Morphine Versus Methadone for Opiate Exposed Infants With Neonatal Abstinence Syndrome
Phase: PHASE4
Conditions: Neonatal Abstinence Syndrome
Sponsor: University of New Mexico

PROTOCOL TITLE:
PROTOCOL TITLE:
Morphine versus Methadone for Opiate Exposed Infants with Neonatal Withdrawal Syndrome: A
pilot study
PRINCIPAL INVESTIGATOR:
Name: Nicole Yonke, MD, MPH
Department of Family Medicine
VERSION NUMBER:
Version 5.0
DATE:
4/9/18
REGULATORY FRAMEWORK:
Please indicate all that apply:
DOD (Department of Defense)
DOE (Department of Energy)
DOJ (Department of Justice)
ED (Department of Education)
EPA (Environmental Protection Agency)
FDA (Food and Drug Administration)
HHS (Department of Health and Human Services)
Other:      
Is this a clinical trial under ICH-GCP E6?    Yes    No
If yes, please confirm that the research team is familiar with and agrees to comply with
the investigator requirements cited in ICH-GCP E6.   Yes    No
ICH-GCP E6 can be accessed by copying and pasting this URL into your browser:
http://www.fda.gov/downloads/Drugs/Guidances/ucm073122.pdf
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Table of Contents
1. Objectives
4
2. Background
4
3. Study Design
5
4. Inclusion and Exclusion Criteria
5
5. Number of Subjects
6
6. Study Timelines
6
7. Study Endpoints
7
8. Research Setting
7
9. Resources Available
8
10.Prior Approvals
9
11.Multi-Site Research
10
12.Study Procedures
11
13.Data Analysis
11
14.Provisions to Monitor the Data to Ensure the Safety of Subjects
11
15.Withdrawal of Subjects
12
16.Data Management/Confidentiality
12
17.Data and Specimen Banking
14
18.Risks to Subjects
15
19.Potential Benefits to Subjects
15
20.Recruitment Methods
16
21.Provisions to Protect the Privacy Interests of Subjects
16
22.Economic Burden to Subjects
16
23.Compensation
18
24.Compensation for Research-Related Injury
18
25.Consent Process
18
26.Documentation of Consent
22
27.Study Test Results/Incidental Findings
22
28.Sharing Study Progress or Results with Subjects
23
29.Inclusion of Vulnerable Populations
23
30.Community-Based Participatory Research
25
31.Research Involving American Indian/Native Populations
25
32.Transnational Research
25
33.Drugs or Devices
26
Checklist Section
28
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1. Objectives
1.1. Describe the purpose, specific aims, or objectives.
1.2. State the hypotheses to be tested.
We propose a pilot randomized controlled trial to evaluate morphine vs methadone treatment of
infants with in-utero opiate exposure. Specifically, length of treatment, need for additional
medication to treat withdrawal, and length of hospital stay will be compared.
2. Background
2.1. Describe the relevant prior experience and gaps in current knowledge.
2.2. Describe any relevant preliminary data.
2.3. Provide the scientific or scholarly background for, rationale for, and significance of the
research based on the existing literature and how will it add to existing knowledge.
Over the last ten years there has been a striking increase in opiate abuse in pregnant women, and
the optimal care for neonatal abstinence syndrome is now an important public health issue.
Neonates exposed to opiates in utero can develop a constellation of withdrawal symptoms known
as neonatal abstinence syndrome (NAS) that includes CNS irritability, gastrointestinal side
effects and autonomic dysfunction1. Infants with NAS are at risk for multiple medical
complications including failure to thrive and seizures, they often require prolonged hospital stays
and account for significant health care costs. From 2009 to 2012 the incidence of NAS increased
from 3.4 to 5.8 per 1000 hospital births, for a total of 21 732 affected infants2. The average length
of stay for infants with NAS is 16.9 days, and admissions for NAS account for an estimated $1.5
billion in hospital charges2. 
Between 21% to 94% of exposed infants develop signs of withdrawal severe enough to warrant
pharmacologic treatment1,5,6. Investigators have recently shown that stringent weaning protocols
decrease neonatal opiate exposure and length of hospital stay3,7. Multiple protocols for opiate
weans exist, including methadone, morphine, and now buprenorphine, however evidence
surrounding the optimal treatment regimen is conflicting. While one study comparing methadone
to morphine for infants with NAS demonstrated no significant difference in length of hospital
stay,3 others have found decreased length of stay with methadone4. These studies have used
different weaning protocols and have not calculated morphine equivalents between study arms,
making direct comparisons between morphine and methadone difficult. 
Methadone has been the standard of care for opioid abuse treatment in pregnancy since the
1970s. At University of New Mexico, infants exposed to opiates including methadone or heroin
in-utero who develop NAS requiring pharmacologic treatment undergo a treatment wean with
methadone, whereas infants exposed to buprenorphine undergo a wean with morphine.  However,
morphine is used frequently to treat neonatal abstinence syndrome among methadone-exposed
infants throughout the US. Anecdotal evidence at our institution suggests that infants treated with
morphine have shorter hospital stays compared to infants treated with methadone.
References
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1. Hudak ML, Tan RC; COMMITTEE ON DRUGS; COMMITTEE ON FETUS AND
NEWBORN; American Academy of Pediatrics. Neonatal drug withdrawal. Pediatrics. 2012
Feb;129(2):e540-60. doi: 10.1542/peds.2011-3212. Epub 2012 Jan 30.
2. Patrick SW, Davis M M , Lehmann C U  and Cooper W O .Increasing incidence and
geographic distribution of neonatal abstinence syndrome: United States 2009 to 2012 Journal of
Perinatology (2015) 35, 650–655; doi:10.1038/jp.2015.36; published online 30 April 2015
3. Hall ES, Wexelblatt SL, Crowley M, et al; OCHNAS Consortium. A multicenter cohort study
of treatments and hospital outcomes in neonatal abstinence syndrome. Pediatrics. 2014;134(2).
Available at: www.pediatrics.org/cgi/ content/full/134/2/e527
4. Brown MS, Hayes MJ, Thornton LM. Methadone versus morphine for treatment of neonatal
abstinence syndrome: a prospective randomized clinical trial. J Perinatol 2015; 35(4): 278–283
5. Ebner N., Rohrmeister K., Winklbaur B., et al: Management of neonatal abstinence syndrome
in neonates born to opioid maintained women. Drug Alcohol Depend 2007; 87: pp. 131-138
6. Logan B.A., Brown M.S., and Hayes M.J.: Neonatal abstinence syndrome: treatment and
pediatric outcomes. Clin Obstet Gynaecol 2013; 56: pp. 186-192
7. Hall ES, Wexelblatt SL, Crowley M, Grow JL, Jasin LR, Klebanoff MA, McClead RE,
Meinzen-Derr J, Mohan VK, Stein H, Walsh MC; OCHNAS Consortium. Implementation of
a Neonatal Abstinence Syndrome Weaning Protocol: A Multicenter Cohort Study. Pediatrics.
2015 Oct;136(4):e803-10. doi: 10.1542/peds.2015-1141. Epub 2015 Sep 14.
3. Study Design
3.1. Describe the study design (e.g., observational; randomized placebo-controlled clinical
trial, etc.)
This study is a pilot randomized controlled clinical trial of morphine versus methadone for the
treatment of neonatal withdrawal syndrome for neonates exposed to opiates other than
buprenorphine in utero.
3.2. Describe blinding, if applicable
Since we are using existing treatment protocols that include different timing intervals of
medication administration between methadone and morphine, neither nursing staff nor
physicians can be blinded.
4. Inclusion and Exclusion Criteria
4.1. Describe how individuals will be screened for eligibility
Initial screening will include all infants with in –utero exposure to opiates other than
buprenorphine, including methadone, heroin, and prescription opiates.  In utero-exposure will be
determined by self-reported opiate use in pregnancy and urine drug screen positive for opiates
and/or methadone on admission to the hospital.
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4.2. Describe the criteria that define who will be included or excluded in your final study
sample.
Infants will be eligible if they are born at UNM Hospital at greater than 34 weeks gestation, and
if their primary in-utero drug exposure was and opiate other than buprenorphine, as evidenced
by maternal history and a maternal or infant urine drug screen positive for methadone and/or
opiates on admission.  Infants will be excluded if they are born prior to 34 weeks, require
neonatal intensive care unit stay greater than 24 hours, have any serious medical comorbidities,
and if the primary substance exposure in-utero was buprenorphine, or was not opiates.
4.3. Indicate specifically whether you will include each of the following special populations:
(You may not include members of the above populations as subjects in your research
unless you indicate this in your inclusion criteria.)
•
Adults unable to consent
•
Individuals who are not yet adults (infants, children, teenagers)
•
Pregnant women
•
Prisoners
Our study population is newborns only.
1.4. Indicate if you excluding any particular populations (e.g., women, children, persons not
fluent in English, a particular racial or ethnic group, etc.) and provide justification
We will exclude infants whose consenting parent or guardian is not fluent in English or
Spanish. Based on our current Milagro clinic population, non-English speaking families are
extremely rare. We will include a Spanish short-consent form in the case of unanticipated
Spanish speaking families.
2. Number of Subjects
2.4. If this is a multicenter study, indicate the total number of subjects to be accrued across
all sites.
N/a
2.5. Indicate the number of subjects to be recruited at this site.
100 infants.  This estimate is based on historical review of the number of infants exposed to
methadone or heroin in utero delivered at UNM per year. We are increasing the recruitment goal
to 100 after finding our overall birth rate is lower and the infant withdrawal rate is lower than
expected due to changes in hospital policies since the withdrawal rate was last calculated (i.e.
rooming-in). The recruitment will take place over 2 years.
2.6. Provide sample size justification
Note 1: When studies involve consent, an individual is considered a research subject once
they have provided consent.  If the research includes screening procedures after consent,
please indicate the number of subjects that need to be recruited and the number that will
actually participate in the research post-screening.
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Note 2: When studies involve the use of human data or specimens, the number should
describe the total number of individuals from whom those data or specimens originated.
Note 3: Over-enrollment (exceeding the numbers described to the IRB) is a protocol
violation.  If you need to include more subjects, a modification must be submitted to and
approved by the IRB prior to doing so.
This pilot study will provide estimates of effect size, and standard deviations for sample size
calculations for a larger RCT.
Using data gathered from births on the Family Maternal Child Health service in 2015, we
estimate approximately 78 newborns with in-utero methadone or heroin exposure per year.
To find a difference of 3 days in length of hospital stay, 272 infants would need to be
recruited, which we predict would take over 3 years. We have found however that our birth
rate is lower than expected and the infant withdrawal rate is also lower than expected. For
this reason, an initial pilot study will be conducted with infants born over 2 years from
approval of the IRB (approximately September 2016- September 2018, 100 infants). This
initial pilot study will enable data to be gathered regarding feasibility and troubleshooting of
the study protocol in preparation for a larger study.
3. Study Timelines
3.4. Describe:
•
The duration of an individual subject’s participation in the research
•
The duration anticipated to enroll all subjects
•
The expected duration for the investigators to complete the study (complete analysis)
Parents or guardians of eligible infants will be approached for enrollment and randomization
