Att 7_IRB approvals

OFFICE OF HUMAN RESEARCH ETHICS
720 Martin Luther King, Jr. Blvd.
Bldg. 385, 2nd Floor
CB #7097
Chapel Hill, NC 27599-7097
(919) 966-3113
Web site: ohre.unc.edu
Federalwide Assurance (FWA) #4801

To: Elizabeth Mayer-Davis
Nutrition Operations

From: Non-Biomedical IRB
Approval Date: 2/08/2017
Expiration Date of Approval: 2/07/2018
RE: Notice of IRB Approval by Expedited Review (under 45 CFR 46.110)
Submission Type: Renewal
Expedited Category: 
Study #: 10-2341
Study Title: SEARCH for Diabetes in Youth: Carolina Site (SEARCH 4)
This submission has been approved by the IRB for the period indicated.
Study Description: 
SEARCH for Diabetes in Youth is an observational multi-center study that has had ongoing data collection
since 2002. This current application delineates work to be completed in SEARCH, Phase 4 (the 4th five year
funding cycle) at the Carolina Site. SEARCH.
First, in the Registry Study, SEARCH will:
• Ascertain newly diagnosed in 2013 and forward incident cases of youth less than 20 years and living in SC
at diagnosis;
• Provide consultation and support to inform development of low-cost sustainable public health surveillance
system;
• Assess mortality among 2002-2015 incident cases (cases previously identified in SEARCH, Phases 1-3)
Secondly, in the Cohort Study, SEARCH will:
• Assess the prevalence and incidence of and risk factors for acute and chronic microvascular and
macrovascular complications of diabetes;
• Determine the degree to which barriers of care, quality of care, and the process of transition from pediatric
to adult care impact disease factors and diabetes-related outcomes;
• Maintain and supplement the previously established SEARCH repository for biological specimens
Thirdly, SEARCH will work with the TraCS Institute and a third-party machine-learning company, CoVar,
to build one or more machine-learning algorithms that allow SEARCH investigators to extract date of
diabetes diagnosis from the full-text clinical notes of (1) patients previously identified in SEARCH, Phase 3
and (2) patients to be identified in the current phase of SEARCH.

Submission Description: 
1. Cohort study: the online survey packet and the paper forms packet have both been updated to reflect some
edits and clarifications.  A summary table of the edits has been added as a separate attachment.  Previous
versions of the cohort survey packets have been replaced with the updated version.
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2. Cohort study: the invitation letter has been updated to include information that someone currently
pregnant must wait to schedule visit until four months after pregnancy has ended.  (This is not a change in
protocol, but was not previously stated in the letter.  We are adding to the letter to let participants who may
be pregnant know that they need to wait to schedule (or reschedule a previously scheduled) visit.)  The visit
instructions were also edited to note this information about pregnancy and that if the participant was
hospitalized for DKA within 4 weeks of their visit, they should call to reschedule.
3.  Registry study:  The visit instruction page was edited to note if the participant was hospitalized with DKA
within 4 weeks of their visit, they should call to reschedule.
These documents will also be submitted to the Greenville Health System IRB for approval for the SC sites. 
They will not be implemented until approved by both IRBs.
Regulatory and other findings:
This research, which involves children, meets criteria at 45 CFR 46.404 and/or 21 CFR 50.51 (research
involving no greater than minimal risk). Permission of one parent or guardian is sufficient. The surveys do
not ask sensitive information and the blood draw and eye photography present minimal risk.
This research meets criteria for a waiver of written (signed) consent according to 45 CFR 46.117(c)(2) for:
(1) completion of the IPS survey; (2) for the sample of cohort participants will complete survey-only data
collection; and (3) for the collection of the overnight urine sample.  Written consent will be collected before
the urine is given to the research staff the next day. 
This research meets criteria for waiver of informed consent for research [45 CFR 46.116(d)] and waiver of
HIPAA authorization [45 CFR 164.512(i)(2)(ii)]  for the case ascertainment and validation portion of the
study.
This approval includes a limited waiver of HIPAA authorization to identify potential subjects for recruitment
into this research study (Registry Study only), as allowed under 45 CFR 164.512. This temporary waiver
provides access to protected health information (PHI) to confirm eligibility and facilitate initial contact, after
which consent and HIPAA authorization will be sought. Access and use is limited to the minimum amount of
PHI necessary to review eligibility criteria and to contact potential subjects.
Human subject interaction/intervention or interaction with identifiable data for SEARCH 4 may not occur
until an updated Certificate of Confidentiality is uploaded through a modification.
The Board agreed that this research involves no more than minimal risk and future reviews may be done on
an expedited basis, under Expedited Review, Category 9.
Social security numbers (SSN) may be collected for this study for tax identification and/or payment
purposes. The subject is required to disclose his/her SSN in order to receive the incentive payment(s).
Investigator’s Responsibilities:
Federal regulations require that all research be reviewed at least annually. It is the Principal Investigator’s
responsibility to submit for renewal and obtain approval before the expiration date. You may not continue
any research activity beyond the expiration date without IRB approval. Failure to receive approval for
continuation before the expiration date will result in automatic termination of the approval for this study on
the expiration date.
If applicable, your approved consent forms and other documents are available online at 
http://apps.research.unc.edu/irb/index.cfm?event=home.dashboard.irbStudyManagement&irb_id=10-2341.
You are required to obtain IRB approval for any changes to any aspect of this study before they can be
implemented. Any unanticipated problem involving risks to subjects or others (including adverse
events reportable under UNC-Chapel Hill policy) should be reported to the IRB using the web portal at 
page 2 of 3

