Initial Review Submission Form (Version 1.

0)

1.0 Initial Review Submission Packet

Note: This is the submission packet. The Study Application should be

attached below under "Study Application Form". To access the attached
"Study Application" , click on the "Edit/View" icon next to it.

To create and attach your consent form(s), go to section "Consent

Documents" below.

To upload and attach any study related document(s) that were not already
attached in the Study Application, go to section "Other Study Documents"
below.

1.1 Study Title:

Needs Assessment for the development of an Integrated Pediatric Assessment Service (iPAS) in Primary
Care-- Phase 2

1.2 IRB Number:

H-44318

1.3 Principal Investigator:

PI Name:

Samantha Diaz, PhD

PI Email Address:

sadiaz@bu.edu

PI Phone Number:

2.0 Study Application Form

2.1 Attach the IRB application you completed for this protocol:
(For an Initial Submission the application will automatically attach for you)

Edit/
Version Title
View

1.0 Study Application (Version 1.0) - Attached

3.0 Consent Documents

3.1 In this section, you can create and attach a new consent/assent form, or revise an existing one and
attach it to this submission. Once this is done, all the new and revised consent/assent forms should
 be listed below as part of this submission (click on the Help (?) icon on the right for instructions):

Sponsor Expiration Consent Checked View

Version Title Category Language
Version Date Outcome Out Document

No Consent(s) have been attached to this form.

4.0 Other Study Documents

4.1 If a document was already attached in the Study Application, DO NOT upload it again here. This will
create duplicates of documents which will need to be voided later. In this section, you can upload and
attach any other study documents (e.g. protocol, investigators brochure, recruitment materials,
instruments, case report forms, study handouts or other miscellaneous documents) that have not
been attached as part of the Study Application. Click on the Help icon (?) on the right for instructions.

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Version Title Category
Version Date Outcome Out Document

No Document(s) have been attached to this form.

5.0 Additional Special Routing

Your submission might be routed automatically to one or more

"Special Routing" signoffs. For more information, click here.
You can track your submission by following the instructions here.
Once all the required signoffs are collected and your submission is
received by the IRB, you will receive a system notification stating
that the submission was received.

5.1 Implicit and Explicit Bias in Research

Boston Medical Center (BMC) and Boston University School of Medicine (BUSM) are committed to equity,
diversity and inclusion across our tripartite mission of patient care, research and education. With regards
to research, embedding principles of equity, vitality and inclusion from study inception through
publication leads to more innovative, creative science that improves health across diverse communities.
Therefore, the Committee to Reduce Implicit and Explicit Bias in Research has recommended systems-
level changes to identify and minimize racism, sexism and other forms of bias in research design and
reporting. Please see the Report from the Committee to Reduce Implicit and Explicit Bias in
Research for further information.

Please complete and attach the following form. The responses to the questions in this form will be
reviewed by the Department Chair/Section Chief at the time of routing sign-off, with the goal of ensuring
that the potential for bias is minimized. If you have any questions about this process and/or completing
this form, please contact Dr. Megan Bair-Merritt at Megan.Bair-Merritt@bmc.org.

Reduction of Explicit and Implicit Bias in Research Form

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Version Date Outcome Out Document

Reducing
Implicit and
Reduction of
1.0 Explicit Bias in
Bias form
Research 27.90 KB
Form
5.3 In-person Interaction at BMC

Does this study involve in-person interaction with research subjects in Boston Medical Center
(BMC) space?

Yes
No

Does this study require study staff to be on-site at BMC to conduct study activities?

Yes
No

5.4 Boston Medical Center Employees

Does this study involve targeting Boston Medical Center Employees (faculty, staff, laboratory
personnel, or trainees) for recruitment? (Answer No if BMC employees might incidentally participate
but are recruited regardless of their employment status.)

Yes
No

5.5 Perinatal Research Review Committee

Does your research fall under any of the following categories:

Research that involves human research subjects from Labor & Delivery, the post-partum inpatient
floors, the neonatal intensive care unit (NICU), or the Well Baby Nursery of Boston Medical Center;
or
Research that solely involves the study of pregnant or inpatient postpartum patients at Boston
Medical Center (including chart review research)

Yes
No

5.6 Cancer or Oncology Research

Does your research fall under any of the following categories?

Trials that are recruiting patients with cancer for treatment of disease or symptoms;
studies pertaining to cancer prevention or detection
studies of cancer survivors, i.e. people who have had a previous diagnosis of cancer.
Studies collecting data on patients with cancer, whether prospectively or retrospectively

Yes
No

5.8 Division of Psychiatry

Does your study fall under any of the following categories:

involves subjects who are being recruited from the psychiatry or behavioral health services at
Boston Medical Center or mental health clinical programs affiliated with Boston Medical Center;
will be utilizing data of patients who are or have been getting psychiatric treatment at Boston
Medical Center or its affiliates; or
will require the assistance of staff or faculty of the Division of Psychiatry at Boston Medical Center
or its affiliates.
 Yes
No

5.9 General Clinical Research Unit (GCRU)

Does the study take place in the GCRU or uses its resources?

Yes
No

5.10 Nursing Department

Is the Principal Investigator of the study a nurse at Boston Medical Center?

