B.1.8 LOI3-BIO-02-A Protocol Summary (Excerpted from local IRB Protocol)

Cost-Effective Monitoring of Environmental Chemicals in Breast Milk - [20101027]
ATTACHMENT B.1.8 Exemplar Protocol Summary
(Excerpted from local IRB protocol) LOI3-BIO-02-A and LOI3-BIO-05

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OMB #: 0925-0593
EXPIRATION DATE: 07/31/2013

institutions, there will be no sharing of patient identifying information across sites. The results of this
formative research study will be used to inform the NCS Steering and Protocol Committees as they
move forward to finalize the NCS Protocol anticipated to be conducted by approximately 100 Study
Locations throughout the US, agency funding permitting. The University of Miami is the Study Center
overseeing the four Florida National Children's Study sites, located in Miami-Dade, Hillsborough, Baker,
and Orange counties.

4.3.

If you have cited references above, please attach a bibliography, including title, full
author list, journal, date and pages. This bibliography should include only those
articles referenced above.
Name

Description

Breast Milk Study References

Version
0.01

4a. Description of Study (cont'd)
Rationale and Methodology
4.4. * In non-technical, lay language, describe the study design and all study procedures, in
order of sequence and timing. Include length of subject participation, what tasks are
involved in the study, what tests or procedures subjects will be asked to complete or
undergo, specific measures to be used, etc. If applicable, include frequency of visits,
duration of visits, and study procedure calendar.
This pilot study seeks to develop a reliable cost-effective method for screening of environmental
chemicals in breast milk to facilitate research on the potential effects of such chemicals on infant and
child development in the general population. New mothers who are less than 3 weeks postpartum and
who intend to breast feed for a minimum of 2-4 months will be recruited from the University of Miami
Healthy Start programs for voluntary participation in the project. Subjects will be asked to complete a
questionnaire about their overall health, pregnancy, labor, delivery, and neonatal outcomes, lactation
experience, neighborhood and family residence, occupation, and known exposures to environmental
chemicals such as pesticides and herbicides. During follow-up visits at approximately 1 month, 2
months, 3 months, and 4 months in the home or at the medical center according to individual preference, the
mothers will be asked to update the questionnaire and provide a 3-4 oz. self-expressed (pumped) breast
milk sample for screening for environmental chemicals at the University of Miami laboratory and
express mailing for GC/MS testing at Battelle Laboratories in Columbus, Ohio. Each visit will be
scheduled at the mother's convenience and will last approximately an hour. Incentives ($25 at first visit and
$50 at final visit) will be given upon completion of the survey/questionnaire and provision of the breast milk samples.
4.4.A. Standard Measures: Click the "Add" button to open the search window, then click the "Find"
button to browse and select measures.
Name of Measure
Brief Description
Type of Measure
There are no items to display

NOTE: A copy of the first page of each standard measure is provided in the Library of Standard Measures for
verification. Ensure that the version being used in this study is the same as the version that has been selected.

Upload any questionnaires and/or assessment tools to be used that are not listed
above:
Name
Description
Version
Breast Milk Questionnaire 3-3-11 415pm.doc

0.01

Breast Milk Study 3-3-11 415pm.doc

0.01

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Name

Description

Phone Call Script 3-3-11 415pm.docx

Version
0.01

4.5. Identify and distinguish between those procedures that are standard treatment versus those
that are experimental/research-specific.
Not applicable
The environmental exposure questionnaire and testing of breast milk for chemical exposure or
contamination of the target chemicals are not currently routine or standard of care for clinical diagnostic
or treatment purposes. Thus, the protocol is entirely research-specific.
4.6. Describe any therapeutic alternatives that may exist for the study population.
Not applicable

