Running head RESEARCHRESEARCH 3.docx

Running head: RESEARCH
RESEARCH
3
Topic: Research
Student Name:
Institution:
Research Question
What are the root causes of obesity among children in the
United States?
Problem Statement
A young person is not viewed as hefty until the weight is no
less than 10 percent higher than what is prescribed for their
tallness and body sort. Obesity most regularly starts between
the ages of 5 and 6, or amid puberty. Examines have
demonstrated that a kid who is stout between the ages of 10 and
13 has an 80 percent possibility of turning into a fat grown-up.
The reasons for obesity are unpredictable and incorporate
hereditary, natural, behavioral and social elements. Obesity

happens when a man eats a greater number of calories than the
body smolders. On the off chance that one parent is fat, there is
a 50 percent chance that his or her youngster will likewise be
large. Be that as it may, when both guardians are large, their
kids have an 80 percent shot of being fat. Albeit certain
therapeutic issue can bring about obesity, under 1 percent of all
obesity is brought on by physical issues.
Null Hypothesis
There is a 96.4% chance that an obese adult will give birth to an
obese child.
Alternative Hypothesis
The probability of an obese parent giving birth to an obese child
is less than 96.4%.
The independent variable is the variable we are occupied with.
The progressions to the reliant variable are what we are
attempting to gauge with all their favor procedures. In our
exploration the reliant variable is the child's capacity to create
obesity issues. We're attempting to quantify the adjustment in
weight as impacted by dietary patterns. A dependent variable is
a variable accepted to influence the independent variable. This
is the variable that the scientist, will control to check whether it
rolls out the independent variable improvement. In our
investigation of obesity among youngsters, our autonomous
variable is the recurrence of their dietary patterns.
The variables chosen are the parent, eating habits, genetics and
behavioral aspects. These variables play an important role in
determining the body growth of a child. The statement of the
problem is the point of convergence of your exploration. It
states what will be examinees, whether the research will be
done through trial or non-trial examination, and what the
motivation behind the discoveries will be. As a part of the
Introduction, viable problem statements answer the question on
why the research is being conducted.
Running head: Accounting Standard Setting in the Private

Sector
4
a. Financial statements must provide a neutral scorecard of the
effective of transactions
Money related explanations like the accounting report should
along these lines give an unbiased scorecard of the impacts of
exchanges. Speculators, banks, controllers, and different clients
of the monetary reports settle on business and financial choices
in view of data gave in money related proclamations. All the
data in the monetary articulation ought to be pertinent,
dependable, and auspicious and moved down by reasons. An
effectively working economy requires believable money related
data as a reason for choices about assignment of assets. In the
event that the monetary explanations are to be made helpful;
financial movement must be accounted for without ornamenting
the message keeping in mind the end goal to diminish
uncertainty. Money related explanation ought to be effortlessly
translated and comprehendible.
Collection and esteem pertinence display concentrate on profit
quality estimation. Gathering models are utilized to quantify the
degree of income administration under current standards and
enactment. These models accept that administrators utilize
optional gatherings, i.e. gatherings over which the director can
apply some control, to oversee income (Healy and Wahlen,
1999; Dechow et al., 1995). Profit administration is accepted to
contrarily impact the nature of monetary reporting by
decreasing its choice handiness (e.g. Cocoa, 1999; Van
Tendeloo and Vanstraelen, 2005). The fundamental favorable
circumstances of utilizing optional gatherings to quantify
income administration is that it can be figured in view of the
data in the yearly report. What's more, when utilizing relapse
models it is conceivable to look at the impact of organization
attributes on the degree of profit administration (Healy
&Wahlen 1999; Dechow et al. 1995). In addition, this sort of
research is replicable. Themain trouble when utilizing