Yes
No

5.16 Will any School of Dental Medicine students or residents be involved in the design or conduct of the
research study?

Yes
No

5.17 BMC Clinical Trial Office

Has the CTO Intake Form been submitted to the Clinical Trial Office for this study?

Yes
No

Does your study involve the provision of any of the following Boston Medical Center (BMC)
clinical services or use of BMC infrastructure listed below (if this is a chart review, select “No”) See
Help (?) for more information:

Investigational Pharmacy Service (For study drug maintenance and dispensation. Follow IPS
policy. No offsite study drug storage allowed.)
Investigational Device (IDE) implants
Infusion services
Radiology (e.g. MRI, CT/PET/MUGA Scans)
Pathology (e.g. Histology Slides)
Lab Medicine (Processing or Providing Analysis of blood/tissue samples)
Cardiology (e.g. EKGs)
Ophthalmology (e.g. Retinal Exams)
Performing Physical Exam in BMC clinical space
Drawing Blood in BMC clinical space

Yes
No

5.18 BMC Pathology

Does your study involve procuring and/or processing samples, i.e. tissue or slides, through Pathology at
BMC?

Yes
No
5.19 BMC Laboratory Medicine Services

Does your study include activities that requires the involvement of Laboratory Medicine services at BMC
including but not limited to specimen procurement, lab testing, phlebotomy, point of care testing such as
urine pregnancy, use of lab CLIA, etc?

Yes
No

5.23 BMC Research Technology Program (RTP)

Does your study include any of the following? (Note that these criteria are referring to use of proposed
*new* technology or *new* software that is not currently being used at BMC; rather, the new
technology or software is being implemented for the purposes of this research study).

• Technology is being used at BMC to further the care of BMC patients as part of the research study; or
• Technology is used to gather data from Boston Medical Center patients for research purposes; or
• Software that is used as part of the research study is integrating with existing software hosted by
Boston Medical Center

Examples include, but are not limited to, Epic EHR build(s), use of new servers, data integrations for
research, and study-specific 3rd party software use-case review.

Yes
No
 Study Application (Version 1.0)

1.0 General Information

*Please enter the official title of your study:

Needs Assessment for the development of an Integrated Pediatric Assessment Service (iPAS)
in Primary Care-- Phase 2

*Please enter the Study Nickname you would like to use to reference the study:

Needs Assessment for Pedi IPAS-- Phase 2

* This field allows you to enter an abbreviated version of the Study Title to quickly identify this
study.

2.0 Add Department(s)

2.1 List departments associated with this study (Note: The primary department should
accurately reflect the primary Department or Section of the PI. Please verify that the primary
department listed is correct (in some cases the "default" department of BU/BMC Medicine
has been selected). For large departments, the PI's appropriate "section" should be listed as
the primary department (e.g. if the PI is from Neurology or Infectious Disease). If the PI is
from the SPH - select the appropriate department within SPH (e.g. Epidemiology) as
primary.):

Primary
Department Name
Dept?
BMC/BUMC - BMC - Psychiatry

3.0 List of Internal (BMC/BUMC) Study Personnel. All personnel listed in this
section will have access to this study (limited or full access).

3.1 * Please add a Principal Investigator for the study:

(Note: Only faculty members can serve as Principal Investigators on IRB protocols for
studies at the School of Dental Medicine)

Samantha Diaz, PhD

Select if applicable
Student Resident
Fellow
If the Principal Investigator is a Student, Resident, or Fellow, the name of the
Supervising Principal Investigator (formerly known as Faculty Sponsor) must be
supplied BOTH in Section 3.3 (Study Contact) AND in Section 3.4 (Supervising Principal
Investigator) below.

3.2 If applicable, please select the Research Staff personnel. Individuals must be listed if they
will have contact with research subjects or their identifiable data in the performance of any
research related activities, including enrollment, consenting, collection of study data,
interventions, long-term follow-up or data analysis, either as Co-Investigators in A) or as
Research Support Staff in B).
A) Additional Investigators

Depestre, Sohenga, PsyD

Co-Investigator
Fuchs, Cara, PhD
Co-Investigator

B) Research Support Staff

Baul, Tithi Devy, MPH

Data Manager/Analyst
Perez, Daisy Carolina, MPH
Project Manager

3.3 *Please add a Study Contact:

Baul, Tithi Devy, MPH

Depestre, Sohenga, PsyD
Diaz, Samantha, PhD
Fuchs, Cara, PhD
Perez, Daisy Carolina, MPH

The Study Contact(s) will receive all important system notifications along with the Principal
Investigator. The study contact(s) are typically either the Study Coordinator or the Principal
Investigator. A Study Contact must also be listed in Section 3.1, 3.2, 3.4, or 3.6. If the PI is a
student, resident, or fellow, the Supervising Principal Investigator MUST be entered here.

3.4 If the PI is a student, resident, or fellow, you MUST add the Supervising Principal
Investigator here:

3.5 Please ONLY list the PI's Department Chair/Section Chief below. The system will
automatically route for signoff to any additional "Special Routing" approvals, so please do
not list those here.

Henderson, David Carlton, MD

Department Chair/Section Chief

**Add the name of the individual authorized to approve and sign off on this study from your
Department (e.g. the Department Chair or Dean). This should be someone other than the Principal
Investigator. For more information, click here.

