Principal Investigator Checklist for Initial Review IRB Submissions

[IRB Managers Office Ph: (212) 686-7500 Extn: 4455 Fax:
(212)951-3468]{.underline}

[e-mail:]{.underline} <Parameshwar.Mahasreshti@va.gov>

[IRB Coordinator: Sheila Sumrell Ph. (212) 686-7500 Extn: 7475 Fax212)
951-6308]{.underline}

[e-mail:]{.underline} <Sheila.Sumrell@va.gov>

[Yolonda Ortiz (212) 686-7500 extn: 4209) e-mail:]{.underline}
<Yolonda.ortiz@va.gov>

[Ann Marie Klekman (718) 630-3645 Fax: (718) 630-3796 for
IACUC]{.underline}

[e-mail:]{.underline} <AnnMarie.Klekman@va.gov>

[AO Brooklyn: Leslie Dowers (718) 836-6600 extn: 3838]{.underline}

[e-mail:]{.underline} [leslie.dowers@va.gov](../leslie.dowers@va.gov)

1.  **This Check List (Mandatory)**

2.  **PI cover memo accompanying request to review**

3.  **Data Security and VA Research Information Storage & Security**

**Appendices C and D** Available on the R&D web site

4.  **Certification of Exemption** (If applicable) or NA

> <http://www1.va.gov/visns/visn03/rd/forms/certificationexemption.doc>

5.  **Request for Expedited Review** (If applicable) or NA

> <http://www1.va.gov/visns/visn03/rd/forms/expeditedreview.doc>

6.  **Request to Review Research Proposal/Project**

> Signed by PI, section chief and service chief.
>
> <http://www1.va.gov/visns/visn03/rd/forms/reviewproposal.doc>

7.  **Abstract** (less than 500 word summary of the protocol-see
    guidelines below)

> Abstract signed and dated by P.I.
>
> <http://www1.va.gov/visns/visn03/rd/forms/abstractguidelines.doc>

8.  **Protocol** (in sufficient detail for committees to evaluate
    scientific merit)

9.  **VA Research Consent Form 10-1086** (Version Mar. 2006) or NA

> <http://www1.va.gov/visns/visn03/rd/forms/10-1086.doc>
>
> (make certain you specify the amount of payment as well as the
> timeframe
>
> for payment, or include a statement that subjects will not be paid.
>
> Address the issue of vulnerable subjects.)

10. **Human studies questionnaire** (Version 3 Revised 1/5/2007)
    <http://www1.va.gov/visns/visn03/rd/forms/humanquest.doc>

11. **Drug and Device study forms:**

-   **1572 for non FDA approved drugs** signed and dated or NA

> <http://www.fda.gov/opacom/morechoices/fdaforms/cder.html>

-   **Pharmacy Support form** or NA

> for each drug and placebo signed by Research Pharmacy Chief
>
> <http://www1.va.gov/visns/visn03/rd/forms/pharmacyform.doc>

-   **10-9012** signed for each drug and placebo (list ingredients of
    placebo). or NA

> <http://www1.va.gov/visns/visn03/rd/forms/10-9012.doc>

-   **IND and/or IDE approval** or NA

> (document not needed if the number is supplied in the human studies
> questionnaire)

12. **Research Staff Credentialing Checklist Form**

> Signed by P.I.
>
> <http://www1.va.gov/visns/visn03/rd/forms/credentialing.doc>
>
> Include the following training certificates for the PI and all staff
> listed on form
>
> **(Make certain that the certificates will not expire before R&D
> meeting)**
>
> **[Certificates for Human Studies]{.underline}**
>
> Overview GCP+HSP (VA or CITI) certificate
>
> <https://www.citiprogram.org/default.asp>
>
> VHA Privacy Policy Training (HIPAA) certificate
>
> <http://www1.va.gov/visns/visn03/rd/rdtrain.asp>
>
> **[M.D.s please enter your clinical privileges expiry
> date]{.underline}**
>
> <http://vaww.nyharbor.med.va.gov/pp.asp> (intranet only)
>
> **[Scope of Practice]{.underline}**
>
> For non-clinicians/Nurses, investigators and coordinators: [(edit this
> template to include only the highest degree obtained, be gender
> specific in the summary description and indicate actual duties and
> title of the individual)]{.underline}
>
> <http://www1.va.gov/visns/visn03/rd/forms/rcscope.doc> -VA paid
>
> <http://www1.va.gov/visns/visn03/rd/forms/rcscopenonva.doc> -Non-VA
> paid

13. **[Fellows and residents please supply RCVL or WOC
    papers.]{.underline}** or NA

> **[View video tape "Balancing Society's Mandates" and "IRB Review
> Criteria"]{.underline}**
>
> (Please contact Sheila Sumrell (X7475) at the Manhattan Campus or
> Leslie Dowers
>
> (X3388) at the Brooklyn Campus for an appointment).

14. **Budget page** (if funded) or NA

> (unfunded studies may not list co-PI's on request to review)
>
> <http://www1.va.gov/visns/visn03/rd/forms/budget.doc>

15. **Page 18** (investigator data sheet) for PI&CO-PIs if this is your
    first study or NA

> <http://www1.va.gov/visns/visn03/rd/forms/page18.doc>

16. **Financial Conflict of Interest Form 10-1313-14** (R&D FORM
    No. 002) or NA

([Required for PI and all personnel with 5% or more effort on
project)]{.underline}

> Enter "None" in [Section IX 10 &11]{.underline} if you do not have any
> duties.
>
> <http://www1.va.gov/visns/visn03/rd/forms/conflictofinterest.doc>

17. **Research Protocol Safety Survey** or NA

> <http://www1.va.gov/visns/visn03/rd/forms/safety.pdf>
>
> Signed and dated by P.I.

**[Note: IRB Office will not accept incomplete applications. Incomplete
applications will be returned to the P.I. for completion.]{.underline}**

**[Do not forget to include this check list along with the
application.]{.underline}**

To use links, press and hold the control key while left clicking the
link. If this does not work, cut and paste the URL into your browser. If
you have problems accessing forms or if you have any questions, please
contact IRB Manger Dr. Parameshwar Mahasreshti or IRB coordinator Sheila
Sumrell.

If the internet is unavailable, all forms are accessible from the VA
intranet at: <http://vaww.nyharbor.med.va.gov/rdforms.asp>