IRB HANDBOOK IRB A-Z Handbook E.docx

IRB HANDBOOK
IRB A-Z Handbook
Effective September 16, 2013
Capella University
225 South Sixth Street, Ninth Floor
Minneapolis, MN 55402
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IRB HANDBOOK

Table of Contents
Introduction to the IRB A to Z Handbook
................................................................................ 3
Preparation for IRB Review
...............................................................................................
....... 4
Developing a Human Research Protection Plan 5
Documenting the Plan in Your IRB Submission Materials 5
Determining Submission Requirements
......................................................................... 5
Selecting the IRB Application 6
Selecting the Informed Consent or Assent Form Templates 7
Identifying Instrument Requirement(s) 8
Identifying Other Supporting Documents 8
Completing Application Forms, Letters, and Templates
.................................................... 8
Completing the IRB Application 9
Drafting the Informed Consent or Assent Form(s) 10
Drafting the Recruitment Material(s) 10
Obtaining Research Site Permissions 10
What if I can’t get permission before IRB review? 11
Assessing and Revising Submission Materials
............................................................... 12
Assessing IRB Submission Materials 12
Revising IRB Submission Materials 12
IRB Submission and Review
...............................................................................................
... 13
Submitting Your IRB Application

................................................................................. 13
Registering and Activating an Account 13
Starting an application 13
Sending your application to your mentor 14
Completing IRB Office Screening Process
.................................................................... 14
Undergoing IRB Review
.............................................................................................
15
Introduction to the Levels of Review 15
Receiving the IRB Decision Letter 16
IRB Decisions 16
Revising Your Study in Response to IRB Decision 17
Obtaining IRB Approval or Exemption
......................................................................... 18
Reviewing the IRB Approval Letter 19
Post-IRB Approval Procedures
..............................................................................................
20
Ensuring Ongoing Compliance
.................................................................................... 20
Requesting Modifications to IRB-approved
Studies........................................................ 20
Submitting a Modification Request Package
................................................................. 20
Implementing the Modification 21
Undergoing Continuing Review
................................................................................... 21
Submitting a Continuing Review Package 21

Reporting Adverse Events or Unanticipated Problems
.................................................... 21
Reporting Noncompliance 22
Closing Your Study
...............................................................................................
.... 22
Notifying the IRB of Study Closure 22
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IRB HANDBOOK
INTRODUCTION TO THE IRB A TO Z HANDBOOK
The Institutional Review Board (IRB) reviews research that
involves human participants in order
to ensure that it is conducted ethically and that the rights of
participants are protected.
The IRB process is intended to ensure that researchers comply
with federal, state, and
international regulations as well as ethical principles and
responsible practices. The IRB
supports research by partnering with the researcher to promote
research integrity, while also
working to maintain public trust in research. Nevertheless, the
IRB process, like many
processes that are subject to regulatory oversight, may

sometimes appear bureaucratic and
even daunting.
The goal of the IRB A to Z Handbook is to support you in
navigating this challenging, yet
critically important process. Consider this handbook your step-
by-step guide to navigating the
IRB process from point A to point Z.
The following flow chart provides an overview of the topics this
handbook covers, including
• Preparing for IRB review
• Submitting your IRB application and supporting materials
• Understanding the IRB review process
• Making revisions to your materials as required by the IRB
• Ensuring continuing compliance with regulations and Capella
policy
• Closing your study upon completion
All of the flow charts are interactive, as is the Table of
Contents. There are also several links
included in this handbook which will take you to additional
resources in iGuide that help
researchers design, review, conduct, and share research. By
following this handbook, reviewing
additional recommended resources in iGuide, and paying careful
attention to detail, you will be
well positioned for success in the IRB process.
We recommend that you start at beginning of this handbook—

point A— and proceed
systematically through each step of the guide until you reach
the end—point Z. You might find
out something helpful along the way!
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PREPARATION FOR IRB REVIEW
Careful preparation for IRB review will ensure your success in
the process. By carefully
reviewing this handbook, you are positioning yourself for
success! Preparation includes
developing an understanding of the IRB process and having
clear expectations of what you
will encounter along the way. Preparation also includes
attention to how you will protect
participants as part of your study and how you will assemble
and craft your IRB submission
materials.
This section is intended to take you step by step through the

process of preparing for IRB
review. Here is a highlight of topics to be covered in this
section:
• Developing a Human Research Protection Plan
• As part of your research design process, you should begin to
develop a plan for how
you will protect the rights of your participants and the
confidentiality of their data
and records.
• In preparing for IRB review, you will need to identify which
application, and
supporting documents will be required for IRB submission.
• Completing IRB Materials
• Careful attention to detail in preparing your IRB application
and supporting
documents ensures your success in the process.
• Assessing and Revising IRB Materials
The IRB process is an iterative one that requires multiple
revisions to ensure the quality and
accuracy of the submission materials.
We encourage you to start from the beginning and spend time
reviewing each section to
ensure you are well prepared to submit a package to the IRB.
Remember that you have to obtain IRB approval prior to
recruiting participants and
collecting any data.

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Developing a Human Research Protection Plan
Before you begin the IRB process, it is important to know what
the IRB is looking for when
it reviews a study. The IRB conducts ethical reviews of research
studies to ensure that
human participants are protected. The IRB focuses on
• Protecting the privacy of participants and confidentiality of
their data or records
• Respecting the autonomy and dignity of participants
• Ensuring that decisions concerning participation are voluntary
• Minimizing risks while maximizing benefits to participants
• Ensuring participants have adequate information to make
informed decisions
• Ensuring that the benefits and risks of research are equally
distributed
• Protecting vulnerable populations
Specifically, the IRB reviews the study to ensure that it adheres

to regulatory criteria for
ethical research with human participants.
Documenting the Plan in Your IRB Submission Materials
When researchers are attentive to ethical concerns and
participant protections as they
design their studies, the IRB process becomes far less daunting.
Indeed, extremely well-
prepared researchers need only transpose their plans into the
IRB application and
supplemental documents.
More often, however, researchers who begin work on their IRB
submission materials realize
that some details of the plan still need to be fine-tuned and that
more attention is needed to
the logistics or “nuts and bolts” of their research process.
IRB review requires that researchers provide very specific and
concrete details concerning
their process from start to finish. For example, it is not enough
for a researcher to indicate
that “teachers will be recruited to participate in the study.” The
IRB requires detailed
information such as how many teachers will be recruited, how
their contact information will
be obtained, how they will be approached including the specific
scripts or written documents
to be used, and how their voluntary consent will be obtained.
Some researchers, particularly those who prefer to focus on the
big picture, find this level of
attention to detail exasperating and frustrating. However,
careful attention to detail at this
stage of the process pays off: The IRB-approved protocol

provides a precise road map for
the researcher to follow while actually conducting the study.
Determining Submission Requirements
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Once you know more about what your research will entail and
what kind of Human Research
Protection Plan will need to be in place, you must determine
what documents will be
required for IRB submission. Required IRB submission
documents include:
• IRB Application
• Informed Consent/Assent Forms
• Supporting Documents
These materials comprise your IRB submission “package.”
Before online IRB submission,
researchers actually compiled a package of materials to submit
via postal mail to the IRB!
The IRB package contains a number of different forms and
documents. You may be

concerned that this is a lot of documents to prepare. We suggest
that you take it one small
step at a time, and that you take advantage of our checklists in
order to approach the
process in an organized manner.
This section will help you identify the documents that you will
need for submission.
Selecting the IRB Application
As you prepare for IRB submission, you will need to determine
which IRB application to
complete. The IRB Application is the primary document used to
convey information
concerning your Human Research Protection Plan to the IRB. It
is critical that you select the
right application as you begin your IRB process.
The IRB Application can be found in IRBManager in the left
hand menu (you will need to be
logged in to access and complete the form as it is a web based
form).
Capella University’s IRB has two different IRB Applications:
• IRB Application
• IRB Records-Based Research Application
If you are only going to analyze records that exist at the time of
IRB submission, such as
standardized test results or clinical case files, you must
complete an IRB Records-Based
Research application.

