Miami Schneiderman HCHS Visit 2 IRB approval

University of Miami
Human Subjects Research Office (M8089)
P.O. Box 016960, Miami, Florida 33101
1500 NW 12 Avenue, Suite 1002, Miami, Florida 33136

Ph.: 305-243-3195
Fax: 305-243-3328
www.hsro.miami.edu

APPROVAL

January 8, 2014
Neil Schneiderman
5665 Ponce de Leon Boulevard
Flipse Building
Coral Gables, FL 33146
305-284-6634
nschneid@miami.edu
Dear Dr. Neil Schneiderman:
On 1/8/2014, the IRB reviewed the following submission:
Type of Review:
Title of Study:
Investigator:
IRB ID:
Funding:

Initial Study
Visit 2 of the Hispanic Community Health Study
Neil Schneiderman
20131007
National Heart, Lung, and Blood Institute, Funding
Source ID: Contract #HHSN268201300004I
IND, IDE, or HDE: None
Documents Reviewed: • Anthropometry.pdf, Category: Questionnaire/Survey;
• Family Cohesion.pdf, Category: Questionnaire/Survey;
• Pregnancy Complications History.pdf, Category: Data
Collection Sheet;
• Tobacco Use Questionnaire.pdf, Category:
Questionnaire/Survey;
• Sitting Blood Pressure.pdf, Category: Data Collection
Sheet;
• Medication Use Survey.pdf, Category:
Questionnaire/Survey;
• Medical History Questionnaire.pdf, Category:
Questionnaire/Survey;
• BIOSPECIMEN COLLECTION FORM.pdf, Category:
Data Collection Sheet;
• Participant Feedback.pdf, Category:
Questionnaire/Survey;
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• 20131007_ICF_UMMain_ENG.pdf, Category:
Consent Form;
• Chronic Stress.pdf, Category: Questionnaire/Survey;
• Acculturation Questionnaire.pdf, Category:
Questionnaire/Survey;
• Participant Safety Screening Form.pdf, Category: Data
Collection Sheet;
• Alcohol Use Questionnaire.pdf, Category:
Questionnaire/Survey;
• Socio Economic_Occupation Questionnaire.pdf,
Category: Questionnaire/Survey;
• Health Care Questionnaire.pdf, Category:
Questionnaire/Survey;
• PHANTOM FORM.pdf, Category: Data Collection
Sheet;
• Personal Identifiers.pdf, Category: Data Collection
Sheet;
• V2 Invitation Miami.pdf, Category: Recruitment
Materials;
• AV_Consent.pdf, Category: Consent Form;
• Reproductive and Medical History.pdf, Category: Data
Collection Sheet;
• Well-Being Questionnaire.pdf, Category:
Questionnaire/Survey;
• Social Support.pdf, Category: Questionnaire/Survey;
The IRB approved the study from 1/8/2014 to 1/7/2015 inclusive. Before 1/7/2015 or within
45 days of the approval end date, whichever is earlier, you are to submit a completed
Continuing Review to request continuing approval or closure.
If continuing review approval is not granted before the expiration date of 1/7/2015 approval
of this study expires on that date.
To document consent, use the consent documents that were approved and stamped by the
IRB. Go to the Documents tab to download them.
NOTE: Translations of IRB approved study documents, including informed consent
documents, into languages other than English must be submitted to HSRO for approval
prior to use.
In conducting this study, you are required to follow the requirements listed in the
Investigator Manual (HRP-103), which can be found by navigating to the IRB Library
within the IRB system

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Should you have any questions, please contact: Meghan Stein, IRB Regulatory Analyst,
(phone: 305-243-3195; email: m.stein@med.miami.edu)
Sincerely,
[This is a representation of an electronic record
that was signed electronically and this page is
the manifestation of the electronic signature]
Amanda Coltes-Rojas, MPH, CIP
Director
Regulatory Affairs & Educational Initiatives

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