GCU SCHIP Assessing a Healthcare Program Policy Evaluation Template Program/policy evaluation is a valuable tool that can help strengthen the quality of pr

GCU SCHIP Assessing a Healthcare Program Policy Evaluation Template Program/policy evaluation is a valuable tool that can help strengthen the quality of programs/policies and improve outcomes for the populations they serve. Program/policy evaluation answers basic questions about program/policy effectiveness. It involves collecting and analyzing information about program/policy activities, characteristics, and outcomes. This information can be used to ultimately improve program services or policy initiatives.

Nurses can play a very important role assessing program/policy evaluation for the same reasons that they can be so important to program/policy design. Nurses bring expertise and patient advocacy that can add significant insight and impact. In this Assignment, you will practice applying this expertise and insight by selecting an existing healthcare program or policy evaluation and reflecting on the criteria used to measure the effectiveness of the program/policy.

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To Prepare:

Review the Healthcare Program/Policy Evaluation Analysis Template provided in the Resources.
Select an existing healthcare program or policy evaluation or choose one of interest to you.
Review community, state, or federal policy evaluation and reflect on the criteria used to measure the effectiveness of the program or policy described.

The Assignment: (2–3 pages)

Based on the program or policy evaluation you selected, complete the Healthcare Program/Policy Evaluation Analysis Template. Be sure to address the following:

Describe the healthcare program or policy outcomes.
How was the success of the program or policy measured?
How many people were reached by the program or policy selected?
How much of an impact was realized with the program or policy selected?
At what point in program implementation was the program or policy evaluation conducted?
What data was used to conduct the program or policy evaluation?
What specific information on unintended consequences was identified?
What stakeholders were identified in the evaluation of the program or policy? Who would benefit most from the results and reporting of the program or policy evaluation? Be specific and provide examples.
Did the program or policy meet the original intent and objectives? Why or why not?
Would you recommend implementing this program or policy in your place of work? Why or why not?
Identify at least two ways that you, as a nurse advocate, could become involved in evaluating a program or policy after 1 year of implementation.

* A clear and comprehensive purpose statement, introduction, and conclusion is provided which delineates all required criteria.