If your study involves activities with participants such as
interviews or surveys, you will
need to complete the general IRB application.
Sometimes a study involves a review of existing records and
activities with participants. In
such case, you should complete the general IRB Application.
You will be asked questions
about records during the application.
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While the IRB Application is the primary document you will use
to convey information to the
IRB, it is just one of the many documents you will need for
submission. The next sections
describe the other forms and documents you will need to
complete or create before you
submit a package to the IRB.
Selecting the Informed Consent or Assent Form Templates
If your research study involves human participants, you must
have a process in place to
ensure that they receive adequate information about your study
in order to make an
informed decision as to whether to participate. This process
must be designed so that
participants are able to decide without undue influence. Even

the use of participant records
containing identifiers typically requires a process to ensure that
individuals have an
opportunity to choose who has access to private information and
how it will be used.
Informed consent is the process of obtaining consent and is
document via the informed
consent form. These processes are referred to as “informed
consent” for adults or “assent”
for children/minors.
Informed consent is document through the signed informed
consent form.
Capella University’s IRB requires all researchers to use
Capella's informed consent/assent
form templates. The templates have been designed to assist you
in providing the
appropriate information to participants in accordance with the
requirements of the federal
regulations for informed consent.
It is important to remember that you may not obtain informed
consent from any
participants until you have received Capella's IRB approval for
your research study.
Adult Informed Consent Template
If your research involves interactions with adult
participants and your informed consent procedures include
obtaining signed informed consent, this template should
be used.
Adult Informed Consent Template for Internet Survey Use

If your research involves an online survey or questionnaire
and your informed consent procedures do not include
obtaining hand-signed informed consent, you should use
this template.
Adult Informed Consent Template—Waiver of
Documentation of Consent
Sometimes a research study can qualify for a waiver of
documentation of consent. In such cases, the researcher
will still inform participants about the study and obtain
their consent to participate, but the consent will not be
documented via a signed form.
Requests for a waiver must meet the criteria described in the
federal regulations, at
http://dhhs.gov/ohrp/; only the IRB can make the final
determination regarding the
appropriateness of a waiver.
Parental Permission Form
If your research study involves children or minors, parental
permission (and child assent) is
most likely required. You should consult the local and state
laws where the research will
take place for any unique requirements.
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Child Assent Template (ages 7-11)
If your research study involves children between the ages of 7
and 11 who have the ability
to provide assent, this template should be used. It is important
that you check the local and
state laws where the research will take place for any specific
definitions regarding children,
legal representatives, and any other requirements.
Children under the age of 7 are generally thought to be too
young to document their assent.
If your study includes children under 7, you should use verbal
and nonverbal clues to
indicate consent and not the assent form document.
Minor Assent Template (ages 12-17)
If the research involves minors between the ages of 12 and 17
who have the ability to
provide assent, this template should be used. It is important that
you check your local and
state laws regarding any specific definitions regarding minors,
legal representatives and
custodians, and any other unique requirements.

Identifying Instrument Requirement(s)
Researchers generally rely on instruments to collect their
research data. An instrument may
include an inventory or scale, survey, interview script or
observation checklist. If your study
involves the use of an instrument, you must provide the
following documents as part of
your IRB package:
• A copy of the instrument(s).
• A letter granting permission for you to use the instrument. A
permission letter is
required for the use of existing instruments and must come from
instrument authors
or publishers. Permission must be specifically obtained to
modify the instrument. If
you are purchasing the instrument for use in your study, a
purchase agreement may
replace the permission letter.
Identifying Other Supporting Documents
Several additional supporting documents may be needed for IRB
review. What is required
depends on the nature of your research study. Documents can
include
• Copy of your school approved Research Plan/Scientific Merit
Review Form
• Drafts of Recruitment Materials
• Research Site Permission Letters

• Additional documentation for doctoral researchers
Completing Application Forms, Letters, and Templates
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Once you’ve developed your Human Research Protection Plan
and identified what
documents are needed for your IRB submission, you are ready
to complete your IRB
materials.
You will likely need to revise these documents several times to
ensure that they are
accurate, complete, and clear. Always double-check each form
and document just prior to
submission to make sure that all of the documents in your
package are in alignment and
that the information you have provided is consistent from
document to document.
Completing the IRB Application
Many researchers imagine that the IRB application and
supplemental forms are similar to

those they have encountered in the doctor’s office or when
applying for a license. Generally
speaking, such forms can be completed in one sitting, without
much advance preparation.
Seldom is it necessary to make revisions, seek additional input,
consider new ideas, or
grapple with difficult ethical issues.
Unfortunately, researchers who have similar expectations
concerning the IRB process are
often distressed to realize that the development of an IRB
submission package is likely to
require more time and energy than it takes to file taxes (another
process subject to state
and federal regulations). IRB “forms” are hardly forms at all;
rather, they are a series of
guided questions that give you an opportunity to reflect on your
Human Research Protection
Plan in an organized and systematic way to ensure that you have
adequately met the
regulatory criteria for approval.
In order to demonstrate to the IRB that your plan for protecting
human participants is
adequate, your forms must be intelligible to the reviewer (a
layperson who may not have
expertise in your field) and must demonstrate that your study
meets the regulatory criteria
for approval. The reviewer will look for evidence that your
decisions are based on thoughtful
attention to responsible and ethical practices and a clear
assessment of risk, and that you
have adequate rationale for your recruitment strategies,
informed consent processes, study
procedures, data management plans, and so on.

Before you start completing your IRB application and
supplemental forms, here are some
general tips to enhance your success:
• Complete a few sections at a time. Do not try to complete the
entire application or all
of the supplemental forms in one sitting, as it will be hard to
maintain adequate
focus and attention to detail.
• Read each question carefully and reflect on your response
before answering. Consult
your Human Research Protection Plan.
• Write clear and concise responses.
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• Write your response as if you are addressing a member of the
general public who is
well educated but does not have expertise in your field. Avoid
jargon; strive for
clarity and comprehensibility.
• If you run out of space, consider ways to be more concise.
Space is limited on the
application. It is not recommended that you cut and paste from
your Research Plan
form or early chapters of your dissertation. If you still need
more space, use the

