THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S IRB APPLICATION AND IS ONLY TO BE COMPLETED AND SUBMITTED AS AN ASSIGNMENT FOR NSG6101. INSTITUTIONAL REVIEW BOARD FOR THE PROTECTION OF HUMAN SUBJECTS IN RESEARCH This form is to be used for requesting IRB review for exempt, expedited and full board studies Please note that handwritten and/or incomplete forms will be returned to you. CHECKLIST FOR IRB APPLICATION SUBMISSION (to be completed by PI before submission to IRB) FORMCHECKBOX Application Form with Signatures/ Confidentiality Agreements FORMCHECKBOX NIH Training Certificate(s) FORMCHECKBOX Protocol or Attached Research Proposal and/ or Contract/ Grant FORMCHECKBOX Solicitation Announcements/Recruitment Flyers FORMCHECKBOX Data Collection Instruments/Research Questions/Questionnaires/Surveys FORMCHECKBOX Informed Consent Documents FORMCHECKBOX Parental/Legal Guardian Permission Form (if applicable) FORMCHECKBOX Child Assent Form (if applicable) FORMCHECKBOX Approval from Study Sites (if applicable) FORMCHECKBOX Medical Screening Instrument (if applicable) FORMCHECKBOX Debriefing Plan (if applicable) FORMCHECKBOX Student as Principal Investigator Worksheet (if applicable) Project Title PART I - INVESTIGATOR and RESEARCH PERSONNEL 1) PRINCIPAL INVESTIGATOR (Undergraduate students cannot serve as Principal Investigator, but may be listed as a Co-Investigator.) Name: FORMCHECKBOX Dr. FORMCHECKBOX Mr. FORMCHECKBOX Ms. FORMCHECKBOX Professor Highest Degree Completed: Investigator Status: FORMCHECKBOX Faculty FORMCHECKBOX Graduate Student FORMCHECKBOX Staff E-mail Address: College/Department: Campus Mailing Address: Daytime Phone: 2) CO-INVESTIGATOR – 1 (if applicable) Name: FORMCHECKBOX Dr. FORMCHECKBOX Mr. FORMCHECKBOX Ms. FORMCHECKBOX Professor Highest Degree Completed: Investigator Status: FORMCHECKBOX Faculty FORMCHECKBOX Graduate Student FORMCHECKBOX Other FORMCHECKBOX Undergraduate FORMCHECKBOX Staff E-mail Address: College/Department: Campus Mailing Address: Daytime Phone: 3) CO-INVESTIGATOR – 2 (if applicable) Name: FORMCHECKBOX Dr. FORMCHECKBOX Mr. FORMCHECKBOX Ms. FORMCHECKBOX Professor Highest Degree Completed: Investigator Status: FORMCHECKBOX Faculty FORMCHECKBOX Graduate Student FORMCHECKBOX Other FORMCHECKBOX Undergraduate FORMCHECKBOX Staff E-mail Address: College/Department: Campus Mailing Address: Daytime Phone: 4) FACULTY SPONSOR (if applicable) Name: FORMCHECKBOX Dr. FORMCHECKBOX Mr. FORMCHECKBOX Ms. FORMCHECKBOX Professor Highest Degree Completed: E-mail Address: College/Department: Campus Mailing Address: Daytime Phone: 5) STUDENT INVESTIGATORS/RESEARCH ASSISTANTS (if applicable) Name: E-mail: Phone: Name: E-mail: Phone: Name: E-mail: Phone: Name: E-mail.

1. THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S IRB
APPLICATION AND IS ONLY TO BE COMPLETED AND
SUBMITTED AS AN ASSIGNMENT FOR NSG6101.
INSTITUTIONAL REVIEW BOARD
FOR THE PROTECTION OF HUMAN SUBJECTS IN
RESEARCH
This form is to be used for requesting IRB review for exempt,
expedited and full board studies
Please note that handwritten and/or incomplete forms will be
returned to you.
CHECKLIST FOR IRB APPLICATION SUBMISSION
(to be completed by PI before submission to IRB)
FORMCHECKBOX
Application Form with Signatures/ Confidentiality Agreements
FORMCHECKBOX
NIH Training Certificate(s)
FORMCHECKBOX
Protocol or Attached Research Proposal and/ or Contract/ Grant
FORMCHECKBOX
Solicitation Announcements/Recruitment Flyers
FORMCHECKBOX
Data Collection Instruments/Research
Questions/Questionnaires/Surveys
FORMCHECKBOX
Informed Consent Documents

2. FORMCHECKBOX
Parental/Legal Guardian Permission Form (if applicable)
FORMCHECKBOX
Child Assent Form (if applicable)
FORMCHECKBOX
Approval from Study Sites (if applicable)
FORMCHECKBOX
Medical Screening Instrument (if applicable)
FORMCHECKBOX
Debriefing Plan (if applicable)
FORMCHECKBOX
Student as Principal Investigator Worksheet (if applicable)
Project Title
PART I - INVESTIGATOR and RESEARCH PERSONNEL
1) PRINCIPAL INVESTIGATOR
(Undergraduate students cannot serve as Principal Investigator,
but may be listed as a Co-Investigator.)
Name:
FORMCHECKBOX
Dr. FORMCHECKBOX
Mr. FORMCHECKBOX
Ms. FORMCHECKBOX
Professor
Highest Degree Completed:
Investigator Status:

