Vulnerable populations in research However, it is important that research includes vulnerable people, such as those with mental Research with children and other vulnerable groups Research involving vulnerable groups raises a number of ethics concerns. According to the Tri-Council Policy Statement 2 (TCPS2), which guides the ethical conduct of research involving humans and/or human biological materials in Canada, some Engaging vulnerable populations in research is a critical focus for researchers seeking to find ways to improve safety and well-being for broader populations. •Discuss the ethical principles involved in human subjects research with vulnerable populations. Medical research involving human participants must have a scientifically sound and rigorous design and execution that are likely to produce reliable, valid, and At later meetings of the Task Force on Research Specific to Pregnant Women and Lactating Women, task force members expressed that removal of the vulnerable population Culturally safe research with vulnerable populations. g. Understanding how "vulnerable" populations and the speci fic circumstances of a protocol may change the risk/benefit ratio Fetuses, and Neonates: Research related risks to this population are those that are Data and resources on populations and vulnerabilities, with a focus on public health emergencies. 9 (61 reviews) NBAC proposed a concept of vulnerability in research based on features of The Guidance recognises that research with vulnerable research participants can make an important contribution to improving the lives of vulnerable people. As expected, the most highly prevalent policies pertained to populations Clinical research studies, both nursing and medical, occur in many critical care units. In the philosophical literature, vulnerability is understood not only to be an However, volunteers from vulnerable populations are often difficult to recruit into studies. Theory Med Bioethics. e. A service of the National Library of Medicine, National Institutes of Health. [Google Scholar] Office of the United Researchers must consider several strategies in conducting research with vulnerable populations (see Table 3) to ensure that voices are captured. To illustrate our framework, we A second part is devoted to ethics in research on human subjects, whether it refers to vulnerable population (Loue & Loff, 2019), clinical trials (Macarie & Tebeanu, 2019), risk Researchers who desire to make positive changes for vulnerable populations often conduct problem-focused studies. As stated by the National Bioethics Advisory CIOMS The protection of dependent or vulnerable persons and populations is described itself as a. University of Populations in Research Requiring Additional Considerations and/or Protections. Securing a proxy signature may, however, help to demonstrate that the researcher is not attempting to take Data science must include vulnerable populations in the research design, analysis and inference of data findings in order to make interpretations that are valuable and are considered vulnerable because of risks to their unborn children. Many quality of life research projects employ clinical We argue that the principle of justice, commonly interpreted as preventing an inequitable burden of research, should also prevent inequitable access to research and its potential benefits for Keywords: Digital Age, Vulnerable Populations, Public Mental Health, Cyberbullying, Digital Addiction, Digital Technologies, Digital Health Interventions Important note: All contributions to Vulnerable Populations: Safeguarding Children 2 Children are a vulnerable population because they lack the autonomy and decision making capacity to ethically and In this empirically informed theoretical reflection, ethical perspectives on involvement of vulnerable populations in health research were explored using data collected An IRB that regularly reviews research involving vulnerable subjects, such as those with impaired consent capacity, is required by HHS and FDA regulations to consider whether one or more perceptions of vulnerable populations. Many quality of life research projects employ clinical trials, surveys The US federal research regulations identify pregnant women, human fetuses, and neonates; prisoners; and children as particularly vulnerable. According to this criterion, there are consent-based and fairness-based reasons for calling a group vulnerable. R. The model has a population-based focus that places Actively involving the most vulnerable populations groups in research projects in order to assess and address their needs is an important step towards reducing health Research involving vulnerable populations must enlist specialized recruitment strategies to ensure appropriate protection for such individuals. A number of variables go into such judgments, Vulnerable populations in research: The case of. 2006;27:245–264. For this reason, vulnerable Some population groups are more vulnerable to disasters due to characteristics such as age, gender and sexual identities, race, culture, religion, disability, socio-economic status, geographical location, or migration status. It is important to parities in vulnerable populations. principle; additionally, concerns relating to vulnerability are grounded in both the A “vulnerable participant” is any individual who lacks the ability to fully consent to participate in a study. Many study participants felt that during the COVID-19 pandemic and consequent lockdowns, vulnerable populations were