within 12 hours of birth. Infants will participate until hospital discharge. Based on our projected
numbers of eligible infants over 1 year, enrollment time for a pilot study would be approximately
1 year, with an additional 6 months for data analysis.
Study Endpoints
3.5. Describe the primary and secondary study endpoints.
3.6. Describe any primary or secondary safety endpoints.
3.7. Describe any exploratory endpoints.
The primary research endpoint is length of hospital stay. Secondary research endpoints include
length of treatment, need for a second treatment agent, need for assisted nutritional support
(including increased kcal requirement, procedures including NG tube placement), need for
additional consults outside the range of traditional complications of NAS, parent satisfaction,
breastfeeding initiation, breastfeeding status at discharge.
There are no safety endpoints because the morphine protocol is already in use for buprenorphine
exposed babies at UNMH and has been proven for safety.
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4. Research Setting
4.4. Describe the sites or locations where your research team will conduct the research.
Participants will be recruited from UNMH during inpatient hospitalization when presenting for
birth and from Milagro prenatal clinic in the third trimester. Participants will primarily be
pooled from births to the patients of the Milagro prenatal substance abuse program, which has
locations currently at the Family Medicine Center, the Southeast Heights Clinic, and the
Addiction and Substance Abuse Program.
4.5. Identify where your research team will identify and recruit potential subjects.
The research team will recruit patients prenatally at the above clinic locations in the third
trimester of pregnancy, and/or within 24 hours of birth on Labor and Delivery, the Mother Baby
Unit, and the Intermediate Care Nursery-3. If parents or guardians are interested in participating,
the infant’s care provider will ask permission to inform the study staff to approach them about
participating in the study.  IRB-approved study staff will approach only those parents or
guardians who give permission to their infant’s care providers. The study team will approach
potential participants in person in the hospital, or on the phone after the potential participant’s
provider has presented the study to the parents or guardians and after they have indicated
willingness to further discuss the study with a research team member. A research assistant will
maintain personal contact with all parents or guardians and a 24-hour number to reach study
personnel with any concerns will be available.
4.6. Identify where research procedures will be performed including any laboratory analytics
Maternal and or infant urine drug screens used to determine study eligibility will be performed at
UNM inpatient laboratory as part of the standard newborn hospitalization protocol.
4.7. Describe the composition and involvement of any community advisory board
N/a
4.8. For research conducted outside of UNM HSC and its affiliates describe:
•
Site-specific regulations or customs affecting the research
•
Local scientific and ethical review structure/requirements (Note: include any
approvals (IRB, facility, or other) with your submission)
n/a
9. Resources Available
9.1. Describe the qualifications of the PI and study staff (e.g., training, experience, oversight)
as required to perform the research. When applicable describe their knowledge of the
local study sites, culture, and society.
Nicole Yonke, MD, MPH (Principle Investigator) is an Assistant Professor/ Attending Physician
in Family Medicine at UNM. She attended medical school and completed her Family Medicine
and Preventive Medicine residencies at Oregon Health Sciences University.  She completed her
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fellowship in Maternal Child Health and joined faculty at UNM in 2013. Her special interests
include women’s health, caring for pregnant women and newborns, women affected by substance
abuse during pregnancy, family planning, and preventive medicine.
Mary Beth Sutter, MD is an Associate Professor/ Attending Physician in the Department of
Family Medicine. She completed her residency in Family Medicine at Memorial Hospital in
Pawtucket, Rhode Island and completed her fellowship in Maternal Child Health at the
University of New Mexico in 2015. Clinically she works with the Maternal Child Health Team,
as well as attending in the Milagro Clinic and the Intermediate Care Nursery-3. Her previous
research includes the introduction and assessment of group prenatal care.
Sherry Weitzen, MD, PhD is an Assistant Professor/ Attending Physician in Family Medicine at
UNM. She graduated from the Sackler School of Medicine in Tel Aviv, and completed her
family medicine residency at UNM. Prior to medical school, she was a public health researcher
at Brown University. She now attends in the Intermediate Care Nursery and in the FOCUS
program.
Sarah Gopman, MD is an Associate Professor/ Attending Physician of Family Medicine at UNM.
She received her medical degrees from the Oregon Health Science University School of
Medicine in Portland in 2000. She graduated from the UNM Family Medicine Residency
Program, and then completed a Maternal and Child Health Fellowship in our department. She
attends in the Milagro clinic and on the Maternal and Child Health Service, as well as in the
Intermediate Care Nursery-3.
Larry Leeman, MD, MPH received his medical degree from University of California, San
Francisco in 1988, completed residency training in Family Medicine at UNM, and an obstetrics
fellowship from the University of Rochester. He directs the Family Medicine Maternal and
Child Health service and fellowship and co-medical director of the UNM Hospital Mother-Baby
Unit, and is Medical Director of the Milagro Program. Areas of research include rural maternity
care, pelvic floor outcomes after childbirth, family planning, and vaginal birth after cesarean
(VBAC).
Ariele Bauers, CNM, is a midwife who works in outpatient Milagro clinics and also provides
newborn and postpartum care on the Family Medicine Maternal Child Health Service. She has
cared for numerous Milagro families through the neonatal withdrawal process in her two years
at UNM.
9.2. When applicable, describe which licensed physicians/providers will be responsible for
medical decision-making and ordering and evaluation of necessary diagnostics and
therapeutics.
Resident and attending physicians currently practicing in the newborn nursery, Mother Baby
Unit, and the ICN-3 will be responsible for medical decision-making and ordering and
evaluation of necessary diagnostics and therapeutics. They will be expected to follow the
already established clinical protocols. The research team will inform the primary medical team
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which opiate (methadone or morphine) will be used to treat infants enrolled in the study at the
time of initiation of therapy.
9.3. Describe other resources available to conduct the research: For example, as
appropriate:
•
Justify the feasibility of recruiting the required number of suitable subjects within the
agreed recruitment period. For example, how many potential subjects do you have
access to? What percentage of those potential subjects do you need to recruit?
As described above in the power calculation, there are approximately 78 newborns a
year on our service with in-utero methadone or heroin exposure. Assuming not all of
these infants would be participants, we estimate that it would be possible to recruit 60
infants for a pilot study within a year. After conducting the study for a year, our
withdrawal and birth rates were lower than expected, therefore we are requesting a
modification to extend the study to 2 years total with approximately 100 recruited
infants.
•
Describe the time that will be devoted to conducting and completing the research.
Recruitment will be on a rolling basis over a year as infants are born. We estimate an
additional 6 months for data analysis. During the study period, time would be spent
conducting consent conversations and collecting data from the electronic medical
record. Once the study is complete, time will be spent analyzing the data for trends.
•
Describe the facilities available to conduct the research.
The primary facility is UNM Hospital.
•
Describe the availability of medical or psychological resources that subjects might
need as a result of an anticipated consequences of the human research.
Assigned social workers are present on Labor and Delivery, Mother Baby Unit, and
ICN-3, and are available to meet with all families. Families also have access to a
community health worker (Michele Wooton) in the Milagro Clinic who helps women
access social services and arrange counseling prenatally and postpartum. A primary
nurse is available to answer questions and concerns regarding infants being treated for
NAS in all of the hospital units.
•
Describe the process to ensure that all persons assisting with the research are
adequately informed about the protocol, the research procedures, and their duties and
functions.
Core research staff will meet to discuss the protocol prior to study initiation. The
protocol will also be presented at a department-wide continuing medical education
conferences (Family Medicine Resident School, Pediatrics Resident School) so that
resident physicians are adequately informed about the protocol, research procedures
and their duties. During many weeks core research staff will be attending physicians
on the Maternal Child Health Service, Newborn Nursery service or ICN-3 and will be
caring for the patients involved in the study. During weeks in which other physicians
are attending on these services, core research staff will reach out to supervising
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physicians on these services to discuss any potential issues that may arise via email or
in person meeting.
•
If CTSC resources are being accessed, the signed CTSC resources attachment must be
uploaded on the CTSC Submission page in Click.
10. Prior Approvals
1.1. Describe any approvals that will be obtained prior to commencing the research. (e.g.,
school, external site. funding agency, laboratory, radiation safety, or biosafety
approval.)
1.2. Upload the required Departmental Review Form signed by your Department Chair (or
authorized designee if the PI is the Department Chair) into Click under “supporting
documents.”
1.3. If a study includes ionizing radiation, the Radiation Safety Attachment (HUS-FORM_1)
must be uploaded (attached) in Click with your submission.  The consent should include
radiation exposure information in the Risks section.
1.4. If applicable to the study, include the signed “Biological Specimens” and/or “Drug
Attachment” in Click with your submission.
2. Multi-Site Research
1.1. If this is a multi-site study where the UNM HSC PI is the lead investigator, or UNM
HSC is the coordinating site, describe the processes to ensure communication among
sites, such as:
•
All sites have the most current version of the protocol, consent document, and HIPAA
authorization.
•
All required approvals have been obtained at each site (including approval by the
site’s IRB of record).
•
All modifications have been communicated to sites, and approved (including approval
by the site’s IRB of record) before the modification is implemented.
•
All engaged participating sites will safeguard data as required by local information
security policies.
•
All local site investigators will conduct the study appropriately.
•
All non-compliance with the study protocol or applicable requirements will reported
in accordance with local policy.
1.2. Describe the method for communicating to engaged participating sites:
•
Adverse events
•
Problems
•
Interim results
•
Data and safety monitoring reports
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•
The closure of a study
1.3. If the UNM HSC investigator is serving as the “sponsor-investigator” of a