3. FORMCHECKBOX
Faculty FORMCHECKBOX
Graduate Student FORMCHECKBOX
Staff
E-mail Address:
College/Department:
Campus Mailing Address:
Daytime Phone:
2) CO-INVESTIGATOR – 1 (if applicable)
Name:
FORMCHECKBOX
Dr. FORMCHECKBOX
Mr. FORMCHECKBOX
Ms. FORMCHECKBOX
Professor
Highest Degree Completed:
Investigator Status:
FORMCHECKBOX
Faculty FORMCHECKBOX
Graduate Student FORMCHECKBOX
Other
FORMCHECKBOX
Undergraduate FORMCHECKBOX
Staff
E-mail Address:
College/Department:

4. Campus Mailing Address:
Daytime Phone:
3) CO-INVESTIGATOR – 2 (if applicable)
Name:
FORMCHECKBOX
Dr. FORMCHECKBOX
Mr. FORMCHECKBOX
Ms. FORMCHECKBOX
Professor
Highest Degree Completed:
Investigator Status:
FORMCHECKBOX
Faculty FORMCHECKBOX
Graduate Student FORMCHECKBOX
Other
FORMCHECKBOX
Undergraduate FORMCHECKBOX
Staff
E-mail Address:
College/Department:
Campus Mailing Address:
Daytime Phone:
4) FACULTY SPONSOR (if applicable)
Name:

5. FORMCHECKBOX
Dr. FORMCHECKBOX
Mr. FORMCHECKBOX
Ms. FORMCHECKBOX
Professor
Highest Degree Completed:
E-mail Address:
College/Department:
Campus Mailing Address:
Daytime Phone:
5) STUDENT INVESTIGATORS/RESEARCH ASSISTANTS
(if applicable)
Name:
E-mail:
Phone:
Name:
E-mail:
Phone:
Name:
E-mail:
Phone:

6. Name:
E-mail:
Phone:
Name:
E-mail:
Phone:
PART II – FUNDING INFORMATION
1) Check all of the appropriate boxes for funding sources for
this research. Include pending funding source(s).
FORMCHECKBOX
Extramural
FORMCHECKBOX
College
FORMCHECKBOX
Department
FORMCHECKBOX
Other:
P.I. of Grant or Contract:
Sponsor:
Contract/Grant No.
(if available):

7. Contract/Grant Title:
***Please provide one complete copy of the proposal submitted
to the sponsor with this application. Please note that
submission of your grant application is a regulatory requirement
and will be maintained for the record with your application.
The IRB will not utilize the grant during the review process
other than to confirm that the grant proposal is consistent with
the IRB proposal. You must submit all necessary
documentation for the application in addition to the copy of the
grant.
PART III – EDUCATION AND TRAINING
All research personnel (faculty, staff, graduate students
working on a thesis or dissertation, anyone using data for
purposes of independent research, students involved in data
collection, faculty sponsors, persons receiving grant monies for
human subject research or those personnel with management
responsibilities) must complete this section.
1) Have all key research personnel completed the required NIH
training?
No FORMCHECKBOX
Yes FORMCHECKBOX
***If No, DO NOT submit this application. Your application
will not be considered until you have completed the IRB
training and can provide a copy of your NIH course completion
certificate.
(Please include a copy/copies of all certificate(s) with each
application.)
***Please note that this NIH training is a mandatory
requirement to be completed every three years.

8. ***If you have not completed the NIH training, but have
completed a comparable course (e.g. CITI training), please
include documentation of those courses.
2) If other necessary training/education is required for
completion of this study, please attach copies of certificates or
other documentation (e.g., HIPAA training, phlebotomy
training).
PART IV – INVESTIGATOR ASSURANCE
1) Institutional Review Board Policy Compliance Agreement
· I certify that the information provided in this application is
complete and correct.
· I understand that as Principal Investigator, I have the
responsibility for the conduct of the study, the ethical
performance of the project and the protection of the rights and
welfare of human participants.
· I agree to comply and to assure that all affiliated personnel
comply with all South University IRB policies and procedures,
as well as with all applicable federal, state and local laws
regarding the protection of human participants in research.
· I agree that I have the appropriate expertise to conduct this
study.
· I assure that this study is performed by qualified personnel
adhering to the South University IRB approved protocol.
Student PI’s must attach student PI worksheet (see appendix A).
· I assure that no modification to the approved protocol and
consent materials will be made without first submitting for
review and approval by the South University IRB an amendment
to the approved protocol.
· I agree to obtain legally effective informed consent from the
research participants as applicable to this research and as