prioritised. Recently, there has been a rise in the interest in the vulnerabilities of special populations Vulnerable groups, including travel-eligible tourists with medical conditions (e. According to Luna: This concept of vulnerability is Vulnerable Research Participants. The chapters outline how research can democratize knowledge generation to make it more accessible and socially This paper advances a new criterion of a vulnerable population in research. Luebbert R, Tait RC, Chibnall JT, Deshields TL. "The term 'vulnerable population' is generally saved for those that are not viewed as 'autonomous agents' and/ or their voluntariness is compromised” Protection of Vulnerable The underrepresentation of the majority of cancer patients in clinical trials represents a major drawback. Research is centered on the four major ethical principles: confidentiality, respect for diverse opinions, The SIGCHI community has made several efforts to research vulnerable populations and their use of technology. doi: 10. Therefore, it The growing significance of social media in research demands new ethical standards and practices. Contemporary considerations in Generally, vulnerable populations refer to groups of people whose range of options is severely limited, who may be subjected to coercion or who may be compromised in their The HHS regulations for the protection of human subjects in research at 45CFR 46 include five subparts. Nevertheless, some vulnerable populations are under Discussion Testing the features against Hurst's definition demonstrates that they all concern the same issue: pregnant women are only vulnerable because a higher exposure to risk due to A vulnerable population refers to a group of individuals who require greater protection against potential risks associated with participating in research. 45 CFR 46. § 46, Vulnerability in the Research Context. Save. Various health service design Vulnerabilities often characterize the availability of immigrant populations of interest in social behavioral science, public health, and medical research. • A set of questions for researchers to follow while engaging with vulnerable groups so as to empower them Addressing the needs of understudied and vulnerable populations first and foremost necessitate correct application and interpretation of research that is designed to Background: Community-based participatory research (CBPR) is effective in addressing health disparities. 111(b): “When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with Working with Vulnerable Populations: A Multicultural Perspective presents case studies, original research, and literature reviews that would engage students and professionals Vulnerable populations, namely communities with limited access to resources or at a higher risk to experience bias or discrimination, were less likely to engage in such virtual Research cannot maximize population health unless it improves health for all members of the public, including special populations such as children, older adults, and people living with rare diseases. A vulnerable group includes persons Indeed, for the hypothetical research vignettes, the rates at which certain populations were deemed vulnerable in the different scenarios, and the safeguards applied to them, may provide evidence to support the belief that The need to conduct research among vulnerable populations can be viewed as foremost a public health imperative: Stigmatized and marginalized, these populations often Purpose of review: This review is designed to update readers on recent discussions and research regarding vulnerable populations in medicine, including patients who are socioeconomically Vulnerable populations in research: the case of the seriously ill. The Nuremberg Code. For example, in minors, consent is modified to A vulnerable population component is a part of some of the drills and exercises that are currently available through the CPHP network; however, there is an urgent need for more drills and Special consideration must be given to protecting the welfare of potentially vulnerable research participants. This book advocates for community-based research with vulnerable populations within the field of higher education. To engage ethically with vulnerable populations requires an investment of time and energy. POLICY . The Department of Health and Human Services (DHHS) federal regulations recognize certain categories Understanding the characteristics of vulnerable populations is vital to capture the complexity of quality of life assessment. 1007/s11017-006-9000-2. 4 Our account emphasizes that the researcher's first obligation is not to make the research participant even more vulnerable than they already are. However, it is important that research includes vulnerable people, such as those with mental Children: Research with Children FAQs; Exempt Research Determination FAQs; Informed Consent FAQs; Investigator Responsibilities FAQs; IRB Registration Process FAQs; Prisoner Beyond what are characterized as Special Populations in U. Undue influence is when a person uses Table 1. Ensuring that informed consent is Protecting Vulnerable Populations in Research Misti Ault Anderson, MS, MA Senior Advisor for Public Health Education Division of Education and Development HHS Office for Human The “Community Assessment” chapter describes how to assess community health needs and apply the nursing process to community health nursing. 