Effects of Early Community Services on Child and Family Development
Phase: NA
Conditions: Child Development
Sponsor: University of Maryland, Baltimore

Effects of Early Community Services on Child and Family Development 
ClinicalTrials.gov Identifier: NCT04019977 
Document date: March 24, 2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Hospital, both located in Baltimore, MD. For the purposes of this study, Sinai Hospital will serve as the community/catchment area. Nurse home visitors recruit these
news mothers while they are still in the hospital/maternity ward. Following Dodge et al. (2013; 2014), when the 
officially begins, nurse home
visitors will enroll new mothers into MFC every other day only (on odd dates). Those new mothers who are not City residents and/or give birth on an even date will not be
offered MFC. They will be considered the “control” group and are expected to access community services as they normally would. 
staff will
recruit ALL Baltimore City residents who give birth at Sinai Hospital, regardless of odd/even birth date, while they are still in the hospital/maternity ward and with post-
discharge outreach. If a mother who gives birth on an odd date declines the MFC program, she will still be recruited into the research study. Given that the effects of MFC
are a key study question, and MFC is being provided on a random-assignment basis according to child birthdate, this study follows a RCT design. At the same time, we
note that its approach is different than many RCT’s, in that prospective research participants are not being explicitly invited to be randomized.
3
* Describe the relevant prior experience and gaps in current knowledge. Describe any relevant preliminary data:
While nurse home visiting programs have been shown to be effective in reducing infant injuries and improving outcomes for children and families, Family Connects is the
first nurse home visiting program to be implemented on a community-wide scale. Evaluations of the Family Connects Program has been conducted by Dodge and
colleagues in Durham, North Carolina (Dodge et al., 2013; 2014), demonstrating positive effects such as reduced infant emergency room use and overnight hospital
stays, increased families’ use of community resources, and improved family well-being. No randomized controlled trials of Family Connects have occurred outside of
North Carolina, however. The proposed study seeks to expand the research on the Family Connects Program and assess its outcomes in a mid-sized, mid-Atlantic city.
4
* Provide the scientific or scholarly background, rationale, and significance of the research and how it will add to existing
knowledge:
Nurse home visiting programs have been shown to be effective in reducing infant injuries and improving outcomes for children and families. Dodge and colleagues’
(2013; 2014) initial evaluations of Durham Family Connects demonstrated the efficacy of a community-wide brief, targeted nurse home visiting program for reducing
infant emergency room use and overnight hospital stays, increasing families’ use of community resources, increasing families’ use of high-quality child care, and
improving other aspects of family wellbeing such as home safety and supportive parenting by both parents. In addition, recent unpublished data from Dodge et al.
indicate positive effects on official investigations of child maltreatment. The proposed study will add to existing research by evaluating the Maryland Family Connects
program in one community in Baltimore, MD.
 
ID: VIEW4E02805EA0C00
Name: v2_Justification, Objective, & Research Design
View: v2_Supporting Literature
Supporting Literature
 
