Research & Development Administrative Office

Department of Veterans Affairs Puget Sound Health Care System

Mailstop 151 1660 S. Columbian Way Seattle, WA 98108 (206) 764-2018 Fax
(206) 764-2391

November 2005 **REVISED FORMS**

#  AND INSTRUCTIONS

TO ALL INVESTIGATORS

All research projects conducted at or by the VA Puget Sound Health Care
System must be reviewed and approved by the Research & Development
Committee prior to initiation. The attached \"Request for R&D Committee
Approval\" packet, [revised November 2005,]{.underline} must be used for
all submissions to the R&D Committee. Previous versions will not be
accepted. Included is a flowchart illustrating the review process for
R&D proposals. Packets are available on the Medical Center R&D Website
(Intranet)
[http://research.puget-sound.med.va.gov](http://research.puget-sound.med.va.gov/).
If you do not have access to the VA Intranet, contact Angela Wright,
764-2492 or <Angela.Wright@med.va.gov> and the application will be sent
to you electronically.

**All forms must be filled out [completely]{.underline}\--this includes
all the required signatures and attachments. Proposals will be returned
to the PI without action if any of the forms are missing or incomplete.
All information must be typed\--handwritten information will not be
accepted.**

**The completed packet must include:**

-   Request for R&D Committee Approval form (version dated April 04)

-   Attachment A: Research Project Hazard Assessment

-   Attachment B: Research & Development Portfolio Review

-   Attachment C: VA Form 10-1436 Project Data Sheet

-   Attachment D: Tissue Bank Form (if applicable)

-   All other enclosures required as indicated on the R&D Committee
    Approval form.

**Required IRB/Subcommittee Reviews (preliminary to R&D Committee
review)**

> **Scientific subcommittee review** is required for all projects,
> [except]{.underline} those that have been submitted, peer-reviewed and
> funded by a national organization that has an established peer-review
> process (e.g. NIH, American Heart Association (National), etc.). All
> others must be reviewed by one of two local scientific review
> subcommittees:

-   Medical or Clinical Research protocols (the complete packet) must be
    received in the R&D Office, Bldg 1, Room 508, no later than 10
    working days prior to the next R&D Committee meeting in order to be
    reviewed (see schedule below).

-   Local scientific review is required for submission to VA of Medical
    Research Service Merit Reviews (including Epidemiology and Clinical
    Research Merit Reviews) as follows:

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-   For VACO March 15 submission, submit to local R&D office by January
    1.

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-   For VACO September 15 submission, submit to local R&D office by July
    1.

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-   Health Services, HSR&D Nursing Research Initiative applications, or
    Epidemiology protocols must be received by the HSR&D Office, Met
    Park, for review no later than 1 week prior to the 1st Friday of the
    month.

**[Approvals]{.underline} by UW human use IRB (Committee V) or other
relevant subcommittees,** such as Institutional Animal Care and Use,
Biohazard, Recombinant DNA or Radiation Safety, [must be included with
the R&D Packet at time of submission to the R&D Office]{.underline}.
Note: as of January 1, 2001, if the project uses human subjects, the PI
must also include in the packet submitted to the R&D Office a copy of
the certification that they have completed the mandatory annual Human
Studies training provided by UW (either by attendance at one of UW\'s
training sessions, or by completion of web-based training available
through their website and Good Clinical Practices training available
through the following URL:
<https://www.ees-learning.net/dod/loginhtml.asp?v=dod>. The
certification must be provided for the PI and each Co**-**Investigator.
This is a VA requirement.

Also note that as of April 20, 2001, per VHA Directive 2001-028, for
proposed research involving children (i.e. under age 18) as subjects,
PIs must request and receive a waiver from HQ prior to submitting the
proposal to the R&D Committee.

### Deadline for receipt of materials for R&D Committee Review

The R&D Committee meets on the 2nd Thursday of each month. The deadline
for receipt of R&D packets in the Administrative Office **[is 2 weeks
(10 working days) prior]{.underline}** to the next R&D Committee
meeting. Packets received less than 10 working days prior to the R&D
Committee meeting date will be held over for review at a subsequent
meeting.

The amount of material being reviewed by the R&D Committee and its
Subcommittees has increased substantially. The review process itself has
become more demanding as attention to compliance, ethical and
administrative requirements have increased. Your cooperation in
providing complete application material to the R&D Office in a timely
manner will significantly assist the R&D Committee in providing
appropriate consideration or your proposal.

Questions regarding this process should be addressed to Angie Wright,
(206) 764-2492.

Charles Keelin

Administrative Officer, R&D