Att 7_IRB approvals_April 2011

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

MEMORANDUM
______________________________________________________________________________________

To:

Ronny Bell, Ph.D.
PHS - Epidemiology

From:

Chair, IRB # 2
Institutional Review Board

Date:

4/13/2011

Subject:

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

Study Documents:
Protocol Version: SEARCH 3 Protocol; Other Documents: CES-D form, Colorado IRB Approval Letter, 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, Family Medical History form, Food Frequency
Questionnaire, Health Questionnaire - Parent version, Health Questionnaire - Participant version, Initial Participant
Survey - Parent version, Initial Participant Survey - Participant version, 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, Medical Record Validation of Self-Report, Medication Inventory form, Neuropathy
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 Examination form, Quality of Care - Parent version, Quality of Care - Participant
version, Specimen Collection form, Supplemental Questionnaire for age 10 and older, Tanner Stage - Female,
Tanner Stage - Male, Unanticipated Occurrence Condition Reporting form, Unregistration form
The Institutional Review Board (IRB) has approved the above-named protocol and study documents, after review at
a convened meeting on 4/12/2011. A submission requesting renewal together with a summary progress report must
be submitted to the Board at least one month prior to 4/12/2012.
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.

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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.
Federal regulations and Board policy require that you promptly report to the Board for review/approval:
·

Proposed changes in the research activity (e.g., protocol amendments; consent form revision;
advertisements). Changes may not be initiated without IRB review and approval, unless necessary to
eliminate an immediate hazard to subjects.

·

Serious adverse events and unanticipated problems involving risks must be reported to the Board,
institutional officials, FDA, sponsor and other regulatory agencies as required by the protocol, local policy
and state or federal regulation.

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 Hawkins, Ph.D.

2
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

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Institutional Review Board - Federalwide Assurance #00002988
Cincinnati Children's Hospital Medical Center

Date:

3/16/2011 2:03 PM

From:

IRB Committee

To:

Principal Investigator: Lawrence Dolan
Division: Endocrinology

Re:

Study ID: 2011-0407
Study Title: SEARCH for Diabetes in Youth

The above referenced protocol and all applicable additional documentation provided to the CCHMC
IRB were reviewed and APPROVED using an EXPEDITED review procedure in accordance
with 45 CFR 46.110(b)(1)(see below) on 3/16/2011 .
This study will be due for continuing review at least 30 days before: 3/15/2012.
The following documents were reviewed and approved:
Name
CES-D | History
Cohort description 10-17 years | History
Cohort description 5-10 years | History
Cohort description adult | History
Cohort instructions | History
Cohort intro letter | History
cohort lab result description | History
Cohort reminder letter | History
Consent for 2012 visits | History
Consent for Single Follow-up Visit | History
Consent for volunteers | History
Contact information | History
Eating Problems | History
Family conflict | History
Family medical history | History
Food Frequency | History
Health Questionnaire | History
IPS | History
IPS letter | History
IPS thank you letter | History
Low blood sugar | History
Medical record review | History
Medication inventory | History
MNSI | History
PDQ | History
PedsQL - diabetes-specific | History
PedsQL - generic | History
Protocol - version 1 | History
Quality of Care | History
Registry description | History
Registry instructions | History
Registry lab result description | History
Registry reminder letter | History
Result letter - participant | History
Result letter - provider | History

