NURS 5001 Mock IRB Template

SECTION A: CONTACT INFORMATION AND AGREEMENT

1. Investigators: 2. Date Submitted to IRB

Patricia Bond, Sarah Liberty Taylor, Lindsay Thompson,
03/29/2020
Sherri White
3. Title of Research Project
Feel the burn to prevent the burnout Contact Number 800-362-0014

NOTE:
The HSRR/IRB Committee reserves the right to terminate this study at any time if, in its opinion,
(1) the risks of further experimentation are prohibitive, or
(2) the above agreement is breached.

SECTION B: PURPOSE OF PROPOSED RESEARCH (Author: Patricia Bond)

Study Overview: Give an overview of your project. Each of the following MUST BE addressed within this
section (leave no question blank). Enter your response below each question, using as much space as
needed.

1. What background data or studies suggest this project is important, interesting, and worth
completing with human subjects? Brief overview – state the research gap identified in the
Review of Literature.

Several studies have been completed regarding nursing burnout. Nursing burnout contributes to
job satisfaction, nurse retention and patient safety. (McHugh, Kutney-Lee, Cimiotti, Sloane, &
Aiken, 2011). More high-quality research is recommended utilizing larger sample sizes, longer
periods of time and a measurable, defined evaluation tool.

2. What is your research question, purpose and/or aim in conducting this research?

Research question is: Among large university hospital acute care nurses who have experienced
nursing burnout, how does following an exercise program for six months affect burnout
symptoms?

3. Describe the theoretical framework selected for your study and explain how the theory will
be incorporated into the study design.

Orem’s self-care deficit theory (Smith & Parker, 2020) was chosen, burnout occurs when nurses
do not take care of themselves. The theory will be appropriate for designing the program of
nurses working to take care of themselves so that they can effectively care for patients.

4. Include information regarding where and when the research will be conducted, what
research instruments or equipment will be used, etc.

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 Participants will utilize the Vanderbilt University Medical Center (VUMC) employee fitness
center. Maslach’s Burnout Inventory (MBI) (Leiter & Maslach, 2019), (see Appendix 1) will be
used to measure responses of participants. Participants will complete a weekly guided journal
describing burnout symptoms and how they are feeling while progressing throughout the study
(see Appendix 2). Researchers will provide participants with guided journal information and
supply the journal.

Permission is required by VUMC for researchers to utilize employee fitness center and to monitor
badge reading in and out of facility. A conference area will be required to discuss study with
participants and obtain consent. Researchers will provide postage for journals to be returned to
researchers.

5. What will participants be asked to do? What are the anticipated outcomes?

Participants will be asked to participate in an exercise program by attending VUMC employee

fitness center at least three days per week for minimum of twenty minutes of exercise of their
choice. Participants will complete MBI (Leiter & Maslach, 2019) prior to starting study and at
termination of the study. Participants will also complete weekly guided journals addressing
burnout symptoms and personal thoughts of progression. Expected outcomes are decreased
burnout symptoms and participant satisfaction with personal progression.

6. Please provide an estimated timeline for your research study. If the study has more than one
phase, please clearly map out the different phases (illustrations or diagrams may be
included).

Research investigators will obtain permission to send system-wide email to VUMC nurses
regarding burnout symptoms. When permission is obtained, research investigators will send out
email and give thirty days for responses. After thirty days, research RN will arrange with medical
center for space to meet with participants over a weeklong period to discuss risks and obtain
consent. Will have all participants complete the MBI (Leiter & Maslach, 2019) at baseline,
allowing participants one week to complete initial inventory. Final survey will be sent to
participants after one hundred eighty days of exercise intervention and will allow one week for
participants to complete inventory

SECTION C: RESEARCH PROCEDURES AND METHODS (Author: Sherri White)

Procedural Overview: Give an overview of your procedures and methods for this research project. Each
of the following MUST BE addressed (leave no question blank). Enter your response below each
question, using as much space as needed.

1. Please describe the specific research design (quantitative, qualitative – include additional
specifics such as descriptive, correlational, phenomenological, etc.) and describe why this
method is appropriate for your research question.

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 This research design will be conducted as a mixed method, qualitative, interpretive
phenomenological inquiry for a one hundred eighty day period April 1, 2020 to October 1,
2020. Structured interviews by the research nurses will be conducted with each study
participant prior to the beginning of their exercise activity, at a ninety day interval on July 1,
2020 and again at one hundred eighty days on October 1, 2020. Phenomenological research
will aid researchers to determine themes from participants responses at baseline, ninety days
and one hundred eighty days. Phenomenological studies allow participants to describe their
experiences to researchers and allows researchers to assemble pertinent information that helps
to respond to the research question based on themes that emerge through interview analysis.
Interpretive phenomenological inquiry will allow researchers to also analyze the exercise
journals of each participant to view their thoughts and feelings prior to and after exercise to
determine themes in their exercise experiences (Polit & Beck, 2017, p. 470-473).