FDA-regulated trial, describe how sponsor responsibilities will be fulfilled, including,
but not limited to:
•
Trial Monitoring
•
Investigational Product Accountability
•
Safety and other interim reporting to investigators and FDA
•
Unanticipated Problem reporting to investigators, IRBs, and FDA
This is not a multi-site study.
12. Study Procedures
1.2. Describe, in chronological order, all research procedures and interventions being
performed and when they are performed. Include:
•
Each specific intervention, procedure, examination, imaging, laboratory test, etc. that
subjects will undergo for the purposes of the research and the purpose of it.
•
Each drug, biologic, device, or other such product used in the research, the purpose,
and the regulatory status (e.g., investigational, marketed – on label, marketed – off
label, etc.)
•
Each survey, questionnaire, interview, focus group, etc., that subjects will be asked to
complete or participate in for the research and the purpose of it.
•
Each data source that will be used to gather information about subjects and the
purpose of it (confidentiality will be addressed later.
•
Indicate whether subjects would already be expected to undergo any of the
procedures for clinical, diagnostic, or other non-research purposes
•
Include all referenced study instruments, such as questionnaires, scripts, diaries, and
data collection forms with your submission as separate attachments.
At the first clinic visit or at presentation to OB Triage for opiate replacement therapy, clinicians
routinely discuss hospital policy regarding NAS treatment for all women requesting treatment for
opiate dependence in pregnancy.
When women are admitted to Labor and Delivery and/or up to 12 hours postpartum, research
staff will approach patients about study enrollment. Women will be approached for study
enrollment if their medication list on admission includes methadone, if they self-report
methadone use prenatally, if their urine drug screen is positive for methadone and/or opiates on
admission and is negative for buprenorphine.
Research staff will use a standardized script at enrollment (Attachment: Consent script.)
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If women choose to enroll in the study, and their infants require treatment for NAS, their infants
will be randomized and assigned a study number for treatment using the methadone or morphine
protocols at the time treatment is required (Attachment: NICU NAS pharmacy protocol) We are
choosing to consent more parents or guardians of infants than will ultimately participate fully in
the study because we know that about 75% of infants exposed to opiates other than
buprenorphine will require medications for withdrawal, and it is possible that the time for
initiation of medication may be after hours. Therefore the consent process occurs at a
non-stressful time for parents/ guardians, and the primary medical team for the infant can quickly
initiate therapy when needed.
All infants will be monitored for signs of withdrawal using the standard UNM NAS scoring
protocol (Attachment: NICU NAS pharmacy protocol). Standard of care at UNM is to treat
infants exposed to methadone or heroin in-utero with methadone if they require pharmacologic
therapy for NAS, therefore treatment will not be withheld if they choose not to enroll in the
study. Standard of care is also to obtain a urine drug screen on all infants with reported exposure
to opiates in pregnancy. Enrolled patients will thus undergo routine urine drug screening. The
only difference from standard care with regards to the study protocol is the treatment of half of
the methadone or heroin exposed infants with morphine. The morphine protocol is proven for
safety and efficacy currently in buprenorphine exposed infants at the University of New Mexico,
and for all opiate exposed infants in many other institutions.
Randomization will occur by a stratified method in groups of six to ten participants to attempt to
control for prenatal exposure (heroin or methadone).
Infants randomized to receive methadone will receive treatment using our standard Methadone
Withdrawal Protocol (Attachment: NICU NAS pharmacy protocol).
Infants randomized to receive morphine will receive the drug using the standard Morphine
Withdrawal Protocol (Attachment: NICU NAS pharmacy protocol).
If at any time in the study, infants require transfer to higher level of care in the Neonatal
Intensive Care Unit (excluding an initial 24 hour transition period after birth), they will become
excluded from the study and data collection on these infants will stop. These infants will
continue to receive the standard of care therapy as determined by the Neonatal ICU team. If
infants require transfer of care to the Intermediate Care Nursery-3 from Mother Baby Unit or
Carrie Tingley Inpatient Unit, they will continue to be enrolled in the study and data collection
will continue until hospital discharge. In our current experience, the number of infants needing
transfer is minimal, and in most cases involves transfer from a floor unit to the ICN-3. It is very
rare to require transfer to the NICU for neonatal abstinence syndrome after treatment has been
initiated.  Infants requiring initial NICU admission for less than 24 hours for a non-withdrawal
related reason (i.e. cardio/respiratory transition related to birth, hypoglycemia related to maternal
diabetes, etc) will be included in the study if they are able to transition to the ICN-3 or Newborn
Nursery within 24 hours after birth.
Physicians and nurses cannot feasibly be blinded to the study drug due to differences in drug
administration times for methadone vs morphine as described in the protocols above.
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Newborn outcomes, including length of hospital stay, length of treatment (defined as number of
days on opiate replacement therapy) will all be collected through the electronic medical record
and recorded in a password protected database. Please see the attached data collection form for
all outcomes.
At hospital discharge, parents will be asked to complete the HCAHPS patient satisfaction tool,
which is a standard, validated instrument of hospital satisfaction (Attachment: HCAHPS tool).
13. Data Analysis
1.3. Describe the data analysis plan, including any statistical procedures.
1.4. Provide a power analysis
Data will be analyzed using STATA 13.0.  Continuous variables will summarized as means or
medians.  Differences in maternal and neonatal characteristics between methadone and morphine
groups will be compared using bivariate analyses.  Length of stay will be summarized as mean
and median, and the length of stay will be compared between the morphine and methadone group
using parametric and non-parametric methods.  Multivariable regression analyses will be used to
estimate the effect of morphine versus methadone on length of stay, controlling for pretreatment
differences in maternal and neonatal characteristics between treatment group.
Based on obtained sample size, and difference in length of stay between groups, the standard
deviation of the difference, and type I error set at 0.05, we will determine the power of the
difference estimate.  These statistics will be used for sample size determination for planning of
future studies.
2. Provisions to Monitor the Data to Ensure the Safety of Subjects
This section is required when research involves more than Minimal Risk to subjects. Describe:
2.1. The entity (e.g., DMC, DSMB) or individuals (e.g., medical monitor) who will perform
data and safety monitoring.  Describe whether they are independent of or affiliated with
the sponsor or investigator.  If a DMC or DSMB is planned, describe the composition of
the committee or board. Generally, a DSMB or DMC should be composed of experts in
all scientific disciplines needed to analyze and interpret the data (e.g., epidemiologists,
biostatisticians, subject matter experts).
2.2. The safety information that will be collected and monitored.
2.3. The frequency or periodicity of review of data, such as specified points in time or after a
specific number of participants have been enrolled.
2.4. The plans for review of scientific literature and data from other sources that may inform
the safety or conduct of the study.
2.5. The procedures for analysis and interpretation of the safety data.
2.6. The conditions that would trigger a suspension or termination of the research (i.e.,
stopping rules), if appropriate.
2.7. The plan for reporting findings to the sponsor, investigators, and HRRC.
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A Data and Safety Monitoring Plan will be developed and will be led by Dr. Andrew Hsi at the
University of New Mexico. Dr. Hsi is an expert in the field of neonatal abstinence syndrome. Dr.
Hsi will monitor the study approximately every 3 months.  The report on the Data and Safety
Monitoring Plan at Continuing Review will include enrollment and dropout rates, protocol
deviations, review of subject symptoms, and preliminary analysis of the primary outcome
(newborn length of stay.)
3. Withdrawal of Subjects
3.1. Describe any anticipated circumstances under which subjects may be withdrawn from
the research without their consent.
Infants will be withdrawn if they develop a serious medical comorbidity (eg
intubation/ventilation, serious allergic reaction) or require transfer to the neonatal
intensive care unit.
3.2. Describe any procedures for orderly termination/safe withdrawal (e.g., tapering of
meds, physical exams, laboratory or other tests, etc.).
This is not applicable to our study. If an infant is withdrawn from the study voluntarily
or for the above reasons, they will continue to receive the standard of care therapy but
data collection will stop.
3.3. Describe any procedures for partial withdrawal (e.g., from procedures but allowing
continued data collection by record review, phone contact, etc.).
This is not applicable to our study. If an infant is withdrawn from the study voluntarily or for
the above reasons, they will continue to receive the standard of care therapy but data
collection will stop.
3.4. Describe the disposition of existing data/specimens when a subject withdraws.
Describe any restrictions on a subject’s ability to withdraw any already gathered data
or specimens (e.g., unable to retrieve because it has been stripped of identifiers and no
code exists to allow re-linking).  (Note: FDA requires that existing data be maintained
for studies subject to FDA oversight.)
If an infant is withdrawn from the study, all of the data related to that individual will be
discarded. Data collection will occur upon hospital discharge of the infant, therefore
there is not a risk of not being able to retrieve data.
3.5. Describe withdrawal procedures and any limitations in the consent document.
Please see the consent document for specific information (Attachment 4.)
4. Data Management/Confidentiality
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4.1. Indicate how the research team is permitted to access any sources of information about
the subjects. Note whether the research requires the access, use, or disclosure of direct
identifiers (e.g., name, medical record number, etc.)
The research team will access data from infants’ medical record through password protected
Powerchart access, and enter data into a password-protected database.
4.2. Note whether the research requires the access, use, or disclosure of Protected Health
Information.
The research team will have access to protected health information through Powerchart.
4.3. Note whether the data includes information that may be considered sensitive or require
additional protections such as HIV, genetic test results, mental health information,
substance abuse information, criminal records, etc.
Mother’s history of substance abuse will be collected and is a requirement for study enrollment.
1.1.
Indicate whether a Certificate of Confidentiality will be used to protect data from
forced release (e.g., subpoena) and whether the certificate is in place or will be
applied for once IRB approval is in place.  More information on Certificates of