* I have posted an example of this assignment. Pick whatever topic pertaining to subject that you can find information on. Available online at www.sciencedirect.com
Nurs Outlook 66 (2018) 386–393
www.nursingoutlook.org
Omics research ethics considerations
Janet K. Williams, PhD, RN, FAANa,*, Cindy M. Anderson, PhD, CRNP, ANEF, FAHA,
FNAP, FAANb
b
ARTICLE
INFO
Article history:
Received 29 January 2018
Accepted 29 May 2018
Available online 6 June 2018.
Keywords:
Omics
Research
Ethics
Nursing
a
College of Nursing, The University of Iowa, Iowa City, IA
College of Nursing, The Ohio State University, Columbus, OH
ABSTRACT
Background: Pending revisions to the Common Rule include topics consistent with
respect for persons, justice, and beneficence for research subjects in studies using
omics technologies and are relevant to omics research.
Purpose: Synthesize trends in bioethics, precision health, and omics nursing science
for novice and experienced nursing scholars from which to consider bioethics
questions.
Methods: Review topics addressed in the National Institute of Nursing Research
(NINR) strategic plan, Common Rule pending revisions, and publications regarding human subjects protection policies.
Discussion: Omics research involves decisions regarding understandable informed consent, broad consent, data sharing, trust, equal benefit, equal access,
societal variables, privacy, data security, and return of findings to participants.
Conclusion: Principles of respect for persons, justice, and beneficence as articulated in the Belmont report and reflected in the American Nurses Association (ANA)
Code of Ethics provide guidance for human subjects protection procedures to
advance omics and nursing science.
Cite this article: Williams, J. K., & Anderson, C. M. (2018, JULY/AUGUST). Omics research ethics considerations.
Nursing Outlook, 66(4), 386–393. https://doi.org/10.1016/j.outlook.2018.05.003.
Although recognition of the importance of bioethics in human subjects research is not new, laboratory
techniques involving omics technologies, the potential for use of personal information or biospecimens
beyond currently envisioned studies, and a vision of
precision or personalized health strategies all create
a climate within which implementation of research
bioethics introduces new examination of bioethics
issues. The term omics refers to technologies and
methods used for identification of actions and roles of
molecules that constitute cells (Ferranti, Grossmann,
Starkweather, & Heitkemper, 2017) and may include
“identifiable biospecimens and biospecimens that are
newly obtained through direct interaction with a person”
(Bierer, Barnes, & Lynch, 2017, p. 787). Scientific inquiry
into the associations of omics with human health and
disease may involve collection of multiple sources of data
including information or biospecimens from or about
living individuals. For example, biospecimens with the
addition of phenotypic or other personal data relevant
to the research question to be answered are necessary
for precision health analytics. Findings from omics
research may be used to monitor individual risk, to
develop new knowledge, to contribute to personalized
Components of this paper were presented by Dr. Williams at the 2017 American Academy of Nursing Panel discussion on Policy on Precision Health: Addressing the Intersections Between Omics, Informatics and Bioethics. This research did not receive any specific grant
from funding agencies in the public, commercial, or not-for-profit sectors.
* Corresponding author: Janet K. Williams, College of Nursing, The University of Iowa, 50 Newton Road, Iowa City, A 52242.
E-mail address: janet-williams@uiowa.edu (J.K. Williams).
0029-6554/$ — see front matter © 2018 Elsevier Inc. All rights reserved.
https://doi.org/10.1016/j.outlook.2018.05.003
Nurs Outlook 66 (2018) 386–393
interventions, or to contribute to understanding of
how environment interacts with an individual’s physiology (Ferranti et al., 2017). Thus, the conduct of human
subjects research involving omics methods requires
adherence to bioethical principles underlying the federal
and institutional policies.
Considerations of bioethics questions are informed
by major policies that provide the context within which
omics nurse scientists conduct their studies. Proposed
changes to the Common Rule (Federal Policy for the
Protection of Human Subjects: Six Month Delay of the
General Compliance Date of Revisions While Allowing
the Use of Three Burden-Reducing Provisions During the
Delay Period, 2018) reflect advances in research designs
and procedures that affect protection of human subjects. Important issues addressed in the pending revised
Common Rule are components to be considered in
studies involving humans using omics research. The
purpose of this article is to synthesize trends in bioethics, precision health, and omics nursing science for
novice and experienced omics nursing scholars from
which to consider bioethics questions that are relevant to their programs of omics research.
Background
The Federal Policy for the Protection of Human Subjects, also known as the Common Rule, was first
developed in 1981 in response to consequences of failed
oversight of human research participants (Hodge &
Gostin, 2017). Findings from a 1979 conference, titled
the Belmont report, defined the basic ethical principles of the United States Health and Human Services
(Federal Policy for the Protection of Human Subjects:
Six Month Delay of the General Compliance Date
of Revisions While Allowing the Use of Three
Burden-Reducing Provisions During the Delay Period,
2018) human subjects research protection regulations
(The Belmont Report, 1979). In 2015, a systematic plan
to revise the Common Rule was published by the Office
for Human Research Protections (Federal Policy for the
Protection of Human Subjects, 2017), which is currently pending implementation (Federal Policy for the
Protection of Human Subjects: Six Month Delay of the
General Compliance Date of Revisions While Allowing
the Use of Three Burden-Reducing Provisions During the
Delay Period, 2018). The Common Rule guides the institutional review board (IRB) oversight of individual
research protocols, with IRBs charged with assuring the
protection of human subjects in individual research
studies, including those employing omics approaches
and methods. The ANA Code of Ethics represents professional expectations and provisions that are applicable
and relevant to human subject research (American
Nurses Association, 2015). Specifically, respect for human
dignity, primacy of the patient’s interests, protection of
rights to privacy and confidentiality, obligation to
