Appendix H. Institutional Review Board Approval Letter

App H Institutional Review Board Approval Letter.pdf

Third National Survey of WIC Participants (NSWP-III)

Appendix H. Institutional Review Board Approval Letter

OMB: 0584-0641

Document [pdf]

Download: pdf | pdf

APPENDIX H
INSTITUTIONAL REVIEW BOARD APPROVAL LETTER

August 3, 2017
Principal Investigator: Paul Ruggiere, Ph.D., M.S., B.B.A.
Sponsor: United States Department of Agriculture Food and Nutrition Services
Protocol Number: 2016-001
Study Title: “Third National Survey of WIC Participants (NSWP-III)”
Dear Dr. Ruggiere:
The above-referenced study meets the requirements for a research study that may be reviewed through
expedited review procedures set forth in federal regulations.
Utilizing the expedited review procedures, the following action was taken on the continuing review of the
above referenced study on behalf of IntegReview by Christina Walker, M.D. on August 3, 2017.
Approved:
Principal Investigator
Investigative site(s) as previously approved by IntegReview
Protocol, Version 1.0 dated July 29, 2016
Upon evaluation of the request for Waiver of documentation of Informed Consent, the expedited reviewer
has determined that the request meets the criteria as identified in 45 CFR 46.116(d).
IMPORTANT
• The following changes in approved research may not be implemented until you have received
approval from IntegReview except where necessary to eliminate apparent immediate hazards
to the human subjects:
Protocol Amendments
Change in the Principal Investigator and/or Sub-investigators (only if the Subinvestigators will be performing study-related procedures that the PI is not qualified
through expertise to perform)
Change in the address at the study site or the addition of a study site(s)
• Only Informed Consent documents containing IntegReview’s approval stamp may be utilized:
There must be procedures in place to guarantee that consent has been voluntarily
obtained and properly documented.
For participants that do not speak English, the informed consent document must be in
a language understandable to them.
Only IntegReview staff may initiate modifications to Informed Consent documents.
The Informed Consent document will be maintained in our computer files, and
IntegReview will make all revisions following IRB approval.
• Only recruiting materials containing IntegReview’s approval stamp may be utilized. All
audio/video recording(s) must be submitted for IRB approval prior to broadcast.
• Revision requests should be submitted on IntegReview’s forms, which are available in
IRBManager.
• Visit our website at www.integreview.com for information on research regulations, reporting
requirements, Sponsor training, Investigator and research personnel training, etc.
3815 S. Capital of Texas Hwy, Suite 320, Austin, TX 78704
Tel. 512.326.3001 Local Fax. 512.697.0085 http://www.integreview.com
IRB Registration Numbers: IRB00008463, IRB00003657, IRB00004920, IRB00001035, IRB00006075

Paul Ruggiere, Ph.D., M.S., B.B.A.
United States Department of Agriculture Food and Nutrition Services, Protocol Number 2016-001
Page 2

IntegReview approval for this study expires August 2, 2018.
In order to obtain extended IRB approval, IntegReview must receive your form for continuing review two
weeks prior to the IRB expiration date. Appropriate forms will be forwarded to you approximately four
weeks prior to the approval expiration date. Should the study end before you receive notification, submit a
Closure Notification form.
REPORTING REQUIREMENTS
To ensure compliance with the applicable federal regulations as well as International Conference on
Harmonisation (ICH), E6: Good Clinical Practice: Consolidated Guideline, IntegReview requires
notification of the following for review/approval:
• Report immediately:
Changes in research that were initiated without IRB review and approval to eliminate
apparent immediate hazards to the human subjects to ensure the continued safety and
welfare of subjects
Modifications to previously approved documents
Receipt of investigator/site 483, Determination letter or Warning letter
If your license is suspended, revoked, placed on probation or restricted in any state or
country
Safety information that may help to provide additional protections for subject’s safety and
well-being, throughout the course of the study and after study completion.
Communication of results from a research study to subjects when those results directly
affect their safety or medical care
Reports of pregnancy
• Report within 10 days of discovery:
Revisions to the report of prior investigations
Unanticipated adverse device effects
Non-compliance – Failure by an investigator and/or sponsor to follow IntegReview’s
requirements, applicable regulations or to protect human research subjects, including but
not limited to the principles of the Belmont Report
Serious non-compliance issues - non-compliance as defined as above and as determined to
be serious in a way that adversely affects the rights and welfare of human subjects
following the investigation and review by the IRB
Continuing non-compliance issues – A pattern of repeated non-compliance or serious noncompliance as determined by the IRB
Significant deviations – Significant deviations are those that deviate from the approved
protocol, informed consent process and affect or potentially affect the safety of subjects.
IntegReview does not consider protocol deviations to be different from protocol violations.
Unanticipated problems should be reported regardless of whether they occur during the
study, after the study completion, or after participant withdrawal or completion. Any
unanticipated problems involving risks to human subjects or others that are (1) unexpected
(in terms of nature, severity, or frequency) given (a) the research procedures that are
described in the protocol-related documents, such as the IRB-approved research protocol
and informed consent document; and (b) the characteristics of the subject population being
studied; (2) related or possibly related to participation in the research (possibly related
means there is a reasonable possibility that the incident, experience, or outcome may have
been caused by the procedures in the research); and (3) suggests that the research places
subjects or others at a greater risk of harm (including physical, psychological, economic, or