3.6 If applicable, please select the Administrative Assistant(s):

Perez, Daisy Carolina, MPH

List here anyone performing administrative tasks only (not engaged in research and having no
contact with subjects or identifiable data; where training and COI disclosure are not required) An
Administrative Assistant can also be a Study Contact.

4.0 Review Path Determination

4.1 Review Path Determination
 This project meets the definition of Not Human Subject Research (NHSR). Examples are non-research
Quality Improvement/Quality Assurance projects; studies that involve obtaining anonymous data
/tissues or coded data; or BMC/BU Medical Campus is not 'engaged' in human subjects research.
BMC/BU Medical Campus (the Relying Institution) cedes IRB review to another institution (the
Reviewing Institution) under an Authorization Agreement.
The only research activities in this study involve chart reviews.
This study fits into one or more of the federal Exempt categories or the study does not have external
funding and fits into one or more of the Equivalent Protections Exempt categories.
None of the above. This study requires Expedited review or the review of the Full Board.

4.2 Emergency Use Report

Is this a report of an Emergency Use of an Investigational Drug or Device that has already
occurred? For more information, click here. If Yes, please click here for a guidance document that will
provide step by step instructions on how to submit this emergency use to the IRB.

Yes No

4.3 Individual Patient IND

Is this application for an FDA approved Individual patient (single use) IND under 21 CFR 312.310? If
Yes, please click here for a guidance document that will provide step by step instructions on how to
submit this individual patient IND use to the IRB.

Yes No

4.4 Humanitarian Use Device

Is this application for an FDA approved Humanitarian Use Device under 21 CFR 814?

Yes No

5.0 Required Training and Conflict of Interest

5.1 BMC/BU Medical Campus Institutional Requirements for training

The PI confirms the following:

All individuals at Boston Medical Center or Boston University Medical Campus who will have contact with
subjects or their identifiable data have been listed on this application in Section 3.0 (including those who will
obtain informed consent, analyze identifiable data, perform study interventions, recruit subjects, etc.)

All individuals listed in Section 3.0 have completed their INSPIR profile or have been asked to do so.

All individuals listed in Sections 3.1, 3.2, and 3.4 are up to date with human subjects training and with GCP
training if required. For more information, click here.

5.2 Conflict of Interest Disclosure

I confirm that all those responsible for the design, conduct, or reporting of the proposed program, including at
minimum, all Senior/key personnel in the grant application, will, before this application is submitted, have completed
the required financial interest disclosure through COI Smart for Boston Medical Center or through the Financial
Interest Disclosure form for Boston University (for contact info, click on the (?) Help icon). NOTE: The IRB
considers any missing financial interest disclosures to be noncompliance by the Principal Investigator.

I confirm
 Of the financial interest disclosure forms that will be completed, will any significant financial
interests that are related to the research be disclosed?

Yes No

6.0 Exemption Categories

6.1 Categorical Exemptions

Certain types of human research studies can be designated as exempt if all of the study
activities fit into one or more specific categories and the study is minimal risk.

Prisoners: Research on prisoners (incarcerated subjects) qualifies for Exempt categories (4.1), (4.2), (9),
(10), and (11), but only if the research is aimed at involving a broader subject population and only
incidentally includes prisoners.

Drugs/Devices: Research on drugs/devices does NOT qualify for any exempt category.

Substance Use Disorder Programs: Research with external funding and research involving interaction with
or data from subjects identified as patients at a BMC federally-assisted substance use disorder clinic(s)
[see the (?) Help icon for the list of such clinics) does NOT qualify for categories (9), (10), (11), (12), or
(13).

Retention of Data and Samples for Extra Use: Research involving the retention of biological samples or
data for extra use by the study investigator(s) or by other investigators qualifies for categories (9), (10),
(12), and (13). Extra use means any analysis that is in addition to that required for the study endpoints.
Research with the sole purpose of establishing a repository does NOT qualify for any exempt category.

For more information, click here.

Please select the most appropriate exempt categories from the list below.

(1) Educational Research: Research conducted in established or commonly accepted educational

settings, that specifically involves normal educational practices. For research submitted for initial exempt
determination on or after July 1, 2017, the research must not be likely to adversely impact students’
opportunity to learn required educational content or the assessment of educators who provide instruction.
This exemption includes most research on regular and special education instructional strategies, and
research on the effectiveness of or the comparison among instructional techniques, curricula, or
classroom management methods.

(2.1) Anonymous surveys/interviews/focus groups: Research that only includes interactions

involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures,
interview procedures or observation of public behavior (including visual or auditory recording), if the
information obtained is recorded in such a manner that the identity of the human subjects CANNOT
readily be ascertained, directly or through identifiers linked to the subjects. In most cases this category
does not apply to children.

(2.2) Identifiable surveys/interviews/focus groups: Research that only includes interactions

involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures,
interview procedures or observation of public behavior (including visual or auditory recording), if the
information obtained is recorded in such a manner that the identity of the human subjects CAN readily be
ascertained, directly or through identifiers linked to the subjects. In most cases this category does not
apply to children.

