IRB Project Review Form Instructions

Complete this form using Microsoft Word

You may use Microsoft Word to fill all requested information. Please DO NOT leave a question
blank. If a question does not apply to your research, please write N/A.

Prepare all necessary supporting documents and accompanying materials

1.

2.
3.

Documentation of consent procedures (one or more of the following must be provided):

a. Consent form(s)
b. Verbal Consent Script
c. Cover letter
d. Any survey instruments or questionnaires to be used
A list of interview questions or topics, in as much detail as possible (if interviews are used)
An electronic copy of NIH human subjects training workshop certificate for the Principal
Investigator and Faculty Mentor. NOTE: THIS POLICY WAS IMPLEMENTED ON

JULY 1, 2015.
4.

Any other supplementary materials specifically requested in this application form

Email this form and supporting documentation to the appropriate address

If you are a student Principal Investigator, email the entire application package to
your faculty mentor / research advisor for evaluation before IRB submission.
After your faculty has reviewed and given consent to your application and any
documents (e.g. interview protocol, consent forms), you then email
[email protected] with your intent to submit. The IRB chair will enroll you in
the IRB course site on Brightspace. All email communication with the IRB must
be from your secure EU email address.
Faculty applicants: Email the IRB ([email protected]) with your intent to submit and
the name and email address of either your dean or department chair. Once you have
been enrolled in the course site on Brightspace, you will be able to then submit all your
documents via Brightspace.
Please note that, although most applications can be reviewed and approved simply
with an electronic signature, the IRB may, at its discretion, request submission
of a signed hard copy. Whereas there is a space for your signature, it is not
required. Applying through the secure Brightspace course site serves as your
signature. All approvals will be sent as electronic emails, you can print that in
case you need a hard copy to show to the research site.

Review Timeline
When your packet has been received by the IRB, it will be checked for completeness. If not complete, you
will be requested to submit additional materials necessary for the review. Upon approval, you will receive
approval from the IRB by email. Do not begin collecting data until you receive this approval.

Exempt reviews will generally take no more than 10 business days to be reviewed.
Expedited reviews will take about 10 business days
Full Board reviews will be conducted at the next meeting of the IRB, provided that the
completed application has been received by the IRB at least 10 working days prior to the
scheduled meeting date. The IRB meets on a monthly basis during the fall/spring academic
semesters.

(June-August Exempt, Expedited and Full Board Reviews): Please note that the IRB board
does not review applications regularly during the summer months, so review times may take
longer (approximately 3-4 weeks). Applicants should plan appropriately for such potential delays.

Contact Information
Website:
Mailing address:

http://www.eastern.edu/offices-and-centers/institutional-review-board
IRB, Eastern University
Phone: 610-341-4379
1300 Eagle Road
Email: [email protected]
St. Davids, PA 19087

PART I: Project Description

Principal Investigator(s) (PI):

(please list all names)

Sarah Joy Baker

PI: Please attach an electronic copy of your (PI) NIH human subjects training certificate (NIH training link:
https://phrp.nihtraining.com/users/login.php)

Urban Studies

Department:
Status:

Faculty

Adjunct faculty

Faculty Mentor (if PI is a

student):

Falls Church

Campus:
X

Staff

Graduate Student

Undergraduate student

Course Number:

Dr. Corbitt

n/a

Faculty Mentor: Please attach an electronic copy of your Faculty Mentors NIH human subjects training
certificate (NIH training link: https://phrp.nihtraining.com/users/login.php)

E-mail:

[email protected]

Mail correspondence to:

Project Title:

202-744-8077

Fax:

n/a

Immigrant youth, resilience and the arts

Estimated Project Start

Date: (mm / dd / yyyy)

02/01/2017

Is there, or will there be, extramural funding

that directly supports this research?
YES

Phone:

NO

Estimated Data Collection

Completion Date (Note: IRB approval
cannot exceed one year ): (mm / dd /
yyyy)
Funding agency:
If yes:
PI on grant:

02/01/2018

n/a

n/a

Are you conducting your study with Eastern University students?

