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CARTHAGE COLLEGE INSTITUTIONAL REVIEW BOARD (IRB)

Human Subjects Application


Date submitted: _____10/29/15_______________
Title of project: _________Educator perceptions of barriers to a functional continuum of services__________
Project duration: Start date: ____11/10/15______
End date: __12/29/15_____
Faculty Principal Investigator: ___Cassandra Pofahl_______________________
Address or Campus Box #___3733 Regency Dr__________________________
Phone Number: ___262-417-2220_____________
E-Mail: __cassie.pofahl@gmail.com____
Student Investigator 1: ____________________________________________________________
Address or Campus Box #__________________________________________________________
Phone Number: ________________________________
E-Mail: ____________________
Student Investigator 2: ____________________________________________________________
Address or Campus Box #__________________________________________________________
Phone Number: ________________________________
E-Mail: ____________________
As the signature below testifies, the researcher and supervising faculty are pledged to conform to the following:
As one engaged in investigation utilizing human subjects, I acknowledge the rights and welfare of the human
subjects involved.
I acknowledge my responsibility as a researcher to secure the informed consent of the subject by explaining the
procedures, in so far as possible, and by describing the risks as weighed against the potential benefits of the
investigation.
I assure the IRB that all procedures performed under the project will be conducted in accordance with those
Federal regulations and College policies which govern research involving human subjects. The signatures of the
Faculty Principal Investigator and Department Chair indicate adherence to their disciplines code of ethics and
guidelines for research. Any deviation from the project (i.e., change in research methodology or subject
recruitment) will be submitted to the IRB in the form of an amendment for its approval prior to implementation.
Faculty Principal Investigator:
___N/A______
(name)

_________________________
(signature)

_____________
(date)

__Cassie Pofahl_______
(name)

_________________________
(signature)

__10/29/15_
(date)

___________________________
(name)

_________________________
(signature)

_____________
(date)

_________________________
(signature)

_____________
(date)

Student Researcher(s):

Department Chair:
___________________________
(name)

For IRB Only:


____
Approved
____
Pending requires more information
____
Disapproved

Signature of IRB Routing Office:


______________________________
Date: _________________________

Signature of IRB Chair: ______________________________

Date: __________________

2
(Revised February 2009)

CARTHAGE COLLEGE INSTITUTIONAL REVIEW BOARD (IRB)

Application Form
All fields on the form must be completed. If a field is not applicable, indicate by inserting N/A. Incomplete
forms will be returned for resubmission.

Recruitment/Selection of Subjects
1. Characteristics of subjects (check as many boxes as appropriate).

___Fetuses
___Physically or Mentally Disabled
___Economically or educationally disadvantaged
___Legal Incompetency
___Prisoners
___Pregnant Females
___Minors (under age 18)
_X_Adults (at least age 18)
2. Estimated Number of Human Participants __10__
3. Briefly describe the criteria for selection of subjects (inclusion/exclusion). Include such information as age
range, health status, etc., as well as why you have selected this particular group of participants.
All educators and assistants at JA-Elementary that work with students with special needs in inclusion, bridge, or
MRE rooms.
4. How will you identify and recruit prospective participants? If subjects are chosen from records, indicate
who gave approval for the use of the records. If records are "private" medical or student records, provide the
protocol, consent forms, letters, etc., for securing consent of the subjects for the records. Written documentation
for cooperation/permission from the holder or custodian of the records should be attached. (Initial contact of
subjects identified through a records search must be made by the official holder of the record, i.e. primary
physician, therapist, public school official.) Attach copies of all recruitment tools (advertisements, posters, etc.)
and label as APPENDIX _A_.
Participants that were interested responded to an email invitation that explained the study in September. They also
received a reminder email November 1st.
5. Please describe your relationship to the potential participants, i.e. instructor of class, co-worker, etc. If no
relationship, state no relationship.
All potential participants are coworkers.
6. Performance Sites. List all performance sites (the location/s where the research will actually occur),

and, if applicable, provide a copy of approval from those sites and/or letters of cooperation or
support.
Interviews will be held in the teachers classroom.

7. Expected Duration of the subjects participation and why this time period was chosen, as well as any
anticipated changes in the time period (example, pending IRB approval, the study will be started only with IRB
approval, or other considerations).
Interviews will last approximately 30 minutes.

