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Office of Research

Compliance

Fall 2015/Spring 2016

APPLICATION FOR HUMAN SUBJECTS RESEARCH APPROVAL

MSUB requires all projects that involve human subjects undergo review by the Institutional Review Board (IRB). Approvals are valid for 12 months and may be eligible for a 6-month renewal. For more information regarding human subject research, see http://www.msubillings.edu/orc/pdf/IRB_Guide.pdf.

Make sure you have the current application form. Old forms will not be accepted. 1. Date: 10/24/2016

2. Project Title: Remote Supervision/Observation of Applied Behavior Analysis (ABA) Techniques

3. Principal Investigator

Name

Email

Address

Phone

Relationship to MSUB: ☐Faculty ☐Staff ☒Graduate Student ☐Undergraduate Student

☐No Affiliation, explain:

College/Department: College of Education

4. Faculty Sponsor - required for student projects.

Name

Email

College/Department: College of Education

5. Co-Principal Investigators

1. Name

Email

2. Name

Email

3. Name

Email

6. Application Type: ☒New ☒Renewal

☐Modification/Addendum, explain:

☐Change of Status, explain:

7. Project Type: ☐Faculty Research ☐Thesis/Capstone

☒Class Project, name: Independent Study

☐Other, explain:

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8. Funding Source: ASMSU - Billings research funding- pending.

9. Collaborative Effort - Are any other institutions involved the in the proposed project? ☐No ☒Yes

- If yes, give name and nature of the collaborative relationship: This project will be conducted in

collaboration with . The study's participants will be employees and their

clients. It will also take place at three locations owned by

☒No ☐Yes10. Other Approval - Has another IRB approved the research study?

- If yes, explain and include a copy of the approval form:

11. Project Description - Provide a concise but thorough description of the steps to be undertaken in the proposed activity and address the involvement of human participants: This study will look at employees who work at facilities that use ABA techniques in the treatment of their clients. It will have three phases. The first phase, baseline, I will record participating employees via video camera while they complete a task with a client. The employees will use ABA techniques to help the client complete the task. The video will be viewed later and the employees accuracy in using ABA techniques will be evaluated. During the second phase, intervention, employees will receive live feedback from a Board Certified Behavior Analyst (BACB) and an

employee using an ipad and a Bluetooth headset. These sessions will be recorded and viewed later to count the number of comments the BACB made to the employee and how accurate the employee performed the ABA techniques. The third phase, maintenance, I will once again record the employees without providing feedback and later evaluate the accuracy of the ABA techniques to see if they have retained the skills from the second phase. The human involvement will include both employees of and their clients. Although the focus of the study is on the employees because we will have to observe how the employees perform ABA techniques with the clients, we must also include the clients in the study. The employees are already required to perform ABA techniques as part of their jobs, so we will not be asking them to perform any task that they are not already required to do. In addition, all clients who will be asked to participate in the study will not be asked to perform any task that they do not already perform in their everyday lives. We simply want to evaluate how well the employees perform the ABA techniques and if the intervention phase leads to any improvement.

12. Objective - Briefly state what you hope to find or observe in this study: I hope to assess how accurately employees perform ABA techniques normally, with only typically provided training. I will then

assess how accurately employees perform ABA techniques after being provided with live feedback.

13. Procedures

Location(s) of study:

Do you have approval to be in this location? ☐No ☒Yes

- If yes, attach a letter from a representative of the location (on letterhead), authorizing you to utilize the space

Variables to be studied or questions to be addressed: How accurate do employees perform ABA techniques

with only typically required training? Will live feedback from a BCBA improve the staff's accuracy in

implementing ABA techniques?

Data Collection Methods; include sample data collection instrument: During baseline and maintanence

phases data will be collected by recording staff via video camera when they are implemening ABA techniques

while working with clients and reviewing the video tapes later with a checklist of all the ABA skills the staff are

required to use and mark how accurate the employees implemented each skill. During the intervention phase

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the employee's session with the BCBA will be recorded via WebEx and will be later reiviewed and the employees

performance will be scored with the same checklist as the baseline phase.