Additional Information Question and Documents at the end of
the form to provide
that information.
• Check with your mentor and search iGuide if you don’t know
how to answer a
question. If both you and your mentor are confused contact the
IRB Office.
Drafting the Informed Consent or Assent Form(s)
Capella University provides informed consent/assent form
templates to guide your drafting.
Here are some general directions when drafting your forms.
• Double-check your template. Are you using the right one?
• Enter text in the [bracketed] fields.
• Delete any brackets [ ] from the form(s).
• Remove any template directions from the form(s).
• Determine if the yellow-highlighted sections apply to your
research
study. If they do apply, remove the highlighting from the text.
If they do not apply
to your study, delete the highlighted statements.
• In areas where there is more than one option—indicated by an
“OR”—choose the
scenario that applies to your study. Delete the other options,
including the “OR.”
• Make sure that the reading level is appropriate for your
research population. Adult

consent forms should be written at an 8th grade reading level.
Adding text or
editing the language will alter the readability of the form. You
can find many no-cost
reading tools on the Internet.
• You are creating a draft for IRB review. You cannot obtain
informed consent or
assent from any participants until you have received IRB
approval from Capella
University’s IRB.
• The informed consent form should be separate from your
recruitment materials. If
you are conducting research via an online survey, the informed
consent information
should be included as the first page of the online survey, not as
part of the invitation
to participate.
Drafting the Recruitment Material(s)
Review your recruitment method to determine how you will
recruit participants. For
example, will you engage in face-to-face recruitment during a
meeting, post a flier, post an
advertisement on a social media site, or use email? Regardless
of the nature of your
recruitment strategy, you must provide drafts of all recruitment
materials for IRB review.
This includes fliers, email scripts, phone scripts, face-to-face
meeting scripts, online
advertisements, social media postings, and so on. Learn more
about best practices in
recruitment on iGuide and how to create recruitment flyers,
advertisements, or letters.

Obtaining Research Site Permissions
If your research will involve participants affiliated with a
particular organization or
association or if you will be engaging in recruitment or research
activities at a research site
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(whether in a physical or online space), you will need to obtain
permission from the site(s).
You must have site permission before final IRB approval. For
that reason, you should seek
permission from all of your research sites before you submit to
the IRB. If the site requires
approval from Capella University’s IRB prior to providing site
permission, you may submit
your application and indicate that conditional approval is
needed.
Permission is likely required if you are collecting information
specifically from participants
because of their affiliation with the site or if the data collected
is likely to reveal information
about the site or the practices of those affiliated with it.
Permission may also be required if

you will use an institution or organization’s
• directory for recruiting
• private property or space for interviews or other research
activities
• private records for research
As you prepare to request permission, do a little research about
the site by seeking
information online or connecting with a contact person at the
site. Determine if site has a
formal or informal process for seeking permission to conduct
research and whether the site
has an IRB of its own. Also determine whether the site requires
you to provide evidence of
Capella’s IRB approval before granting permission.
Anticipate how long it will take to get permission from all of
your research sites. Their
timelines could affect your IRB application process. It may take
just a few weeks to obtain
all of the permissions you need. However, sometimes it can take
much longer, potentially
even several months.
When you request a permission letter, ask the research site to
provide a letter that is
• Written on the institution or organization’s official letterhead
• Signed by appropriate official within the organization that has
the authority to grant
permission.

• Dated
• Provides specific information as to what you have permission
to do at or with the
research site
We recommend that you draft a letter to be used by the site. The
site can make changes to
your letter as needed. Consult the site permission letter template
on iGuide for guidance.
Note that this template is meant to provide you with suggested
language not to be a
editable document.
What if I can’t get permission before IRB review?
Sometimes a research site will ask for Capella’s IRB approval
before granting permission.
However, as you recall, Capella’s IRB asks for the research site
permission before granting
approval. If you run into this situation, don’t panic. Simply
indicate this in your IRB
application and submit for review.
Once your study is under IRB review at Capella and the IRB
determines it meets the criteria
for IRB approval, you’ll receive conditional approval. Then:
• Go back to the research site(s) with documentation of
conditional approval, obtain a
letter of site permission(s), and submit the permission letter(s)
to Capella’s IRB.
• Once you have submitted the permission letter, Capella’s IRB
Office staff will
determine whether you have met the conditions for approval.

• Once full IRB approval is granted, you will be able to start
your research activities.
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Sometimes the research site will require additional revisions to
the research study before
granting permission. If this happens, you will need to submit
those revisions to Capella’s
IRB for review and approval.
Permission is not always required, and figuring out who can
give permission is not always
easy. If you need assistance, contact the IRB Office.
Assessing and Revising Submission Materials
Success in the IRB process depends on the quality and
consistency of your submission
materials. You will and should revise your documents several
times. Work with your mentor
to revise before submitting your IRB application.
Assessing IRB Submission Materials

When reviewing your documents, ask yourself:
• Are my responses clear and consistent? Do they make sense?
• Could someone from the general public understand my
responses?
• Do all the documents reflect the same information?
• Am I missing any documents that are required for IRB review?
Once you have performed this self-assessment, make any
necessary changes and then send
the application to your mentor. Your mentor may suggest
revisions to improve your
materials.
Revising IRB Submission Materials
Here are some general tips when making revisions to your
documents:
• Avoid creating multiple versions of your documents. This
creates confusion and can
lead to future non-compliance if you use an outdated,
unapproved version of a form.
• Check for alignment between documents. Double check any
section that contains
numbers— the amount of time participants will spend in study
activities, the amount
of incentives, the number of participants to be recruited—as
discrepancies are
common.

• Ensure that the “track changes” feature in Word documents
has been turned off and
all changes are integrated into the document.
Coming Next…
Once you have verified with your mentor that the revisions are
ready for IRB submission,
you are ready to start the IRB submission process described in
the next section.
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IRB SUBMISSION AND REVIEW
Once you have completed all of the forms and supporting
documents, you are ready for the
next step in the IRB process. In this section we cover the steps
involved in submitting an
IRB application and what to expect in IRB review. This
includes information on
• When and how to submit an IRB application
• How to complete IRB Office requirements
• What happens in IRB review
• What to do when you obtain IRB approval

Submitting Your IRB Application
IRB applications are submitted via a third party online system
called IRBManager, at . You
do not need to be in iGuide or a courseroom to access IRBNet.
All you have to do is type the
web address in your Internet browser.
Registering and Activating an Account
In order to submit your IRB materials via IRBManager, you will
first need to register and
activate an account. Here are some general tips when
registering:
• Use your preferred email account. You will receive
notifications and decision letters
via email. It is vital that you use an email account that you
check.
• Make sure that your mentor also has an account
• You do not have to choose a user name. IRBManager will
create it for you.
• Register only once
• Click here for instructions on how to register
Starting an application
After you have registered for IRBManager, it’s time to
beginning your IRB application.
IRBManager uses xforms (these are web based form). Therefore
you must be logged into
IRBManager in order to complete your IRB application.

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From the left hand actions menu, choose the appropriate
application. Unless you are
analyzing existing information, this will be the IRB application.
When you complete this form
• Read the help text on the right to the questions for assistance
completing the
application.
• Answer each question on each screen.
• IRBManager will autosave your form as you move from screen
to screen. Yet, if you
need to stop working on your application click ‘save for later’
at the bottom of the
application prior to closing your browser to ensure you’ve saved
your work.
Sending your application to your mentor
After you’ve completed the application, ensure that all the
correct documents were
uploaded; you will send your application to your mentor by
signing and submitting the
application. Your mentor will carefully review your materials to

determine if the application
can be submitted to the IRB. If additional information is
required by your mentor, she/he
will return the application to you. At that time, you will need to
update your answers on the
application and submit again to your mentor. You will receive
an email that states your
mentor returned the application to you.
If your mentor determines that the application is ready to be
reviewed by the IRB, she/he
will submit to the IRB. Only your mentor may submit your
application to the IRB.
Completing IRB Office Screening Process
Once your application and supporting documents are received,
the IRB Office performs an
assessment, often referred to as “screening.” The screening
process ensures that the
reviewer has enough information to conduct a review and to
ensure the correct documents
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were uploaded with the application. If you filled out your
application thoroughly and

uploaded the appropriate documents, you should move through
screening quickly.
If additional documents are needed or if it appears you’ve
uploaded incorrect documents,
the IRB Office will add a note to your application and return the
application to you. You will
receive an email stating that the application was returned to
you. Review the notes on the
application and provide the appropriate information and/or
correct documents.
Then you will sign and submit the application again. This will
send a copy to your mentor for
evaluation. Your mentor will then submit the application to the
IRB.
The IRB Office staff rescreens your package generally within 5
business days. You will
receive an automatic notice from IRBManager indicating that
your study is under review.
Undergoing IRB Review
Once your package is ready and the IRB Office has sent your
package to an IRB reviewer,
you are one step closer to completing the IRB process! This
section will provide you insight
into the IRB review process. You will learn more about
• Each level of review
• How long the review might take

