------------+-----+----------+--------+-----+----+---+---------+

**\## Includes contact with animals (live or dead), their viable
tissues, body fluids, or wastes, and requires enrollment in either the
VA AEPMP or University of Pittsburgh Medical Surveillance Program for
Animal Users**

**II. EXEMPT Personnel (**those for whom you are requesting exemption
from VAPHS requirements for training, education verification,
credentialing, and Authorization)

1.  Exempt researchers include those investigators based at other
    institutions, members of data safety boards, technicians who perform
    routine clinical tests on Human specimens. (Consult Nick Squeglia,
    at 412-954-5387) for clarification of those eligible for EXEMPT
    status).

```{=html}
<!-- -->
```
1.  Submit "**[Request for Exemption]{.underline}**" forms for all
    personnel listed below.

+---+--------------+-----+----------+--------+-----+--------+--------+
|   | **           | **R | ##       | ###    | ##  | **VA   | ###    |
|   | Researcher** | ole | # E-mail | Phone  | # % | Lab/   |  Human |
|   |              | in  |  address | Number |  Ef | Animal |  Subje |
|   |              | P   |          |        | for | Rese   | ct Res |
|   |              | roj |          |        | t i | arch** | earch  |
|   |              | ect |          |        | n P |        |        |
|   |              | \*\ |          |        | roj |        |        |
|   |              | *** |          |        | ect |        |        |
+---+--------------+-----+----------+--------+-----+--------+--------+
| * |              | ##  |          |        |     | Yes    | Yes    |
| * |              |     |          |        |     |        |        |
| 1 |              |     |          |        |     |        |        |
| * |              |     |          |        |     |        |        |
| * |              |     |          |        |     |        |        |
+---+--------------+-----+----------+--------+-----+--------+--------+
| * |              |     |          |        |     | Yes    | Yes    |
| * |              |     |          |        |     |        |        |
| 2 |              |     |          |        |     |        |        |
| * |              |     |          |        |     |        |        |
| * |              |     |          |        |     |        |        |
+---+--------------+-----+----------+--------+-----+--------+--------+
| * |              |     |          | **     | **  | Yes    | Yes    |
| * |              |     |          |     ** |     |        |        |
| 3 |              |     |          |        |  ** |        |        |
| * |              |     |          |        |     |        |        |
| * |              |     |          |        |     |        |        |
+---+--------------+-----+----------+--------+-----+--------+--------+
| * |              | **  |          |        |     | Yes    | Yes    |
| * |              |     |          |        |     |        |        |
| 4 |              |  ** |          |        |     |        |        |
| * |              |     |          |        |     |        |        |
| * |              |     |          |        |     |        |        |
+---+--------------+-----+----------+--------+-----+--------+--------+

**\*\***A=Principal Investigator; B=Co-investigator,
C=Coordinator/Project Manager (The VAPHS considers the individual
responsible for day-to-day study activities and IRB correspondence to be
the coordinator/manager. For Human Research Studies: If no coordinator
is identified, the PI will be responsible for fulfilling the IRB
educational requirements for coordinators.) , D=Other Staff

