LOI2-QUEX-8 IRB Approvals

Attachment 1 LOI2-QUEX-8 - IRB Approvals

EXPEDITED – APPROVAL
May 13, 2011

Daniel Messinger, Ph.D.
University of Miami
Department of Psychology
Coral Gables Campus
Coral Gables, FL 33124

HSRO STUDY
NUMBER:
STUDY TITLE:

20110311
NCS Formative Research Project #8 – Development and Validation
of Autism Case Confirmation Approaches for Use in the National
Children’s Study

IRB ACTION
DATE:

5/13/2011

STUDY
APPROVAL
EXPIRES:

5/12/2012

SPONSOR NAME:

NIH

FWA:

FWA00002247

On May 13, 2011, an IRB Designee approved the following items under the expedited review
process. This study has been approved for the inclusion of minors pursuant to 45 CFR 46.404.
This review confirms that the grant application is consistent with the goals of the research
proposed.
APPROVAL INCLUDES:
New Research Protocol

Research Materials (English Versions Only)
•
•
•
•
•
•
•
•
•

Informed Consent Form - Main
Informed Consent Form - Supplemental
Recruitment Flyer (2)
Clinician to Subject Letter
Colleague to Colleague Letter
ASI
STAT-NCS
Recruitment Script
Parent Self Report

NOTE: Translations of IRB approved study documents, including informed consent documents,
into languages other than English must be submitted to HSRO for approval prior to use.
A request to continue this study must be submitted to the HSRO at least 45 days before IRB
approval expires. If this study does not receive continuing IRB approval prior to expiration, all
research activities must cease, and it may be officially suspended or terminated.
Sincerely,
[This is a representation of an electronic record
that was signed electronically and this page is
the manifestation of the electronic signature]
Amanda Coltes-Rojas, MPH, CIP
Director
Regulatory Affairs & Educational Initiatives
/dsp
cc: IRB File

Brittany Lambert

EXPEDITED – APPROVAL
February 16, 2012

Daniel Messinger, Ph.D.
University of Miami
Department of Psychology
Coral Gables Campus
Coral Gables, FL 33124
HSRO
STUDY
NUMBER:
STUDY
TITLE:

20110311
NCS Formative Research Project #8 – Development and Validation of
Autism Case Confirmation Approaches for Use in the National Children’s
Study

IRB
ACTION
DATE:

2/15/2012

STUDY
APPROVAL
EXPIRES:

2/14/2013

Continuing
Report #:

CRR013683

SPONSOR
NAME:

NIH

FWA #:

FWA00002247

On February 15, 2012, an IRB Designee approved the following items under the expedited
review process.
APPROVAL INCLUDES:
Continuing Report (CRR013683)
Research Materials (English Versions Only)

•
•

Informed Consent Form - Main
Informed Consent Form - Supplemental

NOTE: Translations of IRB approved study documents, including informed consent documents,
into languages other than English must be submitted to HSRO for approval prior to use.
A request to continue this study must be submitted to the HSRO at least 45 days before IRB
approval expires. If this study does not receive continuing IRB approval prior to expiration, all
research activities must cease, and it may be officially suspended or terminated.
Sincerely,
[This is a representation of an electronic record
that was signed electronically and this page is
the manifestation of the electronic signature]
Amanda Coltes-Rojas, MPH, CIP
Director
Regulatory Affairs & Educational Initiatives
/dsp
cc:

IRB File
Brittany Lambert

Page 1 of 2

11000 Kinross Avenue, Suite 102
Los Angeles, CA 90095-1694
http://ohrpp.research.ucla.edu
GC-IRB: (310) 825-7122
M-IRB: (310) 825-5344

APPROVAL NOTICE
New Study
DATE:
TO:
FROM:
RE:

8/15/2011
ALICE KUO
PEDIATRICS-ADMINISTRATION
NANCY LEVINE
Chair, NGIRB
IRB#11-002613
NCS Autism Case Confirmation Formative Research Project

The UCLA Institutional Review Board (UCLA IRB) has approved the above-referenced study. The UCLA IRB's
Federalwide Assurance (FWA) with Department of Health and Human Services is FWA00004642 (IRB00000174).
Submission and Review Information
Type of Review

Full Board Review

Approval Date

8/7/2011

Expiration Date of the Study

4/20/2012

Funding Source(s)

1) NIH/NATIONAL INST OF CHILD HEALTH AND
HUMAN DEVELOPMENT
Grant Title: National Children's Study
Grant Number: Contract HHSN267200700017C

Regulatory Determinations

-- Children as Subjects - The UCLA IRB determined that the research meets the
requirements of 45 CFR 46.404 for research involving children as subjects.