• Types of decisions that are made
• What to do when you receive a decision regarding your study
Introduction to the Levels of Review
While you are not expected to know the differences between
each level of review or how to
interpret the federal regulations, this guide provides information
about what occurs within
each level of the IRB review process. There are three levels of
review:
• Exempt Review
• Expedited Review
• Full Review
Exempt Review
In order to reviewed at the exempt level, studies must be
minimal risk and meet the criteria
for at least one of the six categories listed as exempt in the
federal regulations governing
research. A big difference between exempt review and the other
levels is that an exempt
research study does not require ongoing monitoring or
continuing review. However, exempt
studies at Capella University must be reviewed by the IRB and
must still have well defined
recruitment, consent and other procedures. From an IRB process
perspective, your study
will undergo the same details of review as expedited review.

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The IRB staff will determine whether your research study can
be reviewed at the exempt
level.
Expedited Review
In order to be reviewed at the Expedited level, studies must be
minimal risk and meet the
criteria for at least one of the nine categories listed as expedited
in the federal regulations
governing research. Unlike an exempt study, an expedited study
requires ongoing
monitoring and/or continuing review. You do not need to
identify in the IRB application that
your study qualifies for expedited review. Instead, the IRB
Office staff will determine
whether your research study can be reviewed under the
expedited review process.
Full Review
Research that does not meet the criteria for exempt or expedited
review must be reviewed
by the full IRB Committee. This includes all research that
involves more than minimal risk to
participants. Studies involving sensitive topics and/or
vulnerable participants are generally
subject to full review. Studies involving prisoners or deception
are always subject to full
review.

While exempt and expedited reviews may be conducted by one
or more members of the
committee, a review by the full committee requires a convened
meeting of the committee.
According to the federal regulations, studies that are greater
than minimal risk to
participants must have clear benefits that justify those risks.
This means that the IRB
committee must be particularly attentive to the scientific merit
of the study, since only
studies with the potential to contribute meaningfully to
knowledge in the field may justify
potential risks. Additionally, the IRB must make every effort to
assist the researcher in
minimizing any risks to participants. As a result, review by the
full IRB committee generally
takes much longer compared to exempt and expedited reviews.
Most researchers spend
more than eight weeks in the full review process, depending on
the quality of the submission
and the nature of the ethical concerns presented by the study.
Receiving the IRB Decision Letter
Once your study has been reviewed, the IRB creates an IRB
Decision letter. This letter
details the outcome of your review. Additionally, if the review
requires changes to your
application, the IRB Decision Letter details those required
changes.
The IRB Decision is processed by IRB Office Staff.
Once the decision letter has been created, you and your mentor

will receive a copy of the
Decision Letter via email. A copy of the letter will also be in
IRBManager.
Here are some general tips to keep in mind when you receive
notification of a decision:
• Be aware of the meaning of each decision and the next steps
you will need to take
based on the determination.
• Carefully review the decision letter.
• Contact your mentor to review the decision and consider next
steps.
IRB Decisions
The following are definitions for the various decisions that are
granted by the IRB. It is a
good idea to familiarize yourself with the various decisions, as
you may receive more than
one decision during the IRB review of your research study.
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IRB HANDBOOK
Decision Meaning

Approved
You have received IRB approval.
Approved with Conditions
The IRB has determined that the study meets approval
criteria. However a research site permission letter or a
minor change is required before full IRB approval can
be granted (refer back to the section, Obtaining
Research Site Permission and to the Human Research
Protections Standard Operating Procedures for more
information).
Deferred
The IRB has deferred your study for revisions. The IRB
requires revisions to the study materials or procedures.
Not Approved The Full IRB Committee disapproved your
research
study.
Suspended Your IRB approval is suspended until further notice.
Tabled Without Action
The package was not reviewed by the full IRB, either
because additional experts must be consulted prior to
deliberation or the committee did not have enough
time to review the study at the meeting.
Terminated The full IRB has terminated the study.
Revising Your Study in Response to IRB Decision

Your study will likely need to be revised before IRB approval is
granted. Revisions are
requested in order to ensure the protection of your participants
as well as your compliance
with the research regulations and should be an anticipated part
of the IRB process.
Deferred
• Studies that require revisions are deferred. Studies that have
been deferred must be
revised, resubmitted, and reviewed again by the IRB.
• If your study is deferred, the IRB Decision Letter will be
emailed to you and a copy in
IRBManager. The form and email will contain instructions for
submitting your
revisions.
• Carefully read the IRB Decision Letter with your mentor,
noting the reviewer’s
comments, questions, and concerns. Reviewers try to provide
concrete feedback
concerning required changes and highlight areas of concern for
you to address.
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IRB HANDBOOK
• Once your application is submitted to the IRB, you are unable
to make changes. As

changes are required for the deferral, the IRB Office will return
your IRB Application
to you. You must update the IRB application based on the
decision letter. DO NOT
create a new application. If you create a new application, that
application will be
returned to you as a new application creates a new study in
IRBManager. For ease of
use and for compliance reasons, your study must be tracked
from beginning to end
in the same application.
Approved with Conditions
• Studies requiring only minor revisions may be approved with
conditions. These
conditions must be met before full approval is granted. In most
cases, the IRB Office
Staff can determine whether the conditions have been met and
no additional review
is required.
• The IRB Office will return your IRB Application to you. You
must update the IRB
application and attachments to provide the information
necessary for full approval.
DO NOT create a new application. If you create a new
application, that
application will be returned to you as a new application creates
a new study in
IRBManager. For ease of use and for compliance reasons, your
study must be
tracked from beginning to end in the same application.
Multiple rounds of review and revision are sometimes required

to ensure that a study can be
approved. Following each submission of the application, the
application will be assigned for
review. Upon completion of the review, an IRB Decision Letter
is created, sent to you, and
a copy remains in IRBManager. Therefore you may have
multiple decision letters. Be certain
to note the date of each decision letter when reviewing them.
This cyclical process will
continue until approval has been obtained.
From time to time researchers appear to struggle in making the
revisions necessary for IRB
approval. In such cases, the IRB may notify your specialization
chair, research chair, and
dissertation advisor to ensure you have the support needed to be
successful. A conference
call may be scheduled to develop a plan to ensure your success
in the IRB process.
Obtaining IRB Approval or Exemption
Once you receive email notification that your study is approved
you have made it through
the initial IRB submission and review process! Congratulations!
Once you’re done celebrating, it is important that you read and
review the following
documents:
• The decision letter
• The rest of the IRB A to Z Handbook