Confidentiality is available here: http://grants.nih.gov/grants/policy/coc/index.htm
A certificate of confidentiality will be obtained once IRB approval is in place through the
National Institute on Drug Abuse regarding the mother’s substance abuse history.
4.4. Describe the steps that will be taken secure the data (e.g., training, authorization of
access, password protection, encryption, physical controls, certificates of
confidentiality, and separation of identifiers and data) during storage, use, transmission
and transport.
All study documents will be stored in a locked filing cabinet in the principal investigator’s office.
Electronic data will be stored on a secure server at the University of New Mexico Health
Sciences Center used to repose data entered using the REDCap database platform. No data will
be stored on a laptop computer or on any thumb drive.
4.5. If data will be coded, describe the nature of the code and mechanisms that will be used
to protect the code (e.g., secure storage, limited access, separate location from research
data).
Identifying data will be removed after data collection and referable only by a study number. The
primary investigator will keep the code connecting the data and the participant in a locked office.
All study records will be kept for three years from the start of the study, de-identified, on
password protected computers in a locked office.
The study’s link between participant and study number will be kept separate from data and
specimens, and the link will be destroyed when the study is closed through the HRPO.
4.6. Describe any procedures that will be used for quality control of collected data.
Approximately every 3 months, collected data will be randomly re-inspected by an additional
member of the study team to ensure quality control.
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4.7. If data will be transferred or transmitted to outside locations or entities, describe:
•
What information will be included in that data or associated with the specimens?
•
Where and how data or specimens will be stored?
•
How long the data or specimens will be stored?
•
Who will have access to the data or specimens?
•
Who is responsible for receipt or transmission of the data or specimens?
•
How data and specimens will be transported?
N/A, data will not be transferred to outside locations or entities.
1.10. Describe if data will be collected, transmitted, and/or stored via the internet, the
identifiability of the data, and the security measures that will be employed to protect it.
Data will be collected, transmitted and stored via the intranet. The data will be
de-identified upon collection from the electronic medical record. The data will be stored
only on a shared protected drive on the intranet.
1.1.
Describe if data will be collected by audio or video recording, how the recordings
will be secured, whether and when recordings will be transcribed, if the transcription
will include identifiers, if, when, and how the recordings will be deleted.  Describe if
the subjects will have the opportunity to review the recordings and request full or
partial deletion. If the recordings may include persons other than the subjects,
describe how this will be managed.
N/A
1.2.
Describe if the data will include photographs, what will be included in the
photographs, and how the photographs will be secured.  Describe if subjects will have
the opportunity to review the photographs and request destruction.  If the
photographs may include persons other than the subjects, describe how this will be
managed.
N/A
2. Data and Specimen Banking
4.8. If data or specimens will be banked or archived locally for future use, provide the name
and IRB number of the repository that they will be deposited into.  Describe exactly
what data or specimens will be banked and for what purposes, and whether the data or
specimens will include identifiers, be coded, or be fully stripped of all identifiers with
no code or key that would allow relinking.  Be certain to describe the banking in the
primary consent.  A separate consent and authorization, if applicable, will be necessary
for the banking activity itself and is typically provided by the repository.  If you need to
establish a repository for the purposes of banking or archiving data or specimens, a
separate submission for the repository is needed as this is considered to be a distinct
research activity under the regulations.
N/A
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4.9. If this is a multi-center study, and/or if data or specimens will be banked or archived
elsewhere, identify who the holder of the data or specimens will be, exactly what data
or specimens will be banked and for what purposes, and whether the data or specimens
will include identifiers, be coded, or be fully stripped of identifiers with no code or key
that would allow relinking.  A Materials Transfer or other agreement may be necessary,
please consult with the HSC Sponsored Projects Office at 505-272-6264 or by email at
hsc-preaward@salud.unm.edu. Material Transfer Agreement procedures may be found
at
http://hsc.unm.edu/financialservices/preaward/ancillary-agreements/material-transfer-
agreements/procedures.html.   Be certain to describe the banking in the consent and
authorization, using opt-in procedures, and the procedures for subjects to request
withdrawal of their data or specimens and any limitations on their ability to do so.
N/A
5. Risks to Subjects
5.1. List the reasonably foreseeable risks, discomforts, hazards, or inconveniences to the
subjects related the subjects’ participation in the research.  Describe the probability,
magnitude, duration, and reversibility of the risks. Consider physical, psychological,
social, legal, and economic risks.  Note that almost all research includes confidentiality
risks.
5.2. If applicable, indicate which procedures may have risks to the subjects that are
currently unforeseeable.
5.3. If applicable, indicate which procedures may have risks to an embryo or fetus should
the subject be or become pregnant.  If pregnancy testing or birth control provisions are
required, describe these.
5.4. If applicable, describe risks to others who are not subjects.
5.5. Describe the steps being taken to minimize the probability or magnitude of risks.
Note: All risks described here should also be described in the consent document.
There are risks of stress and inconvenience for parents who participate in the research study as
they will be asked to complete a patient satisfaction survey at the end of their child’s
hospitalization. There are also risks of possible loss of privacy and confidentiality. For this
reason, a Certificate of Confidentiality will be obtained from NIDA, and all data will be kept
confidential and deidentified.
The study will use existing protocols for the treatment of neonatal abstinence syndrome with
either methadone or morphine. The experimental component of the study is the use of the
morphine protocol for a different exposure group (in-utero methadone or heroin).   For this
reason, there are minimal foreseeable medical risks of treatment. Please see the consent
document for details on minimizing risks to subjects.
6. Potential Benefits to Subjects
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6.1. Describe the potential benefits that individual subjects may experience from taking part
in the research. Include as may be useful for the IRB’s consideration, the probability,
magnitude, and duration of the potential benefits.
6.2. Indicate if there is no direct benefit. Do not include benefits to society or others in this
section.
Note: All potential benefits described here should also be described in the consent document.
Possible benefits to subjects include decreased length of stay and improved parental
satisfaction. Given the decreased length of stay observed for infants currently treated with
morphine rather than methadone (in-utero exposure to buprenorphine), we expect a decreased
length of stay in the study population (in-utero exposure to methadone or heroin).
7. Recruitment Methods
7.1. Describe when, where, and how potential subjects will be recruited.
7.2. Describe the methods that will be used to identify potential subjects (e.g., chart review,
referral, etc.).
7.3. Describe materials that will be used to recruit subjects (e.g., emails, scripts,
advertisements, brochures, flyers, etc.). Attach draft copies of the documents or audio
or video recordings with the application. Once the draft has been approved, the final
copy of the printed material, audio or video recording must be submitted for review and
approval prior to implementation.  Please see Worksheet HRP-315 for information on
advertisement standards.
Candidates will be identified and recruited based on eligibility criteria. Prior to delivery, possible
candidates will be identified by review of the Milagro prenatal substance abuse clinic census.
After identification by the primary medical team by chart review, women will be approached
by the research team upon admission to Labor and Delivery, or up to 12 hours after delivery at
UNM Hospital in the Labor and Delivery, Mother-Baby, Newborn Nursery, or Intermediate
Care Nursery-3 Units. When possible, families will be approached to discuss the study within
standard business hours. The recruitment script detailed in the study protocol will be used to
describe the study to patients. (Attachments: Recruitment script, Waiver of consent for
screening/recruitment purposes)
8. Provisions to Protect the Privacy Interests of Subjects
8.1. Describe the steps that will be taken to protect subjects’ privacy interests. “Privacy”
refers to persons and their interest in controlling the access that others have to
themselves.  For example, based on their privacy interests, people may want to control:
•
The time and place/setting where they are examined or provide information
•
The nature of the information they provide
•
The nature of the experiences they are exposed to
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•
Who may observe or have access to information about them
For example, individuals may not want to be approached for participation, provide
responses to a research interview, or undergo a research procedure in a location
where they may be seen or overheard.\
1.2. Describe the steps that will be taken to protect subjects’ privacy including privacy
protections during recruitment, consent, and data collection. Issues related to data are
addressed in the Data Management/Confidentiality Section.
Procedures for protecting against or minimizing the likelihood of loss of privacy include
approaching parents or guardians privately and using a private room to answer test questions.
The treatment plan for the baby will be kept confidential, and discussion regarding treatment
protocols would occur according to routine protocols. Conversations can occur in a private room
in Labor and Delivery, the Mother Baby Unit or Carrie Tingley Hospital. There are no private
rooms in ICN-3, so efforts will be made to create a confidential, quiet space in this clinical
environment (eg a quiet corner in the unit, away from other parents visiting their newborns, or in
a separate conference room away from the unit.) Information that is collected will be labeled
with a study number and kept in a secure locked file. Information that will be entered in to a
database will only contain the study number. Subject’s research data and study records will be
maintained until the youngest subject turns 22 years old.
.
2. Economic Burden to Subjects
8.2. Describe any costs that subjects may be responsible for because of participation in the
research.  Clearly stipulate what procedures are standard of care and what procedures
are research-related in the table below. Please place an X in the box for the responsible
party for each procedure involved.
List any costs to participants (or their 3rd party payer); include any charges for study
procedures, visits, or drug/devices.
Research Procedures
Number of
Samples/Procedu
res
Responsible Party
Study
3rd Party
Payer or
Participant
     