events reportable under UNC-Chapel Hill policy) should be reported to the IRB using the web portal at 
http://irbis.unc.edu. 
The current data security level determination is Level III. Any changes in the data security level need to be
discussed with the relevant IT official. If data security level II and III, consult with your IT official to
develop a data security plan. Data security is ultimately the responsibility of the Principal Investigator.
This study was reviewed in accordance with federal regulations governing human subjects
research, including those found at 45 CFR 46 (Common Rule), 45 CFR 164 (HIPAA), 21 CFR 50 & 56
(FDA), and 40CFR 26 (EPA), where applicable.
CC:
Jennifer Law, Epidemiology Operations
Amy Mottl, Department of Medicine
Emily Pfaff, The North Carolina Translational and Clinical Sciences (TraCS) Institute
Joan Thomas, Nutrition Operations
Katherine Westreich, Medicine-Nephrology

page 3 of 3

February 27, 2017

Bryce A. Nelson, MD, PhD
Attn: Joan Thomas
Children’s Hospital
200 Patewood Drive
Greenville, SC 29605
RE:

IRB File # Pro00010812
Study Title:

SEARCH For Diabetes in Youth – Carolina Center, Phase 4

Items Submitted for IRB Review:

Protocol and Consent Form Continuing Review

Dear Dr. Nelson:
On February 22, 2017, the Institutional Review Board/Committee-B (IRB) of the Greenville Health System reviewed
your research study. Full committee approval of the above-mentioned items was given for one year.
Your study will expire on February 21, 2018. It is the investigator’s responsibility to make sure the proper
reapproval information is submitted to the IRB. This information must be submitted to the IRB in January
2018.
The same requirements as previously outlined for you by the IRB remain in effect as long as the study is ongoing.
Please refer to your initial approval letter for these requirements.
Thank you for your assistance in this matter. If you have any questions, please feel free to call the IRB Office at
(864) 455-4360.
Sincerely,

Robert A. Saul, MD, Chairman
Institutional Review Board/Committee-B
701 Grove Road, ESC Bldg.
Greenville, SC 29605
RAS/gh

Colorado Multiple Institutional Review Board, CB
F490
University of Colorado, Anschutz Medical Campus
13001 E. 17th Place, Building 500, Room N3214
Aurora, Colorado 80045

303.724.1055
303.724.0990
COMIRB Home Page
[email protected]
FWA00005070

[Phone]
[Fax]
[Web]
[E-Mail]
[FWA]

University of Colorado Hospital
Denver Health Medical Center
Veteran's Administration Medical Center
Children's Hospital Colorado
University of Colorado Denver
Colorado Prevention Center

Certificate of Approval
16-May-2016
Investigator:

Dana Dabelea

Subject:

COMIRB Protocol 01-934 Continuing Review

Review Date:

10-May-2016

Effective Date:

10-May-2016

Expiration Date:

09-May-2017

Sponsor(s):

National Institutes of Health~Juvenile Diabetes Foundation~Centers for Disease Control and
Prevention/DHHS~

Title:

SEARCH FOR DIABETES IN YOUTH

Expedited Category:

9

Submission ID: CRV015-1

SUBMISSION DESCRIPTION:
Status: Enrollment continues

Your COMIRB Continuing Review submission CRV015-1 has been APPROVED until the expiration date listed
above. The investigator will need to submit this research for Continuing Review at least 45 days prior to
the expiration date.
Study personnel are approved to conduct the research as described in the documents approved by COMIRB, which are
listed below the REVIEW DETAILS section.
Please carefully review the REVIEW DETAILS section because COMIRB may have made red-line changes (i.e. revisions)
to the submitted documents prior to approving them. The investigator can submit an amendment to revise the documents if
the investigator does not agree with the red-line changes. The REVIEW DETAILS section may also include important
information from the reviewer(s) and COMIRB staff.

COMIRB stamps the approved versions of documents in the top right hand corner. Stamped copies of documents are
available for download through COMIRB’s electronic submission website, eRA(InfoEd).
Click here for instructions on how to retrieve stamped documents.

REVIEW DETAILS:
CRV015-1
The following documents have been reviewed and stamped APPROVED or NOTED as part of this approval:
Continuing review form (CRV015)
Application for protocol review with attachments A, F, H, M, O, P, Q, R, S; v4.27.16
Cohort Assent form; v4, date 1.29.16
Cohort Consent and authorization form; v4, date 4.15.16
Personnel form; updated 4.15.14
Registry Assent form; version 4, date 1.29.16
Registry Consent and authorization form; v4, date 4.15.16
Response Cover letter; dated 4.27.16
Cohort Grant; no version date
SEARCH protocol; version 2, dated 2.11.16
Registry Grant; no version date
Cohort Spanish Assent form; version 1.3, date 3.4.14
Cohort Spanish Consent and authorization form; version 1.3, date 3.4.14
Registry Assent form; v1.4, date 3.4.14
Registry Spanish Consent and authorization form; v1.4, date 4.3.14
Publications:
Yi-Frazier, J., Hilliard, M., Fino, N., Naughton, M., Liese, A., ...Lawrence, J. (2015, October 14). Whose quality of life is it
anyway? Discrepancies between youth and parent health-related quality of life rating in type I and type 2 diabetes. doi
10.1007/s11136-0151158-5.
Shah, A., Dabelea, D., Stafford, J., D'Agostino, R., Mayer-Davis, E., ...Maahs, D. (2015). Change in adiptosity minimally
affects the lipid profile in youth with recent onset type I diabetes. Pediatric Diabetes, 16:280-286. doi 10.1111/pedi.12162.
Chao, L., Beech, B., Crume, T., D'agostino, R., Dabelea, D.,...Merchant, A. (2015). Longitudinal association between
television watching and computer use and risk markers in diabetes in the Search for Diabetes in Youth Study, 16;
382-291. doi: 10.1111/pedi.12163.
Law, J., Stafford., D'Agostino, R. Badaru, A., Crume, T.,...Mayer-Davis, E. (2015). Association of parental history of
diabetes with cardiovascular disease risk factor in children with type 2 diabetes. Journal of Diabetes and Its
Complications, 29; 534-539. http://dx.doi.org/10.1016/j.jdiacomp.2015.02.001.
Abstracts:
Lawrence, J., Hilliard, M., Fino, N., Lang, W., Bell, R., ...Yi-Frazier, J. (2015) Preparation for Transfer from Pediatric to Adult
Care among Adolescents with Type I Diabetes. Diabetes, 64(suppl. 1): A227.
Snyder, L., Stafford, J., Dabelea, D., Divers, J., Imperatore, G. (2015) SEARCH for Diabetes in Youth Study Group.
Socioeconomic, Demographic and Clinical correlates of Poor Glycemic control within Insulin Regimens among Youth with
diabetes, 64(suppl. 1): A670.

If this protocol requires full-board review and includes attachment C and/or D, the PI will be required to complete GCP
training. COMIRB will begin enforcing this new requirement on 9/1/15. It is highly recommended that you complete this