accumulation models, be that as it may, is the way to recognize
optional and non-optional gatherings (Healy and Wahlen, 1999).
Besides, it is just a circuitous intermediary of profit quality,
barring non-money related data.
b. Cost of transaction exist whether or not the financial
accounting standard board mandate their recognition in
financial statement
Expenses of exchanges exist regardless of whether the FASB
commands their acknowledgment in money related articulations.
As indicated by the idea of full revelation every one of the
exchanges ought to be revealed in the money related
explanation to give an unmistakable picture about the
organization to its recipients. Say for instance in the event that
we overlook the liabilities for retiree medical advantages this
would not influence the economies of the exchanges. In any
case, some of this data are avoided the speculators the business
sectors will be unable to perceive these expenses in the short
run in the event that they are not reported. These exchanges will
affect the organization's monetary condition in long run. Thus,
the speculators, controllers, and different recipients of
budgetary reports will most likely be unable to take the business
and financial choices if the expenses are not reported.
This open, precise process for standard setting blocks putting a
specific uncommon enthusiasm over the interests of the
numerous who depend on finan-cial data. The Board trusts that
general society intrigue is best served by creating impartial
bookkeeping guidelines that bring about representing
comparative exchanges correspondingly and diverse exchanges
in an unexpected way. The subsequent money related state-
ments give as total and devoted a photo of a substance as could
reasonably be expected. Enterprises, bookkeeping firms, clients
of money related articulations, and most other invested
individuals have since quite a while ago upheld the proms of
setting up bookkeeping benchmarks in the private segment
without mediation by Congress or different branches of

administer ment. Regardless of various individual issues on
which the FASB and large portions of its constituents have
dissented, that support has proceeded. The subsequent
arrangement of bookkeeping benchmarks and monetary
reporting, while not impeccable, is the best on the planet.
c. In the United States standard setting is in the private sector
comments
The greater part of the standard setting in the United States is in
the private division. AICPA, the American Institute of Certified
Public Accountants assumed an imperative part in the private
division. Since 1973 the essential part in the private area has
been played by The Financial Accounting Standards Board. As
per the Securities Act of 1934 the SEC was given the power to
decide the sound accounting standards (GAAP) and to direct the
bookkeeping calling. The letter of Beresford perceives that the
SEC and congressional advisory groups keep up a dynamic
oversight of the FASB to guarantee that the enthusiasm of
people in general is defended.
In the United States, a great part of the dialog about standard
setting has concentrated on the subject of 'what is the suitable
division of work between general society and private segments
in this field?' With couple of special cases, the answer has been
to relegate the duty regarding setting measures to the private
area. This decision has been founded on two essential
suspicions. In the first place, it is trusted that private division
principles are exceptionally sensitive to market powers, so they
give the best financial esteem. Second, the administration is
comprehended to have no stake in the result of benchmarks
procedures separated from its part as a 'customer of guidelines.'
Thus, by taking an interest in the models procedure as a client,
the administration—it is accepted—can completely serve the
general population's advantage.
These suppositions are not really plainly obvious. For one, on
account of benchmarks, market strengths don't really prompt to

effective results. Since measures display numerous qualities of
open merchandise, standard setting is liable to impressive
market disappointments. In addition, advertise disappointments
are particularly likely on account of data innovation
benchmarks, which offer ascent to externalities and other
system impacts. Similarly risky—as the 1992 Office of
Technology Assessment answer to the Congress brought up—
notwithstanding when willful benchmarks associations venture
into encourage standard setting, bureaucratic disappointments
can postpone the procedure, while irreconcilable
circumstances—related to some extent to standard deals—may
serve to bend results (OTA 1992).
d. Few if any accounting standard are without some economics
impact
Yes beyond any doubt there are financial guidelines which are
without some Economic Impact. On the off chance that a
bookkeeping standard has no monetary outcomes, then the
standard is not required. There are a few approaches to
legitimize this announcement about financial outcomes, and
there are numerous cases in support.
To start with, budgetary articulations are planned to give data to
financial specialists to settling on venture choices. The choices
that come about because of utilizing money related articulations
are themselves monetary outcomes.
Second, all human correspondence is powerful. There is no such
thing as a fair-minded truth. This is upheld by a late Hollywood
discharge, Vantage Point, in which an occasion is seen by seven
people. Each has an alternate vantage point. Since each of the
seven as an alternate point of view, every recounting the
watched occasion varies. All are distinctive, and all can be
right. So also, there is no such thing as lack of bias and
objectivity in either bookkeeping estimations or bookkeeping
gauges.
Third, there are many occurrences where corporate
administrators have neglected to agree to bookkeeping gauges
since they didn't yearning to report terrible numbers (money

