Application for IRB Protocol Review
Enclosed are materials you will need for the efficient review of your proposed
project. Please note that the charge of the Institutional Review Board for the Protection of
Human Subjects (IRB) is to ensure the safety, privacy and ethical treatment of human subjects.
There are several key components to the assurance of ethical and humane treatment of
participants in research. To facilitate the process of approval of your proposal, the IRB has
developed a standard form, which is online for your use. You will note that page 1 asks for basic
information about the proposed study. Page 2 lists questions to which the investigator must
respond. These questions address the nature of the proposed project and the nature of the
participation asked of subjects. While specific instructions for completing the application are
included in the form, it is important to note that the investigator must provide a copy of the
intended informed consent form to be inserted at designated location. An example of such a
form is part of the online application. Deadlines, dates of meetings and additional information
which may be helpful to you can be found on-line .
First review the IRB powerpoint to become familiar with the purpose and process of the Wesley
College IRB. Read and follow the instructions carefully. Please submit one typed electronic
copy of the completed application. Include within the application all information and
supporting documentation.
Please submit your materials to the IRB Chair. The Office of Academic Affairs provides
information on the current IRB chair.
Although not a requirement, the researchers are invited to attend the IRB meeting during the time
of the review of their application. Advisors of student researchers are also encouraged to attend.
Complete all sections. For areas that are not applicable to the research indicate in that area N/A.
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INSTITUTIONAL REVIEW BOARD – HUMAN SUBJECTS PROTECTION COMMITTEE
For IRB use only:
Log Number
IRB
Recommendation
Formal letter
notification date
1.
Principal Investigator (primary person conducting the research Choose an item..
Name: Click here to enter text.Department: Click here to enter text.
E-Mail Address: Click here to enter text.
Current Address:Click here to enter text.
Phone where you can be reached during the day: Click here to enter text.
2.
Co-Investigator: Choose an item.
Name: Click here to enter text.Department: Click here to enter text.
Email Address: Click here to enter text.
Phone: Click here to enter text.
3. If you are a student, provide the following:
Faculty Sponsor: Click here to enter text.Department: Click here to enter
text.
Faculty Sponsor Email Address: Click here to enter text.
4.
5.
Project Title: Click here to enter text.
Check only one: Choose an item.
6. Dates during which project will be conducted: From Click here to enter text.To
Click here to enter text.
5.
Has this project previously been considered by any IRB? Yes ☐
No ☐
If yes, give approximate date of review. Click here to enter text.
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6.
PROPOSED RESEARCH PROJECT
A. Purpose of the study- State concisely and realistically what the study is intended to
accomplish.
Click here to enter text.
B.
Background-Briefly state the background of the study, including some relevant references
and identify the main question the current study is intended to address.
Click here to enter text.
C.
Characteristics of the Subject Population-The following information should be provided:
1. Age Range-What is the age range and why was it chosen? Click here to enter
text.
2. Sex-What is the sex of the subjects? If there is a restriction, provide the rationale.
Click here to enter text.
3. Number-What is the estimated number of subjects? Click here to enter
text.
4. Inclusion Criteria-How did you obtain potential subjects and how will you contact
them? Provide a copy of any planned advertisements.Click here to enter
text.
D.
Methods and Procedures: Provide a step-by-step description of each procedure, including
the frequency, duration, and location of each procedure. Attach copies of any instruments
to be used, such as surveys, rating scales, or questionnaires.
Click here to enter text.
E. How will confidentiality of the data be maintained? Click here to enter text.
F. Describe all known and anticipated risks to the subject. Click here to enter text.
Check the box that best indicates the nature of risk for the research:
"Minimal risk" means that the risk of harm anticipated in the proposed research is not more
likely than those risks encountered in daily life, or during routine physical or psychological
examinations/tests. ☐
“High risk” means that the proposed research can cause physical or psychological harm. ☐
G. Describe the anticipated benefits to the subjects, and the importance of the knowledge that
may reasonably be expected to result from the research.Click here to enter text.
7.
Consent form is attached. ☐
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8.
Copy of the questionnaire or other survey instruments used for the research are attached. ☐
9.
Additions to or changes in procedures involving human subjects as well as any problems
connected with the use of human subjects once the project has begun must be brought to the
attention of the IRB.