4b. Description of Study (cont'd)
Risk/Benefit Assessment
4.7. * Describe the nature, degree, and if available, expected frequency of all potential
economic/financial, legal, physical, psychological, social or other risks to which research
participants may be exposed as a result of their participation in this research. If
applicable, please describe the risk of investigational agents or devices (side effects).
There are no anticipated risks for the mother or her infant from participating in this study. This study is
conducted with lactating mothers who are asked to provide a specimen of self-expressed or pumped
breast milk (approximately 3-4 oz)at 1, 2, 3, and 4 months (subset) and to participate in a questionnaire
upon enrollment and during each breast milk collection visit. The specimen and data collection will be
done at the mother's home or during a visit to the medical center, depending on participant
preference. None of the questions on the survey are offensive or intrusive and all information provided
will be fully protected in accord with IRB and HIPPA procedures. Some mothers may experience
psychological stress when they attempt to establish and maintain breastfeeding. Our specially trained
study personnel will be available to augment the services provided by the Healthy Start Program
whenever necessary to encourage the mother who wishes to breastfeed her infant for as long as
possible and recommended by her physician, but study personnel will not discourage a mother who
feels she cannot continue breastfeeding for whatever reason and withdrawal from the study will in no
way affect any routine services, including lactation services, provided by UM physicians or staff. There
are no anticipated risks for the mother or her infant from participating in this study.
4.8. * Are there potential direct benefits of this research to the subjects?
Yes

No

4.8.A. If yes, provide a description of the potential direct benefits and indicate if all, or only
some, of the subject groups may derive this potential benefit.
Participating mothers will receive routine Healthy Start Program lactation instruction and
support individually reinforced in the outpatient setting by this Breast Milk Study's specially
trained personnel who will be available for consultation as needed during the study period. The
mothers will also be given monetary incentives ($25 at first visit and $50 following completion of the study)
as well as transportation, parking, sample pick-up by study personnel, and loaner breast pump if needed to
facilitate compliance with the protocol and study visit timeline.
4.9. * Are there potential benefits of this research to society?
Yes

No

4.9.A. * Please explain:
Societal benefits are anticipated from this pilot study. The current prevalence and extent of
exposure to environmental chemicals which may be ingested or inhaled by mothers and
thereby excreted into her breast milk, is currently unknown. The NIH-funded National

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Children's Study is seeking to refine methodogies for assessing environmental, biological, and
genetic influences on fetal, infant and child development across the lifespan. Breast milk has
been identified as a key biological specimen for investigation in the National Children's Study
and this formative research study seeks to provide evidence that ELISA screening for
environmental chemicals is a reliable, cost-effective method for detection in the NCS as well as
other prevention-intervention research. Such studies will directly benefit society by improving
the ability to identify such exposures and develop strategies to reduce the future risk of
exposure to environmental chemicals of pregnant and postpartum mothers and their infants.
4.10. * Explain why the risk/benefit ratio supports conducting this research.
This study is a no to minimal risk study in which lactating mothers are asked to provide a specimen of
breast milk at 1, 2, 3, and 4 months (subset) and to participate in a questionnaire upon enrollment and
during each breast milk collection visit. The potential benefit of developing and pilot-testing the
survey/questionnaire and the cost-effective ELISA screening method for screening and detection of
environmental chemicals which may contaminate human breast milk far outweighs the inconvenience
to the mothers who choose to participate. The mothers will receive routine Healthy Start Program
lactation instruction and support which will be further enhanced by this Breast Milk Study's specially
trained personnel who will be available for consultation as needed during the study period. The
mothers will also be given monetary incentives ($25 at first visit and $50 following completion of the study),
study-related transportation, parking and loaner breast pump if needed to foster compliance with the study.

4c. Description of Study (cont'd)
Data
4.11. * Describe follow-up, data storage methods, data security, authorized access to records
and record retention, including site name and address.
Hard copies of demographic data (including personal identifiers for data linkage and case management
tracking purposes) and questionnaires (containing only a study ID without personal identifiers) will be
kept in locked files in the administrative offices of the UM Perinatal CARE Program (Clinical Research
Building, Room 1263) or the UM Division of Neonatology (Jackson Memorial Hospital, Room C-740),
depending upon which Healthy Start Program originally enrolled the mother. Only the Co-PIs (Dr.
Bandstra and Dr. Duara) and authorized research personnel will have access to the data linking
personal identifier information with the study IDs and then only on a "need to know" basis for case
management and tracking, data collection, and quality control of computerized data entry.
Computerized data (e.g., questionnaires, ELISA results) for this pilot study will be entered by study ID
only and stored on study-dedicated computers which will be subject to stringent security controls
according to the University of Miami's approved Federal Information Security Management Act (FISMA)
plan for this formative research project and other research being conducted by the University of Miami
National Children's Study Center.
Under this FISMA authorization, there will be 2 dedicated PCs in the Clinical Research Building and
Neonatology offices, respectively. The study will also require a study-dedicated research laptop which
will be connected directly to the ELISA Reader laboratory equipment in the Batchelor Children's
Research Institute Neonatology Research Laboratory. Data will be securely transferred using only
study IDs without subject identifiers to and from the collaborating USF and Battelle Laboratory sites.
4.12. * Support the study validity by describing the statistical design, including quantitative and
qualitative methods used to analyze data.
This pilot study will use standard descriptive (n's, percentages, means and standard deviations) and
comparative statistics (e.g., t-tests, Fisher's exact, Chi-square) for the comparisons of the efficacy and
cost-effectiveness of the ELISA versus GC/MS methods.

