COMIRB approved document
University of Colorado Hospital
COMPARISON OF THE CHARACTERISTICS OF RESEARCH, QUALITY IMPROVEMENT, AND PROGRAM EVALUATION ACTIVITIES
Use this form to determine the scope and intent of a proposed project. If the proposed project may be disseminated through publication, please complete this
document, develop a brief (1-2 page SBAR) explaining your project and send both documents the Research Nurse Scientist for review. This review process is
important in ensuring the project has been ‘externally’ reviewed to be consistent with project methods and do not conflict with research methods.
RESEARCH
QUALITY IMPROVEMENT
EVIDENCE-BASED PRACTICE
PROGRAM
EVALUATION
INTENT
Intent of project is to develop or
Intent of project is to improve a practice
Intent is to apply the synthesis of
Intent of project is to
contribute to generalizable
or process within a particular institution or
existing evidence to a clinical decision or
improve a specific
knowledge (e.g., testing
ensure it confirms with expected norms
practice change in a unit or institution
program
hypotheses)
DESIGN
Designed to develop or
Not designed to develop or contribute
Designed as an evidence-based
Not designed to
contribute to generalizable
to generalizable knowledge; generally
practice conceptual model i.e., Colorado
develop or contribute to
knowledge; may involve
does not involve randomization to different Model, Johns Hopkins EBP Model, the
generalizable knowledge;
randomization of individuals to
practices or processes
Iowa Model
does not involve
different treatments, regimens, or
randomization of
processes
individuals, but may
involve comparison of
variations in programs
MANDATE or
Activities not mandated by
Activity endorsed or mandated by the
Activity endorsed or mandated by the
Activity endorsed or
ENDORSEMENT
institution or program
institution or clinic as part of its operations institution or clinic as part of its operations mandated by the program,
usually its funder, as part
of its operations
EFFECT ON
Findings of the study are not
Findings of the study are expected to
Findings of the project are expected to
Findings of the
PROGRAM OR
expected to directly affect
directly affect institutional practice and
result in institutionalization of the practice
evaluation are expected to
PRACTICE
institutional or programmatic
identify corrective action(s) needed
change
directly affect the conduct
EVALUATED
practice
of the program and
identify improvements
POPULATION
Usually involves a subset of
Information on all or most receiving a
Evaluation involves a subset of the
Information on all or
individuals - universal participation particular treatment or undergoing a
target population without consideration for most participants within or
of an entire clinic, program, or
particular practice or process expected to
statistical justification of sample size; the
affected by receiving a
department is not expected;
be included; exclusion of information from
goal is for the new practice or practice
particular treatment or
generally, statistical justification
some individuals significantly affects
change to be implemented broadly
undergoing a particular
for sample size used to ensure
conclusions. Initial work can be limited to
practice or process
endpoints can be met
a smaller subgroup to identify and plan for
expected to be used;
implementation or feasibility etc. with the
exclusion of information
expectation that the practice or process
from some individuals
will be extended to the broader
significantly affects
population.
conclusions
BENEFITS
Participants may or may not
Participants expected to benefit directly
Participants expected to benefit
No benefit to
benefit directly – benefit, if any, to
from the activities
directly from the activities
participants expected;
individuals incidental or delayed
evaluation concentrates
on program improvements
or whether the program
should continue
Research, QI, Program Evaluation, EBP Tool
Adapted with permission from COMIRB CF-195, Effective 9-20-13
COMIRB approved document
DISSEMINATION OF
RESULTS
Intent to publish or present
generally presumed at the outset
of project as part of professional
expectations, obligations;
dissemination of information
usually occurs in
research/scientific publications or
other research/scientific fora;
results expected to develop or
contribute to generalizable
knowledge by filling a gap in
scientific knowledge or supporting,
refining, or refuting results from
other research studies
Dissemination of information may
occur in quality improvement
publications/fora; when published or
presented to a wider audience, the intent
is to suggest potentially effective models,
strategies, assessment tools or provide
benchmarks or base rates rather than to
develop or contribute to generalizable
knowledge. Any publication should
footnote that the project was carried out
as QA and did not meet the definition of
research per DHHS regs.