Documents Reviewed included, but were not limited to:

Document Name

Document

https://webirb.research.ucla.edu/WEBIRB/Doc/0/U4A4HRVAIFG45D0QFVFUPD7I95/fr... 8/15/2011

Page 2 of 2

NCS_LOI_8_Formative_Research_Consent_Sup_UCLA.doc.pdf
NCS_LOI_8_Formative_Research_Consent_Main_UCLA.doc.pdf
NCS LOI 8 Site Intro Script1.docx.pdf
NCS LOI 8 Site Intro Script1.docx.pdf
recruitment_flyer.pdf

Version #
0.01
0.01
0.01
0.01
0.01

Important Note: Approval by the Institutional Review Board does not, in and of itself, constitute approval for the
implementation of this research. Other UCLA clearances and approvals or other external agency or collaborating
institutional approvals may be required before study activities are initiated. Research undertaken in conjunction
with outside entities, such as drug or device companies, are typically contractual in nature and require an
agreement between the University and the entity.
General Conditions of Approval
As indicated in the PI Assurances as part of the IRB requirements for approval, the PI has ultimate responsibility
for the conduct of the study, the ethical performance of the project, the protection of the rights and welfare of
human subjects, and strict adherence to any stipulations imposed by the IRB.
The PI and study team will comply with all UCLA 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:










Ensuring that the personnel performing the project are qualified, appropriately trained, and will adhere to
the provisions of the approved protocol,
Implementing no changes in the approved protocol or consent process or documents without prior IRB
approval (except in an emergency, if necessary to safeguard the well-being of human subjects and then
notifying the IRB as soon as possible afterwards),
Obtaining the legally effective informed consent from human subjects of their legally responsible
representative, and using only the currently approved consent process and stamped consent documents,
as appropriate, with human subjects,
Reporting serious or unexpected adverse events as well as protocol violations or other incidents related to
the protocol to the IRB according to the OHRPP reporting requirements.
Assuring that adequate resources to protect research participants (i.e., personnel, funding, time, equipment
and space) are in place before implementing the research project, and that the research will stop if
adequate resources become unavailable.
Arranging for a co-investigator to assume direct responsibility of the study if the PI will be unavailable to
direct this research personally, for example, when on sabbatical leave or vacation or other absences.
Either this person is named as co-investigator in this application, or advising IRB via webIRB in advance of
such arrangements.

https://webirb.research.ucla.edu/WEBIRB/Doc/0/U4A4HRVAIFG45D0QFVFUPD7I95/fr... 8/15/2011

Battelle Memorial Institute
100 Capitola Drive, Suite 200
Durham, NC 27713

Federalwide Assurance FWA00004696
Battelle Institutional Review Board: CPHRE Line of Review No.IRB00000284
Page 1 of 3

INSTITUTIONAL REVIEW BOARD NOTICE OF APPROVAL
Principal Investigator/Project Manager :
Proposal/Project Title :
Client/Funding Agency :

Diane Burkom
NCS Formative Research Project #8: Development & Validation of
Autism Case Confirmation Approaches for Use in the NCS
NIH/NICHD

IRB No. :

N/A

Date of Submission to IRB :

Proposal No. :

N/A

Project No. :

6/1/2011

000073905-ACCTMGMT

(including Task Order and/or Delivery Order)

Subcontract to Battelle from

Drexel University

(if applicable)

Subcontract from Battelle to

N/A

(if applicable)

Level of Review
___Expedited 6/8/2011______ (Category/Reason)

Approved as submitted. Minimal risk.