If a debriefing is planned, describe the procedures and include a sample of the debriefing form or script: A

debriefing is not planned because employees will not be decieved for this study or made to do anything they are

not already required to do for their jobs. They will be given a chance to see the data of their performance at the

end of the study if they wish to.

14. Project Information - Mark if the project involves any of the following:

a) Deception of participants ☐

b) Withholding information from potential participants ☐

c) Any form of punishment ☐

d) Questions about any kind of illegal or illicit activity ☐

e) Purposeful creation of anxiety ☐

f) Any procedures that might be viewed as an invasion of privacy ☒

g) Physical exercise or stress ☒

h) Administration of any substance (e.g., food, drugs) ☐

i) Procedures that might place subjects at risk ☐

j) Any forms of potential abuse ☐

k) Exposure to materials that might be considered offensive ☐

l) Inducements for participation (including course credit) ☐

For each item marked above, please explain: A big part of the study will involve filming of the participants

and the clients they are working with, which could be considered as a invasion of privacy. This will be addressed

by informing potential participants of our intent to film them and obtaining their consent. We will also inform

the families of the clients of our intent to film their child and obtain their consent before we film employees

working with their child. Physical exercise is a regular part of the staff's job since part of their job is to make sure

clients perform chores and that sometimes involves hand over guidance. Also some clients display aggressive

behaviors and staff are required to either redirect them or sometimes place them in a physical hold if it

escalates enough. This study will not have staff do any activity that they are not already required to do but they

may be forced to perform some exercise while participating in this study.

15. Participants – Mark if the project targets participants from any of the following groups:

m) Individuals under the age of 18 ☒

n) Individuals over the age of 65 ☐

o) Individuals who are educationally or economically disadvantaged ☒

p) Individuals who are unable to provide their own legal informed consent ☒

q) Individuals who are in institutions, e.g., prisons, nursing homes ☒

r) Individuals who have physical or mental disabilities ☒

Mark if the project incidentally includes participants from any of the following groups:

s) Individuals under the age of 18 (if yes, explain below methods for reasonably excluding minors) ☐

t) Individuals over the age of 65 (if yes, explain below whether or not participation represents any

specific risk to seniors) ☐

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u) Individuals who are educationally or economically disadvantaged (if yes, explain below whether or

not participation represents any specific risk to persons with any of these disadvantages) ☐

v) Individuals who are unable to provide their own legal informed consent (if yes, explain below

whether or not participation represents any specific risk to persons with this disadvantage) ☐

w) Individuals who are in institutions, e.g., prisons, nursing homes (if yes, explain below whether or

not participation represents any specific risk to persons in any of these contexts) ☐

x) Individuals who have physical or mental disabilities (if yes, explain below whether or not

participation represents any specific risk to persons with any of these disadvantages) ☐

For each item marked above, please explain: 15m: One of the proposed settings of the study will be a

special education classroom in which the students are all younger than 18. Another proposed setting is a group

home where one of the clients residing there is underage. The rest of the settings of the study all contain clients

that are over 18, but are diagnosed with autism, a developmental disabilities or other mental illnesses. 15o:

clientele all receive state funding and several attend a special education classroom instead of

typical classroom and a special day service program. 15p: All clients are not able to give their own legal consent,

as a result permission from their primary guardian will be sought. 15q: Every client, with the exception of two

that attend the special education classroom, reside in an group home. 15r: All of clients

have been diagnosed with autism, developmental disabilities or other mental illnesses. Although the clients are

not the focus of the study, the nature of this study means they are a integral part of it since we cannot evaluate

how well employees implement ABA techniques without viewing them working with clients. The staff

participants are all individuals above the age of 18 and none are part of the above mentioned groups.

