Assessing a Healthcare Program/Policy Evaluation

Omics research ethics considerations Janet K. Williams, PhD, RN, FAANa,*, Cindy M. Anderson, PhD, CRNP, ANEF, FAHA,

FNAP, FAANb a College of Nursing, The University of Iowa, Iowa City, IA

b College of Nursing, The Ohio State University, Columbus, OH

A R T I C L E I N F O

Article history: Received 29 January 2018 Accepted 29 May 2018 Available online 6 June 2018.

Keywords: Omics Research Ethics Nursing

A B S T R A C T

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 regard- ing human subjects protection policies. Discussion: Omics research involves decisions regarding understandable in- formed 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 articu- lated 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 bioeth- ics in human subjects research is not new, laboratory techniques involving omics technologies, the poten- tial 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 Pre- cision 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: [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

Available online at www.sciencedirect.com

Nur s Out l o o k 6 6 ( 2 0 1 8 ) 3 8 6 – 3 9 3 www.nursingoutlook.org

interventions, or to contribute to understanding of how environment interacts with an individual’s phys- iology (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 sub- jects. 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 bio- ethics, precision health, and omics nursing science for novice and experienced omics nursing scholars from which to consider bioethics questions that are rele- vant to their programs of omics research.

Background

The Federal Policy for the Protection of Human Sub- jects, 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 prin- ciples 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 cur- rently 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 in- stitutional 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 pro- fessional 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,

and integrating social justice are relevant consider- ations 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 investiga- tion require additional assurance that basic ethical principles are integrated in the study design and im- plementation to assure protection of human subjects.

Bioethical Considerations for Precision Health

Attention to bioethics and omics in nursing science re- search 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 treat- ment and prevention approaches that take into account individual variability in molecular, genomic, cellular, clin- ical, behavioral, environmental, and/or physiological dimensions (Collins & Varmus, 2015). Another defini- tion describes the goal as identifying an individual’s predisposition to a disease and ways an individual re- sponds 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 individ- ual. 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 in- fluence 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 lan- guage 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, well- ness, and self-management, relies on discovery and/ or application of information about individual factors necessary to understand risk of, occurrence of, or man- agement of symptoms (Grady, 2017a, 2017b). The cross- cutting areas of technology and development of nurse scientists also are closely linked with knowledge nec- essary 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 prin- ciples 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

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considering new challenges for protection of human sub- jects (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 re- search identified informed consent as one of the major topics addressed in the majority of the 299 reviewed pub- lications (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 com- plexity 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 in- volved in health systems and the management of health data may not understand the omics terms and lan- guage. Ample evidence continues to accumulate that health-care providers are not comfortable with their understanding of the meaning or use of genomic in- formation in clinical practice (Williams, Feero, Leonard, & Coleman, 2017). Researchers are likely well informed about the methods they use but may not be conver- sant 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 docu- ment (Menikoff, Kaneshiro, & Pritchard, 2017), and this may be compounded in an omics research environ- ment. In the clinical setting, one group of public hospital patients who were recipients of genomic information regarding genetic testing for hereditary cancer syn- dromes 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 par- ticipants to achieve human subjects protection. The creation of informed consent documents that are un- derstandable to potential participants is essential. Considerations of health literacy and language are re- quired 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, consid- erations 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 doc- ument 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 re- searcher 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 in- dividuals who qualify for the research study (Corsmo & McAllister, 2017).