(3.1) Anonymous behavioral research: Research involving benign behavioral interventions in

conjunction with the collection of information from an adult subject through verbal or written responses
(including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and
information collection and if the information obtained is recorded by the investigator in such a manner
that the identity of the human subjects CANNOT readily be ascertained, directly or through identifiers
linked to the subjects.

(3.2) Identifiable behavioral research: Research involving benign behavioral interventions in

conjunction with the collection of information from an adult subject through verbal or written responses
(including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and
information collection and if the information obtained is recorded by the investigator in such a manner
that the identity of the human subjects CAN readily be ascertained, directly or through identifiers linked
to the subjects.

(4) Anonymous secondary use of data/specimens: Secondary research involving the collection or
study of data, documents, records, pathological specimens, or diagnostic specimens, if these sources are
publicly available or if the information is recorded by the investigator in such a manner that subjects
cannot be identified, directly or through identifiers linked to the subjects, the investigator does not
contact the subjects, and the investigator will not re-identify subjects. (if selected, check all that apply
below):

(5) Federal research: Research and demonstration projects that are conducted or supported by a
Federal department or agency or otherwise subject to the approval of department or agency heads (or
the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to
conduct the research and demonstration projects), and that are designed to study, evaluate, or otherwise
examine: public benefit or service programs, including procedures for obtaining benefits or services under
those programs, possible changes in or alternatives to those programs or procedures, or possible changes
in methods or levels of payment for benefits or services under those programs.

(6) Food research: Taste and food quality evaluation and consumer acceptance studies, (i) if
wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food
ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental
contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by
the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of
Agriculture.

(7) Reserved.

(8) Reserved.
 (9) Identifiable use of non-research data/specimens: Research without external funding involving
materials (data, documents, records, or specimens) that have been or will be collected solely for
nonresearch purposes (such as medical treatment or diagnosis). Please note that this exemption cannot
be used for data from the BMC federally-assisted substance use disorder clinics (Project RESPECT, Office-
Based Addiction Clinic, CATALYST Clinic, or others - see (?) Help Icon for full list)

(10) Identifiable use of existing research data/specimens: Research without external funding involving materials
(data, documents, records, or specimens) that have been collected for research purposes when the consent for the
research does not preclude such additional research.

(11) Quality Improvement research: Research without external funding that involves Quality
Improvement/Quality Assurance where
a. All patients who get an intervention are expected to benefit; and
b. All measurements that are collected are to determine the effect of the process change; and
c. All patients involved in the intervention receive standard care at a minimum; and
d. The intervention meets evidence-based or consensus-based quality standards; and
e. Confidentiality protections are appropriate to the sensitivity of the data collected; and
f. Obtaining consent from the patients for the intervention is not practicable because the
change or intervention will be carried out in a clinical setting where there is no meaningful way for
patients to opt out of receiving the intervention.

(12) Surveys/interviews with children: Research without external funding on children using survey
procedures, interview procedures, focus groups, or observation of public behavior where the investigator
participates in the activities being observed. In order to qualify for exemption in this category, child
assent and parental permission must be obtained with the same disclosures as for abbreviated consent.

(13) Minimal risk research without external funding with adult subjects able to provide abbreviated
consent where the research does not qualify for categories (7) through (12).

6.2 Study Procedures

Provide a description of all the study procedures. Be sure to describe study methods, how you
will select and access data (if applicable), and interventions or interactions with subjects (if
applicable).

A REDCap survey will be administered via email to the pediatric primary care clinical staff including both
medical and behavioral health providers and trainees. The study team will share a REDCap Public Survey
Link to the pediatric primary care operations manager who will then send the survey link to providers who
meet study criteri. Investigators will not collect any identifiers. The survey link will be sent to providers a
maximum of three times to solicit their participation over the course of three weeks. The survey will take
approximately 5 minutes.

6.3 Sample Size/Data Analysis

 Provide an estimate of the anticipated number of subjects who will be enrolled or whose
records will be reviewed. Provide a brief explanation as to the sample size.

We expect our sample size to be 75 individuals. This sample size includes about 61 medical personnel
(including trainees) and 14 behavioral health staff (including trainees) within pediatric primary care.

6.4 Prospective Recruitment and Consent of Eligible Subjects

Describe plans for screening and recruiting potential subjects. Describe how you will obtain
abbreviated consent (see Exempt Information Sheet Template) from subjects prior to
participation. (Note that if your consent process includes obtaining an authorization for use of Protected
Health Information, you must use the Use and Disclosure of Your Health Information language in the
template. If the research is in Exempt category 3.1 or 3.2 and involves deceiving the subjects regarding
the nature or purposes of the research, the abbreviated consent must include informing subjects that
they will be unaware of or misled regarding the nature or purposes of the research.)

Clinical staff will be invited to voluntarily complete the survey via email. The invitation will be sent to
participants by the operations manager in the pediatric primary care clinic, who already has a list of
employees who meet study criteria. Interested clinicians and trainees will click on the REDCap public
survey link which will direct them to a REDCap page that displays the exempt information sheet to review
prior to proceeding with the survey.

7.0 Funding Source

7.1 Funding Source

What is the source of your research funding? If you have multiple sources of funding (including sub-
awards), check all that apply.