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IRB HANDBOOK
These documents and the handbook include important
information regarding the steps you
must take after approval in order to stay in compliance with the
research regulations.
The next section provides detail about the decision letter.
Reviewing the IRB Approval Letter
Once your research study has received approval, the IRB Office
will publish an IRB Approval
letter. In order to stay compliant and avoid unnecessary
complications, it is critical that
you and your mentor review the information provided in the
letter.
Coming Next…
Getting IRB approval is a great accomplishment. When you start
your research activities,
there are a few additional steps to follow. The next section will
provide directions on how to
handle certain situations during the course of data collection
and analysis.
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IRB HANDBOOK
POST-IRB APPROVAL PROCEDURES
Ensuring Ongoing Compliance
Although obtaining IRB approval is a major milestone, efforts
to protect participants and
ensure compliance must continue as long as you are engaged in
research. The IRB will
continue to monitor your study and you may be required to take
action to ensure ongoing
approval. Ongoing communication with the IRB is critical,
particularly if you need to make
any changes to your study, report a problem or participant
concern, or seek continuing
approval. In this section you will learn more about
• Requesting Modifications to IRB-approved Studies
• Undergoing Continuing Review
• Reporting Adverse Events or Unanticipated Problems
• Study Closure Procedures
Requesting Modifications to IRB-approved Studies

If you need to make a change to your IRB approved study,
information available at
https://campus.capella.edu/web/dissertation-research/data-
collection-and-compliance, you should first
contact the IRB Office by emailing the IRB Office. Include
specific details concerning the
changes you would like to make. It is important to contact the
IRB Office because some
changes require IRB review and approval before you can
actually implement them. The IRB
Office will determine whether your proposed modification must
be reviewed and approved
by the IRB prior to implementation.
More significant modifications may require review by the IRB.
If your study involves greater
than minimal risk to participants, your modification will likely
need to be reviewed by the full
IRB committee during a convened meeting.
Submitting a Modification Request Package
If you are asked to submit an IRB Modification Form, available
follow these procedures:
• Complete the IRB Modification Form.
• Prepare any necessary supporting forms or documents. For
example, if you are
modifying your recruitment strategy, include your revised
recruitment materials. If
you are adding a new research site, include a letter of site
permission.
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collection-and-compliance
mailto:[email protected]
IRB HANDBOOK
• Assess your submission materials to ensure that they are
complete, coherent and
that you’ve provided all applicable documents.
• Submit the application.
Implementing the Modification
Once the IRB completes the review of your modification
request, the IRB Office cree a
decision letter. You will receive a copy of this via email and a
copy will be available in
IRBManager evaluation form and decision letter, and you will
receive an auto-generated
email from IRBNet. This is the same type of notification you
saw during the original IRB
review of your research study.
It is important that you and your mentor read the decision letter.
This letter provide
information regarding any conditions that must be met or
followed before approval of the
modification can be granted or once the modification is
approved.
The modification cannot be implemented until the IRB has
approved the modification.

Undergoing Continuing Review
Your IRB approval letter will indicate whether your research
study has an IRB approval
period. This period ranges from a few months to a year. If you
are still collecting data and
your study is about to expire, you must apply for continuing
review.
It is important that you plan ahead; it can take a week for the
continuing review to be
completed, and you may be asked to provide additional
information or documents including
updated site permission letters and scanned consent forms.
Submitting a Continuing Review Package
If you are applying for continuing review, complete the
following steps:
• Complete a Continuing Review Form
• Prepare any necessary supporting forms or documents. You
will need to submit
updated site permission letters as well as a copy of the consent
form you have used
to enroll participants in your study if applicable. If your study
underwent full review,
you will need to upload 2-3 copies of signed consent forms that
were obtained.
These samples will be kept confidential.
• Submit the Continuing Review Application
Obtaining Continuing IRB Approval

When the IRB reviewer completes the evaluation, the IRB
Office will publish the evaluation,
and you will receive an auto-generated email from IRBNet. This
is the same type of
notification you saw during the original IRB review of your
research study.
It is important that you and your mentor read the evaluation
form and decision letter. These
documents provide information regarding any conditions that
must be met or followed
before approval can be granted or following continuing IRB
approval.
Reporting Adverse Events or Unanticipated Problems
You may run into a situation where a participant experience
distress or something goes
unexpectedly wrong (for example, you didn’t expect to have a
participant express serious
emotional or psychological distress during the course of the
research study). For more
21
IRB HANDBOOK
information consult iGuide. If you encounter an unanticipated
problem or adverse event,
you must notify the IRB Office by email.

The Research Education and Compliance Specialist will
investigate all reports of possible
adverse events and/or unanticipated problems.
Reporting Noncompliance
Every member of the research community, including staff, is
required to report any
observed, suspected, or apparent noncompliance to the IRB. If
you accidentally engage in
activities that are not in compliance with your IRB-approved
protocol, cease your research
activities and contact the IRB Office immediately. The Research
Education and Compliance
Specialist will conduct and inquiry and assess whether any
actions are needed to protect
participants and whether you are able to continue with your
study. We recognize that
research can be tricky and that mistakes happen, and self-
reported violations are given
favorable consideration.
Closing Your Study
The completion of the study is a change in research activity that
must be reported to the
IRB. Although participants will no longer be “at risk,” notifying
the IRB of the study’s
conclusion allows it to close its files and provides information
that the IRB may use in the
evaluation and approval of related studies. Continuing oversight
from the IRB is no longer

necessary once a study is closed. Failure to cease research
activities following study closure
will result in a form of noncompliance requiring corrective
action.
Closure of a study occurs when either of the following criteria
is met:
• The researcher has completed data collection and data
analysis, and acknowledges
that he or she will no longer contact participants, enroll
participants, collect further
data for the study, or engage in analysis of identifiable
participant data. In this
scenario, the researcher must complete the IRB Study Closure
Form.
• IRB approval of the study has expired, and the researcher has
not submitted a
Continuing Review Form within the appropriate time frame. In
this scenario, RIO
Staff will close out the study and notify the researcher that all
research activities as
described above must cease.
Notifying the IRB of Study Closure
If your study was reviewed at the expedited level and you are
no longer collecting data,
email the IRB Office to notify us that the study may be closed.
22
collection-and-compliance

IRB HANDBOOK
If your study was reviewed by the Full IRB Board (the full
review level), email the IRB when
your study is done for additional requirements regarding study
closures.
Closing your study is a great accomplishment. We congratulate
you for successfully
completing the IRB process from A to Z. We hope that this
experience will provide you with
tools for future research endeavors.
23
Introduction to the IRB A to Z HandbookPreparation for IRB
ReviewDeveloping a Human Research Protection
Plan/Documenting the Plan in Your IRB Submission
MaterialsDetermining Submission RequirementsSelecting the
IRB Application/Selecting the Informed Consent or Assent
Form TemplatesIdentifying Instrument
Requirement(s)Identifying Other Supporting
DocumentsCompleting Application Forms, Letters, and
TemplatesCompleting the IRB ApplicationDrafting the Informed
Consent or Assent Form(s)Drafting the Recruitment
Material(s)Obtaining Research Site PermissionsWhat if I can’t
get permission before IRB review?Assessing and Revising
Submission MaterialsAssessing IRB Submission