Source of participants

Will sample be random? ☒No ☐Yes

- If no, please describe the criteria that will be used to select participants: Participants will be staff from

each A.W.A.R.E. facility in Billings that use ABA techniques to treat the clients who attend that facility. We will give each staff member of the facility a chance to participate in the study. If more than one staff member at a facility wants to participate then randomization will be used to decide which staff member

will participate in the study.

Number of participants: 5

Justification of sample size: There are five locations of in Billings that use ABA techniques in the

treatment of the clients that reside there. We would like one staff member of each facility to participate for

evaluation of how the employees implement the ABA techniques in those locations. We would like a different

employee from each location to participate in the study so that we can evaluate the effect of the intervention on

more than one individual across several settings.

Characteristics of participants other than those above: Must be a regular employee at one of the facilities

who has worked with clients before or if the staff is new must be in training to regularly work at one of the

facilities with clients.

Recruitment procedures to be used: The investigator will attend a staff meeting at each of the facilities and

explain the purpose of the study and what will be expected if staff are interested in it, emphasizing that it is

entirely voluntary. Copies of the informed consent will be distributed to employees who express an interest and

they will be given a week to return the signed informed consent document if they decide to participate in the

study. A separate consent form will be mailed to the guardians of the clients in the participating locations with

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information on the study and the guardians will be asked to sign and return a consent form giving their

permission to film their child. If the guardians do not consent the child will not be part of the study.

16. Risks, Protection, and Benefits

Identify any foreseeable physical, psychological, social, or legal risks for participants: Participants are not

expected to be exposed to any risk other than those they are already exposed to in their everyday job.

Describe the measures that will be taken to minimize the risks or to protect participants from potential

risks: If participants (employees) feel that a session of this study may interfere with their job or feel like the

client is having a bad day and they feel the session may cause them to have aggressive behavior they can

cancel the session and reschedule. If clients start to behave aggressively during the sessions, then the

sessions will end. For clients, the risk they experience from this study are expected to be minimal since

they will not be asked to perform any task, nor taught a task, that is not already in their approved behavior

program that was approved by their guardians. A potential invasion of privacy is possible due to the videos,

and this will be addressed by only having the investigator and co-investigator view the recordings and

delete the recordings from the camera after uploading them to Dropbox. The recordings will be deleted from Dropbox six months after completion of the study.

Describe any reasonably expected benefits for research participants: Participants will be given a chance to

have how they implement ABA techniques, a big part of their job, evaluated and be given feedback that will

hopefully improve their techniques and increase their job performance. ABA techniques have been shown in the

past to improve the quality of life of people with autism and other disabilities, so the better staff members use

ABA techniques the more likely it is that the clients' quality of life will improve.

17. Confidentiality and Anonymity

Is the study: ☒Confidential or ☐Anonymous

Explain the procedures that will protect the confidentiality or anonymity of the research participants: Fake

names will be used in place of the staff and client's real name. A key that will list the employees, and clients' real names will only be accessed by the investigators.

With regard to individuals’ privacy concerns and identity issues, explain how information will be gathered,

maintained, stored, and ultimately destroyed or archived: Sessions that will be recorded via video camera

and the sessions will be stored on Dropbox after the original is deleted from the camera. After the video is

reviewed by the primary and co-investigator the video will be stored for 6 months on Dropbox in case

further review of the videos are necessary. After the 6 months have passed the videos will be deleted.

Sessions that will be recorded via WebEx will also be kept on Dropbox for 6 months and then deleted after

that time has passed. The names of the participants will be kept confidential by using aliases, with only the

investigators knowing the real names of the participants. A key with the participant's (both employees and

clients) real name and their alias will be kept in a locked box in the primary investigator's office at MSU-

Billings, which is locked when unoccupied.