Paul Ruggiere, Ph.D., M.S., B.B.A.
United States Department of Agriculture Food and Nutrition Services, Protocol Number 2016-001
Page 3

•
•

social harm) than was previously known or recognized. Examples of problems or events
that may meet the definition of unanticipated problems involving risk to subjects or others
may include, but are not limited to the following:
• Imminent threat of a reportable event that has not yet occurred
• Information indicating a change to the risk/benefit ratio of the research
• Death
• Breach of confidentiality, including lost or stolen study documents/data
Report within 30 days of acquisition or discovery
New or additional conflicts of interests
Submit prior to publication/distribution:
Any modification(s) to the previously approved Informed Consent document
New and/or modifications to previously approved recruiting/miscellaneous materials to be
seen or heard by subjects
Submit two weeks prior to IntegReview approval expiration date:
Continuing review documents
Submit upon completion of the study:
Notification of study closure

At its discretion, IntegReview IRB reserves the right to visit the study site.
IntegReview IRB is organized and operates in accordance with the applicable federal regulations, and ICH
Guidelines for Good Clinical Practices, E6. In addition, Standard Operating Procedures have been created
to ensure compliance with these regulations and guidelines.
If you have any questions regarding these procedures or if you wish to appeal the decision of IntegReview,
you may address your comments to the IntegReview Co-chair.
Failure to comply with the Code of Federal Regulations or the requirements or determinations of
IntegReview IRB can result in suspension or termination of IntegReview approval.
Sincerely,

Joseph Mitchell, LVN, CCRP
IRB Administrative Associate II

Anthony Mercado
IRB Administrative Associate I

3815 S. Capital of Texas Hwy, Suite 320, Austin, TX 78704
Tel. 512.326.3001 Local Fax. 512.697.0085 http://www.integreview.com
IRB Registration Numbers: IRB00008463, IRB00003657, IRB00004920, IRB00001035, IRB00006075

November 14, 2017
Principal Investigator: Paul Ruggiere, Ph.D., M.S., B.B.A.
Sponsor: United States Department of Agriculture Food and Nutrition Services
Protocol Number: 2016-001
Study Title: “Third National Survey of WIC Participants (NSWP-III)”
Dear Dr. Ruggiere:
The following item(s) received IRB approval on November 14, 2017 via expedited review by Christina
Walker, M.D.:
One Revised Appendix A1. State Agency Survey
One Revised Appendix A2. Local Agency Survey
One Revised Appendix A3.a Certification Survey Version A (Adult)
One Revised Appendix A3.b Certification Survey Version B (Infant Child)
One Revised Appendix A4.a Denied Applicant Survey Version A (Adult)
One Revised Appendix A4.b Denied Applicant Survey Version B (Infant Child)
One Revised Appendix A5.a Program Experiences Survey Version A (Adult)
One Revised Appendix A5.b Program Experiences Survey Version B (Infant Child)
One Revised Appendix A6.a Former WIC Participant Case Study Interview Guide
One Revised Appendix B1. Notification Email to Regional and State Offices
One Revised Appendix B2. Letter to State Agencies from Regional Offices
One Revised Appendix B3. State Agency Survey Invitation Email
One Revised Appendix B4. State Agency Survey Invitation Letter with Instrument
One Revised Appendix B5. State Agency Survey Reminder Email
One Revised Appendix B6. State Agency Survey Reminder Telephone Script
One Revised Appendix B7. Local Agency Survey Invitation Email
One Revised Appendix B8. Local Agency Survey Invitation Letter with Instrument
One Revised Appendix B9. Local Agency Survey Reminder Email
One Revised Appendix B10. Local Agency Survey Reminder Telephone Script
One Revised Appendix B11.a Certification Survey Recruitment Telephone Script
One Revised Appendix B12.a Text Message Reminder for Scheduled Certification Survey
One Revised Appendix B13.a Telephone Reminder for Scheduled Certification Survey
One Revised Appendix B14.a Denied WIC Applicant Survey Recruitment Telephone Script
One Revised Appendix B15.a Text Message Reminder for Scheduled Denied Applicant Survey
One Revised Appendix B16.a Telephone Reminder for Scheduled Denied Applicant Survey
One Revised Appendix B17.a Program Experiences Survey Invitation Telephone Script
One Revised Appendix B18.a Former WIC Participant Case Study Interview Invitation
Telephone Script
One Revised Appendix B19.a. Program Experiences Survey Invitation Letter
One Revised Appendix B20.a. Program Experiences Survey Invitation Email
One Revised Appendix B21.a Program Experiences Survey Invitation In-Person Script
3815 S. Capital of Texas Hwy, Suite 320, Austin, TX 78704
Tel. 512.326.3001 Local Fax. 512.697.0085 http://www.integreview.com
IRB Registration Numbers: IRB00008463, IRB00003657, IRB00004920, IRB00001035, IRB00006075