1
* Provide a summary of current literature related to the research: If you uploaded a separate research protocol
document in the ‘Research Protocol’ page, cite the applicable section and page numbers from that document in
the answer box below.
Family Connects is a universal nurse home visiting program designed by Dodge and colleagues at Duke University (Dodge et al., 2013; 2014). Family Connects is the
first program of its kind to be implemented on a community-wide scale. Family Connects was developed as a brief, universal, postnatal nurse home visiting intervention
intended to screen for risk, provide brief intervention, and connect families with more intensive evidence-based services as needed. Family Connects is not intended to
be a substitute for intensive programs or services, but is meant to serve as a universal screening to ensure that families are matched with services within their own
communities that most appropriately meet the identified needs. A primary goal of Family Connects is to reduce the incidence of infant injury and use of emergency
medical care in the first year of life.
Family Connects is available to every family in the designated catchment area. Once screening has occurred, however, families with higher needs are triaged and
referred to appropriate services. 
Family Connects is highly structured and consists of 3 to 7 scripted in-person or telephone contacts, with the first contact is at the hospital immediately following the
infant’s birth followed by 1 to 3 nurse home visits when the child is 3 to 8 weeks old, 1 or 2 nurse contacts with community service providers and/or maternal and infant
health care providers, and an in-person or telephone follow-up conversation 1 month later.
During the home visits, the nurse establishes rapport with the mother (and father or other family members, when possible), provides brief education about infant care,
parenting and child development (organized as 20 “teaching moments”), and assesses health and psychosocial risk in each of 12 domains: parenting/childcare (child
care plans, parent-infant relationship, and management of infant crying), family safety (material supports, family violence, past maltreatment), parent mental health
(depression/ anxiety, substance abuse, emotional support), and health care (parent health, infant health, and health care plan). A score of 1 (low risk) in a particular area
requires no further intervention. With a score of 2 (moderate risk), the nurse delivers a brief intervention on the topic, usually consisting of 1 to 3 sessions. For a score of
3 (high risk), the nurse uses motivational interviewing – an evidence-based approach to behavioral change – to connect the family with community resources appropriate
to meet the identified need (e.g., mental health counseling, financial resources or treatment for substance abuse). A score of 4 (imminent risk) requires emergency
intervention. The nurse makes a final visit or phone call 4 weeks after completing the case, to reinforce community connections.
Dodge and colleagues randomly assigned every (even /odd) hospital birth in Durham County, North Carolina over a period of 18 months (N = 4777). They reported a
Family Connects participation rate of 80% of the community population of families of newborns and 84% fidelity to the Durham Family Connects protocol. Hospital
records were analyzed using an intent-to-treat approach to evaluate impact among a representative subset of 549 families.
Dodge et al. (2013) found that families assigned to intervention had 50% less total emergency department use across the first 12 months of life, controlling for
demographic factors. They concluded that nurse home visiting can be implemented universally at high fidelity with positive impacts on infant emergency department
usage that are similar to those of longer, more intensive home visiting programs. This approach was viewed as offering a novel solution, achieving population-level
impact through an individually tailored intervention.
The proposed study will be the first RCT of the Family Connects program outside of Durham, NC.
 
2
If available, upload your applicable literature search: 
Name
Created
Modified Date
 
Dodge et al. 2014: Implementation and randomized controlled trial evaluation of universal postnatal nurse home visiting
2/6/2019 2:46 PM 2/6/2019 2:47 PM
 
Dodge et al. 2013: Randomized controlled trial of universal postnatal nurse home visiting: Impact on emergency care.
2/6/2019 2:46 PM 2/6/2019 2:47 PM
 
 
 
 
ID: VIEW4E02805A7E400
Name: v2_Supporting Literature
View: v2_Study Procedures
Study Procedures