YES
NO X
If yes, and you plan to contact/use more than 100 students in your research, please seek permission from the Vice
President for Student Development and the Department of Institutional Review (please attach a document of
approval from the departments to this application).

Are you conducting your study off the premises of Eastern University such as an agency or school?
If yes, assurance of oversight by that entity must be provided to the IRB in the form of (please attach to application):
A letter of permission from the lead administrator (or his/her designee) to conduct the study, which shows evidence
that the administrator or official oversight group has reviewed the protocol and accepted its use at that institution
IRB #:

n/a

(For Administrative Use Only)

ABSTRACT:
Briefly describe the purpose, research design, and procedures. Specify what the subjects will do:

The purpose of my research is to describe how immigrant youth deal with change and
uncertainty and to identify ways that art-making can address these concerns by fostering
resilience.
I will be conducting arts-based research with a group of students at the International Academy
at Cardozo high school. All of these students are recent immigrants to the United States and
most do not speak English. To understand how these students construct meaning in order to
cope with uncertainty and fear, I will use a qualitative, arts-based approach. This approach will
not only transcend barriers of race, culture, and language, it will also allow me to discover the
ways that art-making can foster resilience by strengthening internal and external resources.
I will create a series of arts-based experiences that center around the image of a turtle as a
metaphor for protection in the midst of transition. Turtles are resilient creatures that carry their
homes with them. For students who have recently immigrated to the United States, the turtle
may offer insights that will help in the transition process.
These sessions will occur over the course of two months. We will meet during the school day,
as many of these students work to support their families. Using the activity as a metaphor, we
will engage in dialogue to extract meaning from the art-making process and apply it to our
lives. For example, we might consider the turtle shell to ask ourselves what our protective
tendencies are in the face of change. Do we tend to hide and retreat back into our shells or do
we forge ahead? This activity will include a pre and post assessment to discover how artmaking has affected the students ability to confront change and if it has increased their
resilience.
To better understand how the art activities influence the students, I will conduct a series of
structured interviews with the participants. Each interview will be recorded so that I can go
back and analyze the data, searching for the frequency of certain key terms that have been
shown to correlate with resilience. I will also conduct one or two focus-group interviews to
better assess group dynamics and analyze how art-making might foster social capital for these
students, specifically through the formation of interpersonal relationships and protective
factors.

PART II: What level of IRB review is needed for your project?
1.

To determine whether your project is exempt from a full or expedited review by the IRB, please answer
the following questions. If you answered YES to any of these questions, then your project is NOT
exempt, and you should answer the questions in this section to determine whether your project
qualifies for expedited review.
No

1.

Are the subjects data directly or indirectly identifiable, and could these
data place subjects at risk (criminal or civil liability), or might they be
damaging to the subjects financial standing, employability, or reputation?

No X

2.

Will subjects be asked to report their own or others sexual experiences,

alcohol or drug use, and will you know their identities?

No

3.

Yes

No X

4.

Yes

No X

5.

Are subjects used who may not be legally competent (under 18 years
old, or subjects with certain conditions of intellectual, emotional or
developmental disability?)
Are personal records (medical, academic, etc.) used with identifiers and
without written consent?
Are any subjects confined in a correctional or detention facility?

Yes

No X

6.

Will alcohol or drugs be administered?

Yes

No X

7.

Will blood/body fluids be drawn?

Yes

No X

8.

Will specimens obtained from an autopsy be used?

Yes

No X

9.

Will you be including pregnant women by design?

Yes

No X

10.

Are live fetuses subjects in this research?

No

11.

Will Non-English speakers be included?

No X

12.

No

13.

Yes X

Yes
Yes X

Yes X
Yes
Yes X
2.

Will economically or educationally disadvantaged populations be

targeted?
Will members from minority groups be targeted?

