Att 7_IRB Approved September 2011

Colorado Multiple Instititutional 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
uchsc.edu/comirb
[email protected]
FWA00005070

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

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

Protocol Amendment Approval
07-Feb-2011
Investigator:

Dana Dabelea

Sponsor(s):

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

Subject:

COMIRB Protocol 01-934 Amendment

Effective Date:

04-Feb-2011

Title:

SEARCH FOR DIABETES IN YOUTH

Amendment Description:
PAM021-1:
Phase 1 of the SEARCH for Diabetes in Youth Study was conducted 2001-2005. The CDC extended the project as SEARCH Phase 2 in 2005-2010.
In October 2010, the CDC awarded the project a grant to continue and expand the work as SEARCH Phase 3 for 2010–2015. This amendment
summarizes the substantive changes in the SEARCH Phase 3 protocol.
Much of the protocol remains identical to Phase 2, however, the changes in study procedures and data collection will be summarized for each of
the following 3 cohorts:
1) Incident cases in years 2010-2014;
2) Prevalent cases in 2009; and
3) Incident cases in years 2002-2006 and 2008.
The estimated completion date for data collection will be extended to September 29, 2015.
See file copy for the protocol changes breakdown.

Sincerely,
UCD Panel C

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
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 Medical School Institutional Review Board (IRBMED) •

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

[email protected]

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]