1949. , early- and mid-stage dementia), represent an emerging niche market in the tourism industry With COVID-19 affecting all types of research, the authors of this article contribute to the discussions on how COVID-19 affects the world of qualitative nursing research in irrefutable HREC: G4-Vulnerable Groups in Research Last Updated: November 2019 2. 4. Enrolling these population in prospective research requires specific IRB Health Domains of Vulnerable Populations. Vulnerability may be defined in different Vulnerabilized shares similarities with commonly used verbiage but offers a linguistic shift to acknowledge the nexus of underlying, and often obscured, upstream Background: The concept of vulnerability is a cornerstone of the theoretical basis and practical application of ethics in human subjects research. Although a substantial body of literature on social media ethics exists, studies on the ethics of Research involving vulnerable populations and the health disparities they face has received increasing priority. The researcher must adopt effective recruitment strategies to aid in Abstract. Article Google Scholar Mkandawire-Valhmu, Lucy, Elizabeth Rice, and Mary Elizabeth It can be difficult for researchers to access research participants from vulnerable populations. Each of these categories require Often vulnerable populations are exposed to research that is driven by dominant epistemologies, research methodologies, and socio-cultural lenses that can exacerbate their vulnerability, negating Prisoners, as a vulnerable population, are in jeopardy of receiving a disproportionate share of the risk associated with human subjects research. Such a review suggests a rich appreciation Vulnerable Populations in Research Purpose 1) This policy sets forth both the criteria and process when reviewing research that involves human participants from a vulnerable population. Patients included in clinical trials are not always representative Introduction Vulnerable populations face significant challenges in navigating the care continuum, ranging from diagnosis of illness to linkage and retention in healthcare. Sometimes they are (iv) When vulnerable populations are involved in research, the appropriateness of involving them should itself be demonstrated. This health status indicator includes data on several health conditions that could make a person more vulnerable in emergency or PDF | Introductory training for In-depth and semi-structured interviewing with vulnerable groups with a critical disucssion on critical reflexivity, | Find, read and cite all the research you Researchers conducting community-based participatory research (CBPR) with vulnerable populations in rural African settings are confronted with distinctive ethical and cultural challenges due to the community context of More than minimal risk research involving this population must be approved by the IRB and the Wisconsin Department of Health Services before study activities can begin. 8 The inclusion of vulnerable populations in genetic studies is clearly This study aims to explore how green spaces can serve vulnerable populations more effectively. Effectiveness of Background: A conceptual model for vulnerable populations research relates resource availability and relative risk to health status. However, it is important that research includes vulnerable people, such as those with mental illness, the Given the dearth of tourism research involving vulnerable populations, there is little discussion in the literature that addresses the methodological issues regarding ethical dangers Some populations are inherently vulnerable due to a lack of autonomy or ability to understand research procedures. This narrative review aims to The main point here is to shift the conceptual starting point of public health intervention research away from specific health outcomes towards the identification of Is any medical research population not vulnerable? Camb Q Healthc Ethics. •Identify where to find the GVSU Actively involving the most vulnerable populations groups in research projects in order to assess and address their needs is an important step towards reducing health Guidance on Vulnerable Populations in Research . 33. Coercion involves a credible threat of harm or force to another individual. Subjects are considered vulnerable In general, the definition of vulnerable populations in research applies to individuals who lack, or believe they lack, free will or decision-making capacity, either contextually or cognitively, to Learn how to identify and protect vulnerable populations in research, such as fetuses, neonates, minors, prisoners, and cognitively impaired. 1 (2017): 93–103. Vulnerabilities often co-occur, The conduct of prior ethics review of human research projects helps to protect vulnerable groups or populations from potential negative impacts of research. The inclusion of certain groups of Furthermore, we know that lower education levels, lower literacy, and a participant’s primary language are all associated with poor comprehension of the informed consent process. The existence of additional protections should not specifically discourage inclusion of these populations in research. Lack of inclusion of vulnerable populations in research perpetuates systemic inequities. In Vulnerable groups involve human samples considered particularly susceptible to coercion or undue influence in a research setting. The conduct of prior ethics review of human research projects helps to protect vulnerable groups or populations from potential negative impacts of research. 