Institutional Review Board
Application Packet
Committee Members:
Mark Cosgrove
James Fuller
Susan Gavin (chair)
Cathy Harner
Joseph Pak
Matt Renfrow
Todd Ream
Patricia Stan
Bill Toll
IRB Application
Introduction
Taylor University is committed to the protection and ethical treatment of human subjects in the
research process. To fulfill this commitment, Taylor University established the Institutional Review Board
(IRB) to review ALL research conducted by or on Taylor University constituents. For example research
conducted by faculty, students or staff and research conducted on faculty, students, staff or alumni.
Taylor University’s IRB is federally registered with the Department of Health and Human Services (HHS)
Office for Human Research Protections (OHRP). This registration allows Taylor’s IRB to provide Federal
Wide Assurances (FWA) for research projects involving human subjects. Taylor’s registration number is
FWA00016004. All principal investigators must complete the CITI certification for Social and
Behavioral (or Biomedical) Human Subject basic refresher course. A copy of the certificate must
accompany this application.
To access CITI training:
 Go to www.citiprogram.org<http://www.citiprogram.org
o If you have never used CITI click register in the upper right corner of CITI home
page. Proceed to step 1.
o If you have used CITI before log in and go to Taylor University courses then add a
course. Skip to Step 7.
 Step 1 - Select Taylor University (your organizational affiliation)
 Step 2 - Enter your personal information (first and last name, email address)
 Step 3 - Create a username and password, and a security question
 Step 4 - Continue answering questions regarding gender, etc.
 Step 5 – the answer is No
 Step 6 – must enter TU email address, department and role in research (i.e. student
researcher – undergraduate)
 Step 7 - check social and behavioral human subjects – basic course
Review and Approval process
All proposals reviewed will be classified into one of three categories as established by OHRP. A brief
description for each category follows. For more detailed information, please visit the OHRP web site at
http://www.hhs.gov/ohrp/policy/index/index.html.
Exempt – The proposal is reviewed only by the chair and determined that it is exempt from
further review. Examples would include, but not limited to the following: Research involving the
use of educational tests, survey procedures, observation of public behavior or the collection or
study of existing data. Although a research project may include the methods listed above, it
does NOT automatically make it exempt. It is possible further review is required.
Expedited – The proposal is reviewed by two members of the IRB. Proposals that would require
expedited review include, but are not limited to the following:
 Collection of data from voice, video, digital, or image recordings made for research
purposes
 Collection of data through noninvasive procedures such as blood pressures, pulse rates,
ultrasound, Doppler blood flow and EKGs
Full – The proposal is reviewed by the full IRB. Proposals that would require full review include,
but are not limited to the following:
 Research involving vulnerable subjects including children
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IRB Application


Research that exposes subjects to more than minimal risks
Research that is particularly private or sensitive in nature
Regardless of the level of review, the IRB considers the following issues about your research:
This list is drawn from the National Institutes of Health IRB protocols.
1. The proposed research design is scientifically sound & will not unnecessarily expose subjects to
risk.
2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
importance of knowledge that may reasonably be expected to result.
3. Subject selection is equitable.
4. Additional safeguards required for subjects likely to be vulnerable to coercion or undue
influence.
5. Informed consent is obtained from research subjects or their legally authorized
representative(s).
6. Risks to subjects are minimized.
7. Subject privacy & confidentiality are maximized.
It is the goal of the IRB to complete the review process within one week of submission, however, this
may not be possible for proposals that require a full review. It is extremely important that all
information is provided that is requested. Incomplete proposals will be returned and will delay the
review process.
Submission
To submit a proposal to the IRB, you must complete and submit a complete research proposal that
includes the following:
 Name of the Primary Investigator and all secondary investigators
 If you are a student conducting the research, you MUST list and have approval from a
sponsoring faculty member.
 Description of the project’s
o Goals
o Design
o Hypotheses and/or research questions
o Location
o Procedures and
o How the data will be obtained
 Description of participant population(s)
 Description of how the data will be analyzed and disseminated
 Identification of Risks to Participants
 Attach a copy of the Informed Consent form
 Attach complete copies of any interview or questionnaire instruments that will be used
 Attach copy of NIH certification
Instructions
To submit a proposal application to the IRB:
 Complete all sections of this proposal application by editing the document with Microsoft
Word.
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IRB Application