If you answered YES to any of the questions above, please do not check anything here and proceed to
the Expedited Review Criteria Section (p. 6). If you answered NO to all of the questions above, then
your research qualifies for exempt review IF it fits into at least one of the following categories. Please
check all that apply:
Educational Research
Research in established or commonly accepted educational settings, involving normal educational
practices. This is for research that is concerned with improving educational practice.

Surveys, Questionnaires, Interviews, or Observation of Public Behavior

The subject matter must not involve sensitive topics, such as criminal or sexual behavior, alcohol or
drug use on the part of the subjects, unless they are conducted in a manner that guarantees
anonymity for the subjects

Surveys, Questionnaires, Interviews or Observation of Public Behavior

Surveys that involve sensitive information and subjects identities are known to the researcher may
still be exempt if: (1) the subjects are elected to appointed candidates for public office; or (2) federal
statute(s) specify without exception that confidentiality will be maintained throughout the research and
thereafter.

Archival Research
Research involving the collection or study of existing data, documents, records, pathological 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. These data/samples must be preexisting, which means they were collected prior to the
current project.

Research Examining Public Benefit or Public Service Programs

To qualify for this exemption, the research must also be conducted by (or subject to review by) an
authorized representative of the program in question. Studies in this category are still exempt if they
include pregnant women by design and their purpose is to examine benefit programs specifically for
pregnant women.

Taste Evaluation Research

Studies of taste and food quality evaluation. Studies of taste evaluation qualify for this exemption only
if
(1) wholesome foods without additives are consumed; or (2) a food is consumed that contains a food
additive present at or below the level that has been found to be safe.

Noneducational/Other Research involving Special Consideration Populations (e.g.,

persons who are not legally competent, emotionally, cognitively or developmentally disabled
populations, non-English speakers, economically or educationally disadvantaged populations,
members from minority groups)
To qualify for exemption, the research must pose no more than minimal risk to subjects. The federal
definition of minimal risk is: The probability and magnitude of harm or discomfort anticipated in the
research are not greater in and of themselves than those ordinarily encountered in daily life or during
the performance of routine physical or psychological examinations or tests.

If you determined that your project is exempt from expedited or full board review, then please
proceed to page 7, Part III. Data Collection Procedures. Otherwise, please answer the following
questions to determine whether your project qualifies for expedited review.

Expedited Review Criteria

1.

To meet expedited review criteria, your project must meet the following conditions:

No more than minimal risk to the subjects

i.

2.

The federal definition of minimal risk is: The probability and magnitude of harm or discomfort
anticipated in the research are not greater in and of themselves than those ordinarily
encountered in daily life or during the performance of routine physical or psychological
examinations or tests.

Subjects must not be confined in a correctional or detention facility

Subjects must be participating in one or more of the ways described in the following section
(see #2).

Your project qualifies for expedited review IF subjects are participating in one or more of the following
ways. Please check all that apply.
Collection of excreta and external secretions
This includes sweat, saliva, placenta, and/or amniotic fluid. None of these may be collected by
invasive procedures, such as those that use cannulae or hypodermic needles, such as
amniocentesis.

Recording of data using noninvasive procedures routinely employed in clinical practice.

This includes but is not limited to the use of contact recording electrodes, weighing, tests of sensory
acuity, electrocardiography and electroencephalography, and measure of naturally occurring
radioactivity.
IMPORTANT EXCLUSIONS: This does NOT include procedures which: (a) impart matter or
significant amounts of energy to the subjects; (b) invade the subjects privacy; or (c) expose subjects
to significant amounts of energy outside the visible range (e.g. ultraviolet light from tanning beds).

Collection of hair or nail clippings, or teeth from patients whose care requires the
extraction or collection of plaque and/or calculus
Collection of dental material must use routine procedures for the cleaning of teeth.

Voice recordings
Recordings made for research purposes such as the investigation of speech defects and speech
pathology.

