IRB Approvals

470 Administra on Building
701 20th Street South
Birmingham, AL 35294-0104
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APPROVAL LETTER
TO:

Kimberlin, David Winston

FROM: University of Alabama at Birmingham Ins tu onal Review Board
Federalwide Assurance # FWA00005960
IORG Registra on # IRB00000196 (IRB 01)
IORG Registra on # IRB00000726 (IRB 02)
DATE:

12-Mar-2019

RE:

IRB-300002219
Cross-Sec onal Cohort Study to Determine the Prevalence of Soil Transmi ed
Helminth (STH) Infec ons in School Age Children in a Rural Poor Community in
Southern Alabama

The IRB reviewed and approved the Revision/Amendment submi ed on 12-Feb-2019 for the
above referenced project. The review was conducted in accordance with UAB’s Assurance of
Compliance approved by the Department of Health and Human Services.
Type of Review:
Expedited
Expedited Categories: 2, 3, 7
Determina on:
Approved
Approval Date:
11-Mar-2019
Expira on Date:
19-Nov-2019
The following popula ons are approved for inclusion in this project:
Children – CRL 1
Documents Included in Review:
consent.clean.190211
surveryquest.190228
praf.190211

UNIVERSITY OF MISSISSIPPI MEDICAL CENTER
2500 North State Street
Jackson, Mississippi 39216-4505
Institutional Review Board
Telephone (601) 984-2815
Facsimile (601) 984-2961

DHHS FWA #00003630
IORG #0000043
IRB 1 Registration
#00000061
IRB 2 Registration
#00005033

Approval Notice
Amendment

10/29/2018
Charlotte Hobbs,
Pediatrics
University Of Mississippi Medical Center
2500 North State Street
Jackson, MS 392164505
RE: IRB File #2016-0111
Parasitic infections in children living in Mississippi

Your Amendment was reviewed and approved by the Expedited Review process on 10/29/2018.
You may implement the amendment.
Please note the following information about your approved research protocol:
Protocol Approval Period:
Sponsor:
Approved Enrollment #:
Participant Population:
Performance Sites:

10/29/2018 - 06/04/2019
The University of Mississippi Medical Center
2000
Minors < 18
Adults - Patients
SON ? Mercy Delta Express School Clinics, Friends of
Children of MS, Inc./Ripley-Blackwell Center, University
Hospital and University Physicians - Grants Ferry

Amendment Summary:While the overall objectives and study procedures are not being
altered. The following changes relate to a general expansion of the
project into other areas of Mississippi as well as a refinement of
collection:1. We propose to change the study title from "Parasitic
infections in children living in the Mississippi Delta (Delta Parasite
Project)" to "Parasitic infections in children living in
Mississippi (Mississippi Parasite Project)"2. We propose to
recruit and enroll patients from UMMC Pediatric outpatient clinics
(Children"s of Mississippi) and the School of Nursing/Delta Mercy
Project health fairs3. We propose to increase the number of stools

collected from each subject from 1 to 3 after guidance received from
the Centers for Disease Control and Prevention4. We propose to offer
non-coercive compensation to parents/guardians of those subjects
who complete study-related procedures (return their stool samples)5.
Working with the UMMC School of Population Health, we have added a
more robust community engagement plan to the study.

Documents / Materials:
Type

Description

Version #

Date

Research Protocol

Mississippi Parasite Project v8

8

09/23/2018

Funding proposal/Grant

CDC BAA Sept 2018

1

09/21/2018

Permission Document October 2018 CLEAN

2

10/11/2018

Assent Document

Assent CLEAN Sept 2018

2

09/23/2018

Flyer

Gelp get rid of germs CLEAN

2

10/11/2018

application/Contract
Parental Permission
Document

Review History:
Date

Type

Decision

10/04/2018

Administrative Review

Revisions Required

10/11/2018

Administrative Review

Revisions Required

10/25/2018

Administrative Review

Revisions Required

10/29/2018

Expedited Review

Approved

Please remember to:
- Use the IRB file number (2016-0111) on all documents or correspondence with the IRB
concerning your research protocol.
- Review and comply with all requirements on the enclosure, UMMC Investigator
Responsibilities, Protection of Human Research Participants.
The IRB has the prerogative and authority to ask additional questions, request further
information, require additional revisions, and monitor the conduct of your research and the
consent process.
Please note, if this study involves an intervention (whether or not it involves a drug or device)
you (or the "responsible party") must register the study before enrollment begins and report
results within 12 months of study closure through Clinicaltrials.gov http://www.clinicaltrials.gov/.
Penalties for responsible parties who fail to register applicable clinical studies are significant
and include civil monetary penalties and, for federally-funded studies, withholding or recovery

of grant funds. For additional information please go to http://irb.umc.edu/GuidanceInfo/
ClinTrialRegistry.htm.
We wish you the best as you conduct your research. If you have questions or need additional
information, please contact the Human Research Office at (601) 984-2815.