CLINICAL SETTINGS (where will project occur, list unit/clinics, etc)
USE OF PLACEBO
Use of placebo may be planned
Comparison of standard treatments,
practices, techniques, processes –
placebo would NOT be used
DEVIATION FROM
May involve significant
Unlikely to involve significant deviation
STANDARD
deviation from standard practice
from standard practice
PRACTICE
Dissemination of results can occur in
scientific or quality improvement
publications and/or presentations;
resulting practice guidelines may also be
shared
Intent to publish or
present generally
presumed at the outset of
the project; dissemination
of information to program
stakeholders and
participants; may be
publicly posted (e.g.,
website) to ensure
transparency of results;
when published or
presented to a wider
audience, the intent is to
suggest potentially
effective models,
strategies, assessment
tools or provide
benchmarks or base rates
rather than to develop or
contribute to generalizable
knowledge. Limitations of
publication: any
publication should
footnote that the project
was carried out as QA and
did not meet the definition
of research per DHHS
regulations.
Use of comparison group data before
practice change (usually current practice).
Placebo would NOT be used
Program may involve significant
deviation from current practice to
incorporate current evidence for practice
If any of the boxes in the research column are checked then the project must be submitted to COMIRB for review and approval.
If the tool indicates that this is quality improvement (QI) or program evaluation (PE) only the signatures detailed below should be obtained
Acknowledgment
I have appropriately used this tool to evaluate my project entitled:
Research, QI, Program Evaluation, EBP Tool
Adapted with permission from COMIRB CF-195, Effective 9-20-13
COMIRB approved document
By my signature below, I affirm that this project meets the definition of:
[Circle the appropriate project description]
Research
Quality Improvement
Evidence-Based Practice
Program Evaluation
I certify that I will conduct my project in compliance with all federal, state and local laws and policies. If during the course of the project
it is amended in such a way as to meet the definition of human subject research under 45 CFR 46 or 21 CFR 56 then I understand that I
must submit to COMIRB for review prior to continuing the project.
Signature of Project Lead
Date
Signature of Mentor
(if applicable)
Date
I have reviewed this project proposal and determine that it meets the criteria for quality improvement or program evaluation as outlined
above and is an appropriate project to be conducted within this Division/ Department/ School/.
e-signature: JoAnn DelMonte, RN-BC, MSN
Signature of Director of Professional Resources
Or Appropriate Authority
(or their designee)
Date
JoAnn DelMonte, RN-BC, MSN
Director of Professional Resources
Print Name of Director of Professional Resources
OR Appropriate Authority
(or their designee)
Position
Research, QI, Program Evaluation, EBP Tool
Adapted with permission from COMIRB CF-195, Effective 9-20-13
COMIRB approved document
Guidelines:
This document should be retained with the project file and referenced as needed.
If you have any questions or concerns that the project may include a research component, submit to COMIRB using the appropriate
forms available on the website:
COMIRB: http://www.ucdenver.edu/academics/research/AboutUs/comirb/Pages/comirb-home.aspx
Definitions:
Human Subjects Research
For the purposes of this policy “human subject research” is defined as an activity that meets the definition of “research” and involves
“human subjects” as defined either by the Common Rule or by FDA regulations.
Research definition:
A systematic investigation, including development, testing and evaluation, designed to develop or contribute to generalizable
knowledge. Activities that meet this definition may be funded or unfunded, or may be conducted as a component of another
program not usually considered research. For example, demonstration and service programs may include evaluation
components, and may constitute research activities under this definition.
Example of Research:
Research findings discussed at a unit journal club indicated that applying heat to the extremity facilitated IV catheter insertion.
Nurses participating in the journal club questioned whether moist or dry heat was more effective. No literature was found
addressing this question. The nurses consulted a Research Nurse Scientist at their organization for help designing a clinical
study. A randomized controlled trial was designed to test which form of heat was more efficacious before IV cannulation. A
research proposal was developed, IRB approval was obtained, and a grant application was submitted to Sigma Theta Tau
Research committee and the team was awarded funding to conduct the study. The study was conducted in the oncology infusion
center. It was found that dry heat was the best type of heat with respect to time to cannulation, number of cannulation attempts,
and patient satisfaction. The study was presented at a local research symposium and published in the Oncology Nurses Forum.