MaterialsRevising IRB Submission MaterialsIRB Submission
and ReviewSubmitting Your IRB ApplicationRegistering and
Activating an AccountStarting an applicationSending your
application to your mentorCompleting IRB Office Screening
ProcessUndergoing IRB ReviewIntroduction to the Levels of
ReviewReceiving the IRB Decision LetterIRB
DecisionsRevising Your Study in Response to IRB
DecisionObtaining IRB Approval or ExemptionReviewing the
IRB Approval LetterPost-IRB Approval ProceduresEnsuring
Ongoing ComplianceRequesting Modifications to IRB-approved
StudiesSubmitting a Modification Request
PackageImplementing the ModificationUndergoing Continuing
ReviewSubmitting a Continuing Review PackageReporting
Adverse Events or Unanticipated ProblemsReporting
NoncomplianceClosing Your StudyNotifying the IRB of Study
Closure
Field Test, Pilot Studies, Test Runs
Field Test
Field tests help establish the credibility of the research
instrument. They are typically used to review qualitative
instruments such as interview guides, open-ended
questionnaires, and observation checklists. Credible instruments
are those that have been reviewed by experts in the field and
determined to be appropriate, clear, coherent, and representative
of perspectives of the field. Field tests also help ensure that
instruments are appropriate for the population and will not put
participants through distress or discomfort. A field test helps
determine if there are better ways to ask questions, questions
that are not needed, and questions that might be stressful or
inappropriate for the participant.
How do I conduct a field test:
1. Select three to five experts who have experience with the
topic and the appropriate professional credentials. Field tests
should be conducted by experts in the field including faculty,
practitioners, or researchers. A field test should never include

people who meet the criteria for inclusion in the study.
Dissertation committee members should not be included as field
test participants. Field tests must include experts who are not
affiliated with Capella University.
2. Send a cover-letter (see template ) by email or mail to request
participation from the experts. Include the instrument to be
reviewed. Field test experts should not provide personal data;
rather they should provide feedback on the research instrument
itself.
3. Once the experts complete and submit the field-test results,
review feedback and make necessary changes to the research
instrument.
4. In submitting your materials to the IRB you will be asked to
provide detailed information on the identity and qualifications
of experts, their feedback on the interview questions, and any
revisions.
Note that Counseling PhD learners should refer to the school
specific Field Test Instructions. All learners should double-
check their school resources for any school specific field test
requirements.
Pilot Studies
A pilot study is most often used to assess the validity and
reliability of a research instrument, but may also be used to test
whether adequate protections for research participants have
been implemented prior to conducting the larger study. Pilot
studies are recommended when you create a new instrument or
modify an existing instrument to the point that new validity and
reliability information is necessary.
How do I conduct a pilot study:
1. Obtain IRB approval for your pilot study. All activities
involving interaction with participants must be approved by the
IRB.
2. Recruit a small sample of participants who meet the inclusion
criteria for the study.
3. Administer the research instrument.
4. Depending on results, revise the instrument prior to

implementing the full-scale study.
5. Seek approval from the IRB for any modifications to the
research instrument.
Pilot study data is generally not included as part of the larger
study.
Test Runs
Your study may benefit from a test run. You may recruit
colleagues, friends and family members in order to practice
implementing research activities. You might practice
introducing yourself, engaging in face-to-face recruitment,
administering informed consent, interviewing participants,
conducting focus groups, or responding to an individual who is
experiencing distress. You might also practice using technology
such as digital recorders or research equipment.
You must ensure that those who offer their assistance
understand that they are not actual participants in the study; test
runs should use mock data, and information collected may not
be used in the dissertation. Those taking part in practice
sessions should not sign a consent form, which is reserved for
actual research participants. Test runs should never be
conducted with those who meet the inclusion criteria for the
study.
Recruitment
Recruitment refers to the process of contacting potential
participants in order to invite them to take part in the research
study. In recruiting participants, you must:
· Protect the privacy of potential participants.
· Provide accurate information about the study to allow
potential participants to consider whether they are interested in
participating.
· Avoid exerting undue pressure or influence on potential
participants
Recruitment Materials
Participants are often recruited using materials such as
newspaper or search engine advertisements, handouts, fliers,
posters, online message board posts, emails, or mailings.

Recruitment materials should provide the information that
prospective subjects need to determine their eligibility and
interest, using a reading level appropriate for the target
audience.
Recruitment materials must include:
· Name of the researcher
· Nature of the researcher's affiliation with Capella University
· The word research
· Purpose of the research
· Inclusion/exclusion criteria used to determine eligibility for
the study
· Contact (phone/email) for additional information
· Details on how to enroll
Recruitment materials might include:
· Brief explanation of study procedures
· Time or other commitment required of the participants
· Location where research will be conducted
· Sponsorship information if applicable
Recruitment materials should not include:
· Misleading statements
· Over-emphasis of the participant incentive (bold and large
print should be avoided)
· Phrases such as "limited enrollment" "study ends soon" "don't
miss your chance" "enroll today!"
· Coercive or enticing statements such as "Join this study and
take charge of your life," or "Help us find the cause of PTSD"
or "Don't our kids deserve a chance?" or similar phrases or
logos
· An understatement of the time commitment necessary for the
study
· Claim that a subject will receive free services or therapeutic
benefits as a result of participation
· Inappropriate images (be conservative when using images,
graphics, etc).
Face to Face
· You may recruit participants in a face-to-face setting. This can

be an effective recruitment strategy because it allows you the
opportunity to present information about the study directly to
potential participants and address questions or concerns.
· You may engage in face to face recruitment at staff or
community meetings, in classroom settings, or with support or
special interest groups. Recruitment in a public setting can be
considered an invasion of privacy that could present an
uncomfortable situation for the potential participant. Therefore,
you must provide a way for potential participants to express
their interest in your study outside of the public setting. It is
important to secure permission before presenting at meetings or
arranging for information tables in public settings. You must
also prepare a script to guide face to face recruitment dialogues.
This script must be reviewed and approved by the IRB. While
engaged in recruitment, you should attempt to stay within the
parameters established by the script, but a more natural delivery
is usually acceptable.
· In face-to-face recruitment, care should be taken to respect the
privacy of the targeted participant. If you plan to present in a
forum where not everyone meets the inclusion criteria, you
should consider whether the venue is appropriate and whether a
potential participant might be subject to embarrassment or
distress
Third party
· It may help to involve a third party who agrees to act as a
liaison between the participants and you. Their responsibility is
to describe the study to potential participants and to provide
your contact information to those who may be interested in
participating. It's important to consider what kind of
relationship the third party recruiter has with potential
participants. Might he or she have undue influence over a
participant's decision? Generally speaking those who are family
members, employers, close friends, or in positions of authority
over the participants should not engage in recruitment.

Phone Calls
· Scripts should be prepared for individuals who are engaged in
recruitment on behalf of you.
· Cold calling potential participants is not a good strategy. A
particular concern is that the individual being targeted by phone
may not be the one who picks up the call. Potential participants
should be given a phone number to call if they are interested in
learning more about the study.
· Researchers recruiting by phone calls should be cautious when
leaving messages in order to protect the confidentiality and
privacy of potential participants. Phone scripts must be
reviewed and approved by the IRB when the telephone is used
in recruitment.
Post Cards
If you decide to recruit through the mail, you should prepare a
cover letter and any other inserts to be included with the
mailing; instructions and contact information should be
included, as well. The IRB will review this material. It is
important to protect the privacy of potential participants by
omitting sensitive information from the mailing, since anyone in
a household may access the mail.
Emails
Email is an effective way to recruit participants; it's less
invasive than a phone call and more efficient that postal mail.
You should consider the appropriateness of this strategy based
on the estimated technical proficiency of the targeted
population and whether they have access to email. You should
prepare the text of the email¿which must be reviewed and
approved by the IRB. Researchers who recruite through email
should always use blind copy (bcc) when sending emails to
multiple individuals to protect the privacy and confidentiality of
participants.
Membership
You must have written authorization if you use an