Student/Resident/Fellow Research with no External Funding (choose if the PI is a student/resident

/Fellow and the study is student/resident/Fellow research)
Department/Internally Funded (choose if the PI is not a student/resident/Fellow and the study has no
specific funding)
Government
Industry
Foundation/Other
Training Grant (e.g. T32, K-award)

7.2 Study Type

Does this study meet the definition of a clinical trial as defined by the International Committee
of Medical Journal Editors (ICMJE)? (See Help (?) for definition). If you are not certain, please
contact the IRB or BMC/BUMC CTgov PRS Administrator, Karla Damus (damusk@bu.edu, 617-
358-5337) to discuss.

Yes No

If this trial has been registered on ClinicalTrials.gov, please enter the 8 digit NCT number in
the box, below:

This study is:

Initiated by the BMC/BU Medical Campus PI

Other
7.3 Funding Details

For instructions on how to complete this section, click on the Help icon.

BU SAP
Grant
View Contract Number Award
Sponsor Name Sponsor Type
Details Type: or BMC Number
AU
Number

No Sponsor has been added to this Study

7.4 Grants Office

In the check boxes below, please indicate which grants office is handling your award/ sub-award.

BU Office of Sponsored Programs (OSP-med)

BMC Research Finance (RF)

BMC Clinical Trial Office (CTO)

Charles River Campus Office of Sponsored Programs (OSP-CRC)

Other (must list below)

Funding Notifications:

I have received a Notification of Award (NoA)

I have received a Just In Time notice (JIT)
I have received a fundable score for this study.

8.0 Study Summary

8.1 Provide a brief summary of the project in terms understandable to a non scientist (in 500 words or
less). Do NOT copy from a grant application.

This study seeks to expand upon the iPAS needs assessment 1 (chart review). To this end, we will gather
data from medical and behavioral health staff and trainees to better understand their perspective as it
pertains to patient needs re: psychological/neuropsychological assessment. The goal of this study is to
explore their experience diagnosing patients with ADHD and referring patients for psychological
/neuropsychological assessment. Findings will be communicated back to these providers and leadership of
both pediatric primary care and the integrated behavioral health leadership team. These findings will
subsequently support the development and implementation of a psychological testing services as a part of
the already exisitng Integrated Behavioral health services within pediatric primary care.

9.0 Study Site Information

9.1 Select one:

Single site research - conducted by BMC/BU Medical Campus investigator(s)

Multi-site research project - BMC/BU Medical Campus is a research site but is NOT the main study site
Multi-site research - BMC/BU Medical Campus is the main research site and/or the BMC/BU Medical
 Campus Principal Investigator is the overall PI of the entire study or the FDA sponsor

9.2 IRB Authorization Agreement – BMC/BU Medical Campus is the Reviewing Institution

Does this study have or require an Authorization Agreement for External (non-BMC/BU Medical Campus)
investigators who will rely on BMC/BU Medical Campus IRB review? ***

Yes No

***If this study has or will require an IRB Authorization Agreement where BMC/BU Medical Campus
investigators will rely on IRB review by another institution, do not check YES here, but instead, go to
Section 4.1 and check the 2nd option, “BMC/BU Medical Campus (the Relying Institution) cedes IRB
review to another institution (the Reviewing Institution) under an Authorization Agreement.".

10.0 Subjects
10.1 Inclusion Criteria

Include age ranges and sex. If study involves different criteria for different cohorts, please list
separately.

Order
Criteria
Number

Any clinicians (physicians, behavioral health providers, nurse practioners, etc.) who work
1 in Pediatric Primary Care in the Department of Pediatrics (including trainees)

10.2 Exclusion Criteria

Include age ranges and sex. If study involves different criteria for different cohorts, please list
separately. Do NOT duplicate inclusion criteria; if no additional criteria, indicate “None.”

Order
Criteria
Number

Violation of inclusion criteria

1

10.3 Race / Ethnicity

Will the expected demographic breakdown of the study population reflect either the Boston
population or BMC population?

Yes
No

If you answered "No", please explain why below:

Our study population includes clinicians and trainees from Boston Medical Center. While BMC makes an
effort to recruit diver clinicians and trainees, we still expect an overrepresentation of non-Hispanic White
clinicians and trainees to participate in this study.

10.5 Special Populations (for more information, click on the (?) Help icon)
 Please indicate if ANY (even one) of the following populations will be recruited (Note:
Enrollment from any of these categories requires prior IRB approval):

Individuals whose HIV testing status is provided to the study team prior to consent being obtained (e.
g., for recruitment)
Individuals identified as a patient of a federally-assisted substance use disorder clinic (Project
RESPECT, Office-Based Addiction Clinic, CATALYST Clinic, or others - see (?) Help Icon for full list)

Please indicate if any of the following populations will be targeted by your research:

BMC Inpatients
BMC Outpatients
BUGSDM Dental Patients
BMC Residents or Fellows
BU Medical Students and/or Graduate Medical Sciences Students
BU Dental Students
BU School of Public Health Students
Homeless**
Individuals with psychiatric disorders**
Terminally ill patients**

**designated as vulnerable

11.0 Recruitment Procedures/Materials

11.2 Recruitment Material

Attach all study related recruitment documents including, but not limited to, materials such as: posters,
flyers, newspaper ads, script for in-person or telephone recruitment (if any). You may download a
recruitment script template here. Final versions of all materials should be attached. If a video, submit a
link to the content (such as a Vimeo or YouTube link). If a website, provide the URL and attach
screenshots for every page. Note that approved brochures downloaded from here are IRB-approved and
do not need to be attached. PLEASE NOTE: If you are mailing recruitment materials to Boston Medical
Center patients, you must ensure that the patient is not on a DO NOT MAIL list. For more information
click the (?) icon.