Personal Utility

In addition to matching the information with the per- son’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 consider- ing omics information, personal utility or value is likely to vary. This means that explanations of the potential

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

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benefits of the research should include the range of topics that may be important to individual research par- ticipants. 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), cog- nitive (e.g., information that explains a symptom or reasons for a particular treatment), behavioral (e.g., in- formation 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 symp- toms).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 op- portunity 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 ob- tained 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 mean- ingful information for consent of future research that cannot be specified (Sugarman, 2017). One example of the challenges is from a study of willingness by outpa- tients of a northern German university hospital to consent for their biospecimens and associated data to be retained in a hospital operated biobank. These re- searchers 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 informa- tion 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 ana- lytic methods (e.g., whole genome or exome sequencing), (h) providing clinically relevant findings to the partic- ipant, and (i) whom to contact with questions (Corsmo

& McAllister, 2017; Sugarman, 2017). Plans beyond the informed consent process may include management of potentially depletable resources, data sharing infra- structures, and rules for data sharing (Burton, Banner, Elliot, Knoppers, & Banks, 2017). One benefit to the re- searcher, 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 re- sponsibilities 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 ca- pacities 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 impor- tance of omics researchers conducting studies with human subjects to provide an informed consent doc- ument 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 re- search. The primary health-care provider can play a pivotal role in making patients aware of research op- portunities, 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 researchers with primary care providers in projects that involve omics methods may be critical for maximizing adherence to prin- ciples of justice for potential participants. However, it is important to keep in mind that there is the poten- tial for blurring the boundaries between clinical care and research, which may result in an expectation that in- volvement in research will lead to a direct clinical benefit for the participant (Sabatello, Callier, Garrison, & Cohn, 2018). A recent report provides helpful discussions on recognizing and acting upon obstacles to building trust. Considerations that have been identified for those engaged in precision medicine research include

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addressing history and experience of mistrust, address- ing the possibility of harm to one’s ethnic or cultural group from research findings, addressing cultural values, attention to communication barriers, and demonstrat- ing the importance of oversight of all research procedures that are consistent with patient and group values (Kraft et al., 2018). In addition, components of justice should be considered.

Equal Opportunity

One aspect of justice is equitable selection of subjects. When there is underrepresentation of a group in the re- search, then that group is unlikely to benefit from the knowledge discovered (Menikoff, 2013). This has been the case with genome-wide association studies, which historically were limited to subject pools largely from European white ancestry (Bustamante, Burchard, & De la Vega, 2011). The potential for increasing disparities from genetic, genomic, or omics research may be com- pounded with the use of big data from multiple sources, which do not represent at-risk populations (Brennan & Bakken, 2015). While people from underrepresented populations may be no less willing to participate in re- search, attention must be given to the development of appropriate and effective plans for recruitment and re- tention of these individuals (Taylor & de Mendoza, 2018). The All of Us Research Program is a large-scale partic- ipant component of the Precision Medicine Initiative. This research program includes strategies to address di- versity of people in the United States (National Institutes of Health, 2018). An example of nursing research that highlights literacy and language is an evaluation of re- cruitment and website materials used by biobanks across the United States to recruit Hispanic individuals. This review found that the materials were written only in English, with most materials above the recommended reading level (Cohn, Hamilton, Larson, & Williams, 2017a; Cohn, Henderson, & Appelbaum, 2017b).

Equal Access to Care

Considerations for omics researchers include assuring that outreach efforts are meaningful and appropriate for each group, reflecting preferences for engagement, enrollment, and partnership (Cohn et al., 2017a, 2017b). People from underrepresented groups have historical- ly had poor access to genetic health-care services. Genetic diversity in genomic research addresses not only ancestry of research subjects but also equitable appli- cation of research findings into health care for all populations (Cornel & Bonham, 2017). Limited access may reflect how health care is paid for, and the extent to which people can use the services (National Academies of Sciences, Engineering, and Medicine, 2018).

Societal Factors

Justice also encompasses recognizing that inequality in health status may reflect societal variables, rather than

an exclusive focus on biologic variables in research designs (Bayer & Galea, 2015; McGlone, Blacksher, & Burke, 2017). Considerations also include assuring that meaningful variables reflecting potential sources of in- equity such as environmental and sociocultural factors are included in the database (McGlone et al., 2017; Taylor & de Mendoza, 2018). Adherence to the principle of justice by researchers using omics methods includes actions to demonstrate importance of trust, attention to enrollment and retention of participants from popu- lations that will benefit from the findings, variables influencing the health of those populations, and the bar- riers to application of findings in health care.

