Tulane IRB Approval Letter

Tulane Human Research Protection Office
Institutional Review Boards
Biomedical
Social Behavioral
FWA00002055

DATE:

January 09, 2018

TO:

Emily Harville

FROM:

Tulane University Biomedical IRB

STUDY TITLE:

Addressing the Rise of Congenital Syphilis

IRB REFERENCE #:

1118637

SUBMISSION TYPE:
ACTION:

Initial Submission
APPROVED

APPROVAL PERIOD:

January 09, 2018 - January 08, 2019

Thank you for your recent New Project submission. The Tulane University Institutional Review Board has
approved your submission.
This approval is based on an appropriate risk/benefit ratio and a study design where the risks have been
minimized. All research must be conducted in accordance with this approved submission.
The following items were included in this submission:
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Consent pregnant.doc (Application Form)
Cover-Sheet-Letter-TemplateIRBChoice_TU_PI.docx (Application Form)
Initial Expedited and Full Board Submission Checklist.doc (Application Form)
Pregnant Protocol-Template.doc (Application Form)
Woman's LOS.pdf (Letter of Support)
Healthy Start Letter of Support - Congenital Syphilis and Mealth care providers 2017.pdf (Letter of
Support)
CDC MOD Flyer.docx (Flyer)
Syphilis Bio Application Part 2 pregnant.docx (Application Form)
Application Part 1 from IRBNet.pdf (Application Form)
Investigator CITI Certificate from IRBNet.pdf (Training Certificate)
PI CITI Certificate from IRBNet.pdf (Training Certificate)
Determination Letter (Decision Letter)
Supplemental Forms (A-O).doc (Application Form)

On November 3, 2017, the Tulane University Biomedical IRB made a determination of Conditions
Required for Approval for the initial submission for this minimal risk study in accordance with 45
CFR 46.110 (b)(1), research category 7.
On January 9, 2018, the Tulane Investigator's response, along with the revised and requested study
documents were reviewed and it was determined that the stipulations have been met.
Criteria for IRB approval of this research is met in accordance with 45 CFR 46.111.
This study is approved for the local enrollment of 40 subjects. An Amendment must be submitted,
reviewed, and approved before exceeding this number. The Tulane University IRB approved and
stamped Consent documents are to be utilized when enrolling subjects.

This study is granted an approval period of January 9, 2018 – January 8, 2019.
Proposed changes to the research study, including enrollment of additional study participants, must be
submitted to the IRB for review and approval prior to implementation, unless a change is necessary to
avoid immediate harm to subjects.
Please remember that informed consent is a process beginning with a description of the study and
assurance of participant understanding followed by a signed consent form. Informed consent must
continue throughout the study with dialogue between the Investigator and research participant. Federal
regulations require each participant to receive a copy of their signed consent form unless this requirement
has been waived by the IRB.
Any unanticipated problems involving risk to subjects or others, deviations from the approved research,
non-compliance, and complaints must be reported to the IRB in accordance with Tulane HRPP policies
and procedures. If this study includes ongoing oversight by a Data Safety Monitoring Board (DSMB) or
other such committee, reports generated by the DSMB or oversight committee must be submitted to the
IRB.
Continuations must be submitted in accordance with Tulane HRPP policies and procedures. 45 CFR
46.109(e) states that an IRB must conduct a continuing review of research at intervals appropriate to the degree
of risk, but not less than one year. The federal regulations provide for no grace period. Failure to obtain
approval for continuation of your study prior to the expiration date will require discontinuation of all
research activities for this study, including enrollment of new subjects.
When all study activities and data analysis have been completed, please notify the IRB within 30 days of
such completion by submitting a Study Closure Form.
This research study will expire on January 08, 2019. As per federal regulations and Tulane HRPP policy,
this study will be administratively closed 30 days after the expiration date, if approval for continuation of
this study has not been granted.
If you have any questions regarding this approval, please contact the HRPO at (504) 988-2665 or
[email protected].
Sincerely,
Tulane University Human Research Protection
Please note that the actual signature by the IRB Chair(s) is not required for this document to be effective
since it is generated by IRBManager pursuant to the IRB Chair's electronic signature and approval. This
process is consistent with Federal Regulations and Tulane standard operating policies with respect to
the IRB and Human Research Protection Office, which consider electronically generated documents as
official notice to sponsors and others of approval, disapproval or other IRB decisions. Please refer to the
HRPO website at http://tulane.edu/asvpr/irb to refer to Tulane's Electronic Signatures and Records Policy.