Sponsor Expiration Document Checked View

Version Title Category
Version Date Outcome Out Document

No Document(s) have been attached to this form.

Are you using promotional recruitment materials for your research study?

Yes
No

11.4 Will you be recruiting or using data from one or more Boston HealthNet Community Health Centers
(CHC)?

No
Yes*

12.0 Privacy and Confidentiality

12.1 Privacy (Privacy refers to an individual’s control over who has access to him/herself)

Please check one:

The following measures will be used to protect the privacy of subjects and potential subjects:

The information that will be obtained from and/or about subjects and potential subjects is the minimum
necessary to conduct the study; and
If any interventions and interactions occur with subjects and potential subjects, they will take place in private
settings.

Other appropriate measures will be used to protect the privacy of subjects and potential subjects
(describe):

12.2 Confidentiality of the Data

In the section below indicate how the study will ensure subject confidentiality and privacy on
all study data/results, documents, CRFs, and other documents/files:

Study data/results, documents, CRFs, and other documents/files will be identified with a unique study
ID #. The study ID # will be linked to a master-code list that contains all study ID #s and direct
subject identifiers (i.e. name, address, DOB, MRN, etc). The master-code list will be maintained
separately from study files and access limited to the researchers.
All study data, documents, CRFs, and other documents/files will be recorded as anonymous. There is
NO master-code. There will be no reasonable way to link study data and documents to individual
subjects, even temporarily AND subject identities cannot be reasonable ascertained via deductive
disclosure.
There is an alternate plan for how subject will be identified in study data, documents, CRFs, and other
documents/files. Please specify in text box below.

You have checked off that all data are recorded anonymously, meaning that there is no way to
link any of the study data to the individual participants. Please provide a brief study-specific
description of how the data will be recorded anonymously.

The study team will generate one REDCap public survey link to send out to participants. The survey will
not ask for any identifying information. The link will be sent by the pediatric primary care operations
manager so that study investigators do not have acces to the list of clinicians to ensure maximum privacy.

Do you plan to share data with a third-party vendor or software application or program? Some
examples include transcription services and smartphone apps. Note: sponsors are not
considered third parties. Please contact the IRB @ medirb@bu.edu if you have questions about
whether this applies to your study.

Yes
No

13.0 HIPAA Compliance

13.1 Do you need access to protected health information (PHI) without signed authorization from the
individual whose information you need?

Yes
No
14.0 Cost/Payment
14.1 Cost

Please describe the costs of research visits and procedures and who (the sponsor, the subject’s
insurance, or the subject) will be responsible for these costs. If any research costs will be billable to
insurance, the costs to the subjects will include deductibles and co-payments. Costs of travel and/or
parking should be included if the study requires additional visits beyond what would be required for
standard clinical care.

There is no cost to participating in this survey.

14.2 Payment

Will the subject be reimbursed for participating in this study? (e.g. money, gift certificates,
coupons, etc.)

Yes
No

15.0 Study Attachments

15.1 Attach here any remaining study documents that you have not attached in previous sections.

Sponsor Expiration Document Checked View

Version Title Category
Version Date Outcome Out Document

Exempt Exempt
1.0 information Information
sheet Sheet 91.19 KB

Provider
Recruitment
1.0 Recruitment
/Advertising
Email 17.84 KB

iPAS Survey for

1.0 Survey
Clinicians
20.81 KB
BOSTON MEDICAL CENTER AND THE
BOSTON UNIVERSITY SCHOOLS OF MEDICINE,
PUBLIC HEALTH AND DENTAL MEDICINE

RESEARCH INFORMATION SHEET

You are being asked to voluntarily participate in a research study. We are doing this study to assess the
needs of pediatric patients as it pertains to accessing and utilizing psychological testing services. We are
asking you to be in this study because you are a clinician in the pediatric primary care department at
Boston Medical Center. If you agree, we will ask you to complete a survey aimed at assessing your
perception of the needs of your patients as it relates to psychological testing. The survey will take you
approximately 5 minutes to complete.

We will not record your name or any information that shows your identity. The only demographic
information that will be collected is your role within the pediatric primary care clinic. You will not be
signing this form, and the survey will be sent to you via the public survey link option in REDCap to
further ensure your anonymity.

If you have any questions, please contact Samantha Diaz, PsyD, Samantha.diaz@bmc.org, 617-414-2282.

Page 1 of 1
Dear Colleagues,

I am happy to share with you a study entitled: Needs Assessment for the development of an Integrated Pediatric
Assessment Service (iPAS) in Primary Care. The principal investigator of this study is Dr. Samantha Diaz,
PsyD, Assistant Professor of Psychiatry at Boston University School of Medicine and Clinical Psychologist at
Boston Medical Center.

You are receiving this email because you work in the Pediatric and Adolescent Primary Care Clinics at Boston
Medical Center. As such, we are inviting you to participate as a key stakeholder in this project.