Type of Approval – See Page 2 of 3 for Requirements and Restrictions
Full Study Implementation

_________________________________________________
Signature
Official, Battelle Institutional Review Board, CPHRE Line of Review
__Margaret R. Pennybacker, PhD_____________________
Print or Type Name

__6/8/2011____________
Date

Battelle Memorial Institute
100 Capitola Drive, Suite 200
Durham, NC 27713

Federalwide Assurance FWA00004696
Battelle Institutional Review Board: CPHRE Line of Review No.IRB00000284
Page 2 of 3

Requirements and Restrictions
IRB Requirements: ____________________________________________________.
Per 45 CFR 46.109(e), the IRB has the authority to observe or to have a third party observe
the consent process and the research.
Per 45 CFR 46.113, the IRB has the authority to suspend or terminate approval of research
that is not being conducted in accordance with the IRB’s requirements or that has been
associated with unexpected serious harm to subjects.

Continuing Review/Approval. Federal regulations require that human subjects research
protocols maintain IRB approval for the entire duration of the research study, including data
analysis and report writing. Apply for continuing approval of 000073905 prior
to_6/7/2012_______, the final day of approval.

Approval for Amendments. Seek the IRB’s approval for any proposed amendments/
revisions to the protocol, including changes to study documents and recruiting materials.
Federal regulations require that the IRB re-review and re-approve human subjects research
prior to implementing any proposed amendments or revisions. Complete and submit an
application for amendment to the IRB manager.

Reporting. The following events must always be reported to the IRB:
•

•
•
•
•
•
•
•

•

Unforeseen events (within one (1) hour of discovery). If, during the course of the
research study, there are any unforeseen events (see definition of unforeseen event on
page 3), notify the IRB manager within one (1) hour of discovery, then follow IRB
instructions
Protocol violations that
o Placed a human subject at risk, or
o Were caused by the action or inaction of a researcher
New or changed risks to human subjects, including new findings
Failure to follow regulations or IRB requirements
Unresolved complaint by a human subject
Audit, inspection, or inquiry by a federal agency
Breach of confidentiality
Change to the protocol taken without prior IRB review to eliminate an apparent
immediate hazard to a human subject
Incarceration of a human subject.

Documentation Control Requirements. Study documents and records, e.g., informed
consent documents and data collection instruments, must be maintained in accordance with
established confidentiality measures. Federal regulations require that all documents and
records be retained for at least three (3) years after a study is formally closed. Battelle policy
or client requirements may require a longer retention.
Copy of approved informed consent document(s) on file.

Battelle Memorial Institute
100 Capitola Drive, Suite 200
Durham, NC 27713

Federalwide Assurance FWA00004696
Battelle Institutional Review Board: CPHRE Line of Review No.IRB00000284
Page 3 of 3

Definitions
Expedited Review – Review of proposed research by the IRB chair or a designated voting
member or group of voting members rather than by the entire IRB. Federal regulations at 45
CFR 46.110 permit expedited review for certain kinds of research involving no more than
minimal risk and for minor changes in approved research. Only the IRB can determine if a
proposed research activity meets the requirements for expedited review.
Adverse Event - An event or incident not previously known or not anticipated to result from:
• The interactions or interventions used in the research;
• The collection of privately identifiable information under the research;
• An underlying disease, disorder or condition of a human subject, and/or,
• Other circumstances unrelated to the research or any underlying disease, disorder or
condition of the subject.
Minimal Risk - The probability and magnitude of harm or discomfort anticipated in the research
are not greater in and of themselves than those ordinarily encountered in daily life or during the
performance of routine physical or psychological examinations or tests. Depending upon
applicable regulations, “minimal risk” may be defined differently for minors and other vulnerable
populations.
Nonconformance - A determination that some aspect of a research study has not been
performed in accordance with applicable laws and regulations, ethical standards, Battelle
policies, IRB requirements, or contractual obligations.
Unforeseen Event - An event that was unforeseen or unexpected, was related to the research,
and had the potential to adversely impact a human subject or the conduct of a human subjects
study. Unforeseen event(s) are reported to an IRB via an established reporting process and
may include incidents that could be categorized as: (1) adverse events; (2) unanticipated
problems; or (3) non-conformances.
Unanticipated Problem - An event in a human research study that is not expected given the
nature of the research procedures and the subject population being studied, and suggests that
the research places subjects or others at a greater risk of harm or discomfort related to the
research than was previously known or recognized.