Paul Ruggiere, Ph.D., M.S., B.B.A.
United States Department of Agriculture Food and Nutrition Services, Protocol Number 2016-001
Page 2

One Revised Appendix C1.a Participant Consent Form Certification Survey
One Revised Appendix C2.a Participant Consent Form Denied Applicant Survey
One Revised Appendix C3. State Agency Survey Thank You Letter
One Revised Appendix C4. Local Agency Survey Thank You Letter
If you have any questions, please contact me at (512) 326-3001.
Sincerely,

Anthony Mercado
IRB Administrative Associate I

November 21, 2017
Principal Investigator: Paul Ruggiere, Ph.D., M.S., B.B.A.
Sponsor: United States Department of Agriculture Food and Nutrition Services
Protocol Number: 2016-001
Study Title: “Third National Survey of WIC Participants (NSWP-III)”
Dear Dr. Ruggiere:
The following client translated documents received IRB approval on November 21, 2017 via expedited
review by Christina Walker, M.D. for the above referenced study:
One New Spanish Appendix A3.c Certification Survey Version A (Adult)
One New Spanish Appendix A3.d Certification Survey Version B (Infant Child)
One New Spanish Appendix A4.c Denied Applicant Survey Version A (Adult)
One New Spanish Appendix A4.d Denied Applicant Survey Version B (Infant Child)
One New Spanish Appendix A5.c Program Experiences Survey Version A (Adult)
One New Spanish Appendix A5.d Program Experiences Survey Version B (Infant Child)
One New Spanish Appendix A6.b Former WIC Participant Case Study Interview Guide
One New Spanish Appendix B11.b Certification Survey Recruitment Telephone Script
One New Spanish Appendix B12.b Text Message Reminder for Scheduled Certification Survey
One New Spanish Appendix B13.b Telephone Reminder for Scheduled Certification Survey
One New Spanish Appendix B14.b Denied WIC Applicant Survey Recruitment Telephone Script
One New Spanish Appendix B15.b Text Message Reminder for Scheduled Denied Applicant Survey
One New Spanish Appendix B16.b Telephone Reminder for Scheduled Denied Applicant Survey
One New Spanish Appendix B17.b Program Experiences Survey Invitation Telephone Script
One New Spanish Appendix B18.b Former WIC Participant Case Study Interview Invitation Telephone
Script
One New Spanish Appendix B19.b. Program Experiences Survey Invitation Letter
One New Spanish Appendix B20.b. Program Experiences Survey Invitation Email
One New Spanish Appendix B21.b Program Experiences Survey Invitation In-Person Script
One New Spanish Appendix B22.b Certification Survey Recruitment In-Person Script
One New Spanish Appendix B23.b Denied WIC Applicant Survey Recruitment In-Person Script
One New Spanish Appendix C7.b Certification Survey Information Letter from State Agencies
One New Spanish Appendix C8.b Denied WIC Applicant Information Letter from State Agencies
One New Spanish Appendix C9.b PES Thank You Letter and Gift Card
One New Spanish Appendix C10.b Former WIC Participant Case Study Interview Thank You Letter
and Gift Card

Paul Ruggiere, Ph.D., M.S., B.B.A.
United States Department of Agriculture Food and Nutrition Services, Protocol No. 2016-001
Page 2

If you have any questions please feel free to contact me at 512-326-3001.
Sincerely,

Jenna Rozacky, B.S.
IRB Administrative Associate II

File Type	application/pdf
Author	Melissa Meyer
File Modified	2017-11-28
File Created	2017-11-28