related outcomes that neglect to achieve an objective). These
officials positively trusted that numbers revealed in
bookkeeping proclamations have financial results, and they
were eager to put everything on the line to achieve their
objectives. Regardless they trust along these lines. Some of the
time this implies organizing business occasions for the planning
of income or cost acknowledgment. Some of the time officials
deal with their profit utilizing bookkeeping traps. Obviously,
there are negative outcomes to being seen or found overseeing
income. At times officials endeavor to impact the organization
of bookkeeping principles. By utilizing the framework to
change the bookkeeping rules, they can set the phase for
reporting great numbers (or if nothing else more attractive
numbers). The moves that corporate officials make are
themselves monetary results of bookkeeping principles.
Conclusions
Concerning the nature of money related reporting data in
light of gathering models don't give immediate and extensive
confirmation concerning the quality of monetary reporting data
and its measurements of choice value (Healy and Wahlen, 1999)
We comprehend that there are various individuals who trust that
their specific transient interests are more imperative than an
adequately working budgetary reporting framework. We
genuinely trust, nonetheless, that you and others in the Congress
will audit the reasons that have driven eras of legislators and
controllers to conclude that impartial budgetary reporting is
basic to the working of our monetary framework and that the
most ideal approach to accomplish that end is to permit the
current private division procedure to continue. We consciously
present that general society intrigue will be best served by that
course. As previous SEC Chairman Richard Breeden said in
declaration to the Senate Banking Committee in 1990:
References
Alexander, D. & Jermakowicz, E. (2006). True and Fair View of
the Principles/Rules
Debate. Abacus, 42(2), 132-164.

- Amir, E., Harris, T. & Venuti, E.K. (1993). A Comparison of
the Value-Relevance of
U.S. Versus Non-U.S. GAAP Accounting Measures Using Form
20-F Reconciliations.
Journal of Accounting Research, 31, 230-264 (Supplement).
- Ashbaugh, H. & Olsson, P. (2002). An Exploratory Study of
the Valuation Properties of
Cross-Listed Firms’ IAS and U.S. GAAP Earnings and Book
Values. The Accounting
Review 77(1), 107–27.
- Ball, R., Kothari, S. & Robin, A. (2000). The effect of
international institutional factors
on properties of accounting earnings. Journal of Accounting and
Economics, 29, 1-51.
- Barth, M., Beaver, W. & Landsman, W. (2001). The relevance
of the value relevance
literature for financial accounting standard setting: another
view. Journal of Accounting
and Economics, 31, 77-104.
- Barth, M., Landsman, W., Lang, M. & Williams, C. (2006).
Accounting Quality:
International Accounting Standards and US GAAP. Working
paper series.
Obesity among children in America
Obesity among children in America | 1
Obesity among children in America
Name of student
Module numberIntroduction
Obesity is becoming a menacing problem in the recent times.
People from all around the world are getting affected by
obesity. Apart from being responsible for making a person look
ridiculous, obesity becomes the root cause for creating many