Moderate exercise
Moderate exercise performed by healthy volunteers.

Experimental procedures (i.e., manipulation of an independent variable)

Research performed to investigate individual or group behavior or the characteristics of individuals,
such as studies of perception, cognition, game theory, or test development.
IMPORTANT EXCLUSIONS: This does NOT include studies that (a) involve significant stress to the
subjects or (b) that are intended to produce a relatively lasting change in behavior.

Educational research with subjects under 18 years of age

Research in established or commonly accepted educational settings, involving normal educational
practices and involving subjects are under 18 years of age. This is for research that is concerned with
improving educational practice.

Studies of archived data, records or diagnostic specimens

This category would include studies of these specimens that do not qualify for exempt review.

Collection of blood samples

Studies involving the collection of blood samples by venipuncture, in amounts not exceeding 550 mL
(about one pint) in an eight-week period and no more than two times per week, from subjects 18
years of age or older and who are in good health and not pregnant.

If your study fits into one or more of the nine types of participation and meets the required criteria, then
your project can receive EXPEDITED REVIEW from the IRB. If your study does not meet expedited
review criteria, then it qualifies for FULL BOARD review. The IRB will determine which level of review is
appropriate for your project, based upon the information you provide in this form.

Full Board Reviews

Research projects that require full board review have the potential for more than minimal risks (physical,
psychological, or social) to subjects and/or include populations with special considerations (including
research on prisoners, persons who are not legally competent, emotionally, cognitively or developmentally
disabled populations).

The IRB will determine which level of review is appropriate for your project, based upon the
information you provide in this form.

PART III: Data Collection Procedures

1.

Please indicate the method(s) to be used: (check all that apply)

X

X Investigator
mail

Survey administered by:

Interview

Subject

Mail

Phone

Please submit a copy of the survey that you will use.

X One-on-one
(specify):

Focus Group

Oral History

Other

Please submit a copy of the interview questions that you will use.

X Observation of Public
Behavior
Archived Data or Records

X Classroom
(specify):
Academic

Taste or Sensory Evaluation

Food Tasting

Public Setting

Medical

Legal

Other

Other (specify):

Olfactory n/a

Therapeutic Evaluation

Biomedical

Psychological

Physical Therapy n/a

Experimental Procedures

Biomedical

Psychological

Other (specify):

Examination of Pathological or Diagnostic Tissue Specimens n/a

Other (briefly describe):

In Person

n/a

n/a

n/a

Internet / E-

2.

Please indicate how the data will be handled: (see the IRB manual, p. 45)
X
1.
X

Anonymous

Confidential

Intentionally identified

What form of consent will be obtained? (refer to the Informed Consent Form Guidelines
document)
Written (please attach consent form). If you are not using written consent please provide
rationale and then select the type of consent below:
Implied (please attach cover letter or describe terms on a separate page)
Verbal
(please attach consent script)
Seeking Waiver of Consent
Consent Not Applicable

2.

(please contact IRB for further information)

(please explain reasons on a separate page)

If the data will be handled in an anonymous or confidential manner, how will confidentiality be
maintained? (please check all that apply)
Anonymous is defined as: data are recorded such that no identifier whatsoever exists to link a
subjects identity to that subjects response. No one can link an individual person to the response of
that person, including the investigator(s). Face-to-face interviews and data collection are never
anonymous.
Confidential is defined as: there exists a documented linkage between a subjects identify and
her/his response in the research. The investigator provides assurance in the protocol and in the
informed consent that the identity of any individual subject will not be revealed in any report of the
study. Confidentiality means that the investigator can (or could) identify individuals who
participated in a study, perhaps through a code.

Coded to a master list and separated from the data

Stored in a locked cabinet
Stored in a locked office
X Stored in a restricted (password-protected) computer
Other (specify):
3.

Who will have access to the data?

I will be the only one to have access to the data.

4.