Beneficence

Privacy

The third principle from the Belmont report is benefi- cence. “Beneficence is the obligation to protect persons from harm by maximizing benefits while mini- mizing potential harm(s)” (New York State Department of Health, 2014). One aspect of this is privacy, referring to privacy of subject identity. The privacy of a person is preserved when their names or other identifying characteristics are protected, and when the researcher does not collect more information beyond that which is needed to meet the aims of the research. Views about personal privacy by people who participate in genetic testing for various purposes are not all the same. For example, a survey was conducted with an international sample of individuals who voluntarily shared their genetic or genomic data from direct-to- consumer (DTC) genetic testing companies on a publicly accessible web platform. Findings included that the ma- jority (74%) had not read the terms and conditions for sharing of their data. Of those who responded, 86% agreed that it was unlikely that findings would affect their insurability, and 64% believed it was unlikely that an employer would use their genetic test data to their disadvantage. The authors of this study note that the majority of respondents (74%) were not engaged in bio- medical research (Haeusermann et al., 2017). However, an international survey of people at risk of Hunting- ton disease, a hereditary neurodegenerative condition, found that 46% had experienced insurance, employ- ment, or societal discrimination based on their at-risk status (Erwin, et al, 2010). These examples illustrate that planning to minimize potential harms includes recognition that perceptions of risk of violation of personal privacy from research studies vary among research subjects.

Confidentiality

Confidentiality refers to not divulging data, without consent. It has been suggested that due to an increas-

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ingly challenging climate to maintain data security, investigators must be prepared for the likelihood that, at some point, data security can be breached, and cus- tomary means to protect data may not be sufficient. In addition to efforts to maintain data security, one element of the informed consent that addresses confidential- ity is that individuals would be told whether or not identifiers will be removed from their information or biospecimens (Bierer et al., 2017).Those who do not want their identified material retained may decide not to enroll in the research. One component of the pending revisions to the Common Rule is a plan for periodic review of identifiability definitions for information and for biospecimens obtained for research purposes, spe- cifically directed to manage confidentiality concerns.

While use of biospecimens for genetic research has been suggested as posing minimal risk, circumstances that may increase risks from breaches of confidential- ity include being unable to implement standard confidentiality measures, obtaining samples from a small population, or samples from readily identifiable indi- viduals. The potential harms, such as risk of loss of employment or insurability may be increased when the research involves searches for genetic factors as- sociated with sensitive conditions like mental illness (Wendler & Rid, 2015). This presents a challenge to researchers to maximize benefits from knowledge gained through the research while reducing risk of harm. A survey of participants in a U.S. cancer registry reported that the majority expressed a desire that their data or specimens be made available to as many studies as possible. However, they also expressed a desire that the researchers would protect the privacy and confi- dentiality of their information (Goodman et al., 2017). These reports illustrate the complexity of assuring privacy and confidentiality as newer research methods and designs are implemented.

Return of Results

Research using omics methods may or may not gener- ate data that could be returned to research subjects, some of which could have clinical implications. The management of research data from omics research in- cludes decisions by the researcher whether the option of receiving clinically relevant individual results from the research will be available to research participants. Disclosure or return of results was the topic in which Callier et al. (2016) reported the greatest growth in number of articles over the 5 years reviewed.The concept of clinically relevant results has multiple interpreta- tions. For example, this could be perceived to pertain to analytic validity, medical significance, and/or per- sonal utility of the results for the individual (Bierer et al., 2017). Omics nurse scientists need a clear and justi- fied plan for how they will handle the potential for return of research results to participants.The relevance of find- ings to a person’s health may include varying degrees of uncertainty. For example, if omics research can yield variants of unknown clinical significance, or findings