9. prescribed in the approved protocol.
· I will promptly report unanticipated problems to the South
University IRB by using the Notification Form provided on the
IRB website.
· I will adhere to all requirements for continuing review and
will complete a Continuance Request form if my research
extends beyond one year.
· I will advise the South University IRB of any change of
address or contact information as long as this protocol remains
active.
· I assure that I have obtained all necessary approvals from
entities other than South University IRB that are necessary to
conduct this research (e.g., cooperation letters or approvals
from other institutions).
My signature below certifies that I am knowledgeable about the
regulations and policies governing research with human subjects
and have sufficient training and experience to conduct this
particular study in accordance with the research protocol.
Principal Investigator
Date (mm/dd/yyyy)
Co-Investigator
Date (mm/dd/yyyy)
Faculty Sponsor
Date (mm/dd/yyyy)
2) Confidentiality Agreement
· I have agreed to assist with the research project described in
this application.
· I agree not to discuss or disclose any of the content or
personal information contained within the data, tapes,

10. transcriptions, or other research records with anyone other than
the Principal Investigator, Co-Investigator, or in the context of
the research team.
· I agree to maintain confidentiality at all times and to abide by
the South University IRB Policy and Procedures Manual.
· If I am aware of any breach in confidentiality, I am required to
report violations of confidentiality to the IRB Committee
Director, who will report this information to the College Dean
and the Vice Chancellor of Academic Affairs.
Principal Investigator
Date (mm/dd/yyyy)
Co-Investigator
Date (mm/dd/yyyy)
Faculty Sponsor
Date (mm/dd/yyyy)
Student Investigator
Date (mm/dd/yyyy)
Student Investigator
Date (mm/dd/yyyy)
Student Investigator
Date (mm/dd/yyyy)
PART V – ADMINISTRATIVE DATA
1) Proposed duration of data collection/analysis
Start date:
End date:
***South University IRB policy dictates that project approvals
may be granted for a maximum of one year, although the exact
approval term will be determined based on the level of
participant risk inherent in the proposal. Should the PIs need an
extension beyond the proposed duration, they can apply by
completing the Continuance Request Form.
2) If this research will result in a thesis or dissertation, please

11. check the appropriate box.
FORMCHECKBOX
Undergraduate Level Project
FORMCHECKBOX
Masters Level Project
FORMCHECKBOX
Doctoral Level Project
(Thesis, Capstone)
(Thesis, Capstone)
(Dissertation, Capstone)
3) Conflict of Interest
Is there any potential or perceived conflict of interest between
the researcher, sponsor and/or South University associated with
this study?
No FORMCHECKBOX
Yes FORMCHECKBOX
***If yes, please explain, including any and all possible
conflicts:
4) Study population
a. Maximum Number of Participants Proposed:
b. Age Range: to(include low/high age range)
c. Gender: FORMCHECKBOX
Males FORMCHECKBOX
Females
d. Site of Subject Recruitment:

12. ***Please note that if recruitment will be conducted at any
physical site other than South University, you will need to
include a letter from management of the proposed site
indicating their approval of your use of the facility.
e. Will medical clearance or medical screening be necessary for
participants to participate because of tissue or blood sampling,
administration of substances such as food or drugs, or physical
exercise conditioning?
No FORMCHECKBOX
Yes FORMCHECKBOX
***If yes, explain how clearance will be obtained. If a
screening instrument will be used, please attach a copy to the
application.
5) Potentially Vulnerable Populations. Please check any groups
included in the study.
FORMCHECKBOX
Children (under 18 years of age)
FORMCHECKBOX
Pregnant Women
FORMCHECKBOX
Elderly (65 & older)
FORMCHECKBOX
Psychologically Impaired
FORMCHECKBOX
Cognitively Impaired

13. FORMCHECKBOX
Prisoners
FORMCHECKBOX
Native American Tribes and/or Tribal Organizations
FORMCHECKBOX
Students currently enrolled in a class instructed by the
investigator
*** If you checked any of the above groups, your proposal will
require full board review.
6) Study Site:
***Please note that if research will be conducted at any
physical site other than South University, you will need to
include a letter from management of the proposed site
indicating their approval of your use of the facility.
PART VI – SUMMARY OF STUDY ACTIVITIES
***Submission of a copy of a grant application or project
proposal does not replace completion of this form. If additional
space is required, you may attach a separate document, but
please respond to each item in this section and label your
responses accordingly. Incomplete proposals will be returned to
you.
1) Provide background information for the study including the
objective of the proposed research, purpose, research question,
hypothesis and other information deemed relevant.
2) Describe the research design of the study (i.e., state whether
the study is correlational, experimental, etc. and define the
variables).

14. 3) Describe the tasks that participants will be asked to perform
including a step‑by‑step description of the procedures you plan
to use with your subjects. Provide the approximate duration of
subject participation for each procedure/ instrument and the
frequency and setting of each administration. Identify any
personnel who will assist with data collection.
***You must submit a copy of each study instrument, including
all questionnaires, surveys, protocols for interviews, etc.
***If someone will be assisting with data collection, but is not
indicated as a co-investigator or research assistant in this
application (i.e. they will be accessing archival data for you)
you must submit a letter of approval indicating that they are
willing and capable to assist.
4) Describe the recruitment procedures. Explain who will
approach potential participants and take part in the research
study and what will be done to protect the individual’s privacy
in this process.
***You must submita copy of any material used to recruit
subjects (e.g., informed consent forms, advertisement, flyers,
telephone scripts, verbal recruitment scripts, cover letters, etc.)
5) Describe how participants will be debriefed.
***If deception is used, the principal investigator should offer
the participant the opportunity to withdraw his/her data after
being debriefed, and this information should be included in the
debriefing script.
PART VII – PRIVACY PROCEDURES
1)
Will data be recorded by audiotape?
No FORMCHECKBOX
Yes FORMCHECKBOX