X
X

Will any of the following be collected? Please check yes or no for each of these 3 categories
below
Yes X
Yes
Yes

No
No
No

Video recordings (either tape or digital)

Audio recordings (either tape or digital)
Photographs

5.

If you answered YES to any of the above in Question 4, then please provide the following
information:
Where will the recordings or photographs be stored?

I will store the recordings in a password-protected cabinet and I will be the only person
with access.
When (approximate date) will this material be destroyed? This should also be included in the
consent form.

January 1, 2019
How will confidentiality be maintained?

I will use pseudonyms to protect the identities of the students.

PART IV: Description of the Population

10

Approximate age range:

14-18

1.

Approximate number of subjects:

2.

How will subjects be selected or recruited, and how will subjects be approached (or contacted)?

To recruit students for these art-based experiences, I will work closely with a teacher at The
International Academy who has a strong rapport with the students and is passionate about their
success. Together, we will identify ten students who have come to the United States within the
last six months and invite them to participate in the group art activities.
3.

Will subjects be compensated (including extra credit*)?

X Yes
If yes, then please explain how much, when, and how they will be compensated, and
explain whether they must complete the project in order to be paid.

No

Students will be compensated with community service hours. Students

need 100 hours of community service hours to graduate.
*If extra credit is to be given, please explain how students who do not participate may
earn extra credit through alternative means.
4.

Are any subjects under 18 years of age?

No

Yes

If yes, both parents must give their permission unless one parent is deceased, unknown, incompetent,
or not reasonably available, or when only one parent has legal responsibility for the care and custody
of the child. Please provide a copy of the parental consent form with the IRB application.
If yes, does the proposed research include children between the ages of 8 and 17 years old? An assent
form should be used for subjects who are 8 to 17 years old. Please provide a copy of the minor assent
form with the IRB application.

5.

Are any subjects not legally competent to give consent?

No
If yes, then please explain how consent will be obtained. Who will give consent on
their behalf? What procedures will be followed? Please attach consent form.

Yes

Yes

6.

Will any minority groups be excluded from the study pool?

No
If yes, then please justify the exclusion.
.

7.

Will any minority groups be targeted in this study?

X Yes
If yes, please provide justification for targeting minority groups.

No

I am working specifically for immigrant students because I want to learn how artmaking can help them in the transition process as they adjust to a new culture and a
new home. If art-making is found to help these students adjust, then the activities can
be replicated in high schools throughout the country with large immigrant
populations.
Specify how risks are minimized for this population.

Risks will be minimized by using pseudonyms and destroying the recorded interviews
after my thesis work.
8.

Is this study likely to involve any subjects who are not fluent in English?
X
No
If yes, please submit both English and translated versions of consent forms and surveys,
if applicable. Please ensure that the translations are accurate.

Yes

9.

Does this study involve subjects located outside of the United States?
Yes X
If yes, please explain on an attached page exactly who the subjects are and the identities
(if possible) and responsibilities of any additional investigators.

No

10. Does this study involve economically or educationally disadvantaged populations? X Yes
No
If yes, please provide justification for including/targeting economically or educationally disadvantaged
populations.

10

Many immigrant students are economically disadvantaged as a result of their

immigrant status. This study seeks to describe the ways that art-making can give
them the internal and external resources to cope with the realities of transitioning to
life in a new culture, which often times includes poverty.
Specify how risks are minimized for this population.

Risks will be minimized by using pseudonyms as well as creating a safe place for
students to engage with the arts.

11

PART V: Use of Deception

If any deception is required for the validity of this activity, explain why this is necessary. Please also
include a description of when and how subjects will be debriefed regarding the deception, and attach a
debriefing script.

n/a

PART VI: Risks and Benefits

1.

Describe any potential risks to the subjects, and describe how you will minimize these risks. These
include stress, discomfort, social risks (e.g., embarrassment), legal risks, invasion of privacy, and side
effects.