2006 Winter;15(1):81-88. As with any clinical study, it is necessary to obtain informed consent from any person participating in the Background Vulnerability is a key concept in traditional and contemporary bioethics. Theoretical Medicine and Bioethics, 27(3), 245–264. Investigators interested This paper advances a new criterion of a vulnerable population in research. The first whether or not an Vulnerable populations in research: The case of the seriously ill. There are several definitions available for the term “vulnerable population”, the words simply imply the disadvantaged sub-segment of the community [1] requiring utmost care, specific ancillary One of the key issues facing researchers studying justice involved youth, is their designation as a vulnerable population, and how that impacts the researchers’ ability to include them as When conducting research, some populations of research participants require special considerations. Contemporary Nurse, 33(1), 69–79. Because The term vulnerable population may be synonymous with other terms including at-risk, marginalized, and special populations. Contemporary considerations in human research considers the Although the importance of including vulnerable populations in research is widely accepted, how to achieve such inclusion remains a challenge. 1. We summarize the literature on Different approaches to define vulnerable populations Determining which individuals or groups should be considered vulnerable and in need of additional protections as research participants Research on vulnerable populations refers to research designs and approaches miss opportunities to involve vulnerable populations in the research process. 12 Notably, However, those populations are most of the time concealed and unseen in big statistical surveys, precisely as they stand at the edges of main social groups. Refugees, asylum seekers, More child/adolescent populations have been identified as vulnerable within the research context; indeed the current prevalence of vulnerable populations has compromised our understanding To protect hard-to-reach, hidden, and vulnerable populations from research related risk—and thereby to aid in successful recruitment—we recommended extreme caution and Understanding the characteristics of vulnerable populations is vital to capture the complexity of quality of life assessment. 5172/conu. This article provides you with some useful Scientific Requirements and Research Protocols. It is essential for researchers to consider ethics throughout all stages of research when working 10. Professor, Department of Sociology and Director, Natural Hazards Center. It draws on When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or subjects including students, employees, and cognitively impaired individuals who may be vulnerable in terms of their research participation. 2012;102(12):2220-5. the seriously ill. 10. F. So, I would encourage you to reflect upon why you are Thus, research involving vulnerable populations will not be subject to expedited review unless a member of the IRB has affirmatively determined that the subjects will not be exposed to any NCBI Bookshelf. IRB Member Judgments of Decisional Requests for approval of any research that exposes vulnerable populations to risks that do not meet one of the above criteria must be submitted to the United States Secretary of Health and Prisoners are considered a vulnerable research population because the very fact of incarceration may make it difficult for them to give truly voluntary informed consent. There are some groups who have been identified by the federal regulations as Vulnerable populations addressed in detail in this document include: people experiencing homelessness; people living in overcrowded • Invest in research and . These studies have covered a range of topics, including health and wellness [149, 150], social support [4, 7, 25, 40, For example, Piggott explores semantic differences among the terms “vulnerable,” “marginalized” and “underserved” in relation to populations with relatively lower health status. There are several key issues for researchers to consider when planning research with vulnerable populations. 1017/s0963180106060099. American Journal of Public Health. Examples of Footnote 6 The second required increased scrutiny of risks and benefits for research involving vulnerable populations, arguing that their involvement is more or less appropriate depending upon the nature and magnitude of risks, the Vulnerable Populations. This need arises because they may 11, 15 Recent scholarship on vulnerability in research ethics has focused on the problem of labeling individuals or groups as vulnerable in ways that fail to consider different A second useful distinction in considering research with vulnerable populations introduces the idea of ‘layers of vulnerability’ (Luna 2009) . National Academies of Sciences, Engineering, and Medicine; Policy and Global •Define vulnerability in terms of human subjects research. FDA regulatory considerations is vulnerability of patient populations in a broader context of international guidance. 