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1
* Describe all procedures being performed for research purposes only (these procedures would not be done if individuals were
not in the study) and when they are performed, including procedures being performed to monitor subjects for safety or to
minimize risks: 
Research staff will visit the Sinai Hospital maternity ward on a daily basis. They will receive regular updates from maternity and MFC staff about new births to Baltimore
City residents. For approximately one year and a half starting July 15, 2019, all Baltimore City residents who give birth on an odd date at Sinai Hospital will be offered
MFC by nurse home visitors employed by 
. From July 15, 2019 – January 14, 2021, research staff will approach ALL new mothers (Baltimore City
residents giving birth on even or odd dates) within 1-3 days of the birth of the baby, while they are still in the hospital/maternity ward. The researchers will provide
mothers with a brief description of the study and a 1-page information sheet (attached). The researchers will request permission to contact the mothers when their infants
are approximately 6 months old to schedule the in-home psychosocial interview. During the hospital meeting, the researchers will confirm mothers’ contact information
and share their own contact information. 
For those mothers who were unable to complete the recruitment process (e.g. because of interruptions by medical staff or visitors, patient falling asleep), our study team
will use the phone number provided by Sinai Hospital to call the mother. Similar to in-person recruitment, during the phone call it will be explained that we are conducting
a study about what it’s like to raise a baby in Baltimore City with mothers who gave birth at Sinai Hospital and are city residents. We will explain that the study is being
conducted in partnership with Sinai Hospital, read through the 1-pager, confirm contact information, and ask her permission to be contacted for a psychosocial interview
when her baby is about 6 months old. For those mothers who are discharged before starting the recruitment process, our study team will send a letter and the project’s 1-
pager to the address provided by Sinai Hospital that introduces the study and states that we will be calling. We will then call using the aforementioned protocol.
All mothers who agree to be contacted will also receive 5 monthly postcards providing a “fun fact” about typical infant developmental milestones. In addition, a member of
the research team will send mothers one text message per month from the RA's work cell phone. These text messages will remind them that we will be inviting them to
participate in the psychosocial interview around the time of their infant’s 6-month birthday. These postcards and text messages will serve the secondary purpose of our
staying in touch with the prospective participants and becoming aware, in real time, of any changes in address or phone numbers. Research staff will copy/paste the
monthly text message from the Notes app or manually type in each message. If a mother texts the RA’s work cell phone with questions about the study, the RA will
respond with the appropriate information (e.g., interview location). In cases where a mother may disclose concerning information (e.g., depressive symptoms),
information about mental health resources will be provided. This list will include resources from 
and other appropriate community referrals. 
Mothers who agreed to be contacted about the research visit will receive a call from a research assistant asking to schedule an in-home or virtual interview at a time
when the child is typically awake and alert, when no or few other family members will be present, and when there will be an opportunity for the mother and research
assistant to talk privately. The in-home research visit, which will take approximately 60 minutes, will be conducted by a 2-person team of research assistants. The use of
2-person teams will maximize the safety of the RA’s in the community as well as the efficiency of the research protocol. Typically, RA #1 will focus on the mother while
RA #2 handles assessment logistics including smooth presentation and removal of any assessment materials, and assistance with caring for the target child and any
other children in the home. For in-home interviews, the following procedures will be conducted: (a) informed consent procedures (described in detail under Recruitment,
below); (b) the psychosocial interview. Upon completion of these procedures, mothers will be paid $50 cash and will receive a list of mental health resources. 
The virtual interviews, which will take approximately 60 minutes, will be conducted by one research assistant through a video conferencing platform (Zoom, FaceTime,
Skype, or Webex) or by phone. The following procedures will be conducted: (a) verbal informed consent procedures (described in detail under Informed Consent below);
(b) the psychosocial interview. One of two payment options will then be provided: cash or electronic gift card. For cash incentives, within one week of the virtual interview,
a team of 2 RA’s will hand deliver $50 cash and list of mental health resources to the participant’s home. The second option, electronic gift cards, will be sent to mothers
via email along with the list of mental health resources.
The psychosocial interview will assess the domains of infant health care, maternal wellbeing, maternal adverse childhood experiences, maternal adult attachment
security, use of community services, including child care, neighborhood collective efficacy (community support), and quality of the home environment, including home
safety and supportive parenting by both mothers and fathers (including non-resident fathers). Basic demographic questions will also be asked. Wherever possible, we will
use standardized and widely used research assessments (e.g., the Edinburgh Postpartum Depression Scale, the 10-item Adverse Childhood Experiences (ACEs)
questionnaire, the Home Observation Measurement of the Environment [HOME] assessment). The principal research assistant (typically RA #1) will administer all
assessments via structured interview, with responses recorded on a secure electronic tablet. RA #1 will complete the following steps before administering the ACEs
questionnaire: 1. Briefly explain what ACEs are and why they are important to understand; 2. Remind participants that their scores are private, but if we learn that an
experience of childhood maltreatment was not reported, we will be legally obligated to consult appropriate authorities about the possibility of making a report; 3. Remind
participants that they can stop at any point, refuse to respond, or talk about how they are feeling; 4. Remind participants that we are providing all participants with a list of
mental health resources, including the phone number for a 24-hour parent hotline staffed by 
. In addition, per HOME protocol, the principal research
assistant will observe, rate, and record several qualities of the home environment and the mother’s parenting behaviors. 
Research staff will monitor participants and minimize risks. These risks include (a) increased maternal sadness or worry evoked by questions about adverse childhood
experiences, and (b) breach of confidentiality. In case mothers disclose risk of self-harm, child maltreatment, or screen positive for postpartum depressive symptoms, a
list of mental health resources will be provided to all participants. This list will include resources from The 
and other appropriate community referrals. Efforts
to monitor and minimize risks will be conducted at every stage of the research process and are detailed below. Breach of confidentiality will be minimized by procedures
for handling data that will safeguard confidentiality. When texting reminders before the 6-month psychosocial interview, full names and confidential identification numbers
will not be used or linked. Research staff will copy/paste the monthly text message from the Notes app or manually type in each message. Moreover, all project cell
phones will be password protected, and these cell phones will be used only by the study team members. Participant names will not be used on any data collection forms.
Participants will be assigned confidential ID numbers. There will be a master list linking participants’ IDs and personal contact information (names, addresses, and phone
numbers). This list as well as the signed project consent forms will be kept in locked cabinets secured within the project office. Only investigators and staff members who
are directly involved in the data collection and processing will have access to the master list or portions thereof. During the home visit, all precautions will be taken to
ensure that the interview is conducted in privacy.
With maternal permission (requested on the consent form), the following records for the target child will be will be accessed and analyzed: (a) records from Sinai Hospital
and/or the Maryland Department of Health; (b) records from the Maryland Department of Human Services; (c) records from the Maryland Family Connects program; and
(d) records the Maryland State Department of Education, all of which will be reviewed for child health and family service needs and receipt until the target child is 6 years
of age. 
The University of Maryland School of Social Work’s Ruth Young Center, directed by Dr. Terry Shaw, has ongoing collaborative relationships with the local and state
entities who will provide these data
eam will work directly with the Ruth Young Center to access the relevant data. Following established
protocol, electronic data will be accessible to a single data manager and the manager’s assistant, both of whom will be highly trained in confidentiality procedures and
ethics. In some cases, these individuals will be responsible for reviewing administrative data and matching cases with identifying information for those who have
consented to have their child’s records accessed and analyzed. In other cases, the agency/holder of the data will conduct the matching processes. In both cases, once
the data are matched and appropriately linked to the current study data, identifiers other than study ID will be removed, and data will be shared with the statistician and
investigators for analysis via file sharing on a secure server. The administrative data will remain in separate files on a stand-alone hard drive, accessible only to the data
manager and the assistant. Identified data will thus never be viewed by other study staff (statisticians or investigators).
As noted above, once this UMB IRB protocol has been approved, we will apply for additional regulatory documents from Sinai Hospital, 
, and other
relevant IRB’s. These outside agencies typically require an approved IRB from the requesting researcher’s home institution before considering any data requests.
 

