1 – Introduction
The introduction should cover the following:
Each of these points can be covered in a couple of sentences or each can have a paragraph
dedicated to it.
Make sure you conclude the introduction with a couple of sentences (or a paragraph)
providing a high-level overview of your proposed study.
Sample: With a surge of COVID-19 patients needing care, HMH hospitals adopted the
Society of Critical Care Medicine tiered staffing model for ICU, telemetry, and
medical-surgical units. After the 2009 Australian H1N1 pandemic, researchers explored the
lived experience of ICU nurses revealing themes related to staffing such as the challenge of
having the appropriate skill mix, the need to work overtime, and staff having to take on new
roles (Corley, Hammond, & Fraser, 2010). There is a gap in the literature regarding nurse
staffing or how staffing ratios were altered in hospitals during pandemics, epidemics or
illness outbreaks. The purpose of this study is to describe the staffing models used in acute
care hospitals during the COVID-19 pandemic. With a better understanding of experiences
during the COVID-19 pandemic, the results from this study will assist nurse leaders and
healthcare administrators in developing a systematic action plan with evidence-based staffing
models for future outbreaks and epidemics.
2.1. Background/literature review (Please provide references and add references in APA
format in the reference list at the end of this document)
The background should offer an overview of the available literature.
Please make sure that you discuss the literature that supports YOUR proposed study. You
can discuss 1-2 more general reference papers in the beginning but make sure that you
focus on similar studies or studies demonstrating a gap.
You might also want to:
studies done in the USA or elsewhere, and clinical studies conducted abroad.
Conclude your background by identifying the gap and explaining in one sentence how you
are going to fill it.
Make sure your background is not unnecessarily long (such as a thesis) as long. A protocol
only needs to include the background to allow the reader/reviewer to familiarize with the
area.
Review of Literature (ROL)
new/revised standards of practice/clinical practice guidelines/best practices, and
statutes/regulations if applicable.
or theoretical framework.
you focus on similar studies or studies demonstrating a gap.
populations together
base your study on doing something already done but better!
project/dissertation that requires a 10-15 page long literature review.
subjects.
you intend to address it with this work. This will give you a good justification for
why you are proposing a study
3 – Rationale, Objectives and Hypothesis
The rationale for the study, the investigator’s goals, and/or the hypothesis to be tested
should be stated here. Objectives should be broken down by primary and secondary which
will then lead to your primary/secondary variables.
3.1. Study Rationale/Problem Statement/Research question or Study significance
Explain in one sentence what the need you intend to cover is.
studies.)
A statement that can be tested with an experiment (usually suggests a relationship).
Scientists generally base scientific hypotheses on previous observations that cannot
satisfactorily be explained with available scientific theory/ data.
The main goal you are trying to achieve. It derives from the research question.
objective above)
Quantitative measures deriving from the objective(s). Defines the outcomes that the study
will measure. Try to have no more than 2-3 primary outcomes. The rest can be secondary or
explanatory.
Primary Outcome Measure 1
Title:
Description: [Description of the metric used to characterize the specific primary outcome
measure, if not included in the primary outcome measure title. If a scale is used to assess
the outcome, please list the name of the scale and its range e.g. knowledge will be assessed
using a 9-item scale ranging from 0-9 with 0 being “no previous knowledge” and 9 being
“expert knowledge”.]
Timeframe: [Time point(s) at which the measurement is assessed for the specific metric
used. The description of the time point(s) of assessment must be specific to the outcome
measure and is generally the specific duration of time over which each participant is
assessed (not the overall duration of the study).]
Primary Outcome Measure 2
Title/Description/Timeframe
3.6. Secondary Outcome Variable(s)/Measure(s) (if applicable)
Secondary Outcome Measures [N/A if not applicable]
Secondary Outcome Measure 1 [for clinical trials, “Secondary outcome measure” means an
outcome measure that is of lesser importance than a primary outcome measure, but is part
of a pre-specified analysis plan for evaluating the effects of the intervention or interventions
under investigation in a clinical study and is not specified as an exploratory or other
measure. A clinical study may have more than one secondary outcome measure.]
Title/Description/Timeframe
Exploratory outcome measure 1
Title/Description/Timeframe
4.1 General Design
Describe in a sentence or two the general design of the study. If applicable, make sure you
mention whether this is a study with a retrospective AND prospective component, or only
prospective, and the type of the protocol (e.g. prospective data / sample collection /clinical
trial/survey-based/ quantitative and/or qualitative), and list control or comparison groups, as
applicable.
Please ensure there is a clear distinction between what is taking place as standard of
care (SOC) versus what is done for research purposes.
You might also want to:
Include a schematic diagram of the study design, procedures and stages as applicable.
Describe the measures taken to minimize/avoid bias (randomization, blinding).
If data is to be collected, make sure the list of datapoints is listed here or is provided in the
appendix (or as a separate attachment).
Describe how long the study is going to last. Take into consideration the time you will need
for the data collection and the time needed for data analysis. Recommend that you allocate
extra time for your study because if you have an end date and you have not finished data
collection you will need to submit an amendment to the IRB.
If this is a clinical trial in which patients will be actively involved, make sure you specify the
duration for which they will be involved and the time needed to analyze the data collected.
When indicating duration, try to use days, months, years, not specific dates as this may
change depending on when you obtain IRB approval.