+---+---+------------------+----+------+--------------------------------+
| * | * |                  |    |      |                                |
| * | * |                  |    |      |                                |
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+---+---+------------------+----+------+--------------------------------+
| - |   |                  |    |      |                                |
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|   | o |                  |    |      |                                |
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|   | p |                  |    |      |                                |
|   | / |                  |    |      |                                |
|   | s |                  |    |      |                                |
|   | u |                  |    |      |                                |
|   | b |                  |    |      |                                |
|   | c |                  |    |      |                                |
|   | o |                  |    |      |                                |
|   | m |                  |    |      |                                |
|   | m |                  |    |      |                                |
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|   | t |                  |    |      |                                |
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|   | a |                  |    |      |                                |
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|   | d |                  |    |      |                                |
|   | . |                  |    |      |                                |
+---+---+------------------+----+------+--------------------------------+
| a | H |                  |    | Yes  | Complete [PART III: Human      |
| \ | u |                  | No |      | Subjects]{.underline} for IRB  |
| . | m |                  |    |      | review.                        |
|   | a |                  |    |      |                                |
|   | n |                  |    |      |                                |
|   | S |                  |    |      |                                |
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|   | / |                  |    |      |                                |
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|   | t |                  |    |      |                                |
|   | i |                  |    |      |                                |
|   | o |                  |    |      |                                |
|   | n |                  |    |      |                                |
+---+---+------------------+----+------+--------------------------------+
| b | I |                  |    | Yes  | Complete [PART III: Human      |
| \ | n |                  | No |      | Subjects]{.underline} for IRB  |
| . | v |                  |    |      | review.                        |
|   | e |                  |    |      |                                |
|   | s |                  |    |      | IND \# (s), if applicable:     |
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|   | m |                  |    |      |                                |
|   | p |                  |    |      |                                |
|   | l |                  |    |      |                                |
|   | e |                  |    |      |                                |
|   | t |                  |    |      |                                |
|   | e |                  |    |      |                                |
|   | I |                  |    |      |                                |
|   | n |                  |    |      |                                |
|   | v |                  |    |      |                                |
|   | e |                  |    |      |                                |
|   | s |                  |    |      |                                |
|   | t |                  |    |      |                                |
|   | i |                  |    |      |                                |
|   | g |                  |    |      |                                |
|   | a |                  |    |      |                                |
|   | t |                  |    |      |                                |
|   | i |                  |    |      |                                |
|   | o |                  |    |      |                                |
|   | n |                  |    |      |                                |
|   | a |                  |    |      |                                |
|   | l |                  |    |      |                                |
|   | D |                  |    |      |                                |
|   | r |                  |    |      |                                |
|   | u |                  |    |      |                                |
|   | g |                  |    |      |                                |
|   | I |                  |    |      |                                |
|   | n |                  |    |      |                                |
|   | f |                  |    |      |                                |
|   | o |                  |    |      |                                |
|   | r |                  |    |      |                                |
|   | m |                  |    |      |                                |
|   | a |                  |    |      |                                |
|   | t |                  |    |      |                                |
|   | i |                  |    |      |                                |
|   | o |                  |    |      |                                |
|   | n |                  |    |      |                                |
|   | R |                  |    |      |                                |
|   | e |                  |    |      |                                |
|   | c |                  |    |      |                                |
|   | o |                  |    |      |                                |
|   | r |                  |    |      |                                |
|   | d |                  |    |      |                                |
+---+---+------------------+----+------+--------------------------------+
| c | I |                  |    | Yes  | Complete [PART III: Human      |
| \ | n |                  | No |      | Subjects]{.underline} for IRB  |