Will information relevant to their participation be provided to subjects after the project? ☒No ☐Yes

- If yes, explain the contexts and nature of anticipated future contacts:

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18. Informed Consent

Will a written consent form be used? ☐No ☒Yes

- If yes, attach sample of informed consent and describe the procedures by which informed consent will

be obtained:

- If no, answer the following questions to the best of your ability:

Will a waiver of consent be gathered? ☐No ☒Yes

- If no, explain why it would be an impractical step in the process of gathering data:

- If yes, explain waiver documentation procedures and attach any necessary accompanying information: Clients of all not able to make any legal decisions for themselves, and many of them are nonverbal and have no other functional way to convey if they want to be part of the study or not. Therefore consent from the client's legal guardian will be obtained in lieu of the client's consent.

- Is it foreseeable that the rights or welfare of any subjects are likely to be adversely affected by waiving informed consent? ☒No ☐Yes

- If yes, explain the nature of the adversity and the steps to be taken to minimize the effects:

19. Conflict of Interest

This project is: ☐Clinical Trial Research ☐Non-Clinical Trial Research

☒Other Student independent research project.

By signing below, I hereby certify:

1. I have read and understand Montana State University Billings’ Conflict of Interest Policy

http://www.msubillings.edu/humres/policies/pdf/Conflict%20of%20Interest%20Policy%20%20Rev

%208.24.12.pdf

☒ PI ☒ Co-PI ☐ Co-PI ☐ Co-PI

2. I have (check the box that applies):

a) No relationships, contractual commitments, or financial interests that are or might reasonably

be perceived to be in conflict with my duties and responsibilities at MSU Billings;

☐ PI ☐ Co-PI ☐ Co-PI ☐ Co-PI

b) A potential conflict of interest which has been duly disclosed previously and there has been no

change which requires an updated disclosure; or

☐ PI x Co-PI ☐ Co-PI ☐ Co-PI

c) Potential conflicts of interest not previously disclosed. If checked, you must complete and

submit a Conflict of Interest Disclosure Statement

http://www.msubillings.edu/humres/forms/Conflict%20of%20Interest%20Form.pdf to the

Human Resources Office and provide a copy to the ORC

☒ PI ☐ Co-PI ☐ Co-PI ☐ Co-PI

Form 2

Student Id:

Dear Parents/Guardians

Montana State University-Billings (MSU-B) in collaboration with is conducting

a research study named Remote Supervision/Observation of ABA techniques. The study will be

conducted with the staff at locations at that use Applied Behavior Analysis

(ABA) techniques in their treatment plans where your child receives services. The purpose of

this research study is to evaluate how staff at each location perform ABA techniques. The study

is being conducted by MSU-B student and employee, , as part of his

graduate program in ABA.

Part of the study will involve video recording staff using ABA techniques when working with

clients. Although the focus on this study is on our staff and not our clients, in order to accurately

assess the employee’s performance using ABA techniques we are asking your permission to film

your child for this study.

This videos will only be viewed by graduate student and employee

employee and Board Certified Behavior Analyst (BCBA)

instructor supervisor of this study from MSU-B and all videos will be

deleted after they have been reviewed. If this study is published, the names of your child will not

be disclosed, instead pseudonyms will be used, although basic demographic information such as

age or diagnostic information may be used.

Our goal in this study is to figure out ways to improve our methods of teaching ABA techniques

to our employees and to better monitor their progress in mastering those skills. With this we

hope to improve the everyday life of your child by helping our employees teach them to be more

independent.

The expected risk of your child in this study is minimal since your child’s everyday life will not

be interrupted and they will continue to work with staff that have worked with them normally.

Staff will also not have your child do anything that they haven’t done before, unless teaching

them that task is part of their behavior plan that you have approved.

Please note that your child’s involvement in this study is completely voluntary. They will not be

penalized if you are not comfortable with them being a part of this study, and if you at first

consent and then change your mind you can withdraw them from this study with no penalty. Any

recordings made with your child will be deleted immediately upon withdrawal of your consent.