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
Psychosocial or behavioral interventions

Neuropsychological or psychophysiological testing

Deception

Other psychosocial or behavioral procedures
 
 
 
ID: VIEW4E09416F57800
Name: v2_Psychological/Behavioral/Educational Methods and Procedures
View: v2_Surveys/Questionnaires
Surveys/Questionnaires
You indicated that this study involves surveys and/or questionnaires.
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VHFWLRQDQGSDJHQXPEHUVIURPWKDWGRFXPHQWLQWKHDQVZHUER[HVEHORZ
1
* List all questionnaires/surveys to be used in the study, including both standardized and non-standardized assessments:
The psychosocial interview will assess the domains of infant health care, maternal wellbeing, maternal adverse childhood experiences, maternal adult attachment
security, use of community services, including child care, neighborhood collective efficacy (community support), and quality of the home environment, including home
safety and supportive parenting by both mothers and fathers (including non-resident fathers). Basic demographic questions will also be asked. Wherever possible, we
will use standardized and widely used research assessments (e.g., the Edinburgh Postpartum Depression Scale, the 10-item Adverse Childhood Experiences (ACEs)
questionnaire, the Home Observation Measurement of the Environment [HOME] assessment).
2
* Upload a copy of all questionnaires/surveys:
Name
Created
Modified Date
 
BBP 6-month Psychosocial Interview
2/7/2019 2:37 PM
1/24/2020 2:39 PM
3
* What is the total length of time that each survey is expected to take?
We have one psychosocial survey that we expect will take 60 minutes to complete.
4
* Are any of the questions likely to cause discomfort in participants or cause harm if their confidentiality were breached?  (i.e.,
Illegal activities)
  ā Yes ý No
5
* Do any questions elicit information related to the potential for harm to self or others?
  ā Yes ý No
5.1
If Yes, what procedures are in place to assure safety?
We are explicit in the consent and assent forms that we are mandated reporters. If we learn that keeping specific information private would put the participant or others in
danger, we may discuss it with them, if possible, or voluntarily seek help from appropriate authorities to protect the participant or the other person. This includes if there
is a risk of the participant hurting themselves. If we learn of any risks to the child’s safety (for example, child abuse or neglect) or unreported childhood maltreatment, we
inform the participant that we will report any concerns to the authorities. We will have a list of mental health resources to provide to all participants.
 