| . | v |                  |    |      | review.                        |
|   | e |                  |    |      |                                |
|   | s |                  |    |      | IDE #(s), if applicable:       |
|   | t |                  |    |      |                                |
|   | i |                  |    |      |                                |
|   | g |                  |    |      |                                |
|   | a |                  |    |      |                                |
|   | t |                  |    |      |                                |
|   | i |                  |    |      |                                |
|   | o |                  |    |      |                                |
|   | n |                  |    |      |                                |
|   | a |                  |    |      |                                |
|   | l |                  |    |      |                                |
|   | D |                  |    |      |                                |
|   | e |                  |    |      |                                |
|   | v |                  |    |      |                                |
|   | i |                  |    |      |                                |
|   | c |                  |    |      |                                |
|   | e |                  |    |      |                                |
|   | s |                  |    |      |                                |
+---+---+------------------+----+------+--------------------------------+
| d | H |                  |    | Yes  | Complete [PART III: Human      |
| \ | u |                  | No |      | Subjects]{.underline} for IRB  |
| . | m |                  |    |      | review.                        |
|   | a |                  |    |      |                                |
|   | n |                  |    |      | Contact Dr. B. Kart at Ext     |
|   | E |                  |    |      | 60-3275 or <Barry.Kart@va.gov> |
|   | x |                  |    |      | for the procedures necessary   |
|   | p |                  |    |      | for Approval by the VA         |
|   | o |                  |    |      | Radiation Safety Committee.    |
|   | s |                  |    |      | Refer to Human Subject         |
|   | u |                  |    |      | Exposure to Ionizing Radiation |
|   | r |                  |    |      | for assistance in preparing    |
|   | e |                  |    |      | your protocol.                 |
|   | t |                  |    |      |                                |
|   | o |                  |    |      |                                |
|   | R |                  |    |      |                                |
|   | a |                  |    |      |                                |
|   | d |                  |    |      |                                |
|   | i |                  |    |      |                                |
|   | a |                  |    |      |                                |
|   | t |                  |    |      |                                |
|   | i |                  |    |      |                                |
|   | o |                  |    |      |                                |
|   | n |                  |    |      |                                |
|   | ( |                  |    |      |                                |
|   | o |                  |    |      |                                |
|   | t |                  |    |      |                                |
|   | h |                  |    |      |                                |
|   | e |                  |    |      |                                |
|   | r |                  |    |      |                                |
|   | t |                  |    |      |                                |
|   | h |                  |    |      |                                |
|   | a |                  |    |      |                                |
|   | n |                  |    |      |                                |
|   | p |                  |    |      |                                |
|   | r |                  |    |      |                                |
|   | o |                  |    |      |                                |
|   | c |                  |    |      |                                |
|   | e |                  |    |      |                                |
|   | d |                  |    |      |                                |
|   | u |                  |    |      |                                |
|   | r |                  |    |      |                                |
|   | e |                  |    |      |                                |
|   | s |                  |    |      |                                |
|   | t |                  |    |      |                                |
|   | h |                  |    |      |                                |
|   | a |                  |    |      |                                |
|   | t |                  |    |      |                                |
|   | a |                  |    |      |                                |
|   | r |                  |    |      |                                |
|   | e |                  |    |      |                                |
|   | c |                  |    |      |                                |
|   | o |                  |    |      |                                |
|   | n |                  |    |      |                                |
|   | s |                  |    |      |                                |
|   | i |                  |    |      |                                |
|   | s |                  |    |      |                                |
|   | t |                  |    |      |                                |
|   | e |                  |    |      |                                |
|   | n |                  |    |      |                                |
|   | t |                  |    |      |                                |
|   | w |                  |    |      |                                |
|   | i |                  |    |      |                                |
|   | t |                  |    |      |                                |
|   | h |                  |    |      |                                |
|   | t |                  |    |      |                                |
|   | h |                  |    |      |                                |
