Principal Investigator Checklist for Initial Protocol IRB Submissions

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

[E-mail:]{.underline} <Stanley.John@va.gov>

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

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

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

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

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

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

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

3.  **Request for Expedited Review** (If applicable. Contact the IRB
    Coordinator.) or NA

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

> Signed by PI, section chief and service chief.

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

> Abstract signed and dated by P.I.
> [http://www.brooklyn.va.gov/docs/abstractguidelines.doc]{.underline}
> or <http://www.manhattan.va.gov/docs/abstractguidelines.doc>

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

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

8.  **VA Research Consent Form 10-1086** \[Version 20081204\] or NA

> <http://www.brooklyn.va.gov/docs/10-1086v20081204.doc> or

<http://www.manhattan.va.gov/docs/10-1086v20081204.doc>

-   Use the [Informed Consent
    Checklist](http://www.brooklyn.va.gov/BROOKLYN/docs/informedconsentchecklist.pdf)
    to ensure all elements of informed consent are included.

-   If compensating research participants make certain you specify the
    amount of payment as well as the schedule of payment, or otherwise
    include a statement that subjects will not be paid.

-   If identifiable information is transmitted outside the VA the
    details should be included in the HIPAA Authorization section of the
    consent form.

-   

9.  **Human studies questionnaire(HSQ)** **(Ver. 4 Revised Jul. 2008)**

> <http://www.brooklyn.va.gov/docs/humanquest.doc> or
> <http://www.manhattan.va.gov/docs/humanquest.doc>
>
> **Please forward a copy of the HSQ & ICF to the ISO & PO for review /
> signatures.\***
>
> Privacy Officer Lindsay Seaquist at (Harbor) <Lindsay.Seaquist@va.gov>
>
> Information Security Officers John Tozzi (NY CAMPUS)
> <John.Tozzi@va.gov>

10. **Research Protocol Safety Survey**

> Signed and dated by P.I.

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

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

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

> (Documentation is required that links the number to the specific
> protocol is required. Indicate page in the protocol or obtain a letter
> from the Sponsor.)

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

13. **Research Staff Credentialing Checklist Form**

> <http://www.brooklyn.va.gov/docs/researchstafftrainingchecklist.doc>
> or <http://www.manhattan.va.gov/docs/researchstaffrainingcheclist.doc>
>
> Signed by P.I.
>
> Include following current training certificates for the PI and all
> staff listed on form
>
> **(Please make certain that all certificates do not expire before the
> IRB meeting)**
>
> **[Include certificates of completion for required trainings
> below:]{.underline}**

-   [Click here for Training Requirements for Human Subjects
    Protection](http://www.research.va.gov/programs/pride/training/default.cfm)

-   Cyber Security Awareness

-   VHA Privacy Policy Training

-   Information Security 201 for Research and Development Personnel

> **[M.D.s please enter your clinical privileges expiry
> date]{.underline}** or NA
>
> <http://vaww.nyharbor.med.va.gov/pp.asp> (intranet only)
>
> **[Scope of Practice]{.underline}
> <http://www.brooklyn.va.gov/docs/sop.doc> or
> <http://www.manhattan.va.gov/docs/sop.doc>**
>
> signed by PI, ACOS R&D and Nursing Chief, if applicable or NA
>
> **[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. **Conflict of Interest Disclosure Form (2008 version)** or NA

> <http://www.brooklyn.va.gov/docs/financialcoi.pdf> or
> <http://www.manhattan.va.gov/docs/financialcoi/pdf>

15. For each PI and personnel with 5% or more effort on project signed
    by the Research Compliance Officer.

**All Forms are available online using the following web links:**

VA NYHHS Intranet site:

<http://vaww.nyharbor.med.va.gov/rdforms.asp>

Internet sites:

<http://www.manhattan.va.gov/services/rdforms.asp>

<http://www.brooklyn.va.gov/services/rdforms.asp>

If you have problems accessing forms or if you have any questions,
please contact the IRB Coordinator Sheila Sumrell or Sandy Diaz at
212-686-7500 ext. 4655 or via e-mail <Sandra.Diaz2@va.gov>.

Note: R&D Office will **no longer accept incomplete applications**. All
incomplete applications will be returned to the P.I. for completion. Do
not forget to include this check list along with the application.

In general, the IRB meets on a monthly basis except for the month of
August, on the first Monday of the month. All submissions must be
received by the deadline for that month's meeting as posted in the [R&D
Meetings
Calendar](http://vaww.nyharbor.med.va.gov/documents/rdcalendar.doc) on
the R&D Homepage and Bulletin Board. Please call the IRB Coordinator for
the most updated schedule.