ID: VIEW4E09460F5EC00
Name: v2_Surveys/Questionnaires
View: v2_Clinical Trial Registration
Clinical Trial Registration
You indicated on the "Type of Research" page that your study is a clinical trial.
1
* Does the UM Clinical Trials Registry policy require registration of this trial?
  ý Yes ā No
2
* Has this trial been registered?
  ā Yes ý No
 
ID: VIEW4E093BF078C00
Name: v2_Clinical Trial Registration
View: v2_Clinical Trial Registration Information
Clinical Trial Registration Information
You indicated that this clinical trial has been registered.
1
* Was this trial registered at www.clinicaltrials.gov?
  ā Yes ý No
2
If no, was this trial registered on a site other than clinicaltrials.gov?
  ý Yes ý No

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harm to the mother or her child(ren) (e.g., significant alcohol or other substance abuse by mother, leaving marks on her child from discipline). If such information raises
reasonable suspicions, the research assistant, in collaboration with their supervisor and/or the PI, will make a Child Protective Services report. Every effort will be made
to discuss these reports with the mother in advance, and with the mother’s MFC nurse, except when it is deemed dangerous to the child or to the person filing the report
to do so. We will permit mothers to be involved in reporting the maltreatment themselves if they choose, which can reduce the stress that a mother may experience as a
result of a report being made. We will also discuss with mothers any concerns about involvement of Child Protective Services. This protocol has been used successfully
in the past by PI Berlin and colleagues. Mandatory reporting requirements for suspected instances of abuse, neglect, and risk of harm to self or others are explicitly
described in the consent form. 
Breach of confidentiality is unlikely. Provisions for minimizing: The data collected for the study will be used for research purposes only, according to protocols that are
reviewed and approved by the UMB IRB. All investigators and research staff will be certified by the UMB IRB, which includes training in handling confidential information.
Procedures for handling data will also safeguard confidentiality. When texting reminders before the 6-month psychosocial interview, full names and confidential
identification numbers will not be used or linked. Moreover, all project cell phones will be password protected, and these cell phones will be used only by the study team
members. Participant names will not be used on any data collection forms. Participants will be assigned confidential ID numbers. There will be a master list linking
participants’ IDs and personal contact information (names, addresses, and phone numbers). This list as well as the signed project consent forms will be kept in locked
cabinets secured within the project office. Only investigators and staff members who are directly involved in the data collection and processing will have access to the
master list or portions thereof. 
Data security will be carefully monitored in the data collection, processing, and analysis stages. Original paper data will be kept in locked compartments separate from
the master list and from access information. Electronic data will be stored on a secure network, with password protection such that only authorized users will have access
to the network. Any temporary data files kept on removable storage devices and printouts from data analysis will be stored in locked compartments when not in use.
Original paper files that contain identifying information will be destroyed at the conclusion of the research. Published data from the proposed study will typically be in the
form of group-level data and will not permit identification of individuals. If any individual-level information is disseminated, care will be taken to disguise the identifying
characteristics of the individual.
 
ID: VIEW4E1B52509F000
Name: v2_Research Related Risks
View: v2_Potential Benefits and Alternatives
Potential Benefits and Alternatives
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1
* Describe the potential direct benefit(s) to participants:
There are no direct benefits to research participation. Randomly assigned intervention participants are anticipated to benefit from intervention participation.
2
* Describe the importance of the knowledge expected to result from the study:
Family Connects is the first program of its kind to be implemented on a community-wide scale. Family Connects was developed as a brief, universal, postnatal nurse
home visiting intervention intended to screen for risk, provide brief intervention, and connect families with more intensive evidence-based services as needed. A primary
goal of Family Connects is to reduce the incidence of infant injury and use of emergency medical care in the first year of life. Understanding the feasibility and efficacy of
Maryland Family Connects will contribute importantly to the nurse home visiting and community intervention literatures. Findings from this study will also have
implications for Maryland infant and maternal health policy.
3
* Describe how the potential risks to participants are reasonable in relationship to the potential benefits:
This is a minimal risk study. The primary risk in this study is that participants may experience some interview questions as intrusive or uncomfortable. As described,
however, the research team will provide a list of local mental health resources to all participants. This will offer support to those who may feel uncomfortable, who have
disclosed risk of self-harm, childhood maltreatment, have screened positive for depression, or need additional support as a result of their participation in the study.
4
* Describe the alternatives to participation in this study. If there are no alternatives, state that participation is voluntary and
the alternative is not to participate. For intervention studies, describe appropriate alternative clinical procedures or courses of
treatment available to subjects.
Participation is voluntary and the alternative is not to participate. The voluntary nature of participation will be explained during the initial contact and during the consent
process, and that there will be no impact of non-participation. Similarly, the right to withdraw at any point in the study will be explained.
 