The students I work with may be undocumented, which poses the risk of deportation if this
knowledge becomes public. To minimize this risk, I will use pseudonyms to protect their
identity. I will also avoid language that refers to their status and I will never ask them if
they have documents.

2.

In the event that any of these potential risks occur, how will the situation be handled (e.g.,
compensation, counseling, etc.)?

I will establish a relationship with a immigration lawyer who can assist the participants if
they face threat of deportation.

3.

12

Will this study interfere with any subjects normal routine?

Yes

No

4.

Describe the expected benefits to the individual subjects and those for society. This is required
information.

The participants will benefit from the metaphor-focused art activities because it will give the
a platform to think about the changes they face in a new culture and how they respond to
said changes. It is my hope that by using the art activity as a metaphor to talk about life,
these students will increase their internal and external resources to confront anxiety and fear
and to thrive despite adverse circumstances.
5.

If blood or other biological specimens will be collected, then please address the following:
a.

Brief description of sampled tissues:

n/a

b. Describe the personnel involved and procedure(s) for obtaining the specimen(s). Please note that IRB
requires that only trained certified or licensed persons may draw blood. Contact IRB for more
information.

n/a

PART VII: Use of Collected Data

Please check all that apply:
X

Thesis / Dissertation
Journal Article / Publication
Grant Activities
Other (briefly describe):

PART VIII: Drug or Alcohol Consumption

Note: If your project is exempt from expedited or full board review, then you may skip this
section and proceed to Part IX on the next page.
1.

Will any Investigational New Drug (IND) or any other substance regulated by the
Food and Drug Administration (FDA) be used?
Yes X No
If yes, then please note that the Eastern University IRB is not able to provide approval
or oversight for your project. In order to conduct research involving Investigational
New Drugs (INDs) or other substances subject to FDA regulation, you will need to work
with a collaborator affiliated with another institution whose IRB is able to provide the
review and oversight required by federal regulations.

2.

Will alcohol be ingested by the subjects?

Yes X No
If yes, then please describe what type and how it will be administered.

13

PART X: Assurances signatures needed only if submitting hard copy

This investigation involves the use of human subjects. I understand Eastern Universitys policy concerning research
involving human subjects and I agree to:
1.

Obtain voluntary and informed consent of persons who will participate in this study, as a required by the
Eastern University Institutional Review Board (IRB).

2.

Report to the Eastern University IRB any adverse effects on subjects which become apparent during the
course of, or as a result of, the activities of the investigators.

3.

Cooperate with members of the IRB who are responsible to review this project, and to give project reports as
required by the IRB.

4.

Obtain prior approval from the IRB before amending or altering the project or before implementing changes
to the approved consent form.

5.

Maintain documentation of IRB approval, consent forms and/or procedures, together with the data, for at
least three years after the project has been completed.

6.

Treat human subjects in the manner specified on this form.

Principal Investigator: The information provided in this form is accurate, and the project will be conducted in accordance with
the above assurances.

Signature

Print Name

Date

Print Name

Date

Print Name

Date

Principal Investigator

Signature
Principal Investigator

Signature
Principal Investigator

Faculty Sponsor (if PI is a student): The information provided in this form is accurate, and the project will be conducted in
accordance with the above assurances.

Signature

Print Name

Date

Date

Faculty Sponsor (if P.I. is a student)

Chair, Director, or Dean: This project will be conducted in accordance with the above assurances.

Signature

Print Name

Chair, Director, or Dean

Please Note:

The IRB approval is effective for only one year. After that, an extension request must be
submitted before you can continue your project.

Institutional Review Board Approval: These assurances are acceptable, and this project has adequate protections
for the subjects. This project has been properly documented and reviewed and is in compliance with federal,
state, and university regulations.
Signature__________________________________ Print Name_______________________ Date_____________
Signature__________________________________ Print Name_______________________ Date_____________

Eastern University IRB use ONLY:

Review Status of Protocol:

14

Exempt

Expedited

Full Board