Project Description
8. Please provide the rationale including specific scientific objectives (aims) of this research and any
previous relevant research (include citations only as relevant to your research), written professionally with
specific technical terms explained or defined. Attach an additional page, if needed, but please limit this
description to no more than one typewritten page (a short paragraph is best). Include a reference list of only those
previous research items cited within this section.
In order to gauge how effectively this continuum is serving both those who work in special education and students
who receive services, perceptions regarding the continuum and the resources available on this continuum are crucial.

9. Methodology: Please present sequentially the procedures you will follow/perform with human participants.
Semi-structures interviews
10. List all questionnaires, instruments, standardized tests below, with a brief description, and provide copies of
each, as applicable, labeled as APPENDIX _B_.
N/A

CARTHAGE COLLEGE INSTITUTIONAL REVIEW BOARD (IRB)


Application Form (continued)

Risks and Safeguards


11. Describe any potential risks or discomforts of participation and the steps that will be taken to minimize
them. Please identify these risks and safeguards through a discussion with your faculty advisor as well as others,
as relevant. Please refer to the guidelines provided at the beginning of this application.
12. Describe the anticipated benefits to the individual participants. If none, state that. (Note that
compensation is not a benefit, but should be listed in the compensation section on the next page.)
13. Describe the anticipated benefits to society and/or the scientific community.
14. Describe procedures in place to protect confidentiality. Who will have access to raw data? Will raw data be
made available to anyone other than the Principal Investigator and immediate study personnel (e.g., school
officials, medical personnel)? If yes, who, how, and why? Describe the procedure for sharing data. Describe
how the subject will be informed that the data may be shared, if applicable.
15. Will participants be: Audiotaped? Yes No
Videotaped? Yes No
If so, describe how/where the tapes will be stored (i.e. locked file cabinet in investigator office), who will have
access to them, and at what point they will be destroyed.
16. Provide details of any compensation (money, course credit, gifts) being offered to participants, including how
the compensation will be prorated for participants who discontinue participation prior to completion.

Informed Consent Process


Attach copies of all consent documents or text and label as APPENDIX ____.
Informed consent is a process, not just a form. Potential participants/representatives must be given the
information they need to make an informed decision to participate in this research.
17. How will you provide information/obtain permission?
18. How and where will the consent process occur? How will it be structured to enhance independent and
thoughtful decision-making? What steps will be taken to avoid coercion or undue influence?
19. Will the investigator(s) be obtaining all of the informed consents? Yes No
If not, identify the name/s and qualifications of the person/s who will be describing the research to
subjects/representatives and inviting their participation.
20. Will all adult participants have the capacity to give informed consent? If not, explain procedures to be
followed.
21. If any participants will be minors, explain procedures and form for parental consent and assent from minor.
22. Will participants be deceived or incompletely informed regarding any aspect of the study? Yes
If so, provide rationale for use of deception.

No

Attach copies of post-study debriefing information (what you will hand out or say to the participants at the
conclusion of the study to inform them of any deception of participants that was involved) and label as
APPENDIX ____.

CARTHAGE COLLEGE INSTITUTIONAL REVIEW BOARD (IRB)

Informed Consent Statement Checklist for Human Subject Research


An informed consent statement is required for all studies involving human subjects. Specify on the informed
consent statement precisely what will be told to, or read by, the subject when the informed consent is obtained.
Follow the sample format provided to help ensure that the statement meets the necessary criteria for approval.
Checking off an item as it is written into the statement will assist you in assuring that each element has been
addressed in the document. (You MUST return this completed checklist with your application packet.)
The following items are required elements of an informed consent statement and each must be included in
the informed consent statement submitted.
____1. Use the heading, Carthage College Informed Consent Statement
____2. Use wording understandable to the subject population (explain technical terminology)
____3. State that the study involves research and describe the following:
a.
b.
c.
d.
e.
f.

purpose
procedures
expected duration of the subjects participation
risks and side effects
safeguards to be used to minimize risks
any benefits to the subject or to others; or to the extent of the contribution to the body of literature or
knowledge

Check the appropriate line for subject population where it includes:


____
____
____
____
____
____

minors (under age 18)


fetuses
pregnant women
persons with mental disabilities
prisoners
economically or educationally disadvantaged

____4. Briefly discuss alternative procedures or courses of treatment if applicable. If some subjects will receive
fewer benefits than other subjects will, discuss ways to offer these benefits, or their equivalent, to the deprived
subjects after the research project is completed.
____5. State the intention to keep the subjects identity in confidence and explain how the confidentiality of the
data collected will be protected (for example: no reference will be made in verbal or written materials that could
link the subject to the study, or that data will be stored in a locked file cabinet and only research personnel will
have access to it).
____6. State the terms of subject compensation for study participation, if any. If the subjects will be paid for
participation, state how and when they will receive payments and/or compensation. If class credit will be given,
list the amount and list alternative ways to earn the same amount of credit.