Print off and sign the assurances section (page 3). If you are a student conducting the research
you MUST have a faculty sponsor sign this form. Scan the signed form and save as a .pdf, .tif or
.gif file type.
Review IRB check list to ensure you have addressed all areas of the proposal requirements
E-mail the complete proposal and all associated files (including all protocols, consent forms,
cover letters, etc. and assurances signature page) to IRB@taylor.edu.
Proposals will be reviewed in the order submitted. Once the review is completed, you will receive
notification from the IRB indicating if the proposal was approved and the level of review.
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IRB Application
Request for IRB Review of Research Involving Human Subjects
Taylor University institutional policy and federal regulations require that research projects involving
human subjects be reviewed to consider:
1. The rights and welfare of the individual(s) involved
2. The appropriateness of the methods used to secure informed consent
3. The balance of risks and potential benefits of the investigation
All research involving human subjects should complete this application. Please send this form with any
supporting documentation to IRB@taylor.edu. Questions may be directed to IRB@taylor.edu.
Section A: Applicant Information and Assurances
Title of Proposed
Research
Primary Researcher’s
Name and
relationship to TU
Anticipated Start
Date of Project
Email
Anticipated
Ending Date
Phone
Department
Co-Researcher(s) if
applicable and
relationship to TU
Faculty Sponsor for
student research
Source of funding if
applicable
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IRB Application
Researcher Assurance:
I certify to the following:
1. The research will not be initiated until written approval is obtained from the IRB.
2. I have completed the appropriate training for human subjects protection through CITI or other
appropriate program.
3. The proposed research includes only those activities described in this application.
4. I will obtain prior written approval for modifications to this project, including but not limited to
changes in procedures.
5. I will report to the IRB any unanticipated problems and adverse effects, as well as my findings
during the course of the study that may affect the risks or benefits to the subjects.
6. I agree to keep records of IRB approved documents and to retain research data with appropriate
confidentiality.
7. I understand that this research is subject to continuing review and approval by the IRB.
8. The information on this application is correct.
______________________________________________ Date __________________________
Researcher #1
______________________________________________ Date __________________________
Researcher #2
______________________________________________ Date __________________________
Researcher #3
______________________________________________ Date __________________________
Researcher #4
Faculty Advisor Assurance: (Student research only includes graduate students)
I have examined the proposal, and I assume the roles and responsibilities required to oversee the
conduct of this research, prevent harms to subjects and foster benefits to the subjects. I will report any
significant and relevant changes in the research proposal, adverse events, or incidents to the IRB. I have
also received certification for human subjects’ research and can confirm that the students have
received appropriate certification.
____________________________________ _______________________________ ________________
Faculty Name (print)
Signature
Date
Instructions:
Once signatures have been obtained, please scan this page and submit it with the completed application
to IRB@taylor.edu.
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IRB Application
Section B: Project Description
Briefly, but completely, answer the following questions. Please keep the use of technical phrasing
and/or jargon to a minimum. Explain in terms or phrases that may be unclear to those who would be
reviewing your material and who are not in your field. [Please type your information into this Word
document. Simply keep typing and use as much space as needed]
You MUST respond to ALL questions
1. Describe the project’s
a. Goals
b. Design
c. Hypotheses and/or research questions,
d. Location (Where will the study be conducted?)
e. Procedures, and
f.
How data will be obtained
2. Describe your participant population(s). Include (a) age, sex, and approximate number (b)
inclusion/exclusion criteria if any. (c) method of recruiting, and (d) inducement to participate.
3. Describe how data will be analyzed and disseminated.
4. Describe security procedures for privacy and confidentiality. Describe how all data collected will
be handled and stored—and when, if ever, forms, or identifiers will be destroyed such that the
participants’ confidentiality or anonymity will be protected.
IF THIS PROPOSAL IS USING EXISTING DATA or DATA SETS SUCH AS NSSE OR HERI ONLY YOU
MAY STOP HERE. ALL OTHERS COMPLETE QUESTIONS 5-7 AND THE INFORMED CONSENT
FORM.
5. Identification of Risks to Participants. Remember there are always risks, even if it is exposure to
the normal risks of everyday life.
a. Please describe any foreseeable risks (physical, emotional and social) to the participants.
Include any methods or devices that will be used to limit participant risk. Describe any
distress that might be caused by the research. If distress is a possible outcome, describe
the planned procedures for debriefing the participants after the research is conducted.
b. If you would like to request a waiver of written informed consent, please explain how
the use of written consent would impede the research or needlessly jeopardize the
participant’s confidentiality. Explain how you will guarantee that oral consent has been
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IRB Application
secured. Researchers proposing to use oral consent must provide a copy of the consent
document that will be read to participants.
c. Please describe the consent process by explaining when and how the participant’s
consent will be obtained. Describe additional steps that will be taken to ensure the
participant’s right to withdraw without penalty at any time and to guarantee their
privacy and ensure confidentiality. Attach the consent form to this application. If
participants include minors (under 18) or other populations who may not be able to give
consent for themselves, describe how parents/guardians will be informed of the study
and give their consent. If the research is part of an in-school or institutional study, what
will teachers, officials or administration be told about the study, and how will their
permission be obtained? (See sample consent form).
6. Describe how medical services will be provided if the subject suffers adverse health effects as a
result of the research and who will bear the cost.
7. Attach complete copies of any interview or questionnaire instruments that will be used.
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IRB Application
Section C: Informed Consent checklist
When using humans as research subjects you must first obtain their informed consent. Use this checklist
to effectively create an informed consent form.