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Supplemental | History
Tanner - female | History
Tanner - male | History
Urine collection instructions | History
Please note the following requirements:
Per 45 CFR 46.116 (21 CFR 50.20) the CCHMC IRB has determined that informed
consent must be obtained from all adult participants and that this consent must be
documented by signature on the IRB approval consent form.
Per 45 CFR 46.408 the CCHMC IRB has determined that at least 1 parent(s) (or guardian)
must give permission for the inclusion of a child in this research and that permission must
be documented by signature on the IRB approved parental permission form.
Per 45 CFR 46.408 the CCHMC IRB has determined that documented assent must also be
obtained from all child participants between 11 and 17 years of age.
Per 45 CFR 164.508 the CCHMC IRB has determined that all adult participants and/or the
legally authorized representative of child participants must provide authorization for the use
and/or disclosure of the protected health information in the conduct of this research.
OTHER APPROVALS: Principal investigators are responsible for assuring final approval from
other applicable review committees and performance sites prior to study initiation. This includes,
but is not limited to, Divisional Scientific Review committee, General Clinical Research Center
(GCRC), Radiation Safety, Institutional Biosafety Committee (IBC), Conflict of Interest (COI)
Committee, and any sites (i.e. schools, hospitals) where the research may be conducted.
Principal investigators are also responsible for obtaining final approval from the FDA and a valid
contract between the sponsor and CCHMC, as applicable. If any of these entities require changes
to the IRB-approved protocol and/or informed consent/assent document(s), the changes must be
submitted to and approved by the IRB prior to implementation.
AMENDMENTS: The principal investigator is responsible for notifying the IRB of any
changes in the protocol, participating investigators, procedures, recruitment, consent
forms, FDA status, or conflicts of interest. Approval is based on the information as
submitted. New procedures cannot be initiated until IRB approval has been given. If you wish to
change any aspect of this study, please submit an Amendment via ePAS to the IRB, providing a
justification for each requested change.
CONTINUING REVIEW: The investigator is responsible for submitting a Continuing Review via
ePAS to the IRB at least 30 days prior to the expiration date listed above. Please note that study
procedures may only continue into the next cycle if the IRB has reviewed and granted reapproval prior to the expiration date.
UNANTICIPATED PROBLEMS: The investigator is responsible for reporting unanticipated
problems promptly to the CCHMC IRB via ePAS according to current CCHMC reporting policy
found on CenterLink.
STUDY COMPLETION: The investigator is responsible for notifying the IRB by submitting a
Request to Close via ePAS when the research, including data analysis, has completed.
If you have any questions about the information in this letter, please contact the Institutional
Review Board office at 513-636-8039.
Thank you for your cooperation during the review process.
Research Categories
4. Collection of data through noninvasive procedures (not involving general
anesthesia or sedation) routinely employed in clinical practice, excluding procedures
involving x-rays or microwaves. Where medical devices are employed, they must be
cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness
of the medical device are not generally eligible for expedited review, including studies of
cleared medical devices for new indications.) Examples: (a) physical sensors that are applied
either to the surface of the body or at a distance and do not involve input of significant
amounts of energy into the subject or an invasion of the subject's privacy; (b) weighing or
testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography,
electroencephalography, thermography, detection of naturally occurring radioactivity,
electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and
echocardiography; (e) moderate exercise, muscular strength testing, body composition

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assessment, and flexibility testing where appropriate given the age, weight, and health of
the individual.
5. Research involving materials (data, documents, records, or specimens) that have
been collected, or will be collected solely for nonresearch purposes (such as medical
treatment or diagnosis). (NOTE: Some research in this category may be exempt from the
HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing
refers only to research that is not exempt.)