other physical problems for the human body. There are various
physical problems that humans have to encounter on being an
obese. In order to be free from obesity one needs to know about
the root causes of obesity and the ways to prevent it from
happening. Obesity can be described as the medical condition in
which excess of body fat starts to accumulate which might cause
other chronic problems. Obesity can affect people of different
age group depending upon the height of the person. It is very
important that people get rid obesity as soon as possible. In
order to do so the root cause of obesity needs to be understood
at first. Therefore the question that needs to be dealt with is
‘What are the root causes to obesity among children of
America’.Problem statement and hypotheses
A person is categorized as obese when his body mass index
(BMI) is more than 30 kilograms/sq. m. obesity can be root
cause to various chronic problems such as heart diseases, type 2
diabetes, osteoarthritis and obstructive sleep apnea. In some
severe cases obesity can also lead to cancer among the patients.
Obesity is caused due to the combination of various factors.
These factors are eating excessive food, lack of physical
activities and in some cases genetic disorder. In some cases it
has even been seen that people with low diet are also getting
obese. That is caused when a person is suffering from low rate
of metabolism. Generally obese people need to spend more
energy in order to keep up with the everyday pace and at the
same time having a heavy weight.
In the present times people suffering from obesity in America
has increased drastically. Especially the rate of obesity among
children is found to be too high. As a result it has turned out to
be matter of concern for the people of America. With the
younger generation growing obese, the people of America needs
to be very careful and take precautions so as to prevent this
issue of obesity among children. In order to do that people need
to understand the causes of obesity among children. Without
knowing the reasons of obesity, it is very difficult to cure the
problem. Therefore people need to know about the root cause of

obesity among children. With the help of this research the
researcher will be able to find out the causes of obesity.
In the attempt to study about obesity among children a
hypothesis needs to be considered that there is more than 95%
probability that an obese adult will give birth to an obese child
another hypothesis needs to be considered is that the probability
of obese parents giving birth to obese children is less than
95%.Literature review
Sahoo, K., Sahoo, B., Choudhury, A. K., Sofi, N. Y., Kumar,
R., &Bhadoria, A. S. (2015).
Childhood obesity: causes and consequences. Journal of Family
Medicine and Primary Care, 4(2), 187–192.
http://doi.org/10.4103/2249-4863.154628
According to the authors, the primary cause of obesity among
children is improper or unbalanced metabolism. In other words
it means that the total intake of energy in the form of food is
more than the total energy consumed. This is dependent on the
lifestyle that people follow. Inappropriate diet, abnormal
routines are a few causes of obesity. As said by the authors,
obesity caused by lifestyle among parents may turn out to be
one of the important causes of obesity among the children. That
is because once the parents develop obesity, they pass this
phenomenon of obesity to their off-springs as genetic problem.
The journal also suggests that financial condition of the country
is also responsible for obesity among children because financial
condition has direct impact on the diet and the food eaten by
children.
Severe Obesity on the Rise Among American Youth. (nd).
Retrieved October 23, 2016, from
http://articles.mercola.com/sites/articles/archive/2014/12/31/chi
ldhood-obesity.aspx
The journal gives a statistical detail of obesity among the young
people of America or the children suffering from obesity. Study
conducted by the researcher proved that more than 17% of
children of America within the age of 2 to 19 suffer from
obesity. The study also proved that nearly 6% of the youth have