organization's membership directory (email, phone or mailing
list) for the purpose of recruiting potential participants. Like all
approval letters, the authorization must be printed on the
organization's letterhead and signed by the person authorized to
grant access.
Social Media
Social media sites, online communities, and email list serves
can be great resources for recruiting potential research
participants, allowing you to access a specific population or
target a broad range of potential participants. You must seek
permission from the moderator of the online community or site
(i.e. the person who administers, manages, or monitors the
online community or group) in order to post information on
online message boards or engage in chat room/discussion board
dialogue with potential participants
Informed Consent
Informed consent is the process by which research participants
decide if they will participant in a research study. As a
researcher, you must ensure that:
· participants voluntarily agree to take part in the study.
· participants are provided with clear and accurate information
concerning the study.
· participants understand the information and have opportunities
to ask questions.
The consent form is a document used to convey information
concerning the study. The consent form must be thorough,
readable and easy to follow. Consent Form Templates are
available to assist you in preparing your consent form.
Obtaining Informed Consent
The following practices should guide the consent process:
· When research is being conducted face-to-face, you should go
over each aspect of the consent form with the participant and
allow adequate time for questions.
· If the consent process is conducted via mail or email or as part
of an online survey, potential participants should be encouraged
to contact you with questions or concerns.

· Use the IRB-approved (stamped) version of the consent form.
· The consent form should be signed and dated by each
participant in accordance with the procedures outlined in the
IRB-approved protocol.
· You must give a copy of their signed consent to participants
once they have signed and keep a copy of the signed consent
form for your records. Signed consent forms may be audited by
the IRB.
Child/Minor Assent & Parental Permission
Research with children or minors requires permission from a
parent or guardian followed by assent from the child or minor.
Older children may be required to sign a statement of assent,
while assent by younger children may be given verbally and
witnessed.
IRBs generally stipulate that children ages seven and older are
capable of assenting to participate in a research study. State
laws vary regarding the age at which a person is no longer
considered a minor. In all cases, it is the researcher's
responsibility to review and understand relevant state laws.
Waiving Documentation of Informed Consent
You may decide not to document the consent process via a
signed consent form. You will obtain informed consent, but will
not obtain the participant's signature on the form. You must
request a waiver of documentation of consent in such cases.
Waivers must be obtained when data will be conducted via an
online survey, since there is no way to obtain a signed consent
form electronically.
Readability
Consent forms intended for the general adult public should be
written at the 8th grade reading level. Assent forms intended for
children and minors should be written a maximum of one
reading grade level below the lowest grade recruited. For
example, if you are recruiting 7th and 8th graders, consent
forms should be written at the 6th grade level. Generally
speaking, children under the age of 7 are considered too young
to take part in an assent process.

Reading levels can be checked using free applications such as
Blue Centauri's Writing Sample Analyzer . In addition,
Microsoft Word has a reading-level application for those using
PCs
Site Permission
Capella University requires researchers to secure site
permission for research conducted at institutions and
organizations such as universities, schools, hospitals, clinics,
businesses, non-profit organizations, and military organizations.
Permission is also required if you obtain data or participant
contact information from a site.
Researchers may submit their IRB materials to the IRB without
the letter of permission, but will not obtain full IRB approval
until site permission has been obtained. To be considered
sufficient, site permission letters must be:
· Written on the organization's official letterhead.
· Signed by an authorized official within the organization.
· Dated within six months of IRB submission.
Keep in mind the following when obtaining site permission:
· Veterans Administration (VA) facilities, military sites, and
other complex organizations such as hospital systems and
school districts may have arduous permissions processes or may
require multiple levels of permission. For additional
information on the DoD Permission requirements, consult the
IRB's Military Permissions Guide.
· If the site has an IRB or formal research review process, you
may be required to obtain IRB approval from the site. Contact
[email protected] for assistance in negotiating this process. You
must determine who has the authority to grant permission to
conduct research at the site. Failing to obtain appropriate
permission can be considered a form of misconduct and could
put your study at risk.
· It is important to adhere to all policies and procedures relating
to obtaining permission to conduct research at the site. Capella's
IRB may require you to submit additional documentation (such
as organizational charts or policies and procedures) or may

consult with the site directly to verify that the appropriate
permissions have been obtained.
· Consider feasibility when exploring potential research sites.
Be familiar with how to obtain site permission, network with
key stakeholders at the site, and have several sites in mind for
your research. Though the signed permission letter must be
dated within 6 months of IRB submission, you need to explore
site permission early in the milestone process to avoid delays at
scientific merit review and IRB review.
Documents Requiring Capella University Signature
If your research involves a data use agreement or contract, or
you are required to submit documentation signed by your
mentor or Capella University in order to obtain site
permission, your documentation must be reviewed prior to
signature. Documents requiring review and signature must be
sent to the IRB Office. The IRB Office will coordinate this
review process on your behalf. The IRB will also review the
agreement to ensure it does not pose risks to participants. It is
imperative that you have these documents reviewed as early as
possible in your dissertation process (ideally at the time of topic
approval) in the event that revisions to the documents are
required or in case Capella University is unable to sign the
agreement.
There are a few data sets, such as restricted ICPSR data,
restricted data from the Institute of Education Sciences (IES),
that Capella University learners are unable to use due to the
required security measures for handling of this data. If you are
seeking access to limited or restricted data sets, contact the IRB
Office, for further information.
Capella University Site Permission
Depending on your research topic and design, it may be possible
to recruit Capella faculty, learners, or alumni as part of your
research.
Requests to post recruitment information on Capella
University's social media sites are often granted provided that
the study does not seek to collect sensitive or proprietary

information from potential participants.
Studies that seek to use Capella University data, draw on
Capella University resources for recruitment, or involve an
action research intervention are approved only in limited
circumstances. Researchers should be aware of the following
requirements for such approvals:
· The researcher has obtained sponsorship from the academic or
business owner of all involved areas, including coverage of any
costs associated with the research
· The study does not pose significant risk to Capella University
or participants in the study
· The topic of the research and target population is directly
related to Capella University. In other words, Capella
University is not being used as a site of convenience
Additionally researchers should note the following:
· CU rarely approves studies that are intended to measure
learner/faculty/staff satisfaction
· CU rarely approves studies in which Capella University is the
only research site.
· If the researcher is external to CU, the study must be approved
by an appropriate IRB
· Learners who wish to use CU as a research site must explore
feasibility early in the milestone process
· The CU site permission request is separate from the IRB
process (the IRB does not grant approval to use CU as a
research site)
Contact the Dissertation Support Center as you develop your
topic and research plan to see if it is feasible to pursue Capella
University as a research site.
Instrument Permission
Using Existing Instruments
A thorough literature review helps you identify existing
instruments that allow for the gathering of relevant data to help
answer the research questions. Journal articles generally include
descriptive information about instruments used in the study, but
such instruments are rarely published as part of the study itself.