15. Will data be recorded by videotape?
No FORMCHECKBOX
Yes FORMCHECKBOX
Will photographs be taken?
No FORMCHECKBOX
Yes FORMCHECKBOX
a. How will subjects be identified in these recordings?
b. Explain your plan for disposal of
tapes/photographs/negatives, including when this disposal will
occur (i.e. after transcription/development or at the conclusion
of the study).
***If you wish to retain the tapes/photographs/negatives beyond
transcription/development, you must provide justification.
***Subjects must be informed of the collection and disposal of
the tapes/photographs/negatives via the informed consent
process.
2) Will you record any direct identifiers (e.g.,, names, social
security numbers, addresses, telephone numbers, etc)?
No FORMCHECKBOX
Yes FORMCHECKBOX
a. Explain why it is necessary to record these identifiers.
b. Describe the coding system you will use to protect against
disclosure of these identifiers.
c. Describe how subject identifiers will be maintained or

16. destroyed after the study is completed.
***If you will retain a link between the study code numbers and
direct identifiers after the data collection is complete, explain
why this is necessary and state how long you will keep this link.
d. Will you provide a link or identifier to anyone outside the
research team?
No FORMCHECKBOX
Yes FORMCHECKBOX
***If yes, explain why and to whom.
3) Where, how long, and in what format (such as paper, digital
or electronic media, video, audio or photographic) will data be
kept? In addition, describe what security provisions will be
taken to protect these data (password protection, encryption,
etc).
4) Will you place a copy of the consent form or other research
study information in the participant’s record such as medical,
personal or educational record? No FORMCHECKBOX
Yes FORMCHECKBOX
***If yes, explain why this is necessary.
***This information should be clearly explained in the consent
document and/or process.
5) Will any record of the subject’s participation in this study be
made available to his or her
supervisor, teacher, or employer?
No FORMCHECKBOX

17. Yes FORMCHECKBOX
***If yes, please explain why this is necessary
.
6) Will you obtain a Federal Certificate of Confidentiality for
this research?No FORMCHECKBOX
Yes FORMCHECKBOX
***If yes, submit documentation of application (and a copy of
the Certificate of Confidentiality award if granted) with this
application form.If the data collected contain information about
illegal behavior, visit the NIH Certificates of Confidentiality
Kiosk http://grants1.nih.gov/grants/policy/coc for information
about obtaining a Federal Certificate of Confidentiality.
PART VIII – INFORMED CONSENT INFORMATION
1) Informed Consent: Please attach, as an appendix, an
informed consent document to this application. South
University IRB requires that all activity involving human
subjects be carried out only AFTER obtaining proper consent
from the participants of the research. Thus an information sheet
or cover letter that contains all required elementsof informed
consent must be attached to this application. You may access a
template for this form on the South University IRB website.
(Please attach an assent form for children/youth participation
and permission forms for parents/legal guardians; or consent
forms for adult participation).
2) Request for Waiver of Informed Consent: Are you requesting
a waiver of informed consent?
No FORMCHECKBOX

18. Yes FORMCHECKBOX
***If yes, provide a written justification for a waiver of
informed consent according to Section 46.116 of 45 CFR 46
(http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
#46.116).
3) Request for Waiver of Documentation of Consent (applies to
studies that do not wish to have signatures of the participants,
i.e. internet research): Are you requesting a waiver of
documentation of consent?
No FORMCHECKBOX
Yes FORMCHECKBOX
***If yes, provide a written justification for a waiver of
documentation of consent according to Section 46.117 of 45
CFR 46
(http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
#46.117).
PART IX – RISKS AND BENEFITS
1) Does the research involve any of the possible risks or harms
to subjects listed below?
No FORMCHECKBOX
Yes FORMCHECKBOX
***If Yes, independent scientific review may be required to
determine if scientific merit

19. justifies this risk.
Check all that apply:
FORMCHECKBOX
Use of deception
***If deception is used, describe in detail here, including the
debriefing process and script.
***If deception is used, the principal investigator should offer
the participant the opportunity to withdraw his/her data after
being debriefed, and this information should be included in the
debriefing script.
FORMCHECKBOX
Use of confidential records (e.g. educational or medical
records)
FORMCHECKBOX
Manipulation of psychological or social variables such as
sensory deprivation, social isolation, psychological stressors
FORMCHECKBOX
Presentation of materials which subjects might consider
sensitive, offensive,
threatening or degrading
FORMCHECKBOX
Possible invasion of privacy of subject or family
FORMCHECKBOX
Social, legal, or economic risk
FORMCHECKBOX
Employment/occupational risk
FORMCHECKBOX

20. Students of the researcher
FORMCHECKBOX
Subordinates and colleagues of the researcher
FORMCHECKBOX
Residents of any facility (i.e., prison)
FORMCHECKBOX
Pregnant women
FORMCHECKBOX
Children and minors
FORMCHECKBOX
Elderly subjects (65+ years of age)
FORMCHECKBOX
Wards of the state
FORMCHECKBOX
Mentally and emotionally disability
FORMCHECKBOX
Individuals who are not fluent in English
FORMCHECKBOX
Other risks (specify):
2) Describe the nature and degree of the risk or harm checked
above.
***The described risks/harms must be disclosed in the consent
form.
3) Explain what steps will be taken to minimize risks or harms
and to protect subjects’ welfare. If the research include
protected populations (See Part V, Item 5 above), please
identify each group and answer this question for each group.