BMI above 35. More than 2% children have BMI above 40
which indicate high obesity. The author says that despite efforts
from the government the anti-obesity campaigns are turning out
to be failure. He also suggests that the diet followed by the
American people is the primary cause of obesity among
children. In order to explain his claim he gives a good example
of how different foods have different fructose and sucrose
content which are the main causes of increase in carbohydrate
content of the body. He even breaks down his claim by
explaining the fact that the beef eaten by the people of America
are injected for better growth. As a result the chance of obesity
increases among the people consuming this beef. The journal
also gives a detailed explanation of how the digestive hormones
and bacteria play important role in weight gaining. On the
whole the journal gives a detailed and beautiful explanation of
the different causes of obesity among children.
Salinsky, E. & Scott, W., (2003). Obesity in America: A
Growing Threat. National Health Policy Forum. Retrieved from:
https://www.nhpf.org/library/background-papers/BP_Obesity_7-
03.pdf
In this journal the authors start explaining the severity of
obesity in America by giving detailed statistics of obesity
American adults. Studies prove that nearly 67% of the males are
obese while 62% females are obese. The authors are taking the
genetic factor as the primary reasons of obesity. They consider
that the obesity among children is caused mostly because one or
both of their parents are obese. The most astounding figure
presented in the journal is the fact that nearly 300,000 lies are
claimed by obesity every year. The authors also explain the fact
that many chronic problems such as heart diseases and diabetes
are caused due to obesity.
Paxson, C., et al., (2006). The Future of Children. Childhood
Obesity. 16(1):
In this journal the primary focus has been to bring awareness
among the parents about obesity. The authors tried to explain
the how parents play important role in determining the obesity

among children the parents should take the responsibility of
determining the life that children should live so that they are
not affected by obesity. Through the journal the authors are
trying to explain the fact that the parents are mostly responsible
for the obesity among children. That is because the diet that the
parents provide the children is the diet that the children follow.
Since obesity is mostly dependent on the diet that is followed so
the parents can be held responsible for obesity among
children.Methodology
In order to understand the different facts that determine the
obesity among children of America, the life the children needs
to be analyzed. Obesity is mostly dependent on the lifestyle that
people lead. Therefore to understand the causes of obesity
among children their lifestyle needs to be analyzed. In order to
do that surveys needs to be done. It is also necessary to analyze
the fact if either or both of the parents are obese or not. It has
been claimed by multiple authors and researchers that obese
parents give birth to obese children. Therefore it is very much
essential to study the fact if children to obese parents are also
obese or not. As a matter of fact it is the determining factor of
the research because in case majority of the obese parents
giving birth to obese children mean that the first hypothesis is
correct which states that for every 95% cases obese parents give
birth to obese children. It will also prove the fact that obesity is
caused due to hereditary phenomenon and it will be established
that obesity will continue genetically through generations. On
the whole this research will help to determine the facts that are
responsible for obesity. Once the people become aware of the
facts, it will be possible to prevent obesity from taking a
menacing shape.
Principal Investigator:
_________________________________________ IRB #:
____________________

A. T. Still University, Arizona Institutional Review Board
Human Participants Research
General Instructions for:
Initial Review Application
Division of Research, Grants and Information Technology
Systems
Requirements for Investigators in Human Subjects Protection
and Financial Conflict of Interest
BEFORE SUBMITTING THIS APPLICATION, please read the
following:
Certificates
· All Investigators must have two certificates on file with the
Division of Research, Grants and Information Technology
Systems (RGIS) BEFORE submitting an application to the
Institutional Review Board (IRB); one for Human Subjects
training, and one for Financial Conflict of Interest training.
· Human Subjects Training:
phrp.nihtraining.com/users/login.php
· Financial Conflict of Interest training:
grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm
· Both certificates for all investigators must be submitted to
Anita Franklin, [email protected] (extension 2397) on the
Kirksville campus. Do not send these certificates to the IRB.
· You must obtain a letter of confirmation from Ms. Franklin
indicating that all investigators listed on your application have