Additional research is often needed to locate the instrument,
assess its appropriateness for the study and for the population
being researched, and to review its credibility, reliability,
validity and limitations.
You should exercise caution when searching the internet for
instruments, since materials available on the internet may not be
scientifically sound. Also, there are many imitation instruments
on the internet that lack validity. A quick search, for example,
reveals numerous online versions of the Myers-Briggs Test. It is
important to go directly to the actual publisher of the
instrument.
You should also be cautious when using instruments developed
by other doctoral researchers, since it may not be possible to
obtain information concerning the credibility, validity, and
reliability of such instruments.
For further information on finding an instrument, visit the
Library's Finding Tests and Measures resource for further
information.
Copyright Restrictions and Permissions
You must obtain permission to use existing instruments for your
data collection or purchase such instruments from the publisher.
The permission must be documented in writing or via email. In
the event that the author of an unpublished instrument is
deceased, permission must generally be obtained from the
author's heirs or estate executors.
Failure to obtain permission to use an instrument represents an
unauthorized use of the instrument and is a copyright violation.
If you have difficulty obtaining permission, explore the
possibility of using another validated instrument in your study.
Permission to use an instrument in a study is not the same as
permission to publish the instrument as part of the research
findings. If you intend to publish the instrument, you must seek
specific permission to do so. Instrument authors and publishers
of instruments may be reluctant to grant such permission due to
copyright restrictions and because many publishers make money
through the sale of instruments.

Developing an Instrument
You may need to develop your own instruments or modify
existing instruments as part of the study. Those engaged in
qualitative research almost always develop their own
instruments. It is important to note that establishing the validity
or reliability of a newly created or modified
instrument¿especially a quantitative one¿is a time and effort
intensive process. The design, development, testing, and
validation of a new instrument often require advanced
knowledge of instrument design. You are encouraged to rely on
existing instruments whose credibility, validity, and reliability
have been established.
You must take appropriate measures to ensure that the
instruments created are credible, valid, and reliable. Accuracy
in measurement is important for scientifically valid and
meaningful research results. Establishing credibility is
generally conducted through an expert review, often referred to
as a field test. Credible instruments have been reviewed by
experts in the field and determined to be appropriate for the
population, clear, coherent, and representative of perspectives
of the field. Experts in the field can include faculty,
practitioners, or respected researchers. Such experts generally
gauge the validity of an instrument, examining whether the
instrument appears to measure what it claims.
Pilot studies are recommended to establish the reliability and
validity of a new or modified quantitative instrument . A pilot
study uses actual participants from the population upon which
the study will be based to assess the validity of instruments and
requires IRB approval.
Conflict of Interest
A conflict of interest in research occurs whenever you have
competing interests that may impact your judgments and
decisions, personal bias, or an investment in obtaining
particular findings . You may also have a conflict of interest if
you stand to benefit financially from your research. Conflicts of
interest are often the result of dual roles¿for example

conducting research within your own workplace or with your
own clients or employees. If unaddressed, conflicts of interest
may lead to an increased risk of harm to research participants
and can undermine the validity of your research findings. In
conducting your research, it is important that you familiarize
yourself with Capella's Conflict of Interest Policy and to
manage the conflict.
Conflict of Interest Webinar
This 30-minute webinar will help you understand best practices
for assessing and managing conflict of interest.
View Conflicts of Interest & Dual Roles
There are two strategies for addressing conflicts of interest in
research:
· Eliminate the conflict of interest: Whenever possible, the best
course of action is to eliminate the conflict of interest. For
instance, conducting research in your own workplace creates a
conflict of interest. The most effective way to handle such a
conflict is to eliminate it by conducting research at a site where
you do not have an affiliation.
· Reduce & manage the conflict of interest: When you cannot
completely eliminate the conflict of interest, he or she should
take appropriate measures to reduce and manage it. For
instance, if you do plan to conduct research at your own
workplace, recruit h participants from a department in which
you have no relationship or interactions with the employees.
Whether a strategy is appropriate depends on the nature of the
conflict and the risks it presents. The greater the level of risk,
the more important it is to eliminate potential conflicts of
interest. The IRB will review your strategy for addressing any
potential conflicts of interest and determine whether it is
appropriate.
Conflict management plans may include:
· Disclosure of the potential conflict to participants through the
informed consent process.
· Changes in the research site to eliminate the conflict.
· Changes in the recruitment or sampling process.

· Monitoring by independent reviewers.
· Divestiture of financial interests.
· Reliance on one's mentor, committee, or a third party to
ensure mitigation of bias through appropriate oversight and
monitoring. This may include review of data and secondary data
analysis.
· Data Security & Destruction
· Research participants share private information with the
expectation that it will not be disclosed except as described in
the informed consent process. If you collect private information
from human participants, you must ensure that data is managed
transported, stored, and destroyed appropriately and that
identifiers, if collected, are protected. Reviewing the adequacy
of your plan to protect the confidentiality of participant data is
a critical role of the Institutional Review Board (IRB), which
ensures the ethical conduct of research and minimizes risk to
participants.
· In this Section
· Data Requiring Protection
· Protecting Participant Confidentiality
· Data Encryption and Destruction· Survey Tool Security
· Most basic free services are not secure. Paid services
generally include enhanced security. An analysis of the privacy
and security features some of these tools is available on Ohio
State University's Web Accessibility Center.
· Visit Ohio State University's Web Accessibility Center
· As a best practice, always review the security statement of the
survey tools for more information. View Survey Monkey' s
security statement as an example. Researchers should look for
information relating to the security of data in transport, data in
use, and data at rest or in storage.
What research activities are allowed prior to IRB Approval?
The following activities, intended to identify a research problem
and brainstorm possible topics, may be undertaken prior to IRB
approval:

1. Review of existing literature to identify common problems or
issues and to seek suggestions for further studies.
2. Review of publicly available data (data that can be accessed
by any member of the public). No permission or approval is
needed to review data that is publicly available.
3. Conversations or consultations with key stakeholders or
experts if all of the following are true:
· Conversations will not be recorded or in any way transcribed.
· Information obtained will not be considered part of the data
collected for the study.
· There will be no systematic analysis of the specific
information discussed.
· No private or identifiable information will be collected.
· Questions asked will not sensitive or personal.
· The conversation will be kept private.
· Key stakeholders and experts will not be asked to provide
information that is confidential or might be damaging to an
individual, community or organization.
· Individuals who might be vulnerable to coercion or distress as
a result of such conversations will be excluded.
You are required to obtain IRB approval prior to collecting data
or interacting with participants outside of the parameters
described above and prior to engaging in analysis of publicly
available data. Data collected during the research planning
process should not be included as part of your published results.
The recruitment of participants, collection of data,
implementation of any kind of intervention, and the analysis of
private identifiable information constitute research activities
that may only be undertaken after IRB approval has been
obtained.
Planning in Action Research
Action research is challenging because the research planning
process is not easy to differentiate from the research activities
themselves. Action research often requires the following:
1. Engagement with a community, organization or institution to
identify a problem or issue to be addressed or explored through

an action research framework.
2. Development of a strategy or intervention to address or
explore the problem or issue.
3. Development of a concrete plan for implementation of the
strategy or intervention.
4. Submission of a research plan to the IRB for approval.
5. Implementation of an intervention or strategy. This includes
the recruitment of participants to take part in the intervention.
6. Evaluation of the success of the intervention or strategy. This
includes the collection and analysis of data about the
intervention and the experiences of participants.
7. Dissemination, review and discussion of research results.
8. Consideration of next steps.
Steps 1, 2, and 3 are generally considered part of the research
planning process and may be undertaken without IRB approval.
The remaining steps, including the recruitment of participants
as part of the research study, the collection of data, the
implementation of any kind of intervention, and the analysis of
private identifiable information, constitute research activities
that may only be undertaken after IRB approval has been
obtained. You must take care to respect and protect all key
stakeholders¿individuals, communities, and organizations¿that
are part of the action research process.

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