GCU SCHIP Assessing a Healthcare Program Policy Evaluation Template

GCU SCHIP Assessing a Healthcare Program Policy Evaluation Template 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. 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. GCU SCHIP Assessing a Healthcare Program Policy Evaluation Template source_3__williams.pdf source_1__shiramizu.pdf source_2__glasgow.pdf usw1_nurs_6050_healthcare_program_policy_evaluation_analysis_template__1_.doc example..docx.doc ORDER NOW FOR CUSTOMIZED AND ORIGINAL ESSAY PAPERS b 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. GCU SCHIP Assessing a Healthcare Program Policy Evaluation Template * Corresponding author: Janet K. Williams, College of Nursing, The University of Iowa, 50 Newton Road, Iowa City, A 52242. E-mail address: [email protected] (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). GCU SCHIP Assessing a Healthcare Program Policy Evaluation Template 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. GCU SCHIP Assessing a Healthcare Program Policy Evaluation Template “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). GCU SCHIP Assessing a Healthcare Program Policy Evaluation Template 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). GCU SCHIP Assessing a Healthcare Program Policy Evaluation Template 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). 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