filed both certificates with RGIS. Ms. Franklin will provide
this letter upon request, and a copy of this confirmation must be
submitted with the attached application.
Statements of Qualifications
· Faculty and staff investigators are assumed to have current
curricula vitae on file in their departments and are not required
to submit a CV with this application.
· Collaborating investigators who do not have an appointment at
ATSU are required to submit a current CV to Anita Franklin at
RGIS.
· Student qualifications can be verified via a CV, resume or
written statement from a faculty adviser attesting to the
student’s qualifications.
Conflict of Interest
· If any investigators listed on the application have a conflict of
interest or financial relationship with a study funding source,
see ATSU General Order 20-117, Financial Conflict of Interest
(http://www.atsu.edu/policies/fcoi.htm).
· If appropriate, file a Conflict of Interest report with John
Heard, Ph.D., Vice President, RGIS.
· A description of the kind and amount of support for this study
should be attached to this application.
When you have completed the application to the ATSU, Arizona
Institutional Review Board, please submit the entire application,
with all attachments, as one document. The IRB email address
is: [email protected]
You will be informed of IRB receipt of your application and
assignment of a protocol number (#201X-XXX). In most cases,
the review process takes 4 to 6 weeks. The IRB will inform you
if additional documents or clarifications are required. Only
protocols presenting greater than minimal risk to participants
require a full IRB committee review and Principal Investigator
attendance at an IRB meeting. The IRB will inform the
Principal Investigator if attendance at an IRB meeting will be

required.
Please delete these instructions before submitting your
application.
A. T. Still University, Arizona Institutional Review Board
Human Participants Research Initial Review Application
Principal Investigator Name:
Protocol Title:
Application to: □ Kirksville IRB □ Mesa IRB □
Both IRBs (choose a primary review site)
IRB Enters Information in Box
Review Type*
Submission Date: □ Less Than
Minimal Risk (Exempt Review)
□ Minimal Risk (Expedited Review)
Protocol #: □ Greater Than
Minimal Risk (Full Committee Review)
*Checklists the IRB uses for determination of review type are
provided on the IRB website.
http://guides.atsu.edu/content.php?pid=115913&sid=1000350)
Section A. Investigators
Principal Investigator (enter one person’s name only):
Primary Contact Person (if other than Principal Investigator):
Email address: Phone:
Investigator(s)
Contact Information
ATSU Affiliation:
PI Name

Email
Address
Phone
Faculty/Staff/Student/NA
ATSU School:
Dept/Program:
Sub-Inv
Email
Address
Phone
ATSU School:
Dept/Program:
Sub-Inv
Email
Address
Phone
ATSU School:
Dept/Program:
Sub-Inv
Email
Address
Phone
ATSU School:
Dept/Program:

Principal Investigator Assurances: as Principal Investigator on
the protocol presented herein and by my signature below, I
agree to:
● Conduct the study in accordance with the relevant, current
protocol and will only make changes in the protocol after
notifying the A.T. Still University, Arizona Institutional Review
Board and study sponsor, except in an emergency situation to
protect participant safety.
● Personally conduct or supervise the described investigation.
● Inform all study participants if drugs or medical devices used
in this study are for investigational (experimental) purposes
only.
● Ensure that the requirements relating to obtaining informed
consent are met.
● Report any serious and unexpected adverse events that occur
in the course of the study to the A. T. Still University, Arizona
Institutional Review Board and sponsor, as required.
● Ensure that all associates, colleagues, employees and
students assisting in the conduct of the study are informed about
their obligations in meeting the above commitments.
● Maintain adequate and accurate records of study activities
and make these records available as requested by the A. T. Still
University, Arizona Institutional Review Board or the study
sponsor or other over-seeing regulatory agency.
● Comply with all other requirements regarding the obligations
of clinical investigators and all other pertinent requirements per
A. T. Still University, Arizona, federal, state or funding
organization regulations.
Signature of Principal Investigator:
_________________________________ Date:
_____________
Printed Name:
__________________________________________________
Section B: Approval Signatures: Approval signatures are