     
     
     
     
     
     
     
     
     
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Standard of Care Procedures
Number of
Samples/Procedu
res
Responsible Party
Study
3rd Party
Payer or
Participant
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
1.2. List any other costs to participants not already described above.
8.3. Indicate whether subjects will be charged for investigational drugs, devices, procedures
8.4. Explain who will be responsible for paying for treatment of adverse events
8.5. Ensure that the cost section of the consent form reflects the cost that are covered by the
sponsor and the costs for which the subjects (or 3rd party payers) are responsible.
There will be no additional cost to the parents or guardians of test participants other than the
routine hospitalization costs for standard of care. All charges related to hospitalization including
urine drug screens and therapy with either methadone or morphine are considered to be standard
of care and will therefore be billed to the patient’s insurance company (3rd party payer).
23. Compensation
8.6. Describe any plans for compensation or reimbursement for subjects (amounts, methods
(e.g., cash card), and payment schedule).  Describe why the proposed amount is
reasonable and appropriate for the subjects’ time and inconvenience.  Credit for
payment should be prorated and not be contingent upon the participant completing the
entire study.  Any amount paid as bonus for completion of the entire study should not be
so great that it could unduly induce subjects to remain in the study when they otherwise
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would have withdrawn.  Note: Consult with your department official for reporting
requirements associated with cash or merchandise cards distributed to research
subjects.
Participants will be compensated with $20 Walmart merchandise cards.
9. Compensation for Research-Related Injury
9.1. If the research involves more than Minimal Risk to subjects, describe the plan for
compensation in the event of research related injury.
9.2. If subjects are responsible for seeking their own form of care for research-related
injury, describe how this will be communicated and what options are available to
participants.
The research uses already existing protocols and therefore does not pose more than minimal
risk to subjects, as such we do not anticipate any research related injury.
10. Consent Process
10.1. Indicate whether you will you be obtaining consent, and if so describe:
10.1.1. Who will be responsible for obtaining consent and their qualifications/training to
do so.  Be certain to identify which study team members will obtain consent in
Click under Project Contacts.
10.1.2. Where will the consent process take place and the provisions for privacy.
10.1.3. The steps that will be taken to minimize the possibility of coercion or undue
influence
10.1.4. The waiting period available between reviewing the study and consent with the
potential subject and obtaining the consent.
10.1.5. Processes to ensure ongoing consent throughout the study.
10.1.6. Any steps that will be taken to enhance understanding
10.1.7. Any procedure/testing for ensuring that the consent is understood by the potential
subject (e.g., teach back)
The infant’s care provider will approach the parent or guardian to introduce and discuss the
study.  If the infant’s parent or guardian chooses to participate, a co-investigator will perform the
consent process. The consent is structured such that the information regarding the study is
provided in an unbiased manner in order to promote independent and thoughtful decision-making
and in order to avoid coercion or undue influence.
Parents or guardians of eligible infants will be recruited and consented during routine business
hours, during their inpatient stay at UNMH upon admission and up to 12 hours after delivery.
For both groups, the study will be introduced, questions answered, and consent obtained. The
parents or guardians of the subjects will be given a copy of the consent prior to leaving the clinic
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or hospital. The signed consent form will be stored and secured in a locked filing cabinet in the
principal investigator’s office.
HIPAA authorization will be obtained using the standard HRPO HIPAA authorization form.
Subjects not fluent in English
10.1.8. Indicate what language(s) other than English are understood by prospective
subjects or representatives.
10.1.9. If you anticipate enrolling subjects who do not understand or have limited fluency
in English, describe the process to ensure that the oral and written information
provided to those subjects initially and throughout their participation will be in
the language they understand (e.g., use of translations and interpreters). Please
note that translations of consent documents and subject materials will likely be
required once the content of the English-language version is approved.
1.1.1. Short-form consent documents are available for unanticipated enrollments of
persons who don’t understand or have limited fluency in English.  However, based
upon the nature of the research (e.g., clinical trials) subsequent translation of the
consent document may be required so that the subject has access to written
information about the research in a language they understand.
Based on our current population of Milagro patients, non-English speaking families will
represent very few or none of our study pool. A short-form Spanish consent will be requested
from translation services in the case of unanticipated Spanish speaking families. If additional
translation of consent documents is required in this scenario, subsequent translation will be
requested at the time of need.
Cognitively Impaired Adults/Adults Unable to Consent/Use of a Legally Authorized
Representative
1.1.2. The IRB must specifically approve the enrollment of adults unable to consent and
adults with cognitive impairment or limited decision-making capacity.  Complete
the applicable checklist in the Checklists Section of this Protocol Template.
1.1.3. Describe whether the entire subject population or a portion of it is expected to
have limited or no ability to provide legally effective consent.
1.1.4. Describe the process to determine whether an individual is capable of consent.
1.1.5. Describe the process to determine whether a prospective subject is capable of
providing consent.  Include who will be responsible for determining capacity and
how it will be documented.
1.1.6. Describe how the participant’s decisional capacity will be assessed as the study
proceeds in order to evaluate any fluctuation in the participant’s level of capacity
to consent.
1.1.7. If it can be anticipated that some or all subjects will regain capacity to provide
consent, describe the provisions to provide them with information about their
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participation in the research and to seek their consent for ongoing participation,
if applicable.
1.1.8. For research conducted in New Mexico, review “SOP: Legally Authorized
Representatives, Children, and Guardians (HRP-013)” to be aware of which
individuals in the state meet the definition of “legally authorized representative.”
1.1.9. For research conducted outside of the New Mexico, provide information that
describes which individuals are authorized under applicable law to consent on
behalf of a prospective subject to their participation in the procedure(s) involved
in this research.
1.1.10. Describe how the representative’s authority to provide consent will be confirmed.
1.1.11. Describe the process for assent of the subjects. Indicate whether:
•
Assent will be required of all, some, or none of the subjects. If some, indicated, which
subjects will be required to assent and which will not.
•
If assent will not be obtained from some or all subjects, an explanation of why not.
•
Describe whether assent of the subjects will be documented and the process to
document assent.
Subjects who are not yet adults (infants, children, teenagers)
1.1.21. Provide the age range of the children anticipated to be enrolled in the research.
Study participants are newborn infants.
1.1.12. Describe the criteria that will be used to determine whether a prospective subject
has not attained the legal age for consent to treatments or procedures involved in
the research under the applicable law of the jurisdiction in which the research will
be conducted.
•
For research conducted in New Mexico, review “SOP: Legally Authorized
Representatives, Children, and Guardians (HRP-013)” to be aware of which
individuals in the state meet the definition of “children.”
•
For research conducted outside of New Mexico, provide information that describes
which persons have not attained the legal age for consent to treatments or procedures
involved the research, under the applicable law of the jurisdiction in which research
will be conducted.
1.1.23. Describe whether parental permission will be obtained from:
•
One parent (may be permissible, if the IRB approves, for (1) research not involving
greater than minimal risk, or (2) research involving greater than minimal risk but
presenting the prospect of direct benefit to individual subjects)
Parental or guardian permission will be obtained by one parent or guardian as this research only
poses minimal risk.
•
Both parents unless one parent is deceased, unknown, incompetent, or not reasonably
available, or when only one parent has legal responsibility for the care and custody of
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the child. (Permissible for research involving greater than minimal risk and no
prospect of direct benefit to individual subjects.)
1.1.24. Describe whether permission will be obtained from individuals other than
parents, and if so, who will be allowed to provide permission. Describe the
process used to determine these individuals’ authority to consent.
In the case of parental right revocation by NM Children, Youth and Families Department,
the legal guardian assigned to the child would be approached for consent.
1.1.13. Indicate whether the children to be enrolled in the research should be capable of
providing assent.
1.1.14. Indicate if assent will be obtained from all, some, or none of the children and
provide justification.  If assent will be obtained from some children, indicate
which children will be asked for assent.
1.1.15. When assent of children will be obtained describe the proposed assent process
and whether and how assent will be documented.  The assent process and
documentation of assent should be age-appropriate and may consist of different
procedures for different age groups.
Waiver or Alteration of Consent Process (consent will not be obtained, required
element of consent will not be included, or one or more required elements of consent
will be altered)
•
Complete the applicable checklists in the Checklists section of this Protocol Template
if you are requesting a waiver or alteration of consent for this research
•
Consent can be waived for all of some subjects (e.g., the research includes a
retrospective cohort)
•
Consent can be waived in full or in part (e.g., partial waiver for recruitment
purposes)
26. Documentation of Consent
2.1. Describe if you plan to use a consent form to document consent.  Use the UNM HSC
consent generator or one of the consent templates available on the HRPO website.
Attach consent documents as fully editable Word documents (i.e., please don’t submit
protected documents or pdfs).  Please include page numbers in the footer (e.g., Page 1
of XX).
2.2. If the study is collecting and/or storing tissue samples, include a Tissue Banking
Consent Form (and Authorization if the specimens will be accompanied by PHI).
2.3. Describe if you plan to obtain consent but will be using a script, information sheet, or
other mechanism.  If you will obtain consent verbally, attach a consent script and
information sheet, if you will be providing one.  If you will be obtaining consent via an
on-line survey, please use the survey cover letter consent template on the HRPO
website and include your email script with your submission.
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Complete the checklist for “Waiver of Documentation of Consent” in the Checklists
section of this Protocol Template.  If you will be excluding or modifying one or more of
the required elements of consent you will also need to request an Alteration of Consent.
The consent process will take place using a standard script (Attachment 1), as well as