CARTHAGE COLLEGE INSTITUTIONAL REVIEW BOARD (IRB)

Informed Consent Statement Checklist for Human Subject Research (continued)


____7. Include an invitation for the subject to ask any questions at any time about the study and its procedures.
Also, if applicable, include a statement that if the subject experiences any adverse effects, the researcher should be
contacted directly.
____8. Faculty Principal Investigators and Student Researchers name, business address and telephone
number that the subject can use to ask questions and report any study-related problems.
____9. Tell the subject that participation is voluntary, that they may decline to participate. Further, state that
upon participating, they may withdraw or be withdrawn from the study at any time without penalty, and, if
applicable, without loss of benefits. The federal regulations for the protection of human subjects require
these words or an equivalent statement.
____10. Include a statement that says subject has read and understands the consent form, that they acknowledge
receiving a copy of the form, and that they agree to participate in the study. Provide one line for signatures and
the date. Provide two copies of the consent form, one to be retained by the subject, and one to be signed by
the subject and, if applicable, the subjects parent(s)/legal guardian/legal representative and returned to
you.
If the subjects are minors, use the following guidelines for obtaining consent:
6 years and younger only parent(s)/guardian/legal representative need sign
7-8 years old signature of the minor is optional; requires signature of parent(s)/guardian/legal
representative
9-17 years old requires signature of both minor and parent(s)/guardian/legal representative
If the subject is unable to read and understand the written consent form, it must be verbally presented in an
understandable manner and witnessed (with signature of witness). This might apply in cases where subjects are:
mentally disabled, seriously ill, institutionalized, incarcerated, or other vulnerable groups.
When appropriate, one or more of the following additional elements of information may be provided to each
subject:
____11. If you plan to audiotape, videotape, or film the participants, request permission to do so in writing and
indicate how you will be using this material.
____12. If DECEPTION IS USED, include a statement to the effect that the research cannot be fully described at
this time, but at the conclusion of the participation, an explanation will be provided.
____13. Any costs to the subject that may result from participation in the research.
____14. A statement that significant new findings developed during the course of the research, and which may be
related to the subjects willingness to continue participation, will be provided to the subject.
Attach a copy of your Informed Consent Statement to your application, along with this checklist.

CARTHAGE COLLEGE INSTITUTIONAL REVIEW BOARD (IRB)


Application Checklist
Completed and Signed Signature Sheet
Completed Application
Appendix ___Copies of all consent documents (in 12 pt. Font) including:
___ Informed Consent to Participate in Research (adult subjects)
___ Parental Permission/Informed Consent (parents of subjects who are minors or children)
___ Assent to Participate in Research (used when subjects are minors or children)
___ Informed Consent/Permission to conduct study (if conducted in school or other institution, this
would be from the school Principal, any Teachers or Instructors whose classes will be involved, and
also from additional authorities as needed)
***See Informed Consent Statement Checklist for additional details. ***
Appendix __ Copies of any recruitment tools (advertisements, posters, etc.)
Appendix __ Copies of all instruments (surveys, standardized tests, questionnaires, interview topics,
etc.).
Appendix __ Copies of debriefing text if deception is employed
Appendix __ Approval from School District, other locations where research will be performed, etc.
Appendix __ ________________________________________________________________________
(Any additional materials that will assist the Board in completing its review)
Informed Consent Statement Checklist

All fields on the form must be completed. If a field is not applicable, indicate by inserting N/A. Incomplete
forms will result in return for resubmission.
Deliver 2 copies of this completed form and all attachments to:
Carthage College Institutional Review Board
Attn: Deborah Usinger
Clausen Center 213 [(262) 551-5833]
2001 Alford Park Drive
Kenosha, WI 53140
Questions? Read the Human Subjects Application-Guidelines provided in Microsoft Word format at
http://www.carthage.edu/dean/node/127, or contact Leslie Cameron (262-551-5843; email
lcameron@carthage.edu).

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