READ 6406

Creating Your IRB Submission

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?

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.

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.

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

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

Getting Started

Click purple LOGIN at the top

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

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.

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)

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!

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

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.

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.

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.

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."

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/nonstandardizedtests, 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.

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.

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.

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)

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).

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.

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.

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.

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.

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.

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.