Privacy/Confidentiality Agreements
4.13. Describe any privacy agreements or certificates of confidentiality, if applicable.
not applicable

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4d. Description of Study (cont'd)
Deception
4.14.

* Is the use of deception part of the study design?
Yes

No

If yes, please answer the following 3 questions:
4.14.A. Describe in detail the nature of the deception and explain why this is necessary for
the research.
4.14.B.

State how, when, and by whom the research subjects will be debriefed.

4.14.C. Upload a copy of the debriefing script.

5. Study Participants
Per 45 CFR 46, human subjects (participants) means a living individual about whom an investigator (whether
professional or student) conducting research obtains:
1. data through intervention or interaction with the individual; or
2. identifiable private information (i.e. pathological specimens, medical records, etc.)
5.1. * Participant Age:
Check all that
apply

Notes

0-6

Parent Permission/Consent required for each participant

7-17

Parent Permission/Consent & Child Assent required for each participant

18-65

Consent required for each participant unless a waiver of consent is approved by
the IRB

65+

Consent required for each participant unless a waiver of consent is approved by
the IRB

5.2. For the following questions, please use integers for your responses. For any question that is
not applicable, please enter the number 0.
(Do not enter commas, decimal points or special characters)
5.2.A. * Maximum number of subjects in the Protocol to be screened at all sites (regardless
of PI):
200
5.2.B. * Total number of subjects in the Protocol to be studied at all sites(regardless of PI):
120
University of Miami
5.2.C. * Maximum number of subjects to be screened by this PI at UM:
100
* Maximum number of subjects to be enrolled by this PI at UM:
60

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* From the above, how many are expected to complete this study (participate in the
study beyond initial enrollment?
54
Jackson Health Systems
5.2.D. * Maximum number of subjects to be screened by this PI at Jackson Health Systems
(JHS):
0
* Maximum number of subjects to be enrolled by this PI at Jackson Health Systems
(JHS):
0
* From the above, how many are expected to complete this study (participate in the
study beyond initial enrollment)?
0
Miami VA Medical Center
5.2.E. * Maximum number of subjects to be screened by this PI at Miami VA Medical
Center:
0
* Maximum number of subjects to be enrolled by this PI at Miami VA Medical Center:
0
* From the above, how many are expected to complete this study (participate in the
study beyond initial enrollment)?
0

5a. Study Populations
5.3. * Study populations to be included in this study where PI will be conducting research and
those sites where the UM IRB will have oversight responsibility:
Check all that apply
Notes
Normal, healthy volunteers

5.3.A. If other, please specify:

5.3.B. Describe below any additional safeguards that have been included to protect
vulnerable subjects:

5b. Inclusions/Exclusions
5.4. * Is the population being enrolled in this study at high risk for incarceration?
Yes

No

5.4.A. If yes, will the subjects be withdrawn from the study once they are incarcerated?
Yes

No

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5.4.A.(i) If the above answer (question 5.4.A.) is no, describe how
re-contacting/re-consenting, treatment, and/or follow-up will occur:
NOTE: If a subject becomes incarcerated while enrolled in a study, all research interactions and
interventions with that subject, and the obtaining of identifiable private information about the subject,
must cease until the requirements of subpart C have been satisfied with respect to the relevant
protocol.
If notified that a previously enrolled research subject has become a prisoner, the principal investigator
must promptly seek IRB re-review of the protocol in accordance with the requirements of subpart C if
the principal investigator wishes to have the prisoner-subject continue to participate in the research. In
special circumstances in which the principal investigator asserts that it is in the best
interests of the subject to remain in the research study while incarcerated, the IRB
Chairperson may determine that the subject may continue to participate in the research until
the requirements of subpart C are satisfied.