the combined HIPAA/ consent form which is included as an attachment (Attachment 5).
Tissue samples will not be collected.
3. Study Test Results/Incidental Findings
3.1. Individual Results: Indicate whether you intend to share study test or procedure results
with study participants  If so, describe which results will be shared, whom the results
will be shared with (e.g., subjects, parents, primary care physicians), and how the
findings will be communicated (e.g., in person consultation, posting in medical record,
etc.).  If the findings are the results of laboratory tests, indicate whether the tests will be
processed in a CLIA-certified lab.
The primary medical team will be responsible for sharing infant progress with families in person
during routine patient care rounds, which are part of the current standard of care (NAS scores,
expected weaning dates, and expected length of treatment.)
3.2. Incidental Findings: Based upon the nature of the research, and the tests that will be
performed, indicate if you anticipate that the research may result in incidental findings
(traditionally defined as results that arise that are outside the original purpose for
which the test or procedure was conducted (for example, a potential tumor is identified
but this is not the reason imaging was obtained).  If so, please describe your plans for
communication of such results to subjects and their health care providers, if
appropriate.  If there are limitations on the accepted validity of the results (e.g., test
performed in non-CLIA lab, test available in the context of research only), please
describe and provide a plan for confirmatory testing or justification for why it is not
recommended, not necessary, or not possible.  If you do not plan to provide results,
provide justification.
•
Be certain to describe your plans for provision of study results and incidental findings
in your consent documents.
•
For more information on incidental findings, please consult the President’s Bioethics
Commission Report “Anticipate and Communicate: Ethical Management of
Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer
Contexts”:
http://bioethics.gov/sites/default/files/FINALAnticipateCommunicate_PCSBI_0.pdf
•
For information specific to Whole Genome Sequencing, please consult the President’s
Bioethics Commission Report “Privacy and Progress in Whole Genome Sequencing”:
http://bioethics.gov/sites/default/files/PrivacyProgress508_1.pdf
We do not anticipate any incidental findings from our research protocol as it is already in use for
the buprenorphine exposed infant population.
28. Sharing Study Progress or Results with Subjects
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3.3. Describe whether you intend to provide subjects with a summary of the trial progress
while the study remains underway.  If so, describe your plans and the mechanisms that
you will use (e.g., newsletter, handouts, mailings, etc.).  Please note that all written
materials that will be provided to subjects need to be reviewed and approved by the IRB
prior to use.
3.4. Describe whether you intend to provide subjects with a summary of the study results
after the study is complete.  If so, indicate if the information will include study arm
assignment if the study involved blinding.  Please describe your plans for dissemination
of results and the mechanisms that you will use.  Please note that IRB review of
materials may be required, consult with the HRPO prior to distribution.
Study progress will be shared with participants at the conclusion of the study via a mailing.
4. Inclusion of Vulnerable Populations
4.1. If the research involves individuals who are vulnerable to coercion or undue influence,
describe who will be included, why their participation is necessary or warranted, and
any additional safeguards included to protect their rights and welfare. The following is
not intended to serve as a comprehensive list, rather to provide some examples for your
consideration.
4.1.1. If the research includes students or employees, describe protections to
promote the voluntary nature of participation and minimize the risks
associated with access to or use of data by persons in a position of actual or
perceived authority.
4.1.2. If the research includes economically disadvantaged persons, describe the
mechanisms to promote the voluntary nature of participation and to minimize
economic risks associated with participation.
4.1.3. If the research includes educationally disadvantaged persons, describe the
mechanisms to ensure that they are provided information and materials that
enhance their ability to understand the research initially and throughout their
participation in the research.
4.1.4. If the research includes seriously or terminally ill patients, describe the
mechanisms to ensure that they understand the true purposes of the research,
the risk it entails, and what is known or not understood about the likelihood of
individual benefit
4.1.5. If the research involves pregnant women, note this here and complete the
Pregnant Women Checklist in the Checklist Section of this Protocol Template.
4.1.6. If the research involves neonates of uncertain viability or non-viable neonates,
note this here and complete the applicable checklist in the Checklist Section of
this Protocol Template.
Note: For the purposes of the federal research regulations, viability is
established shortly after delivery. “Viable, as it pertains to the neonate, means
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being able, after delivery, to survive (given the benefit of available medical
therapy) to the point of independently maintaining heartbeat and respiration.”
Once a neonate has been determined viable, they are considered a child under
the regulations.
4.1.7. If the research involves prisoners, note this here and complete the Prisoners
Checklist in the Checklist Section of this Protocol Template.
4.1.8. If the research involves persons who have not attained the legal age for
consent to treatments or procedures involved in the research (“children”),
note this here and complete the Children Checklist in the Checklist Section of
this Protocol Template.
4.1.9. If the research involves cognitively impaired adults, note this here and
complete the Cognitively Impaired Adults Checklist in the Checklist Section of
this Protocol Template.
Our research involves infants. Due to the sensitive nature of our perinatal substance abuse
population, we will pursue a Certificate of Confidentiality from NIDA and will discuss
this with patients during the consent process.
5. Community-Based Participatory Research
5.1. Describe involvement of the community in the design and conduct of the research.  If
members of the community will fulfill key research responsibilities such as recruitment
and consent, describe what research activities community members will be responsible
for, how they will be trained, and the plan for quality oversight.  When relevant, please
include information regarding the approval of the research at collaborating sites (e.g.,
Albuquerque Public Schools).
Note: “Community-based Participatory Research” is a collaborative approach to
research that equitably involves all partners in the research process and recognizes the
unique strengths that each brings. Community-based Participatory Research begins
with a research topic of importance to the community, has the aim of combining
knowledge with action and achieving social change to improve health outcomes and
eliminate health disparities.
N/A
6. Research Involving American Indian/Native Populations
6.1. Please provide detailed information of the local research context including how the
research questions are sensitive to community attitudes and how the PI has ascertained
that the proposed research is acceptable to the local population in terms of tribal
regulations, applicable law and standards of professional conduct and practice.  Attach
any supporting documents from tribal officials or entities addressing the status or
requirements for review of the research activity from tribal officials or tribal entities
(for example, Indian Health Services, the Navajo Nation IRB).
N/A
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7. Transnational Research
7.1. When conducting transnational research, you must ensure that subjects are provided
equivalent and appropriate protections for human subjects located outside of the
United States.  Please refer to the following website for current OHRP interpretations
of research standards, equivalent protections, and for a current compilation of
international research standards and regulatory agencies.
http://www.hhs.gov/ohrp/international/index.html
7.2. Location: Describe the research locale and how and why the setting was chosen.
Describe significant cultural norms, local laws, and differences with U.S. culture with
respect to autonomy, perception of research, recruitment, consent, age of majority,
parental permission, etc.
7.3. Study Personnel: Describe the qualifications of the researcher and research team to
perform research in the community/culture where it will occur.  Indicate the research
team’s ability to speak, read, and write the language of the subjects.  Describe the
researcher’s knowledge of or expertise in local or state laws, culture, and community
norms. Indicate if the researcher was invited into the community (provide
documentation, if available).  If not invited, then describe how the researcher will have
culturally appropriate access to the community.
7.4. Consent: Describe the consenting procedure that you intend to use for the research and
why it is appropriate for the community where the research will occur.  Describe how
you will ensure that potential subjects understand the research, and the voluntariness of
their participation.
7.5. Community Consultation: Describe any plans for community consultation to assess
receptiveness to the proposed research and to obtain feedback on how it should be
conducted and any limitations or boundaries that should be respected.  Describe plans
for dissemination of results to subjects and to the community.
N/A
8. Drugs or Devices
8.1. If the research involves drugs or devices, describe your plans to store, handle, and
administer those drugs or devices so that they will be used only on subjects and be used
only by authorized investigators.
8.2. If the drug is investigational (has an IND), identify the holder of the
IND/IDE/Abbreviated IDE.
8.3. For research involving drugs, complete and attach a signed “Drug Attachment”,
available in Click or the HRPO website
8.4. For research involving devices, complete the “Device Checklist” in the Checklist
Section of this template.
This study will involve only morphine or methadone, which are currently in use as part of
accepted and standard of care protocols. Morphine is widely used for the treatment of neonatal
abstinence syndrome nationwide, and is currently used for all neonates with NAS exposed to
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buprenorphine in utero at UNMH. Medication accountability and labeling and dispensing will be
conducted in accordance with standard University Hospital Pharmacy protocol. Security
safeguards in place to ensure proper accountability, access, and medication storage include
standard safeguards in place by University Hospital Pharmacy.  These safeguards will prevent
accidental use outside of the approved research study.
Checklist Section
This section contains checklists to provide information on a variety of topics that require special
determinations by the IRB.  Please complete all checklists relevant to your research.
I.
Waivers or Alterations of Consent, Assent, and HIPAA Authorization
A.
Partial Waiver of Consent for Screening/Recruitment
Complete this checklist if you are requesting a partial waiver of consent so that you
can review private information to identify potential subjects and/or determine
eligibility prior to approaching potential subjects for consent or parental permission.
1. Describe the data source that you need to review (e.g., medical records):
  Medical records will be reviewed to determine mothers in the Milagro
prenatal substance abuse program who are currently receiving medication
assisted therapy with methadone or are known to be using other opiates.     
2. Describe the purpose for the review (e.g., screening):
The review of medical records will be for screening to determine potentially
eligible families to approach for consent at the time of delivery in the hospital.
     