ID: VIEW4E1B5251B0400
Name: v2_Potential Benefits and Alternatives
View: v2_Withdrawal of Participants
Withdrawal of Participants
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1
* Describe anticipated circumstances under which subjects will be withdrawn from the research without their agreement:
The PI of this research study or the sponsor can remove a participant from the study without the participant's approval. Possible reasons for removal include passive
withdrawal (i.e., regularly failing to keep appointments) and/or the PI deciding that the study is no longer in a participant's best interest. The funder could also end the
research study earlier than planned.
2
* Describe procedures for orderly termination:
First, study participants have the right to withdraw from the study at any time. If a participant decides to withdraw, all research activities will halt, and already collected
data will stay in the study database. The research team will ask whether we can continue to access and analyze child health and family services information. If they
agree, this data will be handled the same as the other research data. If they don’t agree, we will stop collecting their information.
A written statement requesting withdrawal from the study will be requested but not required. Second, the PI of this research study or the sponsor can remove a
participant from the study without the participant's approval. Possible reasons for removal include passive withdrawal (i.e., regularly failing to keep appointments) and/or
the PI deciding that the study is no longer in a participant's best interest. The funder can also end the research study earlier than planned. In these cases, every effort will
be made to inform the participant that their participation has been terminated and to document termination reasons and procedures. In the event that a participant fails to
continue their research or program appointments and does not maintain communication with research staff, they will be notified in writing that they have been removed
from the study.
3
* Describe procedures that will be followed when subjects withdraw from the research, including partial withdrawal from
procedures with continued data collection:
A participant may choose to withdraw from the study at any time by notifying research or program staff verbally, at which time the staff person will request permission to
use any existing data that has been collected from that participant.
 

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3
,%&5HYLHZ&ULWHULD - select 'Yes' if the answer is 'Yes' for any of the following questions. Review by the Institutional
Biosafety Committee may be required.
* 3.1 Does the research involve human gene transfer?
-OR-
Does the research specifically apply to human studies in which induction or enhancement of an immune
response to a vector-encoded microbial immunogen is the major goal, and such an immune response has been
demonstrated in model systems, and the persistence of the vector-encoded immunogen is not expected? This
type of research is often referred to as recombinant vaccine trials.
3.2 Does the research involve the exposure of human subjects to pathogenic microorganisms, or the exposure
of research staff to human subjects or samples known or reasonably expected to carry infectious disease(s)?
3.3 Does the research involve the sampling of materials from persons with no known infectious disease and
where the only risk to study staff is occupational exposure to bloodborne pathogens as defined by the OSHA
Bloodborne Pathogen Standard?
  Yes No
4
&DQFHU&HQWHU&ULWHULD - Answer the following to determine if review by the Cancer Center (Hematology-Oncology) may
be required.
* Does the protocol involve in any way studies related to the prevention, treatment, diagnosis, or imaging of
neoplastic diseases?
  Yes No
5
*HQHUDO&OLQLFDO5HVHDUFK&HQWHU5HYLHZ&ULWHULD - the GCRC offers free and/or cost shared resources for patient-oriented
research. Click Here for more information.
Answer the following to determine if review by the GCRC may be required.
* Will the General Clinical Research Center (GCRC) facility or resources be used to conduct this activity?
  Yes No
6
9$5HYLHZ&ULWHULD - Answer the following questions to determine if review by the VAMHCS R&D Committee may be
required.
* 6.1 - Will the research be conducted by VA Investigators including PIs, Co-PIs, and Site Investigators on VA
time (serving on compensated, WOC, or IPA appointments)?
  Yes No
* 6.2 - Will the research utilize VA resources (e.g., equipment, funds, medical records, databases, tissues, etc.)?   Yes No
* 6.3 - Will the research be conducted on VA property, including space leased to and used by VA?
  Yes No
PLEASE NOTE that the research may be funded by VA, by other sponsors, or may be unfunded.
 