A statement explaining the purpose of the research

A statement of the expected duration of the subject’s participation

A description of the procedures to be followed

A description of any reasonable foreseeable risks or discomforts to the subject, including
invasion of privacy

A description of any benefits resulting from the research, either to the subject or others

A statement that informs the subject of his/her right not to be a subject in a research project
that is also a teaching exercise

A statement informing the subject about how his/her anonymity will be guarded, e.g., that their
confidentiality will be protected by assigned code numbers, be limitations of who has access to
data, by data storage in locked cabinets, by locked computer files, etc.

A statement that the subject’s participation is voluntary, and that his/her refusal to participate
will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the
subject may discontinue participation at any time without penalty or loss of benefits to which
the subject is otherwise entitled

If written informed consent is required, a place for the subject to sign and date the form and a
statement that the copy of the signed consent form will be given to the subject for his/her
records

If the subject is a minor or is not capable of giving consent, a statement of parental/guardian
responsibility in consenting to the subject’s participation in the study with a place for the
parent/guardian to sign and date the form in addition to the participant’s signature

The name, address, email, and telephone number of the principal investigator of the research
project, and his/her affiliation with Taylor University. If the principal investigator is a student,
the name, email and telephone number of the faculty advisor is also required

A statement informing the subject that inquiries regarding the nature of the research, his/her
rights as a subject, or any other aspect of the research as it relates to his/her participation as a
subject can be directed to Taylor University’s Institutional Review Board at IRB@taylor.edu or
the Chair of the IRB, Susan Gavin at 756-998-5188 or ssgavin@taylor.edu
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IRB Application
TAYLOR UNIVERSITY
INFORMED CONSENT
[Insert Title of Study (must match Title on Proposal)]
You are invited to participate in a research study of [Insert general statement about study]. You were
selected as a possible subject because [Explain how the subject was identified]. We ask that you read this
form and ask any questions you many have before agreeing to be in the study.
The study is being conducted by [Indicate the investigators’ names and University/Departmental
affiliation]. It is funded by [Indicate study sponsor, if any, and state if the sponsor].
STUDY PURPOSE
The purpose of this study is to [Explain why the research is being done using language understandable to
the subject, e.g., eighth grade level.].
NUMBER OF PEOPLE TAKING PART IN THE STUDY:
If you agree to participate, you will be one of [Insert single number if the study involves only on site or
local and national numbers if a multi-center study. It may also be appropriate to clarify the number of
subjects in different cohorts or groups, if applicable] subjects who will be participating in this research.
PROCEDURES FOR THE STUDY:
If you agree to be in the study, you will do the following things:
[Explain in language understandable to the subject all procedures/tests, including surveys, focus groups,
audio or video taping, assignment to study groups, administration of study medications, x-rays, blood
draws, study visits, etc., which will be employed in the study. Clarify where the procedures will be
performed, how frequently they will be performed, and the expected amount of time each procedure
and/or visit will last. Also clarify the total duration of the study. Identify which procedures are
experimental and which are standard procedures. (If blood is to be drawn, explain how and from where
the blood will be drawn, e.g., “from a vein in your arm.” Indicate the total number of times blood will be
drawn, the amount of blood to be drawn each time, and the total amount of blood to be drawn over the
course of the study. Translate the amount to be drawn to common measurement terms, such as
teaspoonfuls or cupfuls)].
RISKS OF TAKING PART IN THE STUDY:
While on the study, the risks [side effects, and/or discomforts] are:
[List in language understandable to the subject the risks, side effects, and/or discomforts of each of the
procedures to be employed in the study including physical, psychological, social, and legal. Include risks
and side effects of all medications to be given to subjects for the purpose of the study. The likelihood of
the risks and/or side effects should also be included.
Examples of possible risk/side effect statements include:
The risks of completing the survey are being uncomfortable answering the questions.
The risks of completing the interview include possible loss of confidentiality.