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From: IRB [mailto:[email protected]]
Sent: Friday, April 15, 2011 12:44 PM
To: Mayer-Davis, Elizabeth Jane
Cc: Thomas, Joan M; Ruehl, Jennifer
Subject: IRB Notice
A paper copy of the approval memo and any relevant documents are being mailed today.
To: Elizabeth Mayer-Davis
Nutrition CB:7461
From: Public Health-Nursing IRB
Approval Date: 4/13/2011
Expiration Date of Approval: 4/11/2012
RE: Notice of IRB Approval by Full Board Review
Submission Type: Initial
Study #: 10-2341
Study Title: SEARCH for Diabetes in Youth: Carolina Site (SEARCH 3)
Sponsors: Centers for Disease Control and Prevention (CDC); National Institutes of Health (NIH); National
Institute of Diabetes, Digestive and Kidney Diseases
This submission has been approved by the above IRB for the period indicated.
Study Description:
This application includes two distinct aspects of SEARCH 3 (Continuation of SEARCH 2, IRB # 08-0909 and
sustainable surveillance effort, IRB #10-0169.
Purpose: SEARCH for Diabetes in Youth is a multi-center study designed with a two-fold purpose of: (1)
developing a uniform population based approach to finding and understanding rates and types of
diabetes mellitus in youth including the development of a sustainable surveillance effort. (Registry
study) and (2) Monitoring development of complications of diabetes in youth that were previously
identified and participated in a SEARCH study baseline visit (Cohort Study). Participants: Children and
youth from 0-19 years of age with newly diagnosed diabetes living in South Carolina (Registry study) and
individuals diagnosed with diabetes between 2002 and 2008 that previously completed a SEARCH study
baseline visit and have had diabetes for at least five years(Cohort study). Also, for the sustainable
surveillance effort, existing medical records from the UNC system will be used.
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.
This research meets criteria for a waiver of written (signed) consent according to 45 CFR 46.117(c)(2) for
completion of the IPS survey and 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.
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.
Enclosed are stamped copies of approved consent documents and other recruitment materials (when
applicable). You must copy the stamped consent forms for use with subjects unless you have approval to
do otherwise.
You are required to obtain IRB approval for any changes to any aspect of this study before they can be
implemented (use the modification form at ohre.unc.edu/forms). 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 https://irbis.unc.edu/irb.
Researchers are reminded that additional approvals may be needed from relevant "gatekeepers" to
access subjects (e.g., principals, facility directors, healthcare system).
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 40
CFR 26 (EPA), where applicable.
CC: Joan Thomas, Nutrition; Jennifer Ruehl, Nutrition
IRB Informational Message—please do not use email REPLY to this address

 Medical School Institutional Review Board (IRBMED) •
[email protected]

2800 Plymouth Rd., Building 200, Room 2086, Ann Arbor, MI 48109-2800 • phone (734) 763 4768 • fax (734) 763 9603 •

To: Rodica Pop-Busui
From:
There are no items to display
Cc:
Catherine
Mitali
Eva
Rodica

Martin
Mehta
Feldman
Pop-Busui

Subject: Notice of Exemption for [HUM00040643]
SUBMISSION INFORMATION:
Title: SEARCH - CAN READING CENTER
Full Study Title (if applicable): SEARCH for Diabetes in Youth Study
Study eResearch ID: HUM00040643
Date of this Notification from IRB: 8/23/2010 
Date of IRB Exempt Determination: 8/23/2010
UM Federalwide Assurance: FWA00004969 expiring on 11/17/2011 
OHRP IRB Registration Number(s):

IRB EXEMPTION STATUS:
The IRBMED has reviewed the study referenced above and determined that, as currently described, it is exempt from
ongoing IRB review, per the following federal exemption category:
EXEMPTION #4 of the 45 CFR 46.101.(b):
Research involving the collection or study of existing data, documents, records, pathological specimens, or
diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator
in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
Note that the study is considered exempt as long as any changes to the use of human subjects (including their data)
remain within the scope of the exemption category above. Any proposed changes that may exceed the scope of this
category, or the approval conditions of any other non-IRB reviewing committees, must be submitted as an amendment
through eResearch.
Although an exemption determination eliminates the need for ongoing IRB review and approval, you still have an
obligation to understand and abide by generally accepted principles of responsible and ethical conduct of research.
Examples of these principles can be found in the Belmont Report as well as in guidance from professional societies
and scientific organizations.
SUBMITTING AMENDMENTS VIA eRESEARCH:
You can access the online forms for amendments in the eResearch workspace for this exempt study, referenced above.
ACCESSING EXEMPT STUDIES IN eRESEARCH:
https://eresearch.umich.edu/eresearch/Doc/0/LETT6KMRNSP47C44F5TVQA697D/fromString.html[3/18/2011 3:17:16 PM]

Click the "Exempt and Not Regulated" tab in your eResearch home workspace to access this exempt study.

Michael Geisser
Co-chair, IRBMED

John Weg
Co-chair, IRBMED

https://eresearch.umich.edu/eresearch/Doc/0/LETT6KMRNSP47C44F5TVQA697D/fromString.html[3/18/2011 3:17:16 PM]