Considerations for creating IRB submissions for action research projects.

1. READ 6406
Creating Your IRB Submission

2. Agenda
• Why IRB?
• Steps in IRB submission and approval process
• Registering in e-pirate
• Overall considerations for IRB submissions
• Main Components of IRB submission
• Things to think about now
• Questions?

3. IRB: What and Why?
• Action research meets the definition of research because it is
characterized by systematic collection and analysis of data and
dissemination of results that build upon existing knowledge in our field
(sharing results with colleagues or through presentations). Because
you’re doing your projects with “human participants,” they must be
approved by the IRB.
• Students in READ 6406/07 conducting action research will seek and
obtain IRB approval for projects. Approval must be obtained in order to
begin READ 6407.
• E-Pirate is the online system ECU uses for IRB submission and review of
research proposals.

4. Steps in IRB Proposal Prep,
Submission, and Approval
Once your proposal is graded in Bb, you can work on the IRB submission.
Once you finish the IRB submission, a “participant agreement” request is sent to your instructor. Once she
reviews it, she’ll email you with required revisions.
Once you address all revisions, the instructor will “agree to participate” within the system.
Once the instructor agrees to participate, you go back in and hit SUBMIT.
Then the proposal is sent to Dr. Misulis, department chair.
Once she approves it, it is sent to the IRB.
Once you receive IRB approval, you can begin the consent process.
Keep the status sheet updated with your progress.

5. IRB/E-Pirate Resources and Contacts
Module 4 in Bb has an IRB block with lots of links and
information.
ECU IRB Contacts:
Mr. Kenneth Briley email: brileyk@ecu.edu phone: 252-744-5313
Mr. Jason Conrad email: conradj@ecu.edu phone: 252-744-3191

6. Getting Started
Link to ECU e-Pirate Website
(remember to click the purple
box on the bottom/left):
http://www.ecu.edu/cs-acad/rgs/irb/ePIRATE.cfm

7. Getting Started
Click purple LOGIN at the top

8. E-Pirate Profile
Check the Department of Literacy Studies, English Education, and
History Education so the submission will get to the right department
person, Dr. Kathy Misulis.
Update CITI Module date:http://www.ecu.edu/cs-
acad/rgs/irb/upload/How-to-Add-Your-IRB-Training-Completion-
Date.pdf

9. Overall Tips and Considerations
Working quickly is important, but don’t value rushing over thoughtfulness
Keep your study design and participants in mind as you revise.
Remember that you’ll actually be implementing this study in January – sending
home the consent forms, administering the intervention, collecting/analyzing the data
you say you will collect and analyze.
IRB reviewers are most concerned about protection of participants (especially minors),
so pay particular attention to the consent/assent process.
However, things like missing documents or grammar errors/misspellings/typos can
hinder their understanding of your study and will hold up the review.
Don’t leave items blank when possible. Put N/A if they don’t apply so reviewers know
you didn’t skip the item, it does not apply to you or your study.

10. Main Components of IRB Submission
• Study name, your name, instructor name
• Study Identification Information (summary in lay terms, study
locations/setting)
• Reviews (expedited or except)
• Study Summary (start/end dates, research design, short lit review)
• Methods and Procedures (data collection, participants,
consent/assent, data storage & confidentiality)

11. IRB Cheat Sheet
Refer to the IRB Cheat Sheet – a link on the IRB block of module 4.
When you’re ready to work on IRB, open (1) the cheat sheet, (2) your
proposal, and (3) epirate at the same time to work through the
submission.
You can save the submission and work on it over time. Use the “jump
to” navigation option to move from section to section. Save it
continuously. There is a final submit button with an “are you sure”
option to actually submit, so no worries about accidentally submitting!

12. Study Name
*Make sure the first word of the SHORT study name is your last name:
Short Name:
SWAGGERTY: Impact of QAR on 2nd Grade Comprehension and Motivation to Read
Long Name:
Investigating the impact of the Question Answer Relationship strategy on second grade
students’ reading comprehension and motivation to read
*YOU are the Principal Investigator
*Your instructor is the Faculty Supervisor

13. Study Identification: Research
Summary
* Summary of Research in Lay Terms:
Make this succinct. Include action research study, research
question/intervention, grade level, research design, data. See example that
works for quasi-experimental pre/post test design and modify it to fit your
methodological design, context, and focus:
This teacher action research study investigates the following research
question, “xxx.” It is a case study characterized by X research design. The
intervention is x. The researcher is the teacher of record for the
intervention group and another grade level teacher teaches the comparison
group students. The following data sources will be collected and analyzed:
xxx, xxx, and a researcher log. The project will begin January X, and data
collection will occur for approximately X weeks. The goal of the study is to
positively impact student learning and enhance the researcher’s professional
knowledge.

14. Study Locations
Add the school name, district/county, city, and state.
Describe the research setting, listing any safeguards in place for participant
safety:
Describe the school (K-5 school, population of X students, rural, suburban, etc.).
Explain where the study will take place (e.g., in my classroom and Mrs. X second
grade classroom; during the regular school day). Explain that public schools, in
general, are designed with student safety in mind.
Upload letter(s) of support/agreement from the research facility/site(s) unless
research will be conducted at ECU or Vidant Medical Center. This is where you
upload the letters of support from district, principal, comparison teacher, cooperating
teacher (whichever apply). Check district/county website, check with principal. See
templates. See information sheet for action research in our program.

