App_BB.IRB.Approval.Letter

APPENDIX BB

AGE 3 EXTENSION WIC INFANT AND TODDLER FEEDING PRACTICES STUDY –II

IRB APPROVAL LETTER

AMENDMENT REVIEW FORM

(TO ADD OR CHANGE PREVIOUSLY APPROVED RESEARCH)

All changes or new activities for previously approved studies require submission, review, and approval of an Amendment Review Form. Please complete and upload this form to your project’s document library on IRBTRAC along with all other necessary materials to be reviewed. Once the request has been reviewed, you will be contacted. If this change or new activity requires a full Board review, those meetings occur on the second Tuesday of every month. To check the date of meetings, please see the meeting schedule under IRB in WesInfo. Thank you for your cooperation.

1. Today’s Date:

10 / 29 / 2014

Date of Original Approval:

02 / 24 / 2012

Project Name:

WIC Infant-Toddler Feeding Practices - II (Feeding My Baby - A National WIC Study)

Westat Project Number:

8967.01.00

Agency Grant or Contract Number:

GS-23F-8144H

Project Director:

Suzanne McNutt

Ext. 3554

Unit Ops Number/Study Area:

1.21.72/Cancer Studies

Area IRB Representative:

Nancy Weinfield

Ext. 2480

2. Indicate the type of addition or change being requested to a previously approved study.
(select all that apply.)

Name(s) of investigators Project number Introduction of a new IRB or request for Westat to serve as the IRB Study design, survey questionnaire, or procedure(s) Informed consent process, consent form(s), parent permission(s), or assent form(s) Recruitment materials or strategies Incentives Survey instruments Number or type of populations studied	Review of final instrument such as interview questions or data collection sites for a previously approved study Mode of administration of instruments in your study (e.g., from mail or telephone to web or Internet access) Data access rights Any other change in protocol that affects treatment of human subjects: (please specify)
		flyers announcing study extension advance letters for interviews and activities HIPAA release form contact update forms

3. Please provide a brief summary of your change or addition to previously approved research.

   FNS has asked us to extend the study another year to child age 36 months. We are revising the 24-month interview to remove one question and add contact info requests since it is no longer the last interview. We are adding new consent, two caregiver interviews, requests to get child measured and weighed, more WIC adminstrative data at 36 months, and a new HIPAA authorization, as well as an announcement flyer, three contact update requests, and advance letters for the interviews.

4. How does each change or addition affect the risks to participants in your study? (select only one.)

a. No change

b. N/A – no risks

c. Decreases the risk (specify):

     

d. Increases the risk (specify):

     

e. Adds a new risk (specify):

     

FOR HARD-COPY SUBMISSION, PLEASE SIGN HERE:

A signature is not required when you return this form electronically; however, please fill in the date of completion.

The information provided in this request form is complete and correct.

Project Director/ Principal Investigator:

Date:

10 / 29/ 2014

Please attach:

• One document that clearly identifies (through track changes, highlights, or italics) the revision in the previously approved submission.

• Another document labeled “corrected version.”

If you have any questions, feel free to contact Sharon Zack, the IRB Administrator, at x8828.

IRB Administration Use Only Expedited review and approval for the modification(s) on this form:
11/13/14 IRB Chair / Associate Chair / Designee
IRB Office Only Approved – Next continuing review date BEFORE: 02 / 24/ 2015 Conditional approval (Please see attached letter) Did not qualify for expedited review

AMENDMENT REVIEW FORM Page 1 of 2

April 2014 version