C.1.3 IRB Approval Letters LOI2-BIO-18

OMB#: 0925-0593
EXPIRATION DATE: 07/31/2013

ATTACHMENT C.1.3 IRB APPROVAL LETTERS

IRB ID #:

201010715

To:

Jeffrey Murray

From:

IRB-01
Univ of Iowa,

Re:

National Children's Study Formative Research Project: Placental Study

DHHS Registration # IRB00000099,
DHHS Federalwide Assurance # FWA00003007

Protocol Number:
Protocol Version:
Protocol Date:
Amendment Number/Date(s):

Approval Date:

10/12/10

Next IRB Approval
Due Before:

10/12/11

Type of Application:

Type of Application Review:

New Project
Continuing Review
Modification

Full Board:
Meeting Date:
Expedited

Approved for Populations:
Children
Prisoners
Pregnant Women, Fetuses, Neonates

Exempt
Source of Support:

US Department of Health & Human Services, National Institutes of Health

Investigational New Drug/Biologic Name:
Investigational New Drug/Biologic Number:
Name of Sponsor who holds IND:
Investigational Device Name:
Investigational Device Number:
Sponsor who holds IDE:

This approval has been electronically signed by IRB Chair:
Catherine Woodman, MD
10/12/10 1443

IRB ID#: 201010715 10/12/10 Page 2 of 3

IRB Approval: IRB approval indicates that this project meets the regulatory requirements for the protection
of human subjects. IRB approval does not absolve the principal investigator from complying with other
institutional, collegiate, or departmental policies or procedures.
Agency Notification: If this is a New Project or Continuing Review application and the project is funded by
an external government or non-profit agency, the original HHS 310 form, “Protection of Human Subjects
Assurance Identification/IRB Certification/Declaration of Exemption,” has been forwarded to the UI Division of
Sponsored Programs, 100 Gilmore Hall, for appropriate action. You will receive a signed copy from
Sponsored Programs.
Recruitment/Consent: Your IRB application has been approved for recruitment of subjects not to exceed
the number indicated on your application form. If you are using written informed consent, the IRB-approved
and stamped Informed Consent Document(s) are attached. Please make copies from the attached "masters"
for subjects to sign when agreeing to participate. The original signed Informed Consent Document should be
placed in your research files. A copy of the Informed Consent Document should be given to the subject. (A
copy of the signed Informed Consent Document should be given to the subject if your Consent contains a
HIPAA authorization section.) If hospital/clinic patients are being enrolled, a copy of the signed Informed
Consent Document should be placed in the subject’s chart, unless a Record of Consent form was approved
by the IRB.
Continuing Review: Federal regulations require that the IRB re-approve research projects at intervals
appropriate to the degree of risk, but no less than once per year. This process is called “continuing review.”
Continuing review for non-exempt research is required to occur as long as the research remains active for
long-term follow-up of research subjects, even when the research is permanently closed to enrollment of new
subjects and all subjects have completed all research-related interventions and to occur when the remaining
research activities are limited to collection of private identifiable information. Your project “expires” at 12:01
AM on the date indicated on the preceding page (“Next IRB Approval Due on or Before”). You must obtain
your next IRB approval of this project on or before that expiration date. You are responsible for submitting a
Continuing Review application in sufficient time for approval before the expiration date, however the HSO will
send a reminder notice approximately 60 and 30 days prior to the expiration date.
Modifications: Any change in this research project or materials must be submitted on a Modification
application to the IRB for prior review and approval, except when a change is necessary to eliminate apparent
immediate hazards to subjects. The investigator is required to promptly notify the IRB of any changes made
without IRB approval to eliminate apparent immediate hazards to subjects using the Modification/Update
Form. Modifications requiring the prior review and approval of the IRB include but are not limited to: changing
the protocol or study procedures, changing investigators or funding sources, changing the Informed Consent
Document, increasing the anticipated total number of subjects from what was originally approved, or adding
any new materials (e.g., letters to subjects, ads, questionnaires).
Unanticipated Problems Involving Risks: You must promptly report to the IRB any serious and/or
unexpected adverse experience, as defined in the UI Investigator’s Guide, and any other unanticipated
problems involving risks to subjects or others. The Reportable Events Form (REF) should be used for
reporting to the IRB.
Audits/Record-Keeping: Your research records may be audited at any time during or after the
implementation of your project. Federal and University policies require that all research records be
maintained for a period of three (3) years following the close of the research project. For research that
involves drugs or devices seeking FDA approval, the research records must be kept for a period of three
years after the FDA has taken final action on the marketing application.
Additional Information: Complete information regarding research involving human subjects at The
University of Iowa is available in the “Investigator’s Guide to Human Subjects Research.” Research
investigators are expected to comply with these policies and procedures, and to be familiar with the
University’s Federalwide Assurance, the Belmont Report, 45CFR46, and other applicable regulations prior to