2. Clearly demonstrate how the data gathered will address the proposed question. (see
Chapter 13 in Polit and Beck)

Researchers will gather information through baseline interviews, midterm interviews, end of
study exercise interviews and participant journaling will determine how the exercise program is
affecting their burnout experience. Interviews should be 15 to 30 minutes with each participant.
The open-ended questions will allow participants to describe physical symptoms they are
experiencing prior to beginning the dedicated exercise program and then additional interviews
and journaling and open-ended questions will help determine if exercise improves symptoms of
nursing burnout.

 Baseline information for each participant will be gathered from MBI (Leiter & Maslach,
2019) and an interview asking the following open-ended question: Describe any physical
symptoms you are experiencing that you attribute to nursing burnout.

 Midterm interview will analyze the participants journaling to view patterns of exercise and
to determine any feelings they describe surrounding nursing burnout and asking the open-
ended question: Describe any physical or emotional improvement you can contribute to the
exercise activity.

 End of study interview will analyze the participants journaling to view patterns of exercise
and to determine any feelings they describe surrounding nursing burnout improvement
completing MBI (Leiter & Maslach, 2019) post exercise study and asking the open-ended
question: Describe any improvements you feel that exercising three times weekly for twenty
minutes during the last one hundred eighty days has had on your emotional well-being and if
it helped improve the physical symptoms you initially described pre-exercising.

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3. What data collection tools will be used (survey, interviews, focus groups, physiological
measurements, response time, etc.)? How will you ensure reliability/internal
consistency/retest reliability of the tools? (see p. 308 in Polit and Beck)

Christina Maslach is a Professor Emerita of Psychology at the University of California,

Berkeley and is the author of MBI (Plous, 2016). Her reputation as a researcher in the burnout
field and authorship of numerous books on the subject of burnout along with her numerous
faculty positions qualify her work as reliable for this survey assessment. The MBI (Leiter &
Maslach, 2019) assessment categorizes burnout into three areas of emotional exhaustion,
depersonalization, and diminishing accomplishment. This assessment will be given at baseline
and the journaling will be analyzed midterm and at the end of the exercise study as well as a
post exercise analysis of MBI (Leiter & Maslach, 2019).

Polit and Beck (2017) state, “Insights and theories cannot emerge until researchers become
completely familiar with their data” (p. 531, ¶ 1). Researchers will conduct three recorded
interview sessions throughout the six month study at intervals of baseline interview to discover
thoughts prior to the exercise, at three months to analyze participants feelings and progress, and
at six months to determine if nursing burnout was affected by the phenomenon’s of exercise and
journaling. Recording the interviews will allow researchers to transcribe the data accurately
and by verbatim transcription for validity, accuracy and reliability. The journals will be
photocopied and highlighted for specific exercises performed to determine if any particular type
of exercise whether aerobic, strength, flexibility or balance is more effective in reducing burnout
and to see if the recorded negative feelings change to positive feelings associated with a
particular type of exercise.

Recording the interviews and photocopying the journals will ensure the thematic data is mined
appropriately and thoroughly. Once thematic data is discovered it will be categorized for
physiological/emotional effects and physical effects and categorized for consistency

4. How will the data be analyzed?

 For quantitative studies – describe what statistics will be used and why they are
appropriate for the study (for example, descriptive statistics, t-tests, ANOVA,
MANOVA, correlation) – see chapters 16-18 in Polit and Beck.

 If the data are qualitative, what criteria will be used to determine how well the study
answered the research question? What data analysis methods will be used and explain
why the choice is appropriate (see Chapter 24 in Polit and Beck for qualitative data
analysis methods)

Qualitative content analysis of each participants interview sessions and exercise journals will be
used to analyze the data to discover major themes. The information gathered from MBI (Leiter
& Maslach, 2019), each interview and journal entries will be thematically categorized based on
physical symptoms and the number of times similar symptoms occur to determine the most

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 common physical symptom. The same will be completed for physiological/emotional symptoms.
Demographics will be separated by female and male participants, age groups in ten year
increments, acute care specialty, and number of nursing experience years to determine burnout
rates among sexes, age groups, specialties and years of experience. Division of these categories
will also determine the effectiveness of exercise for burnout in each demographic as the study
progresses.

Polit and Beck (2017) describe qualitative content analysis will best explain this study data
because it is the analysis of narrative data and will identify prominent themes and patterns and
help to condense the data into appropriate categories (p. 537).