3. Describe who will conducting the reviews (e.g., investigators, research staff):
  Co-investigators will conduct the reviews. All of the co-investigators are
also physicians involved with the Milagro substance abuse program.     
    
4. Do all persons who will be conducting the reviews already have permitted
access to the data source?
Yes All persons conducting the reviews have permitted access to the data
source as physicians treating this population.
No. Explain:      
5. Verify that each of the following are true or provide an alternate justification
for the underlined regulatory criteria:
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a) The activity involves no more than minimal risk to the subjects
because the records review itself is non-invasive and the results of the
records review will not be used for any purposes other than those
described above.
True
Other justification:      
b) The waiver or alteration will not adversely affect the rights and welfare
of the subjects because eligible subjects will be approached for consent
to participate in the research and are free to decline.  Further, the
information accessed during the records review will not be disclosed to
anyone without a legitimate purpose (e.g., verification of eligibility).
True
Other justification:      
c) The research could not practicably be carried out without the waiver or
alteration because there is no other reasonably efficient and effective
way to identify who to approach for possible participation in the
research.
True
Other justification:      
d) Whenever appropriate, potentially eligible subjects will be presented
with information about the research and asked to consider
participation. (Regulatory criteria: Whenever appropriate, the
subjects will be provided with additional pertinent information after
participation.)
True
Other justification:      
Partial Waiver of HIPAA Authorization for Screening/Recruitment
Complete the following additional questions/attestations if the records you will review
to identify potential subjects and/or determine eligibility include Protected Health
Information (PHI).
6. Will you be recording any PHI when conducting the records review to identify
potential subjects and/or determine eligibility?
Yes. Describe: A list of eligible patients and their estimated due dates will be
maintained in order to efficiently organize efforts for recruitment and approach
for consent when women are hospitalized for birth. This list is already
maintained by the Milagro clinic staff for purposes of clinic tracking and
distribution of gifts when women deliver their babies.          
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No
7. If you answered “Yes” to question 6 above, please describe when you will
destroy identifiers (must be the earliest opportunity consistent with the
conduct of the research) or provide justification for why they must be retained:
The list is currently maintained by medical record number and is accessible
only to Milagro staff and physicians. MRNs will need to remain in place until
women are approached for consent so that they can be identified when they
present in labor. After women are approached for participation in the study
and accept or decline, their medical record number and other information will
be deleted from the list.      
1. The PHI accessed or recorded for identification/screening purposes will not be
reused or disclosed to (shared with) any other person or entity, except as
required by law, for authorized oversight of the research study, or for other
research for which the use or disclosure of the PHI would be permitted under
the Privacy Rule.
True
False
B.
Waiver of Documentation of Consent
Complete this checklist if you intend to obtain consent verbally but will not be
obtaining signatures from subjects on a consent form to document consent.  Waivers
of documentation of consent are commonly requested when using scripts, information
sheets, or email or survey introductions to present the elements of consent instead of
using a traditional consent form.
1. Are you requesting a waiver of documentation of consent for some or all
subjects?
All
Some. Explain:      
2. Provide justification for one of the following:
a) That the only record linking the subject and the research would be the
consent document and the principal risk would be potential harm
resulting from a breach of confidentiality. Each subject will be asked
whether the subject wants documentation linking the subject with the
research, and the subject's wishes will govern.
     
b) That the research presents no more than minimal risk of harm to
subjects and involves no procedures for which written consent is
normally required outside of the research context.
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1. Do you intend to provide subjects with a written statement regarding the
research in lieu of a traditional consent form?
Yes. Please attach a copy to your submission in Click.
No
C.
Alteration of Consent
Complete this checklist if you intend to obtain consent but will be eliminating or
altering one or more of the required elements of consent. Alterations of consent are
commonly requested for research involving deception or for minimal risk research
when an abbreviated consent is desired and one or more of the required element are
not relevant to the research.
Note: FDA-regulated research is not eligible for an alteration of consent.
1. Which element(s) of consent do you wish to eliminate and why?
     
2. Which element(s) of consent do you wish to alter and why?
     
3. Provide justification for each of the following regulatory criteria:
a) The research involves no more than minimal risk to the subjects:
     
b) The waiver or alteration will not adversely affect the rights and welfare
of the subjects:
     
c) The research could not practicably be carried out without the waiver or
alteration:
     
d) Whenever appropriate, the subjects will be provided with additional
pertinent information after participation:
     
D.
Full Waiver of Consent/Parental Permission
Complete this checklist if you are requesting a full waiver of consent for all subjects
or certain subject groups (e.g., retrospective cohort).  Full waivers of consent are
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commonly requested when the research does not include any opportunity for
interaction with subjects (e.g., chart review).
Note: FDA-regulated research is not eligible for a full waiver of consent using these
criteria.  If you believe that your FDA-regulated research may be eligible for a waiver
under another mechanism, such as planned emergency research, contact the HRPO
for assistance in determining what information to provide to the HRRC.
1. Are you requesting a waiver for some or all subjects?
All
Some. Explain:      
1.
Provide justification for each of the following regulatory criteria:
a) The research involves no more than minimal risk to the subjects:
     
b) The waiver or alteration will not adversely affect the rights and welfare
of the subjects:
     
c) The research could not practicably be carried out without the waiver or
alteration:
     
d) Whenever appropriate, the subjects will be provided with additional
pertinent information after participation:
     
E. Full Waiver of Consent/Parental Permission (Public Benefit or Service
Programs)
Complete this checklist if you are requesting a full waiver of consent for all subjects
or certain subject groups (e.g., retrospective cohort) and the research involves the
evaluation of a public benefit or service program.
1.
Are you requesting a waiver for some or all subjects?
All
Some. Explain:      
2.
Provide justification for each of the following regulatory criteria:
a) The research or demonstration project is to be conducted by or subject
to the approval of state or local government officials and is designed to
study, evaluate, or otherwise examine: (i) public benefit or service
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programs; (ii) procedures for obtaining benefits or services under those
programs; (iii) possible changes in or alternatives to those programs or
procedures; or (iv) possible changes in methods or levels of payment
for benefits or services under those programs:
     
b) The research could not practicably be carried out without the waiver or
alteration.
     