This needs assessment will inform the development of a psychological assessment service through the Pediatric
Integrate Behavioral Health (IBH) services in primary care. Psychological Assessment is a testing method that
uses various techniques (including testing batteries, clinical interviews, self-report measures, etc.) to better
understand a person’s behavior, abilities, and personality. This kind of assessment is useful in diagnosing a
myriad of mental health conditions including ADHD, Autism, Learning disabilities, Intellectual disabilities,
gain diagnostic clarity, and much more. Many of the youth served in the pediatric and adolescent clinics present
with questions and concerns that can best be addressed by accessing psychological assessment services. The
goal of this needs assessment is to identify the current needs of this population which will inform the
development of this much needed service.

As a provider within these clinics, we would like to invite you to participate in this needs assessment. We look
forward to this collaboration and meeting the needs of our patients.

Participation in this study will involve approximately 5 minutes of your time to complete the survey. You
will be asked about barriers and facilitators to patients access of psychological testing services, common referral
questions for these services, and will have the opportunity to share any information you think might be relevant
as the team works to create this service.

If you choose to participate, please click on the link to the RedCap survey and answer all of the questions.

We greatly appreciate your consideration of this needs assessment!

Sincerely,

Samantha Diaz, PsyD and Sohenga Depestre, PsyD

_____________
801 Massachusetts Avenue
Crosstown Center, 7th Floor
Boston, MA 02118
Reducing Implicit and Explicit Bias in Research

1. Study H# and Title:

Answer: H-44318 Needs Assessment for the development of an Integrated Pediatric Assessment
Service (iPAS) in Primary Care-- Phase 2

2. Study Summary (may be cut and pasted from IRB sections but please make sure sufficient
information about proposed methods is included):

Answer: This study seeks to investigate the needs of patients within the pediatric primary care clinic as it
pertains to psychological Assessment. Researchers will focus on collecting information from pediatric primary
care clinical staff (physicians, interns, nurses, and behavioral health staff). The survey will focus on
collecting providers perspectives on the clinical needs for patients as it pertains to psychological assessment
(please see specific survey document attached to this application). The purpose for collecting this
information directly from providers is so that we might ensure that our service is highly responsive to the
historical needs of the providers serving our patients. This kind of a service has yet to be implemented
within an Integrated Behavioral Health (IBH) primary care setting, therefore we believe it is important to
document and publish our findings through each step of program development, implementation, and
evaluation. The goal of this project is two-fold, to create a psychological assessment service within primary
care that is uniquely rooted in and responsive to the needs of the patient population and to disseminate the
information we gather as we create this service so that other hospitals might be able to replicate this.

4a. Does your team have the expertise to implement the study as designed, such as experience with
the design (surveys, cohort studies), defining and measuring variables including race/ethnicity or with
the analyses that you are proposing?

☒ Yes

If yes, describe briefly the expertise of each member of the team and their experience with the
proposed methods? If no, what skills are you missing?

Answer: Dr. Diaz is a licensed clinical psychologist who obtained her doctoral degree from William James College
in 2022. She spent two years working as a research assistant at the New York State Psychiatric Institute at
Columbia University Medical Center. Dr. Diaz is currently employed as a clinical psychologist at BMC and is
currently providing direct care, clinical supervision, and program development support in pediatric primary care.
As a clinical supervisor she is currently responsible for training students to conduct psychological assessment and
to this end is actively involved in multiple efforts to integrate psychological assessment into primary care. Dr. Dr.
Depestre is a licensed clinical psychologist who obtained her doctoral degree from William James College in 2022.
She has been a part of several research and quality improvement projects aimed at improving access to behavioral
health care and improving health outcomes for marginalized patients across the lifespan. She is currently
employed as a clinical psychologist at BMC and is providing direct clinical care to patients across the lifespan within
primary care clinics. She is also actively involved in teaching as a summer adjunct professor at her alma mater and
is involved in the Boston University Medical School Family Medicine / Psychiatry residency training program. She
has expertise working with youth and young adults who have experienced significant trauma and other serious
mental illnesses such as first episode psychotic presentations. Dr. Depestre is a clinical supervisor overseeing the
work of a pre-doctoral intern and a postdoctoral fellow providing individual therapy and psychological and
cognitive assessments. She is actively involved in supporting numerous population based initiatives to increase
equitable access to behavioral health and medical care for community members. Dr. Fuchs received her B.A. in
Psychology from Tufts University in 2000, her MPH in Epidemiology from Boston University in 2005, and her Ph.D.
in Clinical Psychology from University of Massachusetts, Boston, in 2011. She served as a Psychology Resident,
Adult Track, at the University of Washington School of Medicine (2010-2011), as an APA Clinical Fellow in Primary

Version 4-14-2021
Care Behavioral Health at Edith Nourse Rogers Memorial VA Hospital in Bedford (2011-2012) and as a Research
Fellow in Integrated Primary Care at the Alpert Medical School of Brown University. She was appointed as
Instructor in Psychiatry and Human Behavior at the Alpert Medical School of Brown University in 2015, was
appointed as Assistant Professor in 2015. She has been employed as an Associate Psychologist in the Department
of Psychiatry at Brigham and Women’s Hospital since 2015 and appointed as Instructor in Psychiatry at Harvard
Medical School since 2016. Tithi Baul the Director of Evaluation Research in the Department of Psychiatry at
Boston Medical Center and Assistant Professor of Psychiatry at Boston University School of Medicine. She has been
responsible for directing, planning, and identifying metrics and data sources needed to evaluate several clinical
programs within the Department of Psychiatry. Her expertise includes both qualitative and quantitative research
methods. Daisy Perez has experience in program management, administration, and operations. As the Senior
Research Manager in the Department of Psychiatry at Boston Medical Center, she partners with over 40 research
staff members, ensures compliance with state and federal regulations, and manages the operationalization,
implementation, and evaluation of training and clinical service grants.