|   | e |                  |    |      |                                |
|   | c |                  |    |      |                                |
|   | u |                  |    |      |                                |
|   | s |                  |    |      |                                |
|   | t |                  |    |      |                                |
|   | o |                  |    |      |                                |
|   | m |                  |    |      |                                |
|   | a |                  |    |      |                                |
|   | r |                  |    |      |                                |
|   | y |                  |    |      |                                |
|   | s |                  |    |      |                                |
|   | t |                  |    |      |                                |
|   | a |                  |    |      |                                |
|   | n |                  |    |      |                                |
|   | d |                  |    |      |                                |
|   | a |                  |    |      |                                |
|   | r |                  |    |      |                                |
|   | d |                  |    |      |                                |
|   | o |                  |    |      |                                |
|   | f |                  |    |      |                                |
|   | c |                  |    |      |                                |
|   | l |                  |    |      |                                |
|   | i |                  |    |      |                                |
|   | n |                  |    |      |                                |
|   | i |                  |    |      |                                |
|   | c |                  |    |      |                                |
|   | a |                  |    |      |                                |
|   | l |                  |    |      |                                |
|   | c |                  |    |      |                                |
|   | a |                  |    |      |                                |
|   | r |                  |    |      |                                |
|   | e |                  |    |      |                                |
|   | ) |                  |    |      |                                |
+---+---+------------------+----+------+--------------------------------+
|   |   | X-Rays           |    |      | (The VA RSC application form   |
|   |   |                  |    |      | is identical to that required  |
|   |   | PET Scans        |    |      | by the University RSC; access  |
|   |   |                  |    |      | here, complete, and submit to  |
|   |   | CT Scans         |    |      | the VA Radiation Safety        |
|   |   |                  |    |      | Committee if needed.)          |
|   |   | Radiation        |    |      |                                |
|   |   | Therapy          |    |      |                                |
+---+---+------------------+----+------+--------------------------------+
|   |   | Radioactive      |    |      |                                |
|   |   | Materials        |    |      |                                |
|   |   | Administered     |    |      |                                |
|   |   | without imaging  |    |      |                                |
|   |   |                  |    |      |                                |
|   |   | Radi             |    |      |                                |
|   |   | o-pharmaceutical |    |      |                                |
|   |   | Therapy          |    |      |                                |
+---+---+------------------+----+------+--------------------------------+
| e | D |                  |    | Yes  | Submit the VAPHS Request for   |
| \ | o |                  | No |      | Approval of Off-Site           |
| . | e |                  |    |      | Storage/Transfer of VA         |
|   | s |                  |    |      | Research Data form with        |
|   | t |                  |    |      | supervisor signatures (note:   |
|   | h |                  |    |      | submissions will not be        |
|   | i |                  |    |      | reviewed by the appropriate    |
|   | s |                  |    |      | subcommittee without these     |
|   | p |                  |    |      | approvals in place).           |
|   | r |                  |    |      |                                |
|   | o |                  |    |      |                                |
|   | j |                  |    |      |                                |
|   | e |                  |    |      |                                |
|   | c |                  |    |      |                                |
|   | t |                  |    |      |                                |
|   | i |                  |    |      |                                |
|   | n |                  |    |      |                                |
|   | v |                  |    |      |                                |
|   | o |                  |    |      |                                |
|   | l |                  |    |      |                                |
|   | v |                  |    |      |                                |
|   | e |                  |    |      |                                |
|   | t |                  |    |      |                                |
|   | h |                  |    |      |                                |
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|   | r |                  |    |      |                                |
|   | a |                  |    |      |                                |
|   | n |                  |    |      |                                |
|   | s |                  |    |      |                                |
|   | f |                  |    |      |                                |
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|   | a |                  |    |      |                                |
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|   | H |                  |    |      |                                |
|   | S |                  |    |      |                                |
|   | ? |                  |    |      |                                |
+---+---+------------------+----+------+--------------------------------+