Explain how long each participant will remain in the study, including follow-up.
Mention the site(s) that will be involved in this study. Include their name and location and
specify if they are HMH/non-HMH sites.
This is also entered into eResearch in “Local Research Locations.”
Describe the participant pool you will choose your participants from and their general
characteristics. Make sure you specify the type of the participant population (e.g.
patients/students, etc.).
Specify the number of participants that will be recruited for your proposed study.
For quantitative studies, recommend that you consult with the statistician to determine the
number of participants and need for power analysis.
For qualitative studies, typically the number of participants is based on data saturation.
Inclusion Criteria: All eligibility criteria should be listed. (Medical criteria, age, demonstration
of disease, ailment, proof of failure using standard therapy, laboratory assessments for
eligibility, etc.).
Exclusion Criteria: As applicable: Age limits; minors, pregnant women, mental
incompetents; use of other medications concomitantly; subjects with other diseases, severity
of illness, etc.
population. A good example for a study that used data collected within the SOC would be
(especially if you will collaborate with DTS to pull data):
Study Title Example: Investigation of Surgical Outcomes for Patients with Knee
Osteoarthritis
Inclusion Criteria:
on ICD-10 code M17 (Unilateral primary osteoarthritis of knee) or M18 (Bilateral
primary osteoarthritis of knee) as primary or secondary diagnosis.
(CPT code: 29881)
● Date Range: Surgeries performed Jan 1, 2021-Dec 31,2021
Exclusion Criteria:
○ Patients with rheumatoid arthritis (ICD-10 code M05 or M06) primary or
secondary OR
○ Patients with post-traumatic knee osteoarthritis (ICD-10 code M17.1) primary
or secondary OR
○ Patients with secondary osteoarthritis due to other conditions (ICD-10 code
M19) as secondary code.
codes: 27447, 27486)
prisoners, cognitively impaired individuals, economically or educationally disadvantaged
individuals, employees, students. When vulnerable populations are included, indicate what
safeguards are in place to minimize coercion or undue influence to participate.
4.3 Withdrawal criteria
subjects withdraw from the research, including partial withdrawal from procedures
with continued data collection or surveillance (if applicable)
All procedures that are STUDY-RELATED must be described here.
Recruitment, consent and any research interventions must be described here. Interventions
might include, but are not limited to: Clinical procedures, surveys, interviews, focus groups
and educational interventions. Also include plans to return results to participants and/or their
treating physician and explain where lab tests will take place (CLIA vs. non-CLIA certified
lab).
applicable.
performed, including procedures being performed to monitor subjects for safety or
minimize risks.
o Procedures performed to lessen the probability or magnitude of risks.
o The source records that will be used to collect data about subjects.
(Attach all surveys, scripts, and data collection forms.)
complete), what data will be collected during this period.
you specify if you will be using targeted analysis or whole exome/genome
sequencing and ensure consistency between the protocol and the consent form.
Please avoid long explanations of procedures that are standard of care unless it is to explain
your research activities. Please make sure there is a clear distinction between what is the
standard of care and what is done for research purposes.
4.4.1. Study discontinuation (if applicable)
subjects related to the subjects’ participation in the research. Include a description of
the probability, magnitude, duration, and reversibility of the risks considering physical,
psychological, social, legal, and economic risks.
currently unforeseeable.
the subject be or become pregnant.
Indicate whether there is the prospect of direct benefit to participants or whether there are no
direct benefits to participants. If there are no direct benefits to participants, the potential
benefits to society should be mentioned. Do not include compensation as a benefit to the
subject.
here. The statistical analysis plan has to be included here, including the timing of any
planned interim analysis and the criteria for termination of the trial. In the statistical section
you might also need to include procedures for accounting for missing, unused, or spurious
data and for reporting deviations from the original statistical plan.
If this is a treatment/diagnostic/prevention (non drug/device/biologic) study, the investigator
should explain the treatment /diagnosis/prevention plan and describe any control or
comparison group, as applicable. Baseline diagnostic tests, initial laboratory assessments
for eligibility, any EKGs, physical exams, etc., should be noted. The use of participant
diaries should be noted, the number of visits etc..
hospitalized for any part of the study.
If this is not a treatment study, the PI should list measures to be used, tests, interviews,
videotaping, and the amount of time the participant will be involved in each component of the
study. All tools, surveys etc. that are going to be used should be explained here. Also include
how they have been created and validated.
experimental: e.g. if lumbar punctures are to be performed, it should be clear which, if any,
would have been performed off study.
Any monitoring should be described. The PI should also discuss reasons for dropping any
participant from the study. (Relapse, lack of patient compliance, etc.).
If applicable also include:
for assessing, recording, and analyzing efficacy parameters).
assessing, recording, and analyzing safety parameters; procedures for eliciting
reports of and for recording and reporting adverse events and intercurrent illnesses;
the type and duration of the follow-up of subjects after adverse events).
Flyers, patient handouts, etc. require IRB approval and should be attached as an Appendix.
intervention)
If the tool was home developed, explain if and how it was piloted. If the tool is copyright
protected, please make sure you have obtained permission before using it for research
purposes.
measurement, reliability and validity. Include who created the tool and if you have
permission to utilize. Include a sample of each tool/instrument/scale in Appendix
description of the number of eligible participants seen in your practice during the study
period.