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Office for the Protection
of Research Subjects Northwestern University
750 North Lake Shore Drive
Suite 700
Chicago, Illinois 60611
irb@northwestern.edu
Phone 312-503-9338
Fax 312-503-0555
9/27/2010
Dr. Martha Daviglus
Professor of Preventive Medicine and Medicine
Preventive Medicine
680 N Lake Shore Dr, Suite 1102
Chicago, IL 60611
daviglus@northwestern.edu
IRB Project Number: CR2_STU00009660
Project Title: Hispanic Community Heal udy/Study of Latinos (HCHS/SOL)
Project Sites:
Northwestern University (NU)
Sponsor Information (Grant #, if applicable):
View National Heart, Lung, and Blood Institute
Submission Considered: Continuing Review Submission Number: CR2_STU00009660
Review Type: Full Review
Meeting Date: 9/27/2010
Panel: Panel Q
Status: APPROVED Approval Period: (10/26/2010 ‐ 10/25/2011)
Dear Dr. Daviglus ,
The IRB considered and approved your submission referenced above through 10/25/2011 . As Principal
Investigator (P.I.), you have ultimate responsibility for the conduct of this study, the ethical performance
of the project, and the protection of the rights and welfare of human subjects. You are required to
comply with all NU policies and procedures, as well as with all applicable Federal, State and local laws
regarding the protection of human subjects in research including, but not limited to the following:
Not changing the approved protocol or consent form without prior IRB approval (except in an
emergency, if necessary, to safeguard the well‐being of human subjects).
Obtaining proper informed consent from human subjects or their legally responsible
representative, using only the currently approved, stamped consent form.
Promptly reporting unanticipated problems involving risks to subjects or others, or promptly
reportable non‐compliance in accordance with IRB guidelines.
Submit a continuing review application 45 days prior to the expiration of IRB approval. If IRB re‐
approval is not obtained by the end of the approval period indicated above, all research related
activities must stop and no new subjects may be enrolled.
IRB approval includes the following:
Written Consent Form/Consent Form and Authorization for Research:
Name
Addendum‐consent‐English‐June7‐2010
Addendum‐consent‐SPANISH‐June7‐2010
Main Consent English Language Clean 06‐15‐2010
Main Consent Spanish Language Clean 06‐15‐2010
Re Draw and Re Collection Lab Addendum English Clean 11‐05‐2009.doc
Re Draw and Re Collection Lab Addendum Spanish Clean 11‐05‐2009.doc
Stadiometer Consent Addendum English Clean 11‐05‐2009.doc
Stadiometer Consent Addendum SpanishClean 11‐05‐2009.doc
Protocol:
Name
0623‐011 Field Center Procedures Part 1 8‐29‐2008.pdf
0623‐011 Field Center Procedures Part 2 8‐29‐2008.pdf
0623‐011 Field Center Procedures Part 3 8‐29‐2008.pdf
0623‐011 Protocol Part 1.pdf
0623‐011 Protocol Part 2.pdf
Investigator Brochure:
Non‐FDA Brochures
There are no items to display
Recruitment Materials:
Name
0623‐011 SRM Flyer 2 Spanish.pdf
0623‐011 SRM Flyer 2.pdf
0623‐011 SRM Flyer 3 Spanish.pdf
0623‐011 SRM Flyer 3.pdf
0623‐011 SRM Flyer Spanish.pdf
0623‐011 SRM Flyer.pdf
0623‐011 SRM Public Service Announcement.pdf
0623‐011 SRM Subject Letter Spanish.pdf
0623‐011 SRM Subject Letter.pdf
AFU Eng/Span Informational Letter‐Updated on Letterhead 5/29/09
AFU Informational Letter‐English Updated 5/26/09
AFU Informational Letter‐English‐Spanish
AFU informational Letter‐Spanish Updated 5/26/09