ID: VIEW4E1AF91AB2400
Name: v2_Organization Review Requirements (other than IRB)
View: v2_Summary of Required Reviews (other than IRB)
Summary of Required Reviews (other than IRB)
 1
Additional Committee Reviews  - Based on your responses to the previous questions, you have identified the following additional reviews.  To complete or view these
additional committees'  forms, click on the links below or exit this application and click on the appropriate button on left side of this submission's webpage.
Name of Related Submission
 
 
This protocol has no related submissions (RSC, GCRC, IBC, etc)
2
Required Department and Specialty Reviews - Based on the PI's organization (department, division, etc.) affiliation and answers to previous questions (use of Cancer
Center, etc.), the organizations listed below are required to review this application.  These reviews are conducted online and no additional forms or steps by the study
team are required.
Name of Organization
Review Status
School of Social Work
Complete
Pediatrics
Complete
 
ID: VIEW4E1C8D9AE4000
Name: v2_Summary of Required Reviews (other than IRB)
View: v2_Additional Documents
Additional Documents
1
Upload all additional documents here:
Name
Created
Modified Date
 
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2/6/2019 7:36 PM
 
2/6/2019 7:36 PM
 
2/6/2019 7:36 PM
 
ID: VIEW4E0962513A000
Name: v2_Additional Documents
View: v2_Final Page of Application
Final Page of Application
 
 
You have reached the final page of this application.  It is recommended that you click on the "Hide/Show Errors" link on the upper or lower breadcrumb row of this
page.  The "Hide/Show Errors" will do a search of your application, and highlight areas that are required or need to be completed prior to submitting. 
 
By submitting this application, you are electronically routing the protocol for departmental scientific review and all other necessary reviews. According to information you
have provided, this application will be routed to the following Departments for review prior to being forwarded to the IRB for review.  These reviews are conducted online
and no additional forms or steps by the study team are required.
 
Name of Organization
Review Status
School of Social Work
Complete
Pediatrics
Complete
 
 
 Required Safety Committee Reviews - In addition to the IRB, the following committees must review this submission. Each additional committee has a separate online
form that the study team will be required to fill out. All committee applications (IRB plus those listed here) must be completed properly before the 'package' of applications
can be submitted. The team may complete these additional forms in any order or at any time prior to submission of the IRB Application. To complete or view these
additional committees' forms, click on the links below or exit this application and click on the appropriate button on left side of this submission's Workspace.
 
Name of Related Submission
 
 
This protocol has no related submissions (RSC, GCRC, IBC, etc)
 
You may check the progress of your application at any time by returning to the Workspace of this submission. A detailed history, including notes, dates, and times of
events, is provided to you for this purpose. 
 
If a reviewer returns the application to you, you must address their concerns and resubmit the protocol for review to all designated departments.  After all departments
have reviewed the application, it will automatically be sent to the IRB for review.  Changes made to the submission after its approval must be submitted as modifications.
 
Investigator Attestation
By submitting this application, I, the Principal Investigator (PI), certify that the information provided in this application is complete and correct. Research will be conducted
according to the submission as described, only by the approved principal investigator and study team members.
 
In addition, I agree to the responsibilities of a PI, including:
Obtaining informed consent (if applicable) from all subjects as outlined in the submission.
Reporting new information to the IRB per the requirements of the Investigator Manual.
If Required, obtaining renewal of the protocol prior to the expiration of the approval period or halt all study activities upon study expiration.
Accepting ultimate responsibility for the protection of the rights and welfare of human subjects, conduct of the study and the ethical performance of the project.
Ensuring performance of all research activities by qualified personnel according to the IRB approved submission.
Ensuring that research personnel have or will receive appropriate training.
Ensuring no changes will be made in the research until approved by the IRB (except when necessary to eliminate apparent immediate hazards to subjects).
 
 
Click the "Finish" button and then click "Submit Application" in the submission Workspace.
 
 
 
ID: VIEW4E1B10C500000
Name: v2_Final Page of Application
View: IRB - Add a Team Member
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1
 

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Add a Team Member
 
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1
 

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Add a Team Member
 

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* 
 
 
3
 Edit Rights - Should this person be allowed full edit rights to the submission,
including: editing the online forms and the ability to execute activities?  Note - a
person with edit rights will automatically be added to the CC list and will receive all
emails regarding this protocol, even if the answer to #4 below is No.
  
 
4
 CC on Email Correspondence - Should this person be copied on all emails sent by
the HRPO office to the PI/POC? Study team members with edit rights will
automatically receive all emails:
  
 
5
 Does this study team member have a potential conflict of interest, financial or
otherwise, related to this research? 
  
 
 Briefly describe experience conducting research and knowledge of the local study
sites, culture, and society: 
 
 
 
View: IRB - Add a Team Member
Add a Team Member