IRB 2
Enclosure(s): (1) Investigator Responsibilities, Protection of Human Research Participants

UMMC Investigator Responsibilities
Protection of Human Research Participants
The IRB reviews research to ensure that the federal regulations for protecting human research
participants outlined in UMMC policy, the Department of Health and Human Services (DHHS)
regulations (45 CFR 46) and the Food and Drug Administration (FDA) regulations (21 CFR
Parts 50 & 56), as well as other requirements, are met. The University of Mississippi Medical
Center's Federalwide Assurance (FWA), FWA# 00003630, awarded by the Office for Human
Research Protections (OHRP) at DHHS, is a written pledge to follow federal guidelines for
protecting human research participants in accordance with the principles of the Belmont
Report. All investigators must read both the Belmont Report and the UMMC FWA to
understand their responsibilities in conducting research involving human participants.
Both documents are available on the Human Research Office webpage, http://irb.umc.edu/
, and in hard copy by request from the Human Research Office. Some of the responsibilities
investigators have when conducting research involving human participants are listed below.

1. Conducting the Research: You are responsible for making sure that the research is conducted
according to the IRB approved research protocol. You are also responsible for the actions
of the study's co-investigators and research staff.

2. Participant Enrollment: You may not recruit or enroll participants prior to the IRB approval
date or after the expiration date of IRB approval. All recruitment materials for any form of
distribution or media use must be approved by the IRB prior to their use. If you need to recruit
more participants than was noted in your IRB approval letter, you must submit an amendment
requesting an increase in the number of participants.

3. Informed Consent: Informed consent is a process that begins with the initial contact and
ends at some point after the study is complete. You are responsible for the conduct of the
consent process, ensuring that effective informed consent is obtained and documented using
only the IRB-approved and stamped consent document(s), and for ensuring that no human
participants are involved in research prior to obtaining their informed consent. Whoever is
presenting the consent document to the potential participant and conducting the consent
discussion must have all pertinent information at hand, be knowledgeable about the study
and the disease or condition involved, if any, and have the ability and experience to answer
questions regarding the study and any treatment involved. Please give all participants a
signed copy of each consent or assent document they sign, and keep the originals in your
secured research files for at least six (6) years. When appropriate, you should place a copy of
the consent document in the participant's medical record.

4. Continuing Review: The IRB must review and approve all IRB-approved research protocols at
intervals appropriate to the degree of risk, but not less than once per year. There is no grace
period. Prior to the date on which IRB approval of the research expires, the IRB will send
you three reminders to submit a Continuing Review, 90, 60 and 30 days prior to expiration.
Although reminders are sent, it is ultimately your responsibility to submit the renewal in

a timely fashion to ensure that a lapse in IRB approval does not occur. If IRB approval
of your research lapses, you must stop new participant enrollment, and contact the IRB
immediately.

5. Amendments and Revisions: If you wish to amend or change any aspect of your research,
including research design, interventions or procedures, number of participants, participant
population, consent document, instruments, surveys or recruitment and retention material,
you must submit the amendment or revisions to the IRB for review with a Request for
Change. You may not initiate any amendments or changes to your research without first
obtaining IRB review and written approval. The only exception is when the change is
necessary to eliminate apparent immediate hazard to participants. In that case the IRB
should be immediately informed of this necessity, but the change may be implemented before
obtaining IRB approval.

6. Unanticipated Events: All adverse events that are unanticipated (unanticipated means that
the event is serious,unexpected, related or possibly related to participation in the
study and places participants at greater risk of harm than previously recognized) and
serious protocol deviations, must be reported to the IRB within ten (10) business days
of discovery. The only exception to this policy is death - the death of a UMMC research
participant must be reported within 48 hours of discovery. Reportable events should be
submitted to the IRB with the Adverse Event/Unanticipated Problem Report form.
Events that do not meet the definition of an unanticipated problem involving risk to
participants or others, including research related injury occurring at a UMMC performance
site or to a UMMC study participant, participant complaints, problems, minor protocol
deviations and non-compliance with the IRB's requirements for protecting human research
participants should be reported as follows: Minor deviations and problems should be
submitted at the time of continuing review, as instructed on the form. All other events should
be reported in writing via letter or email to the IRB with sufficient detail to allow the reviewer
to understand the problem and any actions taken to prevent it from happening again.

7. Research Record Keeping: At a minimum, you must keep the following research related
records in a secure location for at least six years: the IRB approved research protocol and all
amendments; all versions of the investigator's brochure; all informed consent documents; all
recruiting materials; all renewal applications; all adverse or unanticipated event reports; all
correspondence to and from the IRB; and all raw data.

8. Reports to FDA and Sponsor: When you submit the required annual report to the FDA or you
submit required reports to your sponsor, you must provide a copy of that report to the IRB.
You may submit the report with your IRB continuing review application.

9. Provision of Emergency Medical Care: When a physician provides emergency medical care
to a participant without prior IRB review and approval, to the extent permitted by law, such
activities will not be recognized as research and the data cannot be used in support of the
research.

10. Final Reports: When you have completed the study, (no further participant enrollment,
interactions, interventions or data analysis) or stopped work on it, you must submit a Final
Report to the IRB using the Final Report form.

11. On-Site Evaluations, FDA Inspections, or Audits: If you are notified that your research will
be reviewed or audited by the FDA, OHRP, the sponsor, any other external agency, or any
internal group, you must inform the IRB immediately and submit all audit reports received as
a result of the audit to the IRB.

If you have questions or need assistance, please contact the Human Research Office at 601
984-2815.