21. 4) Describe the anticipated benefits of this research for
individual participants in each subject group. If none, state
“none”.
5) Describe the anticipated benefits of this research for society,
and explain how the benefits outweigh the risks.
PART X – COMPENSATION INFORMATION
1) Will any compensation or inducements, i.e. course credit, be
offered to the subjects for their participation?
No FORMCHECKBOX
Yes FORMCHECKBOX
If yes, describe those inducements and include a statement in
the informed consent document explaining how compensation
will be handled in the event the participant withdraws from the
study.
***If yes, describe those inducements.
***The informed consent document must include a statement
explaining how compensation will be handled in the event that
the participant withdraws from the study.
Appendix A: Student as Principal Investigator Worksheet
Level: FORMCHECKBOX
Masters
FORMCHECKBOX
Doctorate
This project has been reviewed to determine that the scope,
anticipated risks and benefits, and methodology are appropriate
for this research by:

22. FORMCHECKBOX
Approval of thesis/dissertation proposal by faculty committee
FORMCHECKBOX
My personal review and approval of research proposal
FORMCHECKBOX
Other:
The student researcher is qualified to conduct independent
research based on the following credentials (check all that
apply):
FORMCHECKBOX
has completed a graduate research methods course
FORMCHECKBOX
has experience as an independent or closely supervised
research assistant
FORMCHECKBOX
has completed NIH training
FORMCHECKBOX
Other:
FACULTY SPONSOR’S ASSURANCE
By my signature as sponsor on this research application, I
certify that the student is knowledgeable about the regulations
and policies governing research with human subjects and has
sufficient training and experience to conduct this particular
study in accordance with the research protocol. Additionally,
· I hereby confirm that I have thoroughly reviewed this IRB
application, including the protocol narrative, and deem it ready
for submission.
· I agree to meet with the investigator on a regular basis to

23. monitor study progress.
· I agree to be available, personally, to assist the investigator in
solving problems, should they arise during the course of the
study.
· I assure that the investigator will promptly report
unanticipated problems and will adhere to all requirements for
continuing review.
· If I am unavailable, e.g. sabbatical leave, vacation, or
resignation, I will arrange for an alternate faculty sponsor to
assume responsibility during my absence, and I will advise the
South University IRB, in writing, of such changes.
· The research is appropriate in design.
Print Faculty Sponsor Name
Faculty Sponsor Signature
Date (mm/dd/yyyy)
Print PI Name
PI Signature
Date (mm/dd/yyyy)
PAGE
Page 1 of 15
THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S
INFORMED CONSENT LETTER AND IS ONLY TO BE
COMPLETED AND SUBMITTED AS AN ASSIGNMENT FOR
NSG6101.

24. For Official Use Only
Date received:
Date reviewed:
End date:
File #:
SELF CONSENT
I have been invited to take part in a research study titled:
This study is being conducted by, who can be contacted at:
I understand that my participation is voluntary and that I can
refuse to participate or stop taking part any time without giving
any reason and without facing any penalty. Additionally, I have
the right to request the return, removal, or destruction of any
information relating to me or my participation.
PURPOSE OF STUDY
I understand that the purpose of the study is to:
PROCEDURES
I understand that if I volunteer to take part in this study, I will

25. be asked to:
BENEFITS
I understand that the benefits I may gain from participation
include:
RISKS
I understand that the risks, discomforts, or stresses I may face
during participation include:
CONFIDENTIALITY
I understand that the only people who will know that I am a
research subject are members of the research team. No
individually-identifiable information about me, or provided by
me during the study will be shared with others except when
necessary to protect the rights and welfare of myself and others
(for example, if I am injured and need emergency care, if the
provided information concerns suicide, homicide, or child
abuse, or if revealing the information is required by law).