required prior to submission of the application.Approval can be
via a physical or electronic signature or email.
Department Chair: All Investigators must obtain an approval
signature from their Department Chair.
I, ______________________am (Dean, Chair or Director) of the
_________________________ (School, Department or Program)
at ATSU, Arizona. I support the research proposed herein.
Signature: __________________________________
Date: ___________
Student Investigators:
Faculty Adviser: ALLATSU student research must be approved
by a faculty adviser. I, _________________, serve as faculty
adviser for this research. I support the research proposed herein
and can attest to the training, skills and supervision of the
students on this research team, especially as is pertinent to
research participant safety.
Signature___________________________________
Date: ____________
Section C: Study Protocol and Research Plan: Provide a brief
description of the research project by answering the 12
questions below. Please include all sections pertinent to the
current study. In the body of the study description, please make
reference to measurement instruments, surveys, letters of
authorization, etc. as appendices (e.g. Appendix A). Copies of
all tests, measurement instruments and other documents to be
used in the study must be included as appendices. Your
response to Section C may not exceed 5 pages.
1. Summarize the historical, scientific, patient care or student
learning significance of the problem to be studied.
2. What is the purpose of the study?

3. List the hypotheses and/or research question(s).
4. Parameters to be Investigated: List the constructs that you
will study (e.g., independent and dependent variables).
5. Research Sites
Will the study be conducted only at an A. T. Still University
facility?
□ Yes □ No
If any aspect of the research will occur at an external site,
provide the information requested below for all external sites.
Include a description of the type of facility. A letter of
cooperation from external sites must be included among the
appendices. The contact person must be a manager or other
decision maker from the external site. An ATSU student cannot
be the contact person.
Organization Name
Type of Facility
Contact Person
Address, phone, email
Does this organization have an IRB?
□ Yes* □ No

□ Yes* □ No
* A letter of approval from the external site’s IRB must be
submitted before this application can be approved by ATSU.
Please provide the contact information for non-ATSU IRBs.
The ATSU IRB prefers to retain final approval, but will discuss
the approval requirements if more than one IRB has jurisdiction
over this study.
6. Study Participant Inclusion/Exclusion Criteria: List the
criteria for both inclusion in and exclusion from the study.
7. Participant Role: What will the participants do in this study
(e.g., complete surveys or tests, perform exercises, donate
biofluids)?
7a. Discuss which study procedures are usual patient Standard
of Care and which study procedures are for research data
collection only. Examples: students observing a simulated
patient interaction in class could be a usual learning experience.
Student self-assessment of confidence level at one week and
four weeks after the simulation class learning could be a
research specific procedure. Or, routine laboratory tests could
be standard of care for participants with diabetes. Enrolling in
a 30 minute exercise program, four times per week could be a
research-specific procedure.
7b. Study Duration: How long will participants be enrolled in
the study?

8. Data Analysis Procedures: Provide an overview of how you
plan to analyze your data.
9. Data Management Plan: Provide a detailed description of
the data security procedures, structures (such as passwords) and
the responsible party (chain of custody) at every stage in the
data management process from initial collection, through
coding, entry, transfer, analysis, storage and destruction.
Where will the data be stored? If data are not stored on ATSU
computers, where will they be stored and who will be
responsible for maintaining data security and confidentiality?
When will the data be destroyed?
10. Risk/Benefit analysis for participants and society:
10a. What are the risks to participants? How will the
risks be minimized? What are possible benefits to research
participants? Briefly, discuss physical, psychological,
economic, legal, loss of privacy or confidentiality risks of harm
to participants. What harm could come to participants if the
data confidentiality were broken?
10b. What are the potential benefits to society?

11. Assurance of Anonymity and Maintenance of
Confidentiality: Participant identifiers should never be stored
with research data. Describe the participant data de-
identification and data storage process.
11a. Will research participants be anonymous? (Anonymous
means that it is NOT POSSIBLE to trace data back to the
participant from whom they were obtained, either directly or
indirectly.)
□ If Yes, go to Question 12. □ If No, go to Question 11b.
11b. Will participant responses be confidential? (Confidential
means that data can potentially be linked to a particular
participant, but that the data will be de-identified)
□ Yes □ No
12. References: Provide 3 relevant references.
Section D: Research Participants
Protocol Summary, Continued
1. What is the maximum number of participants who will be
enrolled in this study? (Provide a number, not a range.)
2. Will the study enroll vulnerable participants? If so, check all
the categories that apply.
□ Students or employees of A. T. Still University
□ Children (participants of less than legal age)
□ Children who are wards of the state, or any other entity