15. Required Reviews
Requested Review Type:
• You do not need full board review (this is only if there is much risk in
participating).
• EXEMPT: Most of you will have exempt studies.
• EXPEDITED: However, if you want to take pictures (great for
conference presentations or PD workshops) or audio or video
record, check expedited.

16. Study Summary
Start/End Dates: Most of you will probably put dates such as January 6th until March
1st here.
Describe the rationale for the type of research design chosen for this study.
Describe why you chose the design your chose. Most will put something like this:
Quasi-experimental pre/post test design is being utilized because it allows for
comparison of the scores of two groups of students.
Describe the current state of knowledge surrounding the research questions to
be addressed in this study. Include any relevant citations to support your
discussion (if not already included in the protocol).
Summarize lit review here – a paragraph. Try to sound smart in explaining what is
known about your topic. ;-) Then type “See attached proposal for complete literature
review and reference list."

17. Methods & Procedures: Behavioral
Methods/Data Collection
Select recruitment methods used on this study: Most of you are
selecting preexisting relationship since you already know the students.
Select all behavioral/data collection methods and procedures
which apply to this study:
Here, most of you will select from these options:
surveys/questionnaires, intervention, standardized/nonstandardized
tests, teacher inquiry.
If you are not the teacher of record and you are using Reading 3D data
or something that the teacher always collects, check existing data
because the teacher of record will supply this existing data for you.

18. Children (Child Participants)
Please discuss your rationale for the classification you have
chosen above:
This research study does not involve greater than minimal risk
because the intervention is characterized by research-based
instructional practices that might be present in any grade x classroom.
The intervention does not take away instructional time.

19. Study Population
Indicate what your primary targeted population will be:
Children (participants under 18 years of age)
Students
If you teach high school and students may be 18, check ADULTS. If
you’re gathering data from parents of students (e.g., survey), check
ADULTS.

20. Study Population continued
Describe how you will obtain parental permission and the child's assent for the
child to participate in the research:
Note how old your participants/students are and what you’ll be seeking. Then
describe your consent/assent process.
At ECU, unless waived by the IRB:
• documented (signed) assent required for 12-17 years of age
• children ages 7-11 years of age should be given the opportunity to give verbal
assent, with the script to be used submitted, reviewed and approved by the IRB
• verbal assent should be documented in your research records or on the parental
permission form
• Under 7 years of age, explain research to extent possible but no documentation is
required (parental permission especially important in this case)

21. Study Population continued
For example, participants are 12-13 years old, so I’ll obtain both
parental consent and signed assent following the reading of a script.
Or, participants are 7-8 years old, so I will obtain both parental consent
and verbal assent following the reading of a script. Or, participants are
5-6 years old, so I will obtain parental consent.
Describe how you will send home copies of the consent letter with
students in their backpacks. Once consent forms come back, you will
read the assent script and students may sign if they agree to
participate (this statement depends on the age of your students).

22. Student Participants
Please indicate how you will minimize the potential for students to
feel coerced to participate. Discuss how the potential confusion
in roles will be addressed.
• Make sure it is clear that you won’t be mad if they choose not to
participate and choosing not to participate won’t impact their grades
in any way. Explain that you’ll tell students that they will all
participate in the instruction, but if they sign the assent form, that
means they give permission you to use their data/assignments in
your study. It is their choice to sign or not sign the form and their
grades will not be impacted by participation or nonparticipation.

23. Consent Forms & Process of Consent
See the link on Blackboard for consent/assent
templates:https://docs.google.com/document/d/1GkLfp5cUJtT3Q-
OrLh8Pvx46SX4woEtE4h8FmDblunk/edit?usp=sharing
THESE DOCUMENTS ARE VERY IMPORTANT. This is not just a hoop to jump
through. This is how you’re communicating your study to
parents/guardians/students. It needs to be written so the audience can
understand it (e.g., if 13 year olds are reading it, don’t use the word
“pseudonym,” rather say “fake name.”).
Make sure you use the templates provided. Don’t change the font style. MAKE SURE
EACH LETTER/SCRIPT WILL MAKE SENSE TO WHOEVER IS ON THE
RECEIVING END OF IT. Put yourself in their shoes.
Make sure that it is clear that kids will participate in instruction, but you’re asking their
permission to use their assignments in your research.

24. Consent Forms & Process of Consent
If you’re involving a comparison group, you’ll need to draft and upload
a separate COMPARISON group consent form if the form for the
intervention students doesn’t make sense for them – adjust the
wording for those in the comparison classroom since they won’t be
doing the intervention. Also make sure the data sources are correct for
the comparison group. Upload this one and label it comparison group
consent form.

25. Consent Forms & Process of
Consent for Studies Certified
Exempt continued
If you are working with kids that require assent (See Bb), be sure to
follow instructions on Bb and create documents/scripts for your
participants and, if appropriate a separate one for the comparison
students. MAke sure you write it so that your population will understand
it!
You’ll need to be the one to talk to all students about the study – not
the comparison teacher. If you have two different scripts you can
include them on the same attachment. ASSENT FORMs are “signed”
by students and should be separate documents and appropriate to
each group of students.

26. Data Privacy and Confidentiality
Where will paper and electronic research data be stored? Please
specify the physical location (building and room number), length
of time it will be stored and how it will be secured to protect
confidentiality:
Digital data will be saved on ECU Pirate Drive. All research data will be
maintained for three years, per federal regulations.

27. IRB Q & A session in
Sabameeting with Mr. Kenneth
Briley is November 19th 4-5
pm. This is drop-in - you don’t
have to attend the entire time.