26. FURTHER QUESTIONS
I understand that any further questions that I have, now or
during the course of the study can be directed to the researcher (
).
Additionally, I understand that questions or problems regarding
my rights as a research participant can be addressed to Dr.
Jessica Hillyer, Institutional Review Board Director of
Compliance and Training, South University, 7700 W. Parmer
Ln., Austin, TX 78729;
[email protected]; 512-516-8779.
My signature below indicates that the researchers have
satisfactorily answered all of my current questions about this
study and that I understand the purpose, procedures, benefits,
and risks described above. I have also been offered a copy of
this form to keep for my own records.
Participant Printed Name
Signature of Participant Date
(mm/dd/yyyy)

27. Signature of Principal Investigator Date
(mm/dd/yyyy)
Page 1 of 2
Part I: Information Sheet
Introduction
My name is Ram Pander, a student at South University. I am
researching immunization and vaccination. I would like to
invite you to participate in this study. Feel free to discuss with
anyone you are comfortable with on matters of this research.
You may take your time before making the final decision on
participating in this study. This consent form may contain
words and phrases that you may not understand, feel free to stop
me and inquire as we go through the information. If any
questions may arise, feel free to ask me.
Purpose of the research

28. Immunization and vaccination are vital for a healthy life. We
want to determine the level of acceptance to different types of
vaccinations while identifying the challenges faced by those
that were not vaccinated.
Type of Research Intervention
This research will involve your participation in half hour a
twenty minutes interview.
Participant Selection
You are being invited to take part in this research because we
feel that your experience as a medical practitioner, victim of
lack of vaccination, well-immunized adult or parent can
contribute much to our understanding and knowledge of
immunization and vaccination.
Voluntary Participation
Your participation in this research is entirely voluntary. It is
your choice whether to participate or not. If you choose not to
participate in all the services you receive at this Centre will
continue and nothing will change.
Risks
You do not have to answer any question that makes you feel
uncomfortable. You do not have to justify not having a response
to other questions.
Benefits
There will be no direct benefit to you, but your participation is
likely to help us find out more about how to increase the rate of
immunization and help those that have not been immunized in
the community.
Reimbursements

29. You will not be provided an incentive to take part in the
research.
Confidentiality
We will not be sharing information about you to anyone outside
of the research team. The information that we collect from this
research project will be kept private. Any information about you
will have a number on it instead of your name. Only the
researchers will know what your number is and we will lock
that information up with a lock and key.
Right to Refuse or Withdraw
You do not have to take part in this research if you do not wish
to do so. You may stop participating in the interview at any
time that you wish. I will give you an opportunity at the end of
the interview to review your remarks, and you can ask to modify
or remove portions of those, if you do not agree with my notes
or if I did not understand you correctly.
Who to Contact
If you have any questions, you can ask them now or later. If you
wish to ask questions later, you may contact me.
This proposal has been reviewed and approved by [name of the
local IRB], which is a committee whose task it is to make sure
that research participants are protected from harm.
Part II: Certificate of Consent
I have read the preceding information, or it has been read to me.
I have had the opportunity to ask questions about it, and any
questions I have been asked have been answered to my
satisfaction. I consent voluntarily to be a participant in this
study
Print Name of Participant__________________

30. Signature of Participant ___________________
Date ___________________________
Day/month/year
If illiterate
I have witnessed the accurate reading of the consent form to the
potential participant, and the individual has had the opportunity
to ask questions. I confirm that the individual has given consent
freely.
Print name of witness____________Thumb print of participant
Signature of witness _____________
Date ________________________
Day/month/year
Statement by the researcher/person taking consent
I have accurately read out the information sheet to the potential
participant, and to the best of my ability made sure that the
participant understands what is contained
I confirm that the participant was given an opportunity to ask
questions about the study, and all the questions asked by the
participant have been answered correctly and to the best of my
ability. I confirm that the individual has not been coerced into
giving consent, and the consent has been given freely and
voluntarily.

31. A copy of this ICF has been provided to the participant.
Print Name of Researcher/person taking the
consent________________________
Signature of Researcher /person taking the
consent__________________________
Date ___________________________
Day/month/year
Informed Consent Form for Interviewees
� A literate witness must sign (if possible, this person should
be selected by the participant and should have no connection to
the research team). Illiterate participants should include their
thumbprint as well.

32. Page 2 of 3
Running Head: IMMUNIZATION AND VACCINATION
1
IMMUNIZATION AND VACCINATION
12
Immunization and Vaccines
Ram Pandey
South University
Nursing Research Methods
NSG6101
Ellen Rearick
Introduction
Immunization is a process whereby an individual, especially a
young child below the age of six, is made resistant against
infectious diseases. Immunization is usually done through the
administration of some medicine commonly known as vaccines.
Vaccines are administered in an individual's body through
several means such as oral and injection. Vaccines are of great
importance in that they boost the body's immunity thus
preventing the individual from being infected with the disease

33. later in life.
Immunization is one of the tools that have been proven to
reduce the number of deaths in the world drastically.
Approximately two million deaths have been avoided annually
because parents are informed about the necessities of
immunizing their children (Russel, 1998). This number is
projected to have increased over the years. Thus, with effective
medical support from organizations such as the World Health
Organization (WHO), the immunization processes can reach the
majority of the population even the hard-to-access group of
people in the society. With improved medical services brought
about by improved infrastructure, WHO has an aim to ensure
each person receives proper immunization during childhood.
Proper immunization will reduce infant mortality rates due to
proper health service.
The most important part of the research is to understand the
relationship between vaccination and immunization of young
children with the improvement in the quality of a healthy life.
There is a need to understand other factors surrounding the
immunization and lack of immunization of children below the
age of six years. In this study, various literature will be studied
to enable the development of a hypothesis and its validity tested
by the procedures of the research. From the literature review, it
clearly shows that immunized children have reduced medical
health problems compared to those that have not been
immunized. Lack of immunization among the children can lead
to the contract of diseases which can easily cause infant
mortality.
Statement of problem
There is some great relationship between the rate of
survival in immunized children and mortality rates due to
diseases caused by a lack of immunization. Immunization has
led to increased chances of survival in children. However, there
are still some children who cannot fully access vaccines due to
certain factors that affect them. The factors that affect them
from accessing vaccines provide some base for research to be