7 The choice of vulnerable population from which the study participants will be drawn is clearly justified 10. Focusing on the single victim interviewee recruited for my human trafficking-related research, this The importance of ethical issues in medical research is well known. Researchers (staff or students) working with vulnerable groups Nursing Research has made a significant contribution in disseminating the body of tested knowledge related to the health disparities experienced by vulnerable populations and the methodologies This chapter is comprised of six sections, exploring how technologies exacerbate existing inequalities; what the specific privacy concerns and needs of certain vulnerable International Journal of Social Research Methodology 20, no. In human research the vulnerable populations comprised of unborn children (Subpart B), prisoners (Subpart C), children (Subpart D), and those with cognitive impairment have been Background: Notwithstanding the need to produce evidence-based knowledge on medications for pregnant women, they remain underrepresented in clinical research. Hurst SA. Given that vulnerable populations have been traditionally marginalized or absent from socioeconomic and political agendas (Delaunay, Augusto, & Qualitative modes of inquiry are especially valuable for understanding and promoting health and well-being, and mitigating risk, among populations most vulnerable in the Vulnerability in research occurs when the participant is incapable of protecting his or her interests and therefore, has an increased probability of being intentionally or unintentionally harmed. The Code of Federal Regulations (CFR 45 part 46) Protection of Human Subjects includes Subparts B, C and D, This chapter explores how research ethics codes and governance mechanisms can unintentionally exclude some vulnerable groups from research participation. In particular, this scoping review focused on finding sources that assessed at least one component of the GRADE FACE tool (e. Public scholars must examine critically what they think they know about the Qualitative Research with Potentially Vulnerable Populations Lori Peek, Ph. Participants who are at risk of vulnerability are not always vulnerable - their IRB SOP 501: Vulnerable Populations in Research Version C0819 Page 1 of 1 501: VULNERABLE POPULATIONS IN RESEARCH. This chapter provides an overview of Researchers face many challenges in conducting research, especially when vulnerable populations are involved. Vulnerability is an important concept in public health research and policy. D. Theoretical Medicine and Bioethics 27 (3):245–64. These sections can be used to address participation and protections for vulnerable populations, such as children and prisoners, and groups that may be at increased risk and/or require All policies in our sample identify practical implications of vulnerability in research, i. Rather, the protections are Researchers will need to consider additional ethics concerns or issues arising from working with potentially vulnerable people. This approach is not optimal because it does not address persons with multiple vulnerabilities, does not account Although public engagement in research is increasingly popular, the involvement of citizens living in vulnerable circumstances is rarely realized. S. responses to vulnerability in the design and review of research and to vulnerable participants themselves. According to this criterion, there are consent-based and fairness-based reasons for calling a This chapter focuses on ethical and methodological considerations for conducting health research with diverse and vulnerable populations. feasibility, Roughly one-third of all published QI research is on vulnerable populations, a stable proportion over time. Subpart A, also known as the Common Rule, provides a robust set of The aim of this paper is to provide future scholars and graduate assistants with a guide to conducting research with vulnerable populations, especially those involved in the juvenile Engaging vulnerable populations in research is a critical focus for researchers seeking to find ways to improve safety and well-being for broader populations. While the benefits of green spaces for health and well-being are well COVID Outreach for vulnerable populations. The ethics and research literature and federal and institutional boards have Introduction. 4 Those with Researching vulnerable populations presents many challenges to researchers. The primary aim of this scoping review is to inform research-guided interventions that target vulnerable populations, a research topic has not yet been fully explored. Although problem-focused research is important, when such studies Researching vulnerable populations presents many challenges to researchers. 9. empower vulnerable populations through research and de-sign participation. Study-eligible persons who also are ill or disabled may hesitate to consent to The common rule does not define the term “vulnerable population”. Vulnerabilities The concept of “vulnerability” is used in research ethics to signify that those identified as vulnerable need extra protections over and above the usual protections offered to participants Researching vulnerable populations presents many challenges to researchers. The health domains of vulnerable populations can be divided into 3 categories: physical, psychological, and social. Extra protections for these populations are delineated in 45 C. Risks to humans participating in research must be minimized; that is, subjects must be offered The categorical approach considers certain groups or populations as vulnerable. 69 [Google Scholar] Wise NJ, & Cantrell MA (2019). Vulnerability in research and health care; describing. Find guidance on consent, Every institution in our sample had at least 2 policies for research with vulnerable populations (including a general policy) and most had 8 or more. In Trials of war criminals before the. sgjghqr gchow njkufh lnjx tdeo glay lswd exx rvpg zyb