## 

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+---+---+--------------+-------------------------------------+---+-----------+
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|   | a |              |                                     |   |           |
|   | n |              |                                     |   |           |
|   | t |              |                                     |   |           |
|   | s |              |                                     |   |           |
|   | . |              |                                     |   |           |
+---+---+--------------+-------------------------------------+---+-----------+
|   |   | **Principal  |                                     |   |           |
|   |   | In           |                                     |   |           |
|   |   | vestigator** |                                     |   |           |
+---+---+--------------+-------------------------------------+---+-----------+
|   |   |              | **(Signature)**                     |   | *         |
|   |   |              |                                     |   | *(Date)** |
+---+---+--------------+-------------------------------------+---+-----------+

+---+---------+---------------+--------------------------+---+-----------+
| * | **The   |               |                          |   |           |
| * | PI is   |               |                          |   |           |
| 2 | resp    |               |                          |   |           |
| 4 | onsible |               |                          |   |           |
| . | for     |               |                          |   |           |
| * | ob      |               |                          |   |           |
| * | taining |               |                          |   |           |
|   | sig     |               |                          |   |           |
|   | natures |               |                          |   |           |
|   | below   |               |                          |   |           |
|   | to      |               |                          |   |           |
|   | verify  |               |                          |   |           |
|   | appr    |               |                          |   |           |
|   | opriate |               |                          |   |           |
|   | INSTIT  |               |                          |   |           |
|   | UTIONAL |               |                          |   |           |
|   | APPR    |               |                          |   |           |
|   | OVAL:** |               |                          |   |           |
+---+---------+---------------+--------------------------+---+-----------+
|   | The     |               |                          |   |           |
|   | Re      |               |                          |   |           |
|   | sources |               |                          |   |           |
|   | ne      |               |                          |   |           |
|   | cessary |               |                          |   |           |
|   | for the |               |                          |   |           |
|   | perf    |               |                          |   |           |
|   | ormance |               |                          |   |           |
|   | of      |               |                          |   |           |
|   | these   |               |                          |   |           |
|   | p       |               |                          |   |           |
|   | roposed |               |                          |   |           |
|   | studies |               |                          |   |           |
|   | are     |               |                          |   |           |
|   | av      |               |                          |   |           |
|   | ailable |               |                          |   |           |
|   | and     |               |                          |   |           |
|   | ad      |               |                          |   |           |
|   | equate, |               |                          |   |           |
|   | and I   |               |                          |   |           |
|   | approve |               |                          |   |           |
|   | their   |               |                          |   |           |
|   | use for |               |                          |   |           |
|   | this    |               |                          |   |           |
|   | p       |               |                          |   |           |
|   | roject. |               |                          |   |           |
+---+---------+---------------+--------------------------+---+-----------+
|   | The PI  |               |                          |   |           |
|   | has     |               |                          |   |           |
|   | re      |               |                          |   |           |
|   | quested |               |                          |   |           |
|   | \       |               |                          |   |           |
|   | _\_\_\_ |               |                          |   |           |
|   | \_\_\_% |               |                          |   |           |
|   | effort  |               |                          |   |           |
|   | to      |               |                          |   |           |
|   | devote  |               |                          |   |           |
|   | to this |               |                          |   |           |
|   | p       |               |                          |   |           |
|   | roject. |               |                          |   |           |
|   | I       |               |                          |   |           |
|   | approve |               |                          |   |           |
|   | this    |               |                          |   |           |
|   | all     |               |                          |   |           |
|   | ocation |               |                          |   |           |
|   | of the  |               |                          |   |           |
|   | pr      |               |                          |   |           |
|   | incipal |               |                          |   |           |
|   | investi |               |                          |   |           |
|   | gator's |               |                          |   |           |
|   | time    |               |                          |   |           |
|   | for     |               |                          |   |           |
|   | this    |               |                          |   |           |
|   | p       |               |                          |   |           |
|   | roject. |               |                          |   |           |
+---+---------+---------------+--------------------------+---+-----------+
|   | **      |               |                          |   |           |
|   | Section |               |                          |   |           |
|   | Chief** |               |                          |   |           |
|   |         |               |                          |   |           |
|   | (If     |               |                          |   |           |
|   | appli   |               |                          |   |           |
|   | cable): |               |                          |   |           |
+---+---------+---------------+--------------------------+---+-----------+
|   |         | **(Typed)**   | **(Signature)**          |   | *         |
|   |         |               |                          |   | *(Date)** |
+---+---------+---------------+--------------------------+---+-----------+
|   | **      |               |                          |   |           |
|   | Service |               |                          |   |           |
|   | Line VP |               |                          |   |           |
|   | or      |               |                          |   |           |
|   | ACOS    |               |                          |   |           |
|   | /R&D:** |               |                          |   |           |
+---+---------+---------------+--------------------------+---+-----------+
|   |         | **(Typed)**   | **(Signature)**          |   | *         |
|   |         |               |                          |   | *(Date)** |
+---+---------+---------------+--------------------------+---+-----------+