A.8 LOI3-BIO-0 IRB Approval Letter

A.8 IRB Approval Letter
OMB# 0925-0647 EXPIRATION DATE: 1/31/2015

CHILDREN’S MEMORIAL HOSPITAL
IRB APPROVAL NOTICE
EXPEDITED NEW STUDY

Office of Research
Integrity and Compliance
2300 Children’s Plaza, Box 205

TO:

Jane Holl, MD, MPH

Fax 773.755.6304

PROTOCOL TITLE:

Analysis of Environmental Chemicals in Dried Blood Spots

Affiliated with

IRB #:

2011-14674

APPROVED:

June 8, 2011 – Expedited Review

EXPIRATION OF
IRB APPROVAL:

June 7, 2012

Chicago, Illinois 60614-3394
773.755.6306

Northwestern University’s
Feinberg School of Medicine

This protocol was approved under the following risk/benefit determination as described in
CFR 45 Part 46, Subpart D:
45 CFR §46.404

Research not involving greater than minimal risk.

The Children’s Memorial Hospital Institutional Review Board (CMH IRB) reviewed and approved,
via expedited review as authorized by 45 CFR 46.110 and 21 CFR 56.110 the above-named protocol.
This research was reviewed and approved under expedited review category #2: Collection of
blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not
exceed 550 ml in an 8 week period and collection many not occur more frequently than 2 times per
week; or b) from other adults and children, considering the age, weight, and health of the subjects,
the collection procedure, the amount of blood to be collected, the frequency with which it will be
collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in
an 8 week period and collection may not occur more frequently than 2 times per week.
Federal regulations require that an IRB conduct continuing review of research not less than once per
year, regardless of whether initial approval was via full board or expedited procedures. Please note
the expiration date for your current IRB approval and be aware that you must submit a progress
report for IRB review prior to the expiration in order to obtain IRB approval for the next approval
period. If the current approval expires and you do not obtain approval for another approval period,
research on this study, including subject enrollment, must cease until you regain approval. If you
have questions about your obligations as principal investigator, please contact the ORIC staff as
listed on the ORIC website: http://www.childrensmrc.org/researchadministration/oric/irb2.

Investigator’s Name: Jane Holl, MD
IRB #2011-14674
Page 2 of 2

YOUR OBLIGATIONS AS PRINCIPAL INVESTIGATOR:
As the Principal Investigator, you are ultimately responsible for the conduct of the study, the
protection of the rights and welfare of human subjects and adherence to the CMH IRB policies and
procedures, including the following:
1. Perform the project by qualified personnel according to the approved protocol and ensure that all
individuals who will interact with subjects and/or have access to identifiable research data have
completed the CMH education requirement.
2. Submit the continuing review progress report for review and an approval on an annual basis as per
CMH IRB policies and procedure.
3. Do not implement changes in the approved protocol or consent form(s) without prior CMH IRB
approval (except to eliminate apparent immediate hazards to safeguard the well being of human
subjects).
4. If written consent is required, obtain the legally effective written informed consent from human
subjects or their legally responsible representative using only the currently approved CMH IRB
stamped consent form(s).
5. Follow the CMH IRB Adverse Events, Other Unanticipated Problems, and Violations reporting
criteria.
6. If this study is a sponsored study, you may NOT begin work on this study including subject
enrollment until your contract/award is fully executed. Please contact the Office of Sponsored
Programs for information about the status of the clinical trial agreement or grant award.
7. Follow the CMH policy pertaining to the access of medical records from Health Information
Management.

Best wishes for a successful study.
Sincerely,

Vita Land, MD, MBA, IRB Chair
Institutional Review Board
Children’s Memorial Hospital