If you have any questions regarding this study, please feel free to contact by phone

at or by email at . You may also contact the MSU-B IRB

office (Office of Research Compliance) at

If you are comfortable with your child being a part of this study, please check the I consent box

below and sign and date your name. This will let us know that it is ok for us to have participating

employees work with your child for this study and to record via video camera employees

working with your child.

If you are not comfortable with your child being a part of this study, please check the I do not

consent box and sign your name at the line below. This will let us know it is not ok for us to have

Form 2

Student Id:

participating employees work with your child for this study and they will not be recorded for this

study.

I understand the statements in this informed consent document and give my consent to my child

participating in the Remote Supervision/Observation of ABA techniques study and give

permission to the investigators to film him/her.

I understand the statements in this informed consent document, but do not consent to my child

participating in the Remote Supervision/Observation of ABA techniques study, please do not

film him/her for this study.

Name of child

Parent/Guardian Signature Date

Printed Name

Investigator Signature Date

Printed Name

Co-Investigator Signature Date

Printed Name

Form 1

Student Id:

Dear Employees,

Montana State University-Billings (MSU-B) in collaboration with is conducting

a study on how Applied Behavior Analysis (ABA) techniques are used in working with

individuals with autism and we are asking employees to be a part of it. The study is called

Remote Supervision/Observation of ABA techniques and is being conducted by MSU-B student

and employee as part of his graduate program in ABA.

The study will involve three phases. In the first phase employees will work with clients

normally while being recording via camera by to obtain a baseline (or starting

point) of the employee’s skills at implementing ABA techniques. Baseline will be conducted at a

time when employees are most likely to use ABA techniques, such as chore time, meal

preparation, school work or when clients practice vocational skills. In the first intervention phase

participants will receive live feedback on their use of ABA techniques while they work with

clients by employee and Board Certified Behavior Analysis (BCBA)

via the use of an Ipad and Bluetooth headset. This will also be conducted at one of the above

mentioned times. The second intervention phase will be a follow up phase were employees will

once again be recorded while working with clients without live feedback to see if they

maintained any improvement they achieved during the second phase. More specific instructions

will be provided to employees who chose to participate.

To protect employee’s privacy any recordings will only be seen by

or instructor supervisor of this study from MSU-B and will be deleted

after they are reviewed. If this study is published your names will not be used in publication,

although your basic demographics (age, gender, how long you have been working at

) may be used.

This study will give employees a chance to have their skills in using ABA techniques evaluated

and receive feedback on how they might improve their implementation of the techniques. If you

are unsure if you have been using ABA techniques correctly or are interested in improving, you

may benefit from participating in this study.

Should you choose to participate in this study risks are minimal. You will not be asked to

perform any task that you do not already do in your every day job, nor is it expected to be a

hindrance in you conducting the duties of your job. Both before and after either the recording

session or life feedback sessions the shift you are working will proceed as it normally does with

no interference from the investigators. This study estimated length is two months, but it could be

longer due to unforeseen circumstances.

Please note that participation of this study is entirely voluntary. You will not be penalized in any

way if you chose not to participate in this study. You are free to participate or drop out of the

study at any time and will not be penalized for your choice. You cannot be fired for your

participation in this study, unless willful abuse or negligence is witnessed.

If you plan on either leaving or transferring to another facility that is not part of this

study in the estimated time length of this study, please do not accept the role of participant. If

Form 1

Student Id:

you have any questions, please feel free to contact by phone at or

email at . You may also contact the MSU-B IRB office (Office of

Research Compliance) at

If you would like to participate in this study, please check the box below, sign on the signature

line and return it to .

I understand the statements in this informed consent document and would like to participate in

the Remote Supervision/Observation of ABA techniques study.

Participant Signature Date

Printed Name

Investigator Signature Date

Printed Name

Co-Investigator Signature Date

Printed Name