SECTION D: HUMAN RISK AND MINIMIZATION OF RISKS (Author: Lindsay Thompson)

Participant Recruitment: Please provide the demographics of the recruitment population(s). Describe
the participants in terms that are most pertinent to the proposal. The IRB Committee members must
understand how working with the target population(s) will address the research objectives, what measures
are appropriate to minimize their risk, and how these measures will be implemented throughout the research
study.

Please fill in the following information below. If you are working with more than one distinct population,
information will need to be provided for each group.

1. Estimated demographic information of participants and number of participants (age,

gender, etc.) if this were a real study.

The researchers will recruit 50 acute care nurses from VUMC. Since the study is voluntary, the
gender of the participants will be male and female ages 20 and older.

2. How was the number of participants required for the study determined?

This study is a mixed methods, qualitative study which will include journal entries, surveys, and
interviews; thus, sampling will follow the grounded theory resulting in the use of 50 study
participants. Since validity is concerned with the soundness of a research study (Polit and Beck,
2017), this study will use 50 participants to ensure the validity of the evidence from the research.

3. Describe how participants will be identified, selected, and recruited to participate in the
study.

Convenience sampling will be used, since the participants will have to volunteer and identify
themselves as willing to participate in the study (Polit and Beck, 2017). All acute care nurses at
VUMC will be sent an invitation via email to join the research study. Participants who decide to
participate will follow the instructions listed in the email to join the study. The convenience
sampling may turn into snowball sampling if not enough nurses volunteer to participate.

4. Are there any exclusion criteria? If so, why are the exclusions needed?

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 The only exclusion criteria would be anyone unable to participate in an exercise program as
deemed by their primary care provider. This is to protect the participant from any harm that may
come from them participating in an exercise routine.

5. Is the population as a whole, or are individuals within the recruited population, considered
“risk-sensitive”? Risk-sensitive populations are those for whom the probability of harm is
likely to be significant because of various life situations: victims of abuse, participants with
debilitating health conditions, individuals engaged in illegal or risky behaviors, etc. In these
instances, the very act of participating may put these participants in categories of
heightened concern.

No, this population is not considered risk sensitive.

6. Is the population as a whole, or are individuals within in the recruited population,

considered “vulnerable”? This refers to participants who are unable to or have limited
capacity to consent.

No, this population is not considered vulnerable.

7. Will either deception or willful withholding of information be used in the study?

No, deception or willful withholding of information will not occur in this study.

If the answer to any of the previous three questions was “Yes”, please describe in detail the precautions
that will be used to reduce risk, the measures to limit the vulnerability, or the justification for deception.
References must be included in this section to demonstrate consistency with current practices in the
literature.

Anonymity and Data Collection/Storage: For most human subject research, one major risk to participants
relates to the personal nature of the data collected from them. Thus, it is imperative to consider how the
data are collected, stored, and reported. If identifying information must be collected, provide justification
for this collection.

8. Are any of the data already collected or considered to be archival data (secondary data,
chart review, etc.)

No, all the data to be collected will be new data for this study.

9. What will you do to protect the confidentiality of your participants? Include details related
to the type of information you will gather, and the material forms (paper, audio, electronic,
etc.) it will take.

Participants confidentiality will be protected by assigning the participants a number for use
instead of their name on the documents. According to Polit and Beck (2017), “when anonymity is
not possible, other confidentiality procedures are needed” (p. 147) like the use of a number for
identification on documents instead of their name. The initial interviews will be recorded and

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 transcribed. According to Polit and Beck (2017), if notes are written during the interview these
notes may be incomplete and may be biased by what the interviewer remembers or their view of the
interview; this has led to the decision to record the initial interviews to eliminate potential bias.
Participants will be journaling during the study and completing the compassion fatigue survey.

10. How will the data and collected materials be stored? Please include information regarding
storage during the collection process, the analysis process, and after the research is
concluded (long-term). Also, please include the specified time that data will be kept and how
it will be destroyed at the conclusion of the study.

All data and documents will be stored and encrypted on a drive that is only accessible by the
researchers. Participants will be asked to complete paper copies of the survey and to complete
their journal entries via word processing and printed and returned to the researchers. Data will
continue to be stored on the encrypted drive throughout the study and will remain there for up to
five years post study. All data including interview recordings will be destroyed, and the data
stored on the drive will be destroyed via current information technology standards.

SECTION E: INFORMED CONSENT DOCUMENT (Author: Sarah Liberty Taylor)

Consent is an on-going process that starts when you first inform the participant about the study and ends
when the data collected are destroyed. Federal regulations require that a formal consent process takes
place where you provide participants with specific information about the study, usually provided in the
consent form. Participants are generally required to sign the consent form and are allowed to keep of copy
of it for their records. In general, the IRB Committee needs to understand how participants will be
recruited and consented to participate in the study. (see chapter 7 in Polit and Beck)

1. Who will present the consent information and how will it be presented? (In person, online,
in writing, etc.)

Consent will be obtained by research RN investigator after it has been explained to participant in
person. A copy will be provided to participant.