The risks of drawing blood include pain, bruising, and rarely, infection.
The side effects associated with take [Insert study medication] are mild diarrhea, confusion, sleepiness,
depression, and headaches. In rare instances, hair loss, rash, decrease in the number of red blood cells
and blood platelets (which could cause fatigue) could occur.
If appropriate, add the following statement: There also may be other side effects that we cannot predict.]
[Explain measures that will be employed to minimize the risks and side effects listed above.
Examples include:
While completing the survey, you can tell the researcher that you feel uncomfortable or do not care to
answer a particular question.
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IRB Application
Explain any psychological, social, or medical services that may be required because of research
participation such as counseling, social support services or medical services. (If there are significant
psychological risks to participation, the subject should be told under what conditions the researcher will
terminate the study).
While you are receiving [Insert study medication], you will be questioned weekly about possible side
effects; you will also be monitored by the blood tests we are obtaining.]
BENEFITS OF TAKING PART IN THE STUDY:
The benefits to participation that are reasonable to expect are [describe any direct benefit to the subject or
benefit to others, which may reasonably be expected from the research. If there is no direct benefit to the
subject, state this. Note: payment to subjects is not considered a benefit of participating in the study and
should not be listed in this section. Rather it should be listed under a separate Payment section.]
ALTERNATIVES TO TAKING PART IN THE STUDY:
Instead of being in the study, you have these options: [List appropriate alternative procedures or courses
of treatment, if any, that might be advantageous to the subjects. If the only other alternative is not
participating, this should be stated.]
CONFIDENTIALITY
Efforts will be made to keep your personal information confidential. We cannot guarantee absolute
confidentiality. Your personal information may be disclosed if required by law. Your identity will be
held in confidence in reports in which the study may be published [Include the following statement, if
applicable, “and databases in which results may be stored.” If tape recordings or videotapes are made,
explain who will have access, if they will be used for educational purposes, and when they will be
destroyed.].
Organizations that may inspect and/or copy your research records for quality assurance and data analysis
include groups such as the study investigator and his/her research associates, the Taylor University
Institutional Review Board or its designees, the study sponsor, [Inset sponsor name], and (as allowed by
law) state or federal agencies, specifically the Office for Human Research Protections (OHRP) etc., who
may need to access your research records.
COSTS
Taking part in this study may lead to added costs to you or your insurance company. You or your
insurance company will be responsible for the following costs: [list the procedures, tests, office visits,
medications, etc. for which the subject or the subject’s insurance is responsible. If appropriate, state that
all standard of care procedures, drugs, tests, etc. will be the responsibility of the subject or his/her
insurance and clarify what is considered standard or care procedures.]. You will not be responsible for
these study-specific costs: [list the procedures, drugs, tests, visits, medications, etc. for which the study
will pay. If appropriate, include the following statement: “If during the study, [name of study drug]
becomes commercially available, you may have to pay for the amount of drug needed to complete the
study.”]
PAYMENT
You [will/will not] receive payment for taking part in this study. [Describe the details and any conditions
of payment. If subjects will not be paid, this should be stated.]
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IRB Application
COMPENSATION FOR INJURY
[If a source of funds for payment of treatment costs is NOT available, include the following statement:]
In the event of physical injury resulting from your participation in this research, necessary medical
treatment will be provided to you and billed as part of your medical expenses. Costs not covered by your
health care insurer will be your responsibility. Also, it is your responsibility to determine the extent of
your health care coverage. There is no program in place for other monetary compensation for such
injuries. If you are participating in research which is not conducted at a medical facility, you will be
responsible for seeking medical care and for the expenses associated with any care received.
[If a source of funds for payment of treatment costs IS available, the source and conditions for payment of
those costs should be identified.]