training as soon as possible to prevent delays on approvals after the 9/1/15 deadline.
For the duration of this research the investigator must:
Submit any change in the research design, personnel, and any new or changed study documents (including
new/changed consent forms, questionnaires, advertisements, ect.) to COMIRB and receive approval before
implementing the changes.
Use only a copy of the COMIRB-approved, stamped Consent and/or Assent Form. The investigator bears the
responsibility for obtaining from all subjects "Informed Consent" as required by COMIRB. COMIRB REQUIRES that the
subject be given a copy of the consent and/or assent form after it is signed.
Provide non-English speaking subjects with a certified translation of the approved Consent and/or Assent Form in
the subject's first language or use a Consent Short Form, as approved for the study.
Inform COMIRB immediately of any Unanticipated Problems that are unexpected and related to the study in
accordance with COMIRB Policies and Procedures.
Maintain approval for the research. COMIRB approval is generally given in one year increments, but the period may
be shorter. Research is required to be submitted for continuing review and re-approval at least 45 days prior to the
expiration date. If a study's approval expires, investigators must stop all research activities immediately (including
data analysis) and contact the COMIRB office for guidance.
Remain actively engaged in the conduct of the research. The investigator must ensure that all enrolled participants
are appropriate for the study prior to study procedures beginning. For FDA-regulated research the investigator
must sign the investigator line on the consent form prior to participants receiving study-related interventions.

Information on how to submit changes (amendments) to your study, requests for continuing review, and reports of
unanticipated problems to COMIRB can be found on the COMIRB website http://www.ucdenver.edu/COMIRB.
Contact COMIRB with questions at 303-724-1055 or [email protected].

As part of this review it was determined that for this research:
1. Risks to subjects are minimized.
2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the
knowledge that may reasonably be expected to result.
3. Selection of subjects is equitable.
4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative in
accordance with, and to the extent required by, §46.116.
5. Informed consent will be appropriately documented in accordance with, and to the extent required by, §46.117.
6. The research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
7. There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
8. Appropriate safeguards are in place to protect potentially vulnerable populations from coercion and undue
influence.

Sincerely,
UCD Panel C

Response Accepted
Institutional Review Board

Kaiser Permanente Southern California

June 08, 2016
KPSC Principal Investigator(s)
Dr. Jean M Lawrence, ScD, KPSC - Research & Evaluation
100 S. Los Robles Avenue,
Pasadena, CA 91188
KPSC Co-Investigator(s)
Kristi Reynolds, PhD
Study Title:

Mary Helen Black, PhD

SEARCH for Diabetes in Youth, Phase 3: California Center (#5836)

At its May 17, 2016 meeting, the IRB voted to approve the protocol modification with the following
condition:
 Limit the number of attempted contacts to a total 4 per subject so that subject’s decisions to
participate are made voluntarily in line with the Belmont Report principle of respect. The IRB
determined that an attempted contact is when information is passed to a human subject by the study
team in any format such as letter, email, text, voicemail and a phone call in which the respondent or
a member of the household responds verbally.
On June 1, 2016, the IRB reviewed and accepted the PI response confirming to limit the number of
attempted contacts to no more than 4.
No further IRB action is required.
Below is a summary of the documents fully approved as part of this modification submission.
Title

Version Date

Modifications spreadsheet for Cohort and Registry study

04/07/2016

SEARCH 4 cohort survey Parent 14 - 17 04-01-2016

04/01/2016

SEARCH 4 cohort survey Parent 10 - 13 04-01-2016

04/01/2016

SEARCH 4 cohort survey Young Adult 18 - 25 04-01-2016

04/01/2016

SEARCH 4 cohort survey Teen 14 - 17 04-01-2016

04/01/2016

SEARCH 4 cohort survey Adult 26+ 04-01-2016

04/01/2016

SEARCH 4 cohort survey Child 10 - 13 04-01-2016

04/01/2016

Certificate of Confidentiality DK-16-014

03/25/2016

Cohort Contact Email Script (Parent)

03/28/2016

Cohort Contact Email Script (Young adult)

03/28/2016

Cohort visit invitation letter for participants 18 and older

03/28/2016

Cohort visit invitation letter for Parents

03/28/2016

SEARCH 4 Protocol Version 2 Feb 11 2016

02/11/2016

The IRB approved the revisions to the 1) Registry and Cohort ICF 18+ and 2) Registry and Cohort Parent
Guardian informed consent form(s)
The informed consent form(s) including the HIPAA Authorization section have been finalized and posted
in the iRIS consent form history queue. If you have any questions or need any information regarding the
consent form(s), please contact Daria Diaz at (626) 405-5972 (tie line 8/335-5972).