may include false positives or false negatives, consid- eration of the ways in which findings are interpreted and considered must be addressed.The potential to dis- cover findings of unknown significance should also be addressed in consent language and research protocols (Hammer, 2016). However, returning research results may provide useful information where clinical actions can be taken. Further, despite the recognition that the clin- ical utility of omics data may change in the future as additional knowledge directs interpretation of find- ings, it is argued that offering to return research data is the right thing to do for those participants who want this information (Angrist, 2011). A third consideration is the potential for people who enroll in research using genetics, genomics, or other omics methods to expect greater personal health benefits than they actually receive from the information discovered in the re- search. A report from the MedSeq group investigating translation and communication of whole genome or whole exome sequencing methods in clinical practice illustrates this point. This report notes that there were common, but unmet, expectations in which results would influence medical decision-making including choices of medications. These inconsistent expecta- tions may have been influenced by enthusiasm from the health-care community as well as from social media (Roberts et al., 2018).

IRBs vary in their views on the obligation of research- ers to disclose genomic incidental findings, with the principles of respect for persons, beneficence, along with a duty to warn being cited as reasons why IRB members would endorse disclosure. Moreover, inadequate or unknown analytic validity, clinical validity, and clini- cal utility are factors limiting endorsing the obligation to disclose incidental findings (Gliwa et al., 2015). Other components to be considered include when to return results, who will return them, how results will be re- turned, and who will receive them (i.e., the subject, their health care provider, and/or their family). These con- siderations also include potential costs in terms of anxiety or follow-up clinical evaluations, burden on par- ticipants to inform at-risk family members, and clinical decisions, if any, that result from the information.

Depending on the investigational methods used, omics research (e.g., genomics research) also has the po- tential to yield secondary findings, also referred to as incidental or unanticipated findings that were not within the purpose of the study.This refers to variants that may have a known association with risk of disease. In early research on this subject, Daack-Hirsch et al. (2013) found that members of the public wanted to be informed when such findings might be possible in a research study, and they wanted health professionals to be engaged with them in reaching decisions on how to use the infor- mation. A recent report by Ryan, DeVries, Uhlmann, Roberts, and Gornick (2017) reported the results of a de- liberative democracy session with 10 small groups of members of the public on this topic. Findings in- cluded consensus that the participants wanted choice and believed that secondary results from genomic

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sequencing should be returned to the person having the test. However, there was less endorsement of report- ing variants associated with adult-onset disorders when the variant is found in a child, or in reporting carrier status of recessive conditions. Issues to be considered in reporting secondary findings are numerous and are challenging in clinical practice. For example, the return of secondary results from a research study that may in- fluence prescription drug responses includes awareness that the information may not be accessed, or used in future prescription decisions, by those in the individ- ual’s primary care setting (Hicks et al., 2017). There are multiple aspects to adhering to the principle of benef- icence in the conduct of research with humans using omics methods. Assuring privacy, maintaining confi- dentiality, and creating research protocol decisions regarding whether and how research results, includ- ing secondary findings, could be returned to subjects are components of promoting benefits and minimiz- ing harms.

Conclusions

Nurse scientists conducting omics research face unique ethical considerations in a rapidly evolving field. Im- plementation of omics research will require advancing omics and bioethics research literacy of local, state, national, and international policy makers, IRBs, as well as clinicians, researchers, and the public. Omics re- searchers must be informed regarding components of their studies that adhere to principles of respect for persons, justice, and beneficence. Researchers can inform discussions of policies at the local level through volunteering to serve on the institution’s IRB and par- ticipating in interdisciplinary dialogue regarding institutional bioethics policies. At the national level, nurse scientists can provide public comment on poli- cies being developed through organizations including the National Academies of Science, Engineering, and Medicine, at the National Institutes of Health and private funders. Attention to respect for persons, justice, and beneficence for individual research subjects and entire populations provides the greatest assurance for partic- ipant protection in omics research.

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