B.4 LOI2-BIO-20 IRB Approval Letters

Human Approval Letter
B.4 LOI2-BIO-20 IRB Approval Letter

Page 1 of 1
OMB #: 0925-0647
Expiration Date: 01/31/2015

May 29, 2011

KJERSTI MARIE AAGAARD-TILLERY
BAYLOR COLLEGE OF MEDICINE
OB-GYN: ADMINISTRATIVE

Baylor College of Medicine
Office of Research
One Baylor Plaza, 600D
Houston, Texas 77030
Phone: (713) 798-6970
Fax: (713) 798-6990
Email: [email protected]

H-27393 - BIOSPECIMEN COLLECTION AND ANALYSIS IN THE NATIONAL CHILDRENS STUDY: METAGENOMIC
ASSESSMENT OF THE MICROBIOME
APPROVAL VALID FROM 5/29/2011 TO 5/28/2012
Dear Dr. AAGAARD-TILLERY
The Institutional Review Board for Human Subject Research for Baylor College of Medicine and Affiliated Hospitals (BCM IRB) is
pleased to inform you that the research protocol and consent form(s) named above were approved.
The study may not continue after the approval period without additional IRB review and approval for continuation. You will receive
an email renewal reminder notice prior to study expiration; however, it is your responsibility to assure that this study is not
conducted beyond the expiration date.
Please be aware that only IRB-approved informed consent forms may be used when written informed consent is required.
Any changes in study or informed consent procedure must receive review and approval prior to implementation unless the change
is necessary for the safety of subjects. In addition, you must inform the IRB of adverse events encountered during the study or of
any new and significant information that may impact a research participants' safety or willingness to continue in your study.
The BCM IRB is organized, operates, and is registered with the United States Office for Human Research Protections according to
the regulations codified in the United States Code of Federal Regulations at 45 CFR 46 and 21 CFR 56. The BCM IRB operates
under the BCM Federal Wide Assurance No. 00000286, as well as those of hospitals and institutions affiliated with the College.
Sincerely yours,

GABRIEL HABIB, M.D.
Institutional Review Board for Baylor College of Medicine and Affiliated Hospitals

https://brain.bcm.edu/esp1/reports/Human/Approval.asp?protocol=231864&title_code=0

11/1/2011

Minimal Risk IRB (Health Sciences)
12/6/2011
Submission
2011-0649
ID number:
CONTRIBUTIONS OF THE MATERNAL-FETAL MICROBIOME INTERACTIONS AND
Title:
CIRCULATING FETAL DNA FROM MATERNAL PLASMA AND CERVICAL AND
VAGINAL FLUID - NCS Substudy
Principal
MAUREEN DURKIN
Investigator:
Point-ofMARIE-NOEL SANDOVAL
contact:
IRB Staff
STACI LOWE
Reviewer:
The convened MR IRB conducted a full review of the above-referenced initial
application. The study was approved for the period of with the expiration date of
10/9/2012.
To access the materials approved by the IRB, including any stamped consent forms,
recruitment materials and the approved protocol, if applicable, please log in to your
ARROW account and view the documents tab in the submission's workspace.
If you requested a HIPAA waiver of authorization, altered authorization and/or partial
authorization, please log in to your ARROW account and view the history tab in the
submission’s workspace for approval details.
Prior to starting research activities, please review the Investigator's Responsibility
guidance, which includes a description of IRB requirements for submitting continuing
review progress reports, changes of protocol and reportable events:
http://arrowhelp.hsirbs.wisc.edu/content/investigator-responsibilities.
Please contact the IRB office at 608-263-2362 with general questions. For questions
related to this submission, contact the assigned staff reviewer.