Sincerely,
Signature applied by Daria Diaz on 06/08/2016
10:14:47 AM PDT
Armida Ayala, MHA, PhD
Director
Human Research Subjects Protection Office
Institutional Review Board

APPROVAL OF SUBMISSION
June 3, 2016
Catherine Pihoker
[email protected]
Dear Dr. Catherine Pihoker:
On 6/3/2016, the IRB reviewed the following submission:
Type of Review:
Title of Study:
Investigator:
Activity ID:
IRB ID:
Funding:

Continuing Review
SEARCH for Diabetes in Youth 4
Catherine Pihoker
CR00000357
PIROSTUDY12074
Name: Centers for Disease Control and Prevention,
Funding Source ID: U18DP006136; Name: National
Institute of Diabetes and Digestive and Kidney
Diseases, Funding Source ID: 1UC4DK108173
Grant ID: None
IND, IDE, or HDE: None
Documents Reviewed: • IPS Information Sheet , Category: Consent Form;
• Registry visit consent, clean, Category: Consent
Form;
• Cohort Survey Cover Letter , Category: Consent
Form;
• Cohort visit consent, clean , Category: Consent
Form;
The IRB approved the Continuing Review from 6/3/2016 to 6/2/2017 inclusive. At least
45 calendar days prior to approval expiration, you are to submit a continuing review with
required explanations. You can submit a continuing review by navigating to the active
study and clicking Create Modification / CR.
If continuing review approval is not granted before the expiration date of 6/2/2017,
approval of this study expires on that date.
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.
Sincerely,
Rosemay Vazeux, MD, CIP, IRB Vice Chair

Page 1 of 1

O f fi ce o f R es earc h
INSTITUTIONAL REVIEW BOARD.

MEMORANDUM
______________________________________________________________________________________

To:

Ralph DAgostino Jr, Ph.D.
Biostatistical Sciences Facult

From:

Chair,
Institutional Review Board

Date:

10/24/2016

Subject:

Human Protocol: IRB00015926
SEARCH for Diabetes in Youth - Phase 3 - Coordinating Center

Study Documents:
Protocol Version: 2015_10_30_SEARCH 4 Protocol_Clean.pdf, 2016_02_11_SEARCH 4 Protocol Version 2
CLEAN.pdf, SEARCH _AIR_protocol_jul2012_changeshighlighted.pdf, SEARCH 3 Protocol 8-2011, SEARCH
AIR _UMD_ Amendment Approval_7_2012.pdf, SEARCH AIR ANCILLARY STUDY PROTOCOL_11_2011,
SEARCH AIR UMD IRB Approval Memo_9_2011, SEARCH EYE_Kidney Ancillary Study Protocol.pdf,
SEARCH_ Harmonization of existing registries of diabetes in youth_Ancillary Study Protocol_7_11_2016.pdf,
SEARCH_AIR_Amendment Application_UMD_7_2012.pdf, SEARCH_Role of epigenetics factors in beta-cell
dysfunction in youth with T1D (Pilot Study)_Ancillary Study Protocol_9_13_2016.pdf; Informed Consent Version:
2015_10_30_SEARCH 4 Cohort Visit Model Consent Template_Clean.docx (approved), 2015_10_30_SEARCH 4
Registry Visit Model Consent Template_Clean.docx (approved), Cohort Consent Template (approved), Registry
Consent Template (approved); Assent Version: 2015_10_30_SEARCH 4 Cohort Visit Model Assent
Template_Clean.docx (approved), 2015_10_30_SEARCH 4 Registry Visit Model Assent Template_Clean.docx
(approved); Other Documents: BROAD_ILLUMINA_SEARCH_MOU_signed.pdf, Cohort Study Recruitment
Brochure (Washington site), Contact Information - Participant, Contact Information Form - Parent version, Diabetes
Eating Problem Survey - age 10 and older, Diabetes Related Family Conflict Survey - Parent version, Diabetes
Related Family Conflict Survey - Participant age 10 and older, Extended Core Information form revised 11-07-11,
Family Medical History form, Food Frequency Questionnaire revised 10-05-11, Health Questionnaire - Parent
version, Health Questionnaire - Participant version, Initial Participant Survey - Parent version revised 11-08-11,
Initial Participant Survey - Participant version revised 11-08-11, Kaiser Permanente IRB Approval Letter, Low
Blood Sugar Survey - Adult age 18 and over, Low Blood Sugar Survey - Child Teen age 10-17 version, Low Blood
Sugar Survey - Parent revised 10-26-11, Medical Record Validation of Self-Report, Medication Inventory form,
Neuropathy form, Participating Relatives form, Pediatric Diabetes Quality of Life - Parent version, Pediatric Quality
of Life - Participant version, PedsQL Child Report (ages 5-7), PedsQL Child Report (ages 5-7) Diabetes module,
PedsQL Child Report (ages 8-12), PedsQL Child Report (ages 8-12) Diabetes module, PedsQL Parent Report for
Children (ages 8-12), PedsQL Parent Report for Children (ages 8-12) Diabetes module, PedsQL Parent Report for
Teens (ages 13-18), PedsQL Parent Report for Teens (ages 13-18) Diabetes module, PedsQL Parent Report for
Toddlers (ages 2-4), PedsQL Parent Report for Toddlers (ages 2-4) Diabetes module, PedsQL Parent Report for
Young Children (ages 5-7), PedsQL Parent Report for Young Children (ages 5-7) Diabetes module, PedsQL Teen
Report (ages 13-18), PedsQL Teen Report (ages 13-18) Diabetes module, PedsQL Young Adult (ages 19 and over),
PedsQL Young Adult (ages 19 and over) Diabetes module, Physical Exam Cohort 11-01-10, Physical Exam
Registry 11-01-10, Quality of Care - Parent version revised 10-26-11, Quality of Care - Participant version revised