☐ No

If no, what skills are you missing?

Answer: Click or tap here to enter text.

4b. Will a student, resident or fellow be instrumental in designing or implementing your study?

☒ Yes

If yes, describe how that trainee will be mentored/supported?

Answer: Melissa Flores, PsyD, will be our research assistant for this project. She will meet with her
primary clinical supervisor and the co-investigator for this study, Sohenga Depestre, PsyD, 1x a week to
be provided mentorship and support specifically related to the project. The student will have direct
access to PI and clinical supervisor at all times and will be assigned tasks over the course of the research
project. The PI, Clinical supervisor and trainee will meet 1x a week for group supervision

☐ No

5. Could the study question, methods or results potentially harm a community that historically has
been marginalized such as women, people of color or other structurally marginalized communities?

Answer: No. It is our goal to create a psychological assessment service within primary care that is uniquely
rooted in and responsive to the needs of the patient population and to disseminate the information we
gather as we create this service so that other hospitals might be able to replicate this.

6. What processes do you have in place to ensure that research-related decision-making is as free
from biases related to racism, sexism and other forms of oppression as possible when the study is
implemented? Please check all that apply, and please add other processes that are not listed to the
Other textbox.

☒ Include the topic of exploring potential biases during study meetings

☒ Empower all study team members to have a safe space to voice concerns and implementing
procedures that support reporting these concerns

If yes, how will you do this? Click or tap here to enter text.

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☒ Engage in implicit bias training

☐ Partner with communities

If yes, how will you do this? Click or tap here to enter text.

☒ Seek expertise about considerations of race, gender, and other forms of oppression in research

If yes, how will you do this? Click or tap here to enter text.

☐ Other: Click or tap here to enter text.

8a. Will you measure sex, race and/or ethnicity?

☐ Yes

☒ No

8b. If yes, describe how you will measure these variables (e.g. open versus closed ended, response
options)?

8c. If yes, how will you use these variables in your analyses?

9. What month/year do you anticipate submitting abstracts or other forms of presentation and what
month/year do you anticipate submitting for publication?

Answer: We anticipate submitting abstracts in 7/2024 and publication 10/2024

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 Pediatric IBH Provider Needs Assessment Questionnaire
What is your Profession?
 Primary Care Provider
 Trainee (Resident, Intern, Fellow, Practicum student)
 Behavioral Health Clinician
What is the Age range of the patients you serve? (Select all that apply):
 Birth – 4 years old  18 – 22 years old
 4 – 12 years old  18 – 22 years old
 13 – 17 years old  22+ years old

In the past 3 months, have you had any encounters with patients whom you believe would
benefit from psychological/neuropsychological assessment services?
 Yes
 No
If so, approximately how many of your patients do you believe would have benefited from
such an assessment?
 Less than 10  26 - 50  76 – 100
 10 - 25  51 - 75  More than 100

In the past 3 months, have you had any patients (including their parent/guardian) request a
referral for psychological/neuropsychological assessment?
 Yes
 No
If so, approximately how many patients (including their parent/guardian) have made such
a request?
 Less than 10  26 - 50  76 – 100
 10 - 25  51 - 75  More than 100

In the past 3 months, have you had any patients (including their parent/guardian) request
support in getting services at school (i.e., IEP support; 504 documentation)?
 Yes
 No
If so, approximately how many of your patients have requested such school support?
 Less than 10  26 - 50  76 – 100
 10 - 25  51 - 75  More than 100
In the past 3 months, have you diagnosed any patients with ADHD utilizing behavioral
rating scales and/or parent-, teacher-, report measures?
 Yes
 No
If so, approximately how many patients have you made this diagnosis for?
 Less than 10  26 - 50  76 – 100
 10 - 25  51 - 75  More than 100

What rating scale(s) or informant/self-report measure(s) did you use?

______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
In your experience, have you made or facilitated a referral for a patient to receive
psych/neuropsychological testing?
 Yes
 No
If so, how long do patients typically wait before being connected with testing services?
 Less than 1 month  3 – 6 months  More than a year
 1 – 3 months  6 – 12 months

Do you think having a psych assessment service within primary care would be beneficial to
your patients?
 Yes
 No
 I don’t know
Based on current/previous patients, what kind of referral questions do you think would be
most helpful for this testing service to be able to answer?
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________

Have you noticed any barriers for patients accessing psychological/neuropsychological

testing? If so, what have those barriers been? (Please include any mitigating factors that
have supported patients access to these services)

______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________

What else would be important to consider in the development of a pediatric primary care
psychological testing service?

______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________