34. carried out.
Objectives
The objectives of this research include:
a.) To determine the reason why some people still do not want
their children to undergo immunization.
b.) To not only understand the political problems but also the
economic and philosophical difficulties the unimmunized
children undergo later in life.
c.) To clearly understand the importance and benefits of parents
ensuring their children are immunized
Null hypothesis
a.) There are no reasons to explain why some people still do not
want their children to undergo immunization.
b.) The political, economic and philosophical difficulties faced
by unimmunized children undergo later in life cannot be
understood.
c.) The importance and benefits of parents ensuring their
children are immunized cannot be clearly understood.
Research Questions
a.) How important is immunization
b.) What are the repercussions of escaping the immunization
process to an individual?
Theoretical framework
Research shows that effective vaccination and immunization of
children in the whole population will lead to an improved health
life of an individual. With the presence of modern statistical
programs used for analysis such as STATA, there will be an
efficient analysis of variables available in this research.
Literature Review
Immunizations and vaccines are considered to be the most
cost-effective intervention when it comes to child survival
(Prinja et al., 2018). However, coverage and access differ from
country to country. This creates large disparities when it comes
to children and immunization across the globe. The Effective
Vaccine Management (EVM) initiative has the main duty of
providing materials that monitor the supply of vaccines. The

35. process must be monitored because with time there has been a
rise in the cost of vaccines. Therefore, the stock level must be
kept at minimum levels as planned by the medical department
without wastage pf resources so that it can be sufficient for the
population.
Logical support has to ensure that there is a supply of high-
quality equipment and vaccines (Markowitz et al., 2007) A
well-managed logistics support program will ensure that there
are reduced cases of adverse side effects brought about by the
vaccines. WHO should also come up with methods aimed at
improving the lives of those that have not been vaccinated. The
organization should also come up with programs which will be
used as a platform for educating those individuals against
immunization. The following consists of a literature review of
the differences and similarities in the world immunization
systems for three countries: Nigeria, India, and Switzerland.
Nigeria
Nigeria has one of the highest percentages of vaccine-
preventable diseases including measles, poliomyelitis,
tuberculosis, diphtheria, and tetanus. According to Oku et al.
(2017), only one-fourth of children receive full vaccinations.
The country is ranked 2nd when it comes to mortality rates from
vaccine-preventable diseases among children. When it comes to
economic development, Nigeria outperforms lower-middle-
income countries but has the lowest immunization coverage
rates in the world. Burroway and Hargrove (2018) investigated
the community and individual-level factors that influence
whether a child is vaccinated in Nigeria. Researchers found
women’s education level to have the largest association with
childhood vaccinations. The reasons associated with low
immunizations throughout Nigeria consists of: concerns about
immunization safety, lack of knowledge regarding vaccinations,
and long distances to health facilities (Oku et al., 2017)
In 1979, Nigeria launched the Expanded Programs on
Immunizations (EPI) to provide routine vaccinations to all
children under the age of one, as well as pregnant women.

36. However, Nigeria is one of only three countries where polio
remains an endemic (Prinja et al., 2018). In October 2012,
Nigeria restructured its polio program and created the Polio
Emergency Operation Centre. The country also uses
supplementary immunization activities (SIAs) to help eliminate
polio. During an SIA, healthcare workers provide all children
under the age of five with oral polio vaccine (OPV). These
campaigns are usually conducted house-to-house; however, it is
difficult for healthcare workers to reach all children due to
incomplete household maps and vaccine refusals (Oku et al.,
2017). Even with the campaign and programs, there are still
currently a substantial amount of children in Nigeria who have
not received vaccinations.
India
Approximately 62% of children in India have full immunization.
A 2015-2016 National Family Health Survey (NFHS) showed
large disparities when it came to different doses of the BCG,
DPT, polio and measles vaccines across all districts of India.
Over the past decade, child vaccination coverage throughout the
country has substantially increased. However, currently, one-
third of children in India have not received immunizations.
While donor and government-funded programs have improved
childhood immunizations throughout central and northern India,
there is little focus on the north-eastern region. According to
Khan, Shil and Prakash (2018), there are state or regional-level
inequalities in immunizations throughout India due to the
differential healthcare facility and socio-economic factors
consisting wealth status, gender preference, place of residence
and health infrastructure. The researchers found that women's
education was positively correlated with vaccination. They also
discovered a positive correlation between childhood
immunizations and institutional deliveries, birth registration
and having an MCP card (Khan, Shil & Prakash, 2018).
Nigeria and India have opposite trends regarding the DPT3
vaccine between 2007 and 2017. In 2007, 3.3 million Nigerian
children and 9.3 million children in India did not receive the