Additional Guidelines for Research:
Research, QI, Program Evaluation, EBP Tool
Adapted with permission from COMIRB CF-195, Effective 9-20-13
COMIRB approved document
For the purposes of this policy, a “systematic investigation” is an activity that involves a prospective study plan which
incorporates data collection, both quantitative and qualitative, and data analysis to answer a study question.
Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions
(i.e., knowledge gained from a study may be applied to populations outside of the specific study population), inform policy, or
generalize findings.
Research as defined by FDA regulations means any experiment that involves a test article and one or more human subjects, and
that either must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g)
of the Federal Food, Drug, and Cosmetic Act, or need not meet the requirements for prior submission to the Food and Drug
Administration under these sections of the Federal Food, Drug, and Cosmetic Act, but the results of which are intended to be
later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or
marketing permit. The terms research, clinical research, clinical study, study, and clinical investigation are synonymous for
purposes of FDA regulations. [21 CFR 50.3(c), 21 CFR 56.102(c)]

Experiments that must meet the requirements for prior submission to the Food and Drug Administration under section
505(i) of the Federal Food, Drug, and Cosmetic Act means any use of a drug other than the use of an approved drug in
the course of medical practice. [21 CFR 3 12.3(b)]

Experiments that must meet the requirements for prior submission to the Food and Drug Administration under section
520(g) of the Federal Food, Drug, and Cosmetic Act means any activity that evaluates the safety or effectiveness of
a device. [21 CFR 812.2(a)]

Any activity in which results are being submitted to or held for inspection by FDA as part of an application for a
research or marketing permit is considered to be FDA-regulated research. [21 CFR 50.3(c), 21 CFR 56.102(c)].
Human Subject as defined by the Common Rule:
A living individual about whom an investigator (whether professional or student) conducting research obtains:
1.
2.
data through intervention or interaction with the individual, or
identifiable private information.
Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of
the subject or the subject's environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject.
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect
Research, QI, Program Evaluation, EBP Tool
Adapted with permission from COMIRB CF-195, Effective 9-20-13
COMIRB approved document
that no observation or recording is taking place, and information which has been provided for specific purposes by an
individual and which the individual can reasonably expect will not be made public (for example, a medical record).
Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the
investigator or associated with the information) in order for obtaining the information to constitute research involving human
subjects.]
Human Subject as Defined by FDA Regulations:
Any individual who is or becomes a subject in research; either as a recipient of the test article or as a control. A subject may be
either a healthy human or a patient. In the case of a medical device, a human subject/participant is also means a human on whose
specimen an investigational device is used.
Research Compared with Quality Improvement/Quality Assurance or Program Evaluation or EBP:
The touchstones for separating quality improvement and program evaluation from research concern the intent of the project, the
degree to which results are designed to contribute to generalized knowledge, the effect of results on program practice or
processes, and the scope of dissemination of results. In general many research methods may also be used in quality
improvement and program evaluation projects. In clinical settings the use of a placebo or significant deviation from standard of
care is unlikely to be viewed as quality improvement or program evaluation.
Quality Improvement:
Quality Improvement Definition:
Quality improvement activities are generally pursued in order to evaluate existing local practices with a goal of documenting
and correcting deficiencies. If the goal of a project is to determine success/effectiveness or failure of a given program or
process and the information gained from that evaluation is used to improve the program, this is not considered research
involving human subjects, even when information is collected in a systematic way, because the results of this type of activity
are not considered applicable to populations other than those under evaluation. Publication or presentation is allowed but
results must not be described as or inferred to be generalizable to a broader population, i.e., they may not be described as
research results.
Quality Improvement Example:
Research, QI, Program Evaluation, EBP Tool
Adapted with permission from COMIRB CF-195, Effective 9-20-13
COMIRB approved document
Routine lab audits revealed that the ED had a high blood culture contamination rate. The ED nurse manager shared this data
with the staff and a clinical nurse volunteered to lead a Quality Improvement initiative to improve the contamination rate. Using
a FOCUS-PDCA model, she identified sources of variation in practice, standardized a blood culture draw procedure, developed
educational materials for the nurses and techs and competency verified all staff on the new procedure. Repeat audits
demonstrated that the contamination rate decreased from 6.38% to 2.7%, which is below the national benchmark.