AFU Moving Card‐English‐Spanish
AFU Thank You Postcard‐English‐Spanish
Chicago SOL Newsletter‐English
Chicago SOL Newsletter‐Spanish
SOL follow‐up recruitment card‐side1
SOL Follow‐up recruitment card‐side2
Survey/Questionnaires:
Name
0623‐011 Alcohol Use Questionnaire Spanish.pdf
0623‐011 Alcohol Use Questionnaire.pdf
0623‐011 Ankle Arm Blood Pressure.pdf
0623‐011 Anthropometry.pdf
0623‐011 Audiometry Exam.pdf
0623‐011 Biospecimen Collection Form.pdf
0623‐011 Clinic Check Sheet.pdf
0623‐011 Dietary Behavior Questionnaire Spanish.pdf
0623‐011 Dietary Behavior Questionnaire.pdf
0623‐011 Economic Questionnaire.pdf
0623‐011 Health Care Use Spanish.pdf
0623‐011 Health Care Use.pdf
0623‐011 Health Survey.pdf
0623‐011 Hearing Exam Questionnaire.pdf
0623‐011 Hearing History Questionnaire.pdf
0623‐011 Informed Consent Tracking.pdf
0623‐011 Medical Family History Questionnaire Spanish.pdf
0623‐011 Medical Family History Questionnaire.pdf
0623‐011 Medication Use Questionnaire Spanish.pdf
0623‐011 Medication Use Questionnaire.pdf
0623‐011 Neurocognitive Assessment.pdf
0623‐011 Occupation Classification and Exposures Questionnaire Spanish.pdf
0623‐011 Occupation Classification and Exposures Questionnaire.pdf
0623‐011 Oral Health Questionnaire Spanish.pdf
0623‐011 Oral Health Questionnaire.pdf
0623‐011 Otoscopy Exam.pdf
0623‐011 Participant Safety Screening Form Spanish.pdf
0623‐011 Participant Safety Screening Form.pdf
0623‐011 Personal Identifiers.pdf
0623‐011 Personal Information Questionnaire.pdf
0623‐011 Phantom Form.pdf
0623‐011 Physical Activity Questionnaire Spanish.pdf
0623‐011 Physical Activity Questionnaire.pdf
0623‐011 Respiratory Questionnaire Spanish.pdf
0623‐011 Respiratory Questionnaire.pdf
0623‐011 Sleep Questionnaire Spanish.pdf
0623‐011 Sleep Questionnaire.pdf
0623‐011 Social Network Index Questionnaire Spanish.pdf
0623‐011 Social Network Index Questionnaire.pdf
0623‐011 Sociocultural Questionnaire Spanish.pdf
0623‐011 Sociocultural Questionnaire.pdf
0623‐011 Tobacco Use Questionnaire Spanish.pdf
0623‐011 Tobacco Use Questionnaire.pdf
0623‐011 Tympanometry Exam.pdf
0623‐011 Weight History Questionnaire Spanish.pdf
0623‐011 Weight History Questionnaire.pdf
0623‐011 Well‐Being Questionnaire Spanish.pdf
0623‐011 Well‐Being Questionnaire.pdf
AFU FPQ Response Card‐English‐Spanish
AFU Informant Interview‐English
AFU Informant Interview‐Spanish
AFU Informant interview‐Spanish Updated 5/26/09
AFU Interview Form‐English
AFU Interview Form‐Spanish
AFU Interview Form‐Spanish 5/26/09 Updated
AFU Physician Questionnaire‐English
AFU Tracking Form
COM08RETAnnualFollowupYear205282010
COM08RETAnnualFollowupYear2Spanish03022010
Food Propensity Questionnaire‐English‐Version B
Food Propensity Questionnaire‐Spanish‐Version B
For more information regarding OPRS submissions and guidelines, please consult
http://www.northwestern.edu/research/OPRS/irb.
This Institution has an approved Federalwide Assurance with the Department of Health and Human
Services: FWA00001549.
*******************
Thanh-Huyen T. Vu, MD; PhD
Department of Preventive Medicine
Northwestern University School of Medicine
680 N. Lake Shore Dr. Chicago, Ste. 1400, IL 60611
Tel: 312-908-6699
Fax: 312-908-9588
Email: huyenvu@northwestern.edu
| File Type | application/pdf |
| File Title | Microsoft Word - Northwestern Office for the Protection.doc |
| Author | uccmey |
| File Modified | 2011-10-07 |
| File Created | 2011-07-11 |