F.
Full Waiver of HIPAA Authorization
Complete this checklist if you are requesting a full waiver of the requirement to obtain
HIPAA authorization for all subjects or certain subject groups (e.g., retrospective
cohort).  Full waivers of HIPAA authorization are commonly requested when the
research does not include any opportunity for interaction with subjects (e.g., chart
review).
1.
Are you requesting a waiver of authorization for some or all subjects?
All
Some. Explain:      
1. Describe your plan to protect health information identifiers from improper use
and disclosure:
     
2. Describe your plan to destroy identifiers at the earliest opportunity consistent
with conduct of the research (absent a health or research justification for
retaining them or a legal requirement to do so):
     
3. Describe why the research could not practicably be conducted without the
waiver or alteration:
     
1. The PHI accessed or recorded for identification/screening purposes will not be
reused or disclosed to (shared with) any other person or entity, except as
required by law, for authorized oversight of the research study, or for other
research for which the use or disclosure of the PHI would be permitted under
the Privacy Rule.
True
False
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G.
Other Waiver Types
If you are seeking another waiver type (e.g., Planned Emergency Research, Waiver of
Parental Permission to Protect Child Participants, Enforcement Discretion for In
Vitro Diagnostics, etc. contact the HRPO office for assistance in determining what
information to submit for the HRRC’s consideration.
II. Vulnerable Populations
A.
Adults with Cognitive Impairments
Complete this checklist if the subject population will include adults with cognitive
impairments.
This checklist does not need to be completed if the research doesn’t involve
interactions or interventions with subjects and will be conducted under a waiver of
consent.
1. Describe why the objectives of the study cannot be met without inclusion of
adults with cognitive impairments.
     
2. Describe how capacity to consent will be evaluated.
     
3. If subjects may regain capacity to consent, or if subjects may have fluctuating
capacity to consent, describe your plans to evaluate capacity to consent
throughout the research and to obtain consent to continue participation if
capacity is regained.
     
4. Describe your plans, if any, to provide information about the research to
subjects and the steps you will take to assess understanding.
     
5. Describe your plans to obtain assent, including whether assent will be
obtained from none, some, or all subjects.
     
6. Describe why risks to subjects are reasonable in relation to anticipated
benefits to the subjects.
     
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7. If this study involves a health or behavioral intervention, describe why the
relation of the anticipated benefit to the risk of the research is at least as
favorable to the subjects as that presented by alternative procedures.
     
8. Describe your plans for monitoring the well-being of subjects including any
plans to withdraw subjects from the research if they appear to be unduly
distressed.
     
B.
Children
Complete this checklist if the subject population will include children.
1. Select the category of research that you believe this research falls within and
provide justification for any associated criteria.  If there are different
assessments for different groups of children or arms (e.g., placebo vs. drug),
include a memo to provide an assessment for each group.
XX Research not involving greater than minimal risk. (Minimal risk
means 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.)
Research involving greater than minimal risk but presenting the prospect
of direct benefit to the individual subjects.
Provide justification for each of the following criteria:
(1) The risk is justified by the anticipated benefit to the subjects:
     
(2) The relation of the anticipated benefit to the risk is at least as
favorable to the subjects as that presented by available
alternative approaches:
     
Research involving greater than minimal risk and no prospect of direct
benefit to individual subjects, but likely to yield generalizable
knowledge about the subject's disorder or condition.
Provide justification for each of the following criteria:
(1) The risk represents a minor increase over minimal risk:
     
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(2) The intervention or procedure presents experiences to subjects
that are reasonably commensurate with those inherent in their
actual or expected medical, dental, psychological, social, or
educational situations:
     
(3) The intervention or procedure is likely to yield generalizable
knowledge about the subjects' disorder or condition which is of
vital importance for the understanding or amelioration of the
subjects' disorder or condition
     
C.
Pregnant Women and Fetuses
Complete this checklist if the subject population will include pregnant women and
fetuses.
This checklist does not need to be completed if the research is both minimal risk and
is not conducted, funded, or otherwise subject to regulation by DHHS, DOD, or EPA.
Provide justification for each of the following:
1. Where scientifically appropriate, preclinical studies, including studies on
pregnant animals, and clinical studies, including studies on non-pregnant
women, have been conducted and provide data for assessing potential risks to
pregnant women and fetuses.
     
1. The risk to the fetus is caused solely by interventions or procedures that hold
out the prospect of direct benefit for the woman or the fetus; or, if there is no
such prospect of benefit, the risk to the fetus is not greater than minimal and
the purpose of the research is the development of important biomedical
knowledge which cannot be obtained by any other means.
     
2. Any risk is the least possible for achieving the objectives of the research.
     
D.
Neonates of Uncertain Viability or Nonviable Neonates
Complete this checklist if the subject population will include neonates of uncertain
viability.
Provide justification for each of the following:
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1. Where scientifically appropriate, preclinical and clinical studies have been
conducted and provide data for assessing potential risks to neonates.
     
2. Each individual providing consent is fully informed regarding the reasonably
foreseeable impact of the research on the neonate.
     
3. Individuals engaged in the research will have no part in determining the
viability of a neonate.
     
1. The research holds out the prospect of enhancing the probability of survival of
the neonate to the point of viability, and any risk is the least possible for
achieving that objective, or, the purpose of the research is the development of
important biomedical knowledge which cannot be obtained by other means
and there will be no added risk to the neonate resulting from the research
     
E.
Nonviable Neonates
Complete this checklist if the subject population will include nonviable neonates.
Provide justification for each of the following:
1. Where scientifically appropriate, preclinical and clinical studies have been
conducted and provide data for assessing potential risks to neonates.
     
2. Each individual providing consent is fully informed regarding the reasonably
foreseeable impact of the research on the neonate.
     
3. Individuals engaged in the research will have no part in determining the
viability of a neonate.
     
1. The purpose of the research is the development of important biomedical
knowledge that cannot be obtained by other means.
     
Verify each of the following:
5.
Vital functions of the neonate will not be artificially maintained
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True
False
1. The research will not terminate the heartbeat or respiration of the neonate
True
False
2. There will be no added risk to the neonate resulting from the research
True
False
F.
Biomedical and Behavioral Research Involving Prisoners
Complete this checklist if the subject population will include prisoners.
Note: Minimal risk for research involving prisoners is the probability and magnitude
of physical or psychological harm that is normally encountered in the daily lives, or
in the routine medical, dental, or psychological examination of healthy persons.
1. Select and justify which allowable category of research involving prisoners
this research falls within:
Study of the possible causes, effects, and processes of incarceration, and of
criminal behavior, provided that the study presents no more than minimal
risk and no more than inconvenience to the subjects
     
Study of prisons as institutional structures or of prisoners as incarcerated
persons, provided that the study presents no more than minimal risk and
no more than inconvenience to the subjects
     
Research on conditions particularly affecting prisoners as a class (for
example, vaccine trials and other research on hepatitis which is much
more prevalent in prisons than elsewhere; and research on social and
psychological problems such as alcoholism, drug addiction, and sexual
assaults)
     
Research on practices, both innovative and accepted, which have the intent
and reasonable probability of improving the health or well-being of the
subject
     
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Epidemiologic studies in which the sole purpose is to describe the prevalence
or incidence of a disease by identifying all cases or to study potential risk
factor associations for a disease, the research presents no more than
Minimal Risk and no more than inconvenience to the subjects, and
Prisoners are not a particular focus of the research.
     
2. Provide justification for each of the following regulatory criteria:
a) Any possible advantages accruing to the prisoner through his or her
participation in the research, when compared to the general living
conditions, medical care, quality of food, amenities and opportunity
for earnings in the prison, are not of such a magnitude that his or her
ability to weigh the risks of the research against the value of such
advantages in the limited choice environment of the prison is impaired
     
b) The risks involved in the research are commensurate with risks that
would be accepted by nonprisoner volunteers
     
c) Procedures for the selection of subjects within the prison are fair to all
prisoners and immune from arbitrary intervention by prison authorities
or prisoners. Unless justification is provided, control subjects must be
selected randomly from the group of available prisoners who meet the
characteristics needed for that particular research project
     
d) The information is presented in language which is understandable to
the subject population
     
e) Adequate assurance exists that parole boards will not take into account
a prisoner's participation in the research in making decisions regarding
parole, and each prisoner is clearly informed in advance that
participation in the research will have no effect on his or her parole
     
f)
When appropriate, adequate provision has been made for follow up
examination or care after research participation, taking into account
the varying lengths of individual prisoners' sentences, and for
informing participants of this fact
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III.Medical Devices
Complete this checklist if the research evaluates the safety or effectiveness of a medical device.  If
more than one medical device is being evaluated, provide the requested information for each.
A.
Device Name:       
B.
Manufacturer:       
C.
Does the research involve a Significant Risk Device under an IDE?
Yes. Include documentation of the FDA approval of the IDE with your submission.
Acceptable methods of documentation include: (1) FDA letter noting IDE number and
approval status; (2) Industry sponsor letter noting IDE number and FDA approval
status; or (3) FDA-approved industry sponsor protocol with IDE number noted
No
D.
Is the research IDE-exempt?
Yes. Include a FDA letter with your submission noting the determination that the
research is IDE-exempt or a letter from the sponsor (or sponsor-investigator)
justifying why they believe the research is IDE-exempt*.
No
E.
Does the research involve a Non-Significant Risk (NSR) Device?
Yes. Include a FDA letter with your submission noting the determination that the
research is NSR or a letter from the sponsor (or sponsor-investigator) justifying why
they believe the research is NSR**.
No
* This FDA guidance includes a description for when a device study is exempt from the
IDE requirements:
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127067.pdf
**This FDA guidance includes information on how to differentiate between Significant
Risk and Non-Significant Risk device studies:
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126418.pdf
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