I agree to provide whatever surveillance is necessary to ensure that the rights and welfare of
the human subjects are properly protected. I understand that I cannot initiate any contact
with human subjects before I have received approval/or complied with all contingencies
made in connection with the approval. I understand that as the principal investigator I am
ultimately responsible for the welfare and protection of human subjects and will carry out
the project as approved.
Click here to enter text.
Click here to enter text.
Signature of Principal Investigator/Program Director
Date
8.
Approval by Faculty Sponsor (REQUIRED FOR ALL STUDENTS):
I affirm the accuracy of this application, and I accept the responsibility for the conduct of
this research and supervision of human subjects as required by law.
Click here to enter text.
Signature of faculty sponsor
Click here to enter text.
Date
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Title of Research: Click here to enter text.
INFORMATION AND CONSENT FORM
Introduction:
You are invited to participate in a research study investigating Click
here to enter text.This study is being conducted byClick here to enter
text., Choose an item. at Wesley College under the supervision ofClick
here to enter text., a faculty member in the Department ofClick here to
enter text..
You were selected as a possible participant in this
research becauseClick here to enter text.. Please read this form and
ask questions before you agree to be in the study.
Background Information:
The purpose of this study is toClick here to enter text.. Approximately
Click here to enter text.people are expected to participate in this
research.
Procedures:
If you decide to participate, you will be asked to Click here to enter
text.. This study will take approximately Click here to enter text.
Risks and Benefits of being in the study:
The study has Click here to enter text.risks.
(Risks must be
explained, including the likelihood of the risk. Describe discomforts and
inconveniences the subjects may reasonably expect. If the subjects will be
told of significant physical or psychological risks to participation, they
also must be told under what conditions the researcher will terminate the
study.)
The benefits to participation are Click here to enter text. (State
benefits. If there are no direct benefits to the subjects, state "There are
no direct benefits to you for participating in this research."). (If
applicable, describe appropriate alternative procedures that might be to
the subject's advantage, if any. Any standard treatment that is being
withheld must be disclosed.)
Confidentiality:
Any information obtained in connection with this research study that can be
identified with you will be disclosed only with your permission; your
results will be kept confidential. In any written reports or publications,
no one will be identified or identifiable and only group data will be
presented. (If it applies to your study, include ways in which you will
maintain confidentiality, e.g. “No one in the daycare center will know your
child’s results.” If you release information to anyone for any reason, you
must state the persons or agencies to whom the information will be
furnished, the nature of the information to be furnished, and the purpose
of the disclosure.)
We/I will keep the research results in a locked file cabinet in (state
where) and only I (or the researcher(s) named in this form) and our/my
advisor will have access to the records while we/I work on this project.
We/I will finish analyzing the data by (specify the ending date of your
research). We/I will then destroy all original reports and identifying
information that can be linked back to you. (If tape or video recordings
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are made, explain who will have access to them, if they will be presented
to others for educational purposes, and when they will be erased or
destroyed.)
Voluntary nature of the study:
Participation in this research study is voluntary. Your decision whether
or not to participate will not affect your future relations with (the name
of any other cooperating institution or) Wesley College in any way. If you
decide to participate, you are free to stop at any time without affecting
these relationships.
Contacts and questions:
If you have any questions, please feel free to contact me, Click here to
enter text., at Click here to enter text.You may ask questions now, or
if you have any additional questions later, the faculty advisor, Click
here to enter text., will be happy to answer them You may keep a copy of
this form for your records.
This project has been approved by the Wesley College Institutional Review Board for the Protection of Human
Subjects
Statement of Consent:
You are making a decision whether or not to participate. Your signature
indicates that you have read this information and your questions have been
answered. Even after signing this form, please know that you may withdraw
from the study at any time.
___________________________________________________________________________
I consent to participate in the study. (If you are video- or audio-taping
your subjects, include a statement such as "and I agree to be videotaped.")
_______________________________________________________________________
Signature of Participant
Date
_______________________________________________________________________
Signature of Parent, Legal Guardian, or Witness
Date
(if applicable, otherwise delete this line)
_______________________________________________________________________
Signature of Researcher
Date
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FOR COMMITTEE USE ONLY
This project:
poses minimal risk.
poses greater than minimal risk.
is Exempt from Continuing Review.
requires Expedited Review.
requires full IRB Review.
Signature
Date
IRB:
Approved to Proceed
Signature
Disapproved________
Date
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