5.5. * What are the criteria for exclusion of participants from the research?
1.) Medical contraindication to breastfeeding (e.g., certain medications, HIV infection).
2.) Mother does not initiate or intend to continue breast feeding for a minimum of 2 months postpartum
3.) Mother's primary language is other than English, Spanish, or Haitian-Creole
4.) Mother does not intend to reside in South Florida (Miami-Dade County or South Broward) for a
minimum of 2 months postpartum

5.6. * Will any population be systematically excluded in this study?
Yes

No

5.6.A. If yes, provide rationale/justification for this exclusion:
It will not be feasible to enroll the occasional mother who may be solely fluent in a language
other than the three major languages spoken in our community. Breastfeeding mothers whose
primary language is English, Spanish, and Haitian-Creole will be screened for enrollment.
Appropriate translations of written consent forms will be used and translators will be used as
needed. Recruitment, case tracking, home visiting, questionnaires, and breast milk sample
collection (including support by lactation nurses) will require in person and telephone
communications between research staff and participating mothers over the course of several
months.

5.7. * What are the criteria for inclusion of participants in the research?
1. Mother of a full-term or premature infant who intends to breastfeed or provide breast milk for her
infant for a minimum of 2 months postpartum.
2. Participant in the UM Healthy Start Lactation Support Program, the UM Starting Early Starting Smart Healthy Start Program, or the UM Jasmine -Healthy Start Program.
3. Mother primarily speaks either English, Spanish, or Haitian-Creole.
4. Mother intends to remain in either Miami-Dade County or South Broward County for a minimum of 2
months postpartum.

5.8. * Will only one group of individuals be systematically selected and recruited for this study
(e.g., welfare patients, racial and/or ethnic minorities, persons confined to institutions or
persons determined to be incapacitated)?
Yes

No

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5.8.A. If yes, please state how this participant group will benefit from the results of the
research and provide the reasons and justifications to target this group:

6. Subject Recruitment
6.1.

* From what sources or by what methods will subjects be recruited?
Check all that apply
Direct contact
Other

6.1.A. If postings within hospital, please indicate name of facility:

6.1.B. If emergency room, please indicate name of facility:

6.1.C.

If other, please specify:
Mothers will be referred from our Healthy Start Programs in the UM Division of Neonatology

6a. Subject Recruitment (cont'd)
6.2. * Provide a step-by-step description of the recruitment procedures used to identify and/or
contact prospective participants:
Mothers will be recruited from our existing University of Miami Healthy Start Programs which provide
case management and multidisciplinary services to mothers and their infants. Healthy Start mothers are
encouraged to provide breastmilk whenever possible as the primary nutrition for their infants and
Healthy Start enhanced services include lactation support for the mothers. Lactating mothers who meet
the minimum eligibility criteria will be referred directly by the Healthy Start staff for participation in the
current Breast Milk Study.
The Breast Milk Study's IRB- and HIPPA-certified research personnel, with translation assistance as
needed, will meet face to face with the mother either in her home or on the medical campus during a
scheduled visit. During this initial visit, eligibility will be confirmed, signed informed consent will be
obtained according to IRB-approved procedures, arrangements for instruction in the proper collection of
the breast milk specimens for this protocol will be made, and the one-month breast milk specimen
collection and pick-up will be scheduled. An enrollment questionnaire will be administered to the mother
to obtain basic demographic information, current and previous pregnancy, labor and delivery
information, lactation experience, current medications, and environmental exposures.

6.2.A. Please upload copies of scripts, recruiting materials, and advertisements:
Name
Description
Version
There are no items to display

NOTE: Any materials that will be given to or seen by potential subjects must be reviewed and
approved by the IRB. This includes assessments, instruments, diaries, questionnaires, and all
screening and recruitment materials, including advertisements, web postings, letters, and

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