Additional Guidelines for Quality Improvement:
If, however, quality improvement activities involving human subjects are used to test novel services or programs for
effectiveness and are presented in a more global fashion or applied to a broader population they should be considered research
involving human subjects.
For example: efforts to assess current clinic practices within a hospital (i.e., local) and to modify those practices to improve
effectiveness would not meet the federal definition of research even though the evaluations collected data in a systematic
manner. Presentation within the local environment (i.e., to the hospital staff) and publication of the results would be
acceptable, so long as results are described as quality improvement and application of the findings is clearly limited to the
location where they were found. If, however, results are presented outside of the local environment at a national meeting or
published in a journal using language that seeks to generalize results beyond the locality of the project or that describes the
study as research, the study would be considered human subject research and need review by the relevant IRB. Another
example of research subject to IRB review would be efforts to assess current clinical practices of a number of local, unrelated
entities and the aggregation of all these efforts to support a change in clinical practice beyond the local. As to each local
organization, the assessment might constitute quality improvement, but when the results are aggregated to support a more
generalizable recommendation, OHRP has determined that the aggregation of separate quality improvement activities
constitutes research.
Evidence-Based Practice
Evidence-Based Practice Definition:
Evidence-based practice is the synthesis and use of existing evidence to inform practice.
Evidence Based Practice Example:
Research, QI, Program Evaluation, EBP Tool
Adapted with permission from COMIRB CF-195, Effective 9-20-13
COMIRB approved document
Fever in patients with head injuries results in increased intracranial pressure and secondary brain injury. However, it was noted
that management of fever in patients with traumatic brain injury varied widely in one neuroscience intensive care unit. A
multidisciplinary team was formed who found, critiqued, and synthesized the literature. The resulting practice guideline
delineated interventions for low, medium, and high fevers that progressed from noninvasive to invasive temperature
management practices; a shivering guideline became an additional product. Evaluation of the guideline implementation resulted
in a three-fold improvement in temperature management practices; monitoring of compliance with the guideline is ongoing.
Program Evaluation:
Program Evaluation Definition:
The systematic collection of information about the activities, characteristics, and results of programs to make judgments about
the program, improve or further develop program effectiveness, inform decisions about future programming, and/or increase
understanding (Patton, 2008). Program evaluation is the inquiry into past, present, and potential programs to understand or
clarify their needs, working processes, or impact. When the purpose of the evaluation is to provide feedback to the program
and/or funder to improve that program, the activity is not human subject research and does not need IRB review and/or
approval.
Presentation of findings to the program and its funders and publication of the results would be acceptable, so long as results are
described as program evaluation efforts and are clearly limited to the program to which they apply and are not described as
research. Program evaluation is considered human subjects research when the intent is to contribute to generalizable
knowledge. If results are presented or published using language that seeks to generalize results beyond the program studied, the
study would be considered human subject research and would need review by the relevant IRB.
Program Evaluation Examples:
Examples of evaluations that would be considered research and need human subjects review include:


Dissemination of evaluations connected to outcomes to affect the development or implementation of other programs similar
in nature
Evaluation undertaken to test a new, modified, or previously untested intervention, service, or program to determine
whether it is effective and can be used elsewhere
Research, QI, Program Evaluation, EBP Tool
Adapted with permission from COMIRB CF-195, Effective 9-20-13
COMIRB approved document
Other examples of program evaluation include:





Evaluating the implementation of a state’s or county’s smoke free policies
Evaluating a comprehensive cancer prevention and control project that uses media, health education, cancer screening
promotion in a geographic region
Evaluating the implementation of an evidence based practice in a clinical setting
Evaluating an educational support program to transition associate degree nursing students to obtain a baccalaureate degree.
Evaluating a diabetes management program conducted by a community clinic
Even when activities constitute quality improvement or program evaluation, it is expected that the gathering of data from human subjects through
direct or indirect interaction will be done with the highest level of regard for the protection of human subjects and in accord with ethical standards.
The Project Lead (and mentor) should use this tool and the accompanying guidance to evaluate each project.
Research, QI, Program Evaluation, EBP Tool
Adapted with permission from COMIRB CF-195, Effective 9-20-13