M e d i c a l C e n t e r B o u l e va r d , Wi n s t o n - S a l e m , N C 2 7 1 5 7 - 1 0 2 3

( 3 3 6 ) 7 1 6 - 4 5 4 2 / fa x ( 3 3 6 ) 7 1 6 - 4 4 8 0

10-26-11, Rationale and Plan for the SEARCH Central Web-Based Tracking Database and Data Management
System, Registry Study Recruitment Brochure (Washington site), SEARCH 4 Cohort All Sites IRB Approved
Consent Assent.pdf, SEARCH 4 REGISTRY All Sites IRB Approved Consent Assent.pdf, SEARCH AIR_UMD
RIB approval _9_2011, SEARCH DATA SECURITY DOCUMENT_6_24_2015, SEARCH ExemptionRequest__Vanderbuilt.pdf, SEARCH Phase 3 Protocol Section 5A_Case Ascertainment & Data Collection_Registry
CLEAN 083111.pdf, SEARCH Phase 3 Protocol Section 5B_Data Collection_Cohort CLEAN 083111.pdf,
SEARCH_AIR_Ancillary Study Protocol _11_2011, SEARCH_GWAS_dbGaP_Certification Approval
Memos_Combined_7_2014.pdf, SEARCH-T2D GENES Study Agreement, Specimen Collection form revised 1014-11, SphygmoCor form, Supplemental Questionnaire for age 10 and older, Tanner Stage - Female, Tanner Stage Male, Unanticipated Occurrence Condition Reporting form, Unregistration form, Vanderbuilt IRB Approval
Memo_Lucy_D'Agostino_Mcgowan.pdf
This is to confirm for your record that the Institutional Review Board reviewed your progress report and consent
form, containing compounded HIPAA authorization language, if applicable, for the above-named protocol. IRB
approval was activated on 10/24/2016 and will expire on 10/23/2017. If the protocol is to remain active longer, a
written request for renewal, together with a summary progress report, and a copy of the current consent form, if
applicable, should be submitted to the Board at least one month prior to expiration.
This research meets the criteria for a waiver of consent entirely according to 45 CFR 46(d).
This research meets the criteria for a waiver of assent according to 45 CFR 46.116(d).
This research meets the criteria for a waiver of HIPAA authorization according to 45 CFR 164.512.
Based on the information provided, the IRB has determined that HIPAA does not apply to this study.
This research, which involves children, meets the criteria at 45 CFR 46.404 (research involving no greater than
minimal risk). Permission of one parent or guardian is sufficient.
Please provide a final report to the Board when the project is completed and Board approval can be terminated.
This IRB is in compliance with the requirements in Part 56, Subchapter D, Part 312 of the 21 Code of Federal
Regulations published January 27, 1981 and Part 46, Subpart A of 45 CFR published January 26, 1981.

Gregory Kucera, Ph.D.

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M e d i c a l C e n t e r B o u l e va r d , Wi n s t o n - S a l e m , N C 2 7 1 5 7 - 1 0 2 3

( 3 3 6 ) 7 1 6 - 4 5 4 2 / fa x ( 3 3 6 ) 7 1 6 - 4 4 8 0