2. How will you document consent? In writing or does participation imply consent? Are your
participants able to sign a form and, if not, how will you document consent? Will you use
more than one form (if you use more than one version of the consent form, each form needs
to have a unique title in order for our staff to keep track of the different forms)?

Consent will be obtained in writing. Informed consent will be discussed, risks and benefits,
purpose of study, and how data will be collected. Participation is on a volunteer basis and
subjects have the right to withdraw from the study at any time. Should subject decide to withdraw
from the study they will notify the study investigators of their decision. If they withdraw, they will
continue to be treated with respect and they will not need to provide their reason for withdrawal.

3. When and where will participants receive the consent form?

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 Participants will sign written informed consent when volunteering for study after consent has
been explained and their questions have been answered.

4. Will you pay participants?

“Payment” is considered to be compensation for participation in the study and is introduced during
recruitment of participants. If “Yes”, how will this be conducted to prevent payment from negatively
affecting informed consent? If “No”, please type “N/A” and move to next question.

Participation is on a volunteer basis and no direct compensation will be given. However, the use
of the employee fitness center is a benefit provided by VUMC.

5. If participants are unable to consent because they are members of vulnerable populations
(minors, prisoners, participants with diminished mental capacity, etc.), what provisions are
in place to obtain consent from a parent or surrogate? What provisions are in place to
obtain assent?

Participants must be able to sign informed consent in order to participate.

Benefits: Benefits are those tangible and intangible times that offset risks to the participants, though not
every study will have direct benefits for the participants. Please address the following questions related to
potential benefits for participants.

6. Will there be any benefits to the participants in your study?

If “Yes,” what are they? If “No,” please enter “N/A” in the response section.

Yes. Participants will be using the employee fitness center privileges to potentially improve their
health and personal well-being associated with increased exercise and potentially decrease the
risks of nursing burnout.

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 References

Leiter, M., & Maslach, C. (2019). MBI: Human Services Survey for Medical Personnel. Retrieved from

Mind Garden: Tools for positive transformation: https://www.mindgarden.com/mbi-human-

services-survey-medical-personnel/698-mbihssmp-individual-report.html#horizontalTab4

McHugh, M. D., Kutney-Lee, A., Cimiotti, J. P., Sloane, D. M., & Aiken, L. H. (2011). Nurses'

widespread job dissatisfaction, burnout, and frustration with health benefits signal problems for

patient care. doi:https://doi.org/10.1377/hlthaff2020.0100

Plous, S. (2016, August 4). Christina Maslach. Retrieved from Social Psychology Network:

http://maslach.socialpsychology.org/

Polit, D. F., & Beck, C. T. (2017). Nursing research: Generating and assessing evidence for nursing

practice. Philadelphia: Wolters Kluwer.

Smith, M. C., & Parker, M. E. (2020). Nursing theory and the discipline of nursing. In M. C. Smith (Ed.),

Nursing theories and nursing practice (Fifth ed., pp. 3-16). Philadelphia, PA: F.A. Davis.

Retrieved January 13, 2020

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 Appendix 1

Maslach’s Burnout Inventory Sample Statements (Leiter & Maslach, 2019)

Emotional Exhaustion
I feel emotionally drained from my work
I feel used up at the end of the workday
I feel fatigued when I get up in the morning and have to face another day on the job
Working with people all day is really a strain for me
I feel burned out from my work
I feel frustrated by my job
I feel I’m working too hard on my job
Working with people directly puts too much stress on me
I feel like I’m at the end of my rope

Personal Accomplishment
I can easily understand how my recipients feel about things
I deal very effectively with the problems of my recipients
I feel I’m positively influencing other people’s lives through my work
I feel very energetic
I can easily create a relaxed atmosphere with my recipients
I feel exhilarated after working closely with my recipients
I have accomplished many worthwhile things in this job
In my work, I deal with emotional problems very calmly

Depersonalization
I feel I treat some recipients as if they were impersonal ‘objects’
I’ve become more callous toward people since I took this job
I worry that this job is hardening me emotionally
I don’t really care what happens to some recipients
I feel recipients blame me for some of their problems

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 Appendix 2

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 Journal

What exercise interventions did you use this week?

Did you notice any burnout symptoms this week? What symptoms did you
notice? How often did you experience these symptoms?

How do you feel your exercise regimen reduced/worsened burnout

symptoms?

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