37. DPT series. During the same period, the population eligible for
the vaccine increased by 23% in Nigeria and decreased by 6% in
India. Nigeria surpassed India in 2014 as the country with the
most children without the DPT3 vaccine (VanderEnde et al.,
2018).
Switzerland
Unlike the other two countries, Switzerland is a developed
country. After several years of low incidence rates each year,
there has been a measles epidemic since 2006. As a result,
coverage rates for MMR doses have increased to 86%. However,
the number of children who are vaccinated in Switzerland is
greatly impacted by parental perception. In Switzerland, all
immunization costs are covered, but whether a child is
vaccinated depends on the parent's initiative to take them to a
pediatrician. Despite the national and international efforts of
health authorities, immunizations in high-income countries have
adversely impacted by a parent's choice to decline childhood
vaccination (Gross et al., 2015).
Switzerland has the highest rates of measles in Europe.
According to Gross et al. (2015), parents in Switzerland believe
childhood diseases are a natural process of gaining immunity
and not necessarily a threat to a child's health. This has created
problems for the country in regards to measles. The MMR
vaccination currently has suboptimal coverage, and as a result,
measles is still a local endemic in Switzerland. According to a
Swiss Federal Office of Public Health (FOPH), only 86% of
children under the age of two have received two doses of MMR.
This is lower than the 95% global goal when it comes to
vaccination (Gross et al., 2015).
Methodology
Research design
The study will utilize questionnaires in the collection of
information for this research. The questions will be a
combination of both open-ended questions and closed questions.
Therefore, this research would focus hugely on descriptive
research design. The presence of participants who are used in

38. this study shows that they are variables of the research.
Research context
The context of this research involves the detailed study of
difficulties faced by individuals who do not access vaccination
facilities. The context, therefore, elaborates how vaccination
facilities can reach those who do not access them and even
those who are against the use of vaccines. The context also
shows the improvement of healthy life in individuals who
access vaccination services while young. WHO aims of reaching
every person is also a research context that is present in the
study.
Procedure
Participants
The study will utilize two types of participants: those that have
been immunized and those that have not been immunized. The
presence of the two types of individuals is necessary as it
clearly shows the effect of being immunized and not being
immunized. It also gives an insight towards the level of
acceptance among parents for the immunization process to be
carried out on their children.
Materials
Questionnaires will be included in the collection of the primary
data necessary for this research. The researchers need to be
physically available to give guidelines and offer assistance to
the interviewees in addition to the instructions provided for at
the beginning of the questionnaire. Analytical programs such as
STATA and SAS will be highly required in the analysis of the
findings.
Variables.
The dependent variables in this study will be the level of
acceptance of the different types of immunizations. The
independent variables will be the participants who will be
interviewed for the purpose of collecting data for this study.
Methods of data collection
Several methods will be used in the collection of data. Such
means include the use of questionnaires and the use of medical

39. records. Use of questionnaires will take place from ward-based
records to ensure easier responding from the respondents. Use
of medical records will be limited to medical practitioners since
they are the ones with the primary data of information.
Information received will later be sent through email to enhance
faster transfer of information.
Methods of data analysis
STATA will be used in the analysis of data received from
the research. The use of STATA makes it easy in making
comparisons and determining the associations between variables
(Friese et al., 2008). One can develop some regression analysis
between variables while using STATA thus making it quite
useful in the analysis of data
Ethical Considerations
The questionnaire should provide for confidentiality and
protection of the participant's identity.
The researchers should also get the necessary approval from the
University’s ethics board before carrying out the research
They should also get written consent from the participants to
avoid future legal issues.
The significance of the proposed research
The proposed research is going to be useful in finding a solution
for individuals who did not undergo vaccination during their
childhood. It also finds a solution to how the general population
can access medical services after birth with reduced payments.
This research would also be an addition to the improvement of
medical services in the medical department.
Research limitations
This research about vaccination and the lack of vaccination
comes along with several limitations. Some of its limitations
include computation of a large amount of data, inadequate
supply of funds and the lack of seriousness when it comes to
vaccination programs. The analysis of this research involves the
computation of data from different health organizations thus
becomes difficult and tiresome to analyze the data effectively.
Secondly, there has been enough supply of resources, especially

40. funds. The available money raised by the government is
allocated to other sectors thus resulting to less amount of money
being allocated to the health services with the aim of ensuring
the whole population receives vaccination (Peyle et al., 2009).
Even after undergoing education programs on the importance of
vaccination, there are still many individuals who cannot stand
their children being immunized.
References
Burroway, R., & Hargrove, A. (2018). Education is the antidote:
Individual-and community-level effects of maternal education
on child immunizations in Nigeria. Social Science &
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Friese, C. R., Lake, E. T., Aiken, L. H., Silber, J. H., &
Sochalski, J. (2008). Hospital nurse practice environments and
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Gross, K., Hartmann, K., Zemp, E., & Merten, S. (2015). ‘I
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‘natural’in parental reasoning against child immunization in a
qualitative study in Switzerland. BMC public health, 15(1), 373.
Khan, J., Shil, A., & Prakash, R. (2018). Exploring the spatial
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Appendices