advance health and human rights and reduce disparities,
387
and integrating social justice are relevant considerations in omics research. These elements share values
with the principles of respect for persons, justice,
and beneficence, which are reflected in the Common
Rule. The unique considerations for omics investigation require additional assurance that basic ethical
principles are integrated in the study design and implementation to assure protection of human subjects.
Bioethical Considerations for Precision Health
Attention to bioethics and omics in nursing science research is timely as there is an increasing focus on the
concept of precision or personalized health. Precision
medicine has been defined as consisting of disease treatment and prevention approaches that take into account
individual variability in molecular, genomic, cellular, clinical, behavioral, environmental, and/or physiological
dimensions (Collins & Varmus, 2015). Another definition describes the goal as identifying an individual’s
predisposition to a disease and ways an individual responds to treatment through integration of personal
and investigational data at the individual level (Dzau
& Ginsburg, 2016). Labeled by various terms, for example,
targeted, personalized, and precision; and referring to
medicine and/or health, this concept will be referred to
in this synthesis as precision health. This is generally
described, as it pertains to the health of each individual. However, these concepts have yet to be fully
articulated as being relevant to populations for whom
societal as well as genetic factors and clinical care influence and public health (Bayer & Galea, 2015), as the
concept of precision health may eventually be applied
to both individuals and populations.
The focus on precision health is reflected in language and major components of the 2016 National
Institute of Nursing Research (National Institute of
Nursing Research, 2016) strategic plan. In particular, each
of the first three components, symptom science, wellness, and self-management, relies on discovery and/
or application of information about individual factors
necessary to understand risk of, occurrence of, or management of symptoms (Grady, 2017a, 2017b). The crosscutting areas of technology and development of nurse
scientists also are closely linked with knowledge necessary to move the precision health components of
nursing science forward. Nurse scientists are uniquely
poised to advance discovery in precision health at both
the individual and population levels. This underscores
the need to clarify considerations of bioethical principles in omics research, integral to protecting research
participants in the generation and implementation of
knowledge regarding the priorities of precision science,
big data, health determinants, and global health (Eckardt
et al., 2017). This forward movement of science using
new methods and technologies such as omics rests on
conduct of research that does not violate principles of
bioethics. The three principles of the Belmont report that
undergird the Common Rule provide a framework for
388
Nurs Outlook 66 (2018) 386–393
Table 1 – Selected Elements of Omics Bioethics
Research Considerations
Respect for persons
1. Understandable informed consent process
2. Key points
3. Personal utility of research participation
4. Broad consent
Justice
1. Trust
2. Equal opportunity to benefit from research
3. Equity in access to care
4. Inclusion of societal variables
Beneficence
1. Privacy of research subjects
2. Confidential data management
3. Benefits and risks if findings are returned to research
subjects
considering new challenges for protection of human subjects (Table 1).
Respect for Persons
The first principle in the Belmont report is respect for
persons. “Respect for persons involves the recognition
that individuals are afforded dignity and autonomy in
making their own choices” (New York State Department
of Health, 2014). Respect for persons is implemented
when a fully informed consent process is completed,
and the participation in research is truly voluntary. A
review of the recent literature on ethical, legal, and social
implications of personalized genomic medicine research identified informed consent as one of the major
topics addressed in the majority of the 299 reviewed publications (Callier et al., 2016).
Understandable Consent
Having the capacity to understand what one is being
asked to agree to do is integral to consideration of respect
for persons. Omics research represents additional complexity due to the functional literacy for the wide scope
of omics terms and procedures necessary to consent.
A common understanding of the language of omics is
limited across virtually all stakeholder groups. This
means that potential research subjects, the research
community, health-care providers, and parties involved in health systems and the management of health
data may not understand the omics terms and language. Ample evidence continues to accumulate that
health-care providers are not comfortable with their
understanding of the meaning or use of genomic information in clinical practice (Williams, Feero, Leonard,
& Coleman, 2017). Researchers are likely well informed
about the methods they use but may not be conversant in methods used in other branches of omics science.
It is commonly recognized that the public may not fully
understand the content of an informed consent document (Menikoff, Kaneshiro, & Pritchard, 2017), and this
may be compounded in an omics research environment. In the clinical setting, one group of public hospital
patients who were recipients of genomic information
regarding genetic testing for hereditary cancer syndromes found some of the information about genomics
to be unnecessary, difficult to understand, and/or not
addressing what they needed to know to maintain their
health (Joseph et al., 2017).
The consent process must assure omics literacy and
confirm understanding among potential research participants to achieve human subjects protection. The
creation of informed consent documents that are understandable to potential participants is essential.
Considerations of health literacy and language are required when preparing the consent document, selecting
words that are understandable in the person’s language.
Considerations in omics research extend beyond
the understanding of risks and benefits of research
participation, incorporating potential implications
of findings. The plan for sharing omics data must be
clarified. Interpretation of findings may be limited by
the current state of the science and the absence of clear
implications for individual or population health. As