IRB ID#: 201010715 10/12/10 Page 3 of 3

conducting the research. These documents and IRB application and related forms are available on the
Human Subjects Office website or are available by calling 335-6564.

Office of Research/Human Subjects Committee
SAD Room 124
Box 2201 SDSU
Brookings, SD 57007

To:

Natalie Thiex and Bonny Specker, National Children’s Study/E.A. Martin
Program

Date:

November 9, 2010

Project Title: NCS Placental Studies
Approval #:

IRB-1011007-EXP

The committee approved the above referenced activity using expedited procedures as described
in 45 CFR 46.110. The activity was deemed to be no greater than minimal risk, and the
following expedited category from 63 FR 60364-60367 was found to be applicable to your
activity:
(3) Prospective collection of biological specimens for research purposes by noninvasive means.
One-year approval of your project will be dated starting 11/9/10. If you require additional time
to complete your project, please submit a request for extension before 11/8/11. Protocol
changes must be approved by the Committee prior to implementation. Forms may be found on
the Human Subjects web page. If there are any unanticipated problems involving risks to
subjects or others, please contact the SDSU Research Compliance Coordinator. At the end of
the project please inform the committee that your project is complete.
If I can be of further assistance, don’t hesitate to let me know.
Sincerely,
Norm

Norman O. Braaten
SDSU Research Compliance Coordinator

Page 1 of 2

Medical College of Wisconsin /
Froedtert Hospital
Institutional Review Board

To: Randall Kuhlmann
Sara
Szabo, MD PhD
Andrew Webb
Steven Leuthner
Date: October 6, 2010
Re: Study Full
Title:
Study # &
Link:

NCS Project 18, Placental Studies, Pilot Study:
Pilot study for evaluation of feasibility of placental tissue collection for RNA
isolation.
PRO00013497

IRB Approval Date: 10/6/2010
IRB Expiration Date : 10/5/2011
The MCW/FH Institutional Review Board #5 has granted approval for the above-referenced submission
in accordance with 45 CFR 46.111 by expedited review, Category #2b & #5. This letter also includes
approval in accordance with 45 CFR 46 Subpart B (pregnant women, fetuses, and neonates).
The consent form and related HIPAA authorization are effective as of 10/6/2010. Signed consent forms
for each subject must be kept on file as part of the project records.
The items listed below were submitted and reviewed when the IRB approved this submission. Research
must be conducted according to the IRB approved protocol listed below:
Consent Ver. 2
Wisconsin IRB Consortium Project Description and Review Request Form
Protocol dated 7/26/10
The IRB also granted approval of a waiver of HIPAA authorization requirements at 45 CFR 164 and a
waiver of informed consent requirements at 45 CFR 46.116 for the purpose of Records Review for
Potential Subjects.

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Any and all proposed changes to this submission must be reviewed and approved by the IRB prior to
implementation. When it is necessary to eliminate hazards to subjects, changes may be made first. this
should be followed promptly by a protocol deviation and amendment.
In accordance with federal regulations, continuing approval for this submission is required prior to
10/5/2011. The Continuing Progress Report (CPR) must be received by the IRB with enough time to
allow for review and approval prior to the expiration date. Failure to submit the CPR in a timely manner
may result in the expiration of IRB approval.
A Final CPR must be submitted to the IRB within 30 days of when all project activities and data
analysis have been completed.
All Unanticipated Problems Involving Increased Risk of harm to Subjects or Others (UPIRSOs) must be
reported promptly to the MCW/FH IRB according to the IRB Standard Operating Procedures.
If you have any questions, please contact the IRB Coordinator II for this IRB Committee, Dee Burns,
at 414-456-8464 or [email protected].
Sincerely,
Patricia Witt, PhD
IRB Chair
MCW/FH Institutional Review Board #5

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