vulnerable population framework serves a vital practical and ethical function in research practice and oversight. research with this sub-segment of population is validated if reasonable direct benefits are foreseen, in compliance with local legal regulations. I've come to think that any discussion of the ethics of conducting research with vulnerable populations, such as children in the developing world, should be grounded in a three-part foundation. Aug 2001. This learning activity provides an overview of ethical and regulatory principles of research with participants perceived as vulnerable. Those generally accepted as being vulnerable include children, prisoners, pregnant women, fetuses, mentally disabled persons, and economically or educationally disadvantaged individuals. 2001, 357: 1432-1433. (New York: Routledge Press, 1990). As Anderson and Corneli explain in their 2018 book, 100 questions (and answers) about research ethics: Some people may be particularly vulnerable to exploitation and harm in the context of research. social work research often involves people considered vulnerable because there may be a risk of painful emotional reactions consequent to speaking of sensitive personal and emotