UCSD IRB Approval Letter

171555

UNIVERSITY OF CALIFORNIA, SAN DIEGO
HUMAN RESEARCH PROTECTIONS PROGRAM

TO:

Dr. Jennifer Wagman

RE:

Project #171555
Addressing the Rise of Congenital Syphilis: Working toward Setting-specific Solutions
among High-RiskPregnant Women

Dear Dr. Wagman:
The above-referenced project was reviewed and approved by one of this institution's Institutional Review
Boards in accordance with the requirements of the Code of Federal Regulations on the Protection of
Human Subjects (45 CFR 46 and 21 CFR 50 and 56), including its relevant Subparts. This approval,
based on the degree of risk, is for 365 days from the date of IRB review and approval unless otherwise
stated in this letter. The regulations require that continuing review be conducted on or before the 1-year
anniversary date of the IRB approval, even though the research activity may not begin until some time
after the IRB has given approval.
The IRB determined that this project presents no more than minimal risk to human subjects in that 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.
Date of IRB review and approval: 10/19/2017
On behalf of the UCSD Institutional Review Boards,

/js
Anthony Magit, M.D.
Director
UCSD Human Research Protections Program
858-246-HRPP (858-246-4777); hrpp@ucsd.edu
Note: IRB approval does not constitute funding or other institutional required approvals. Should your
studies involve other review committees such as Office of Clinical Trials Administration (OCTA), Office
of Coverage Analysis Administration (OCAA), Conflict of Interest (COI), Protocol Review Monitoring
Committee (PRMC), and committees under Environmental Health & Safety (EH&S) such as Institutional
Biosafety Committee (IBC), Human Exposure Committee (HERC), and RSSC (Radiation Safety and
Surveillance Committee), it is the researchers responsibility to ensure that all approvals are in place prior
to conducting research involving human subjects or their related specimens.
Approval release date: 11/27/2017

UCSD HUMAN RESEARCH PROTECTIONS PROGRAM
GENERAL APPROVAL INFORMATION
The information below does not encompass all human subjects protections requirements, however, is
intended to highlight those of significance to ensure awareness by researchers engaged in research
involving human subjects or their related specimens and data.
Approval Letters and Consent Documents
Unless otherwise stated, approval letters will be accompanied by stamped, approved consents. Should a
study be closed to accrual and no consent released as a result, this information will be documented on the
approval letter. Also, any waivers will be documented in the approval letter (such as waiver of
documented consent or waiver of authorization for use of PHI).
The PI must ensure approval is in place from other appropriate review boards (such as Radiation Safety,
Institutional Biosafety Committee, Conflict of Interest, ESCRO, etc.)
If other institutions are involved, the PI must ensure that IRB approvals (or other administrative
approvals) from those sites are secured and forwarded for the study file. In addition, PI’s must ensure that
the clinical trial agreement, as applicable, or other funding (such as a grant) is appropriately in place prior
to conducting any research activities. IRB approval does not constitute funding approval.
Duration of IRB approval
The IRB may grant approval up to 365 days. (See 45 CFR 46.109(d) (DHHS) and 21 CFR 56.109(d)
(FDA)). However, for some studies the IRB may grant approval for a lesser period or a specific number of
subjects to allow for more frequent monitoring. The approval letter or related documentation will indicate
this information.
Because IRB review of research studies must be completed at least annually, investigators should plan
ahead to meet required continuing review dates. Please submit complete continuing review
documentation at least 45 days prior to the expiration date to guard against a lapse in IRB
approval. The signed continuing review facepages and any other required hard copies must be received
by the HRPP office before the continuing review process can begin.
As a courtesy, automated continuing review reminders can be set-up by PIs at various intervals (75 days,
45 days, 30 days, for example) on the website at https://irb.ucsd.edu. However, as these are automated
electronic messages based on data entered, and the HRPP cannot anticipate which type of software
programs (such as spam-blockers or anti-virus software) may block receipt of the messages, PI’s are
required to not rely upon notification, but have internal mechanisms which track continuing review
submission times. Ultimately, it is the PI’s responsibility to initiate a continuing review application,
allowing sufficient time for the review and re-approval process to be completed before the current
approval expires.
Continuing review is required even if no changes are made, or if the only study activity is participant
follow-up, and even if the only study activity is data analysis.

What happens if there is a lapse in IRB approval?
If the IRB has not reviewed and approved a research study by the study expiration date, all research
activities must stop. This includes the following:
All research-related interventions or interactions with currently enrolled subjects (unless the IRB finds
that it is in the best interests of the individual subjects to continue participating in the research
interventions or interactions;*) recruitment and informed consent procedures; and continued collection
and/or analysis of data/information.
*Exception: Research-related interventions or interactions with enrolled subjects may continue if the IRB
determines that stopping the research would jeopardize the rights or welfare of current subjects. The IRB
will decide which subjects should continue receiving the intervention during the lapse in approval. A
request for such an exception must be submitted in writing to the attention of the IRB Chair by the
Principal Investigator. If any project activity—even activity required for participant safety—occurs or
continues after the expiration date, the investigator is out of compliance with both federal regulations and
university policy. Retrospective approval for work done after the expiration date cannot be granted.
Amendment/revision to an IRB approved study
IRB approval is required before implementing any changes in the approved research plan, consent
documents, recruitment materials, or other study-related documents. Please see Amendment Fact Sheet at
http://irb.ucsd.edu/amendmodchg.pdf for submission guidance.
Adverse Event and Unanticipated Problems Reporting
All problems having to do with subject safety must be reported to the IRB within ten working days. All
deaths, whether or not they are directly related to study procedures, must be reported. For adverse events,
please utilize the form found at https://irb.ucsd.edu/UPR_biomedical.doc. For deviations and other
reports, a cover letter and any supplemental information appropriate to the review should be provided.
Please see IRB Guidelines for more information at https://irb.ucsd.edu.
Changes in financial Interest or Conflict of Interest (COI) disclosure
Any changes in the financial relationship between the study sponsor and any of the investigators on the
study and/or any new potential conflicts of interest must be reported immediately to the Independent
Review Committee via the Conflict of Interest Office. If these changes affect the conduct of the study or
result in a change in the required wording of the approved consent form, then these changes must also be
submitted as an amendment request.