omics discovery is advancing at a rapid pace, considerations for sharing findings at a future time when new
evidence of health implications emerge should be
considered.
Key Points
Researchers may consider how to improve clarity in the
informed consent process. If an informed consent document is lengthy, starting the document with a concise
and focused presentation of the summary of key points
that are most likely to be useful to a reasonable person
has the potential to aid in understanding the reasons
why they might or might not want to participate
(Sugarman, 2017). The intent of a key points summary
is to remedy a perception that, in general, informed
consent documents are lengthy and can be difficult to
understand (Menikoff et al., 2017). However, the researcher will need to be aware of what specific aspects
of the research are important or have value to the
subject, and to recognize that these may vary across individuals who qualify for the research study (Corsmo
& McAllister, 2017).
Personal Utility
In addition to matching the information with the person’s capacity to understand it, the idea of personal
utility is important to consider. Personal utility refers
to the value that information has for an individual. In
omics research, the value of scientific information to the
individual must be considered. When one is considering omics information, personal utility or value is likely
to vary. This means that explanations of the potential
Nurs Outlook 66 (2018) 386–393
benefits of the research should include the range of
topics that may be important to individual research participants. In their synthesis of the domains of personal
utility of clinical genomic research, Kohler, Turbitt, and
Biesecker (2017) reviewed literature published from 2003
to 2016 and identified four major personal utility
domains. These are emotional (e.g., relief of anxiety about
potential genomic aspects of a disease or symptom), cognitive (e.g., information that explains a symptom or
reasons for a particular treatment), behavioral (e.g., information that is useful for making decisions such as
about life goals or reproductive planning), and societal
(e.g., participating in the discovery of information that
might benefit others with the same disease or symptoms). Thus, the decision to participate in omics research
may vary depending on what each person believes to
be valuable to him/her. Personal utility may be limited
by the real or perceived absence of a direct link to an
individual’s health. Readability, understandability, and
consideration of what is important to the research
subject are important considerations in planning omics
research and adhering to the principle of respect for
persons.
Broad Consent
Human research involving omics methods includes the
possibility that research samples may be used in future
studies that are as yet unforeseen. This creates the opportunity for subjects to consider a broad consent for
use of information or biospecimens for other research
(Sugarman, 2017). Broad consent is intended to allow
the research subject to give their permission for their
personal information or biospecimens, originally obtained for purposes including original research and/or
clinical care, to be reused in the future for research that
cannot be described (Menikoff et al., 2017). This could
reduce practical barriers to obtaining consent for future
research, but it also may be difficult to provide meaningful information for consent of future research that
cannot be specified (Sugarman, 2017). One example of
the challenges is from a study of willingness by outpatients of a northern German university hospital to
consent for their biospecimens and associated data to
be retained in a hospital operated biobank. These researchers found that, although willingness to give broad
consent was high (89%), understanding of the consent
was not (Richter et al., 2018).
Considerations providing broad consent include
(a) the types of research that could be conducted,
(b) sharing research data or biospecimens with other
researchers, (c) identifying the length of time information or biospecimens would be stored, (d) notifying the
participant about use of data or biospecimens for
specific future studies, (e) potential for identifying data
or biospecimens, (f) using data or biospecimens for
commercial profit, (g) disclosing future research analytic methods (e.g., whole genome or exome sequencing),
(h) providing clinically relevant findings to the participant, and (i) whom to contact with questions (Corsmo
389
& McAllister, 2017; Sugarman, 2017). Plans beyond the
informed consent process may include management of
potentially depletable resources, data sharing infrastructures, and rules for data sharing (Burton, Banner,
Elliot, Knoppers, & Banks, 2017). One benefit to the researcher, and to the body of science, is that biospecimens
from individuals giving broad consent can be stored to
be used at a later time and by other research teams.
However, with this opportunity come management responsibilities and related cost for the researcher and
their institution. The researcher must ensure tracking
of information or biospecimens and linkage to the broad
consent. Further, current information technology capacities within institutions may not allow smooth
linkage between research and clinical components of
the information systems. For example, technologies may
have not yet been developed to track information from
those who refused broad consent (Bierer et al., 2017).
Each of the topics in this section illustrates the importance of omics researchers conducting studies with
human subjects to provide an informed consent document that is understandable and addresses topics
important to the research subject. Development of the
informed consent process also includes attention to use
of unfamiliar terms and concepts, future use of
biospecimens or information, and sharing of data with
other researchers.
Justice
The next principle from the Belmont report is justice.
Justice addresses the fair distribution of research burdens
among socioeconomic, race, age and gender strata, and
the equal opportunity to participate and to benefit from
research (New York State Department of Health, 2014).
Trust
Attention to justice includes awareness of issues that
influence interest and willingness to participate in research. The primary health-care provider can play a
pivotal role in making patients aware of research opportunities, may be consulted on whether the research
opportunity is in the patient’s best interest, and may
be asked to explain the results (Persaud & Bonham,
2018). Thus, engagement by resea…
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