FINANCIAL INTEREST DISCLOSURE
[If an investigator has a financial interest in this research, insert the following statement:]
One or more individuals involved in this research might benefit financially from this study. The
Institutional Review Board (an ethics committee which helps protect people involved in research) has
reviewed the possibility of financial benefit. The Board believes that the possible financial benefit is not
likely to affect your safety and/or the scientific integrity of the study. If you would like more information,
please ask the researchers or study staff.
CERTIFICATE OF CONFIDENTIALITY
[If a certificate of confidentiality has been obtained for this study, include the required informed consent
language found in the approved certificate of confidentiality.]
CONTACTS FOR QUESTIONS OR PROBLEMS
For questions about the study or a research-related injury, contact the researcher [Insert name of
investigator] at [Insert telephone number]. If you cannot reach the researcher during regular business
hours e.g. 8:00AM-5:00PM), please call [Insert applicable information]. After business hours, please call
[state alternate number and person/title the subject should request, e.g. on-call physician].
In the event of an emergency, you may contact [Insert name of investigator] at [List 24-hour emergency
number].
VOLUNTARY NATURE OF STUDY
Taking part in this study is voluntary. You may choose not to take part or may leave the study at any
time. Leaving the study will not result in any penalty or loss of benefits to which you are entitled. You
decision whether or not to participate in this study will not affect your current or future relations with
[Insert appropriate entity, e.g. hospital, University, professor]. [If withdrawal from the study prior to
completion could pose risk to the subject, stat what those risks might be and how orderly termination will
occur.]
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IRB Application
[If appropriate, include the following statement:] You participation may be terminated by the investigator
without regard to your consent in the following circumstances: [State when and why study participation
may be terminated and how orderly termination will occur.]
[If appropriate, include the following statement:] You will be told about new information that may affect
your health, welfare, or willingness to stay in the study. This study may be terminated by [Insert
sponsor/investigator as appropriate] if [State reason for possible premature termination].
(As appropriate – Use the following section and appropriate paragraph.)
USE OF SPECIMENS
[If specimens obtained as part of the study will be used for commercial use, include the following
statement:]
As this is a research institution, specimens obtained in medical situations may later be used for research
purposes. The investigator intends to include specimens taken from you along with other specimens that
may also be used in an attempt to develop products to be sold, and it is not the intention of the
investigator to enter into an agreement with you to become partners in sharing the profits or losses in the
sale of those products.
SUBJECT’S CONSENT
(This section should be in first person.) In consideration of all of the above, I give my consent to
participate in this research study.
I will be given a copy of this informed consent document to keep for my records. I agree to take part in
this study.
Subject’s Printed Name: ______________________________________
Subject’s Signature: ________________________________________
Date: ______________
Printed Name of Person Obtaining Consent: ______________________________________
Signature of Person Obtaining Consent: _____________________________ Date: _______________
If the study involves children who will be providing their assent on this consent document, rather than
on an assent document, use the following signatures:
Printed Name of Parent: ______________________________________
Signature of Parent: _______________________________________
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Date: ______________
IRB Application
Section D: Application check list
The following elements must be included (if applicable) in submitted proposals to be evaluated by the
Institutional Review Board:

Completed proposal application (Section A)

Completed AND signed assurances page (page 4). Please scan the signed document for
electronic submission

Completed project description (Section B). Be sure to answer ALL applicable questions. If items
are left blank, it may delay the processing of your submission

Appropriate informed consent form (Section C)

Letters of permission – e.g. Conducting research at another institution or work place
environment or providing permission to use a survey instrument or other copyrighted material.

Copies of ALL instruments to be used including cover letters or introductory emails.

Copies of CITI training certificates.
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