Attach 62 - NU IRB Approval Letter 7.24.2011

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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

3/29/2011
Richard Gershon
Associate Chairman
Medical Social Sciences (MSS)

gershon@northwestern.edu
IRB Project Number: STU00013098
Project Title: NIH Toolbox for Assessment of Neurological and Behavioral Function
Project Expiration Date: 8/15/2011
Project Sites:
Other: (Specify and Explain)
Northwestern University (NU)
Medical Social Sciences (MSS)
Sponsor Information (Grant #, if applicable):
View National Institute of Health
HHSN260200600007C
View National Institute of Health
1RC2AG036498 - 01

Submission Considered: REVISION
Submission Number: Rev13_STU00013098
Submission Description: Establishing National Norms for the NIH Toolbox for Neurological and
Behavioral Function. Protocol version 10, March 4, 2011. New assessment materials. New authorized
research personnel: David Cella, David Victorson, James Griffith, Zeeshan Butt, Maria Corona, Azra
Muftic
Review Type: Expedited
Review Date: 3/29/2011.
Panel: E
Status: APPROVED

Dear Gershon,
The IRB considered and approved your revision referenced above. The documents approved as part of
this revision are incorporated into the lists below:
Written Consent Form/Consent Form and Authorization for Research:
Name
Version

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NIH Toolbox Norming Adult Consent LA.docx
NIH Toolbox Norming Adult Consent non-LA.docx
NIH Toolbox Norming Assent_13-15Years LA.docx
NIH Toolbox Norming Assent_13-15Years non-LA.docx
NIH Toolbox Norming Assent_7-12Years LA.docx
NIH Toolbox Norming Assent_7-12Years non-LA.docx
NIH Toolbox Norming Parental Consent LA.docx
NIH Toolbox Norming Parental Consent non-LA.docx
NIH Toolbox Pre-testing Adult Consent.docx
NIH Toolbox Pre-testing Assent_13-15Years.docx
NIH Toolbox Pre-testing Assent_7-12Years.docx
NIH Toolbox Pre-testing Parental Consent.docx
Spanish Vocab Adult Consent for calibration_SPA_15Oct10 SVC.docx
Spanish Vocab Assent for calibration_SPA_15Oct10 SVC.docx
Spanish Vocab Parental Consent for calibration_SPA_15Oct10 SVC.docx
Toolbox Adult Consent 09Aug10.doc
Toolbox Adult Consent 09Aug10_SPA_04Oct10.docx
Toolbox Parental Consent 09Aug10.doc
Toolbox Parental Consent 09Aug10_SPA_04Oct10.docx
Toolbox_Assent_13-15Years_09Aug10.doc
Toolbox_Assent_13-15Years_09Aug10_SPA_04Oct10.docx
Toolbox_Assent_7-12Years_09Aug10.doc
Toolbox_Assent_7-12Years_09Aug10_SPA_04Oct10.docx

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Protocol:

Name
Toolbox Protocol for NU-MSS v 10 March 4 2011.docx
Toolbox Protocol for NU-MSS v 10 March 4 2011_clean.docx

Version
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Recruitment Materials:

Name
Attach 68 Respondent Information Packet.docx
NIH Toolbox Re-Contact Form.xlsx
Participant Payment Receipt.doc
Reminder verbiage.docx
Toolbox Screener.docx

Version
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Survey/Questionnaires:

Name
Attach
Attach
Attach
Attach
Attach

Version
1 Automated Audiometry for the NIH Toolbox (AANT)_3-21-11.docx 0.01
10 Pain Assessment Ages 18-85_3-21-11.docx
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11 Sucrose Preference Test_3-21-11.docx
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12 Toolbox Taste Test_3-21-11.docx
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13 Dynamic Visual Acuity (DVA)_3-21-11.docx
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Attach 14 Vision Health-Related Quality of Life Survey_3-21-11.docx
Attach 15 Brief Kinesthesia Test_3-21-11.docx
Attach 16 Pediatric Pain Scale_3-21-11.docx
Attach 17 Tactile Discrimination Test3-21-11.docx
Attach 18 Dimensional Change Card Sort 3-21-11.docx
Attach 19 Bateria III Picture Vocabulary 3-21-11.docx
Attach 2 Hearing Handicap Inventory_3-21-11.docx
Attach 20 Flanker 3-21-11.docx
Attach 21 Imitation Based Assessment of Memory (IBAM) 3-21-11.docx
Attach 22 List Sorting 3-21-11.docx
Attach 23 Oral Symbol Digit Modalities Test 3-21-11.docx
Attach 24 Pattern Comparison 3-21-11.docx
Attach 25 Rey Auditory Verbal Learning Test (RAVLT) 3-21-11.docx
Attach 26 Reading Recognition 3-21-11.docx
Attach 27 Determining Handedness 3-21-11.docx
Attach 27 Vocabulary Comprehension 3-21-11.docx
Attach 29 Spanish Word Accentuation Test 3-21-11.docx
Attach 3 Words-In-Noise Test (WIN)_3-21-11.docx
Attach 30 Instructions for Emotional Health Questionnaire 3-21-11.docx
Attach 31 Emotional Health Questionnaires for Toolbox 3-21-11.xlsx
Attach 32 Emotional Health Questionnaires for Toolshed 3-21-11.xls
Attach 33 9 Hole Pegboard 3-21-11.docx
Attach 35 Endurance 2 Minute Walk Test (2MWT) 3-21-11.docx
Attach 36 Locomotion 4 Meter Walk Test 3-21-11.docx
Attach 37 Grip Strength Dynamometry 3-21-11.docx
Attach 38 Strength Knee Extension 3-21-11.docx
Attach 4 Odor Identification Ages 10-85_3-21-11.docx
Attach 40 Balance Accelerometer Measure (BAM) 3-21-11.docx
Attach 42 Initial Questionnaire - Adult 3-21-11.docx
Attach 43 Initial Questionnaire-Proxy and Child 3-21-11.docx
Attach 44 Additional Somatosensation Questions 3-21-11.docx
Attach 45 Additional Audition Olfaction Taste Questions 3-21-11.docx
Attach 46 Cognition Information Form 3-21-11.docx
Attach 47 Health Care Access and Utilization 3-21-11.docx
Attach 48 Instrumental Activities of Daily Living (IADL) - Adults 3-2111.docx
Attach 49 Applied Cognition - Adult 3-21-11.xlsx
Attach 5 Odor Identification Ages 3-9_3-21-11.docx
Attach 50 Pediatric Perceived Cognitive Function (PCF) - Child 3-2111.docx
Attach 51 Pediatric Perceived Cognitive Function (PCF) - Proxy 3-2111.docx

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Attach 52 PROMIS Pediatric Physical Function Upper Extremity 3-2111.docx
Attach 53 PROMIS Pediatric Physical Function Mobility 3-21-11.docx
Attach 55 Pediatric Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) 3-21-11.docx
Attach 56 PROMIS 29 - Participant 3-21-11.docx
Attach 57 School Performance and Activities 3-21-11.docx
Attach 58 Sociodemographic Form- Parent 3-21-11.docx
Attach 59 Test Anxiety Scale (TAS) 3-21-11.docx
Attach 6 University of Pennsylvania Smell Identification Test (UPSIT)_321-11.docx
Attach 60 Falls Efficacy Scale-International (Short FES-I) 3-21-11.docx
Attach 61 EtOH Questionnaire 3-21-11.docx
Attach 62 Education Adult Self-Report 3-21-11.docx
Attach 63 Education Proxy Report for Children3-21-11.docx
Attach 7 Pain Asssessment Proxy Ages 3-7_3-21-11.docx
Attach 8 Pain Assessment Ages 8-12_3-21-11.docx
Attach 9 Pain Assessment Ages 13-17_3-21-11.docx

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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.

https://www.eirb.northwestern.edu/eIRB/Doc/0/L1OBGTMFERCK74EI330DTAHIC2/fro... 3/31/2011