□ Adults who are wards of the state, or any other entity
□ Pregnant women
□ Fetuses in utero
□ Prisoners
□ Terminally-ill participants
□ Adults who are incapable of giving an informed consent
and have a legally authorized representative
□ Economically Disadvantaged
□ No vulnerable subjects will be enrolled in the study
If any categories of vulnerable participants are checked,
describe additional safeguards that will be used to protect the
rights and welfare of these participants. For example, if
students are being enrolled, describe the process you will
employ to avoid coercion.
3. Provide a description of emergency precautions at the
research site.
□ Emergency response staff at research site (Advanced
Cardiac Life Support, Basic Life Support, or Emergency
Medical Technician)
□ Emergency equipment (ambu bag, epi-pen, Automated
Electronic Defibrillator, other)
□ Telephone call to 9-1-1
□ Other:
□ None of the Above
4. What is the name and address of the nearest hospital for

emergency response?
□ N/A, if study involves no more than minimal risk OR
Hospital Name:
Address:
Distance (in miles) from research site:
5. If this is a treatment protocol, describe any alternative
therapy available to the study participants.
□ Not a treatment protocol/Not Applicable OR
Describe Standard-of-Care, non-investigational therapy
available to participants if not enrolled in the study:
6. How will participants be recruited for this study? (Check all
that apply)
□ Advertising (type of media)
□ Referrals (from where?)
□ Participant Database
□ Investigators’ Clinical Practice (Attach Letter of
Cooperation)
□ ATSU on campus announcement, Please note: ATSU
IRB approval does not include or imply approval for
distribution from any ATSU media outlet, such as Student
Affairs, department newsletter or any other ATSU print or
electronic media. The Principal Investigator is responsible
for obtaining approval from the ATSU media distributor.
□ Other (describe):
7. Check the types of recruitment, advertising or participant
information documents to be used in this study.
These must be attached to the application as appendices.
Note: The IRB must review all final recruitment and
advertisement materials before they are used.

□ Print flyer □ Print
advertisement
□ Radio script □ Television
script
□ Public service announcement □ Press
release
□ Participant letter □ Brochure
8. Compensation: Will study participants be reimbursed,
compensated for costs, or receive gifts associated with being in
this study?
□ Yes □ No
If “Yes,” describe the compensation plan. How much will
participants receive? Will they receive payment in increments
or at the end of study participation?
9. Raffle or Prize:Will the study hold a raffle or provide prizes
for study participants?
□ Yes □ No
If “Yes,” describe the raffle/prize process and how you will
ensure that raffle participation will not violate anonymity of
study participants. What is the value of the raffled item (s)?
10a. Describe the consent process (circumstances and location).
How much time will a potential participant be provided to
determine if he or she would like to participate in the study?
How will anonymity of potential study participants be protected
during the consent process?

10b. If the research involves no more than minimal risk to
participants and the research could not practicably be carried
out without a waiver of the requirement for written informed
consent, this study might qualify for a waiver of written
consent. More information on obtaining a waiver of
informed consent is located on the IRB web site under the
“consent” tab. The Principal Investigator is encouraged to
contact the IRB to discuss a waiver of written consent.
11. Please attach copies of Informed Consent, Child Assent ,
Parental Permission or other consent documents. Use the
consent templates (Form 1: Study Information and Form 2:
Required Information) or other forms as located on the IRB web
site.
http://guides.atsu.edu/content.php?pid=115913&sid=1000453
12. Translation:Will non-English speaking participants be
enrolled?
□ Yes □ No
If “Yes”, how will the consent process be conducted
(e.g. translated consent form, certified translator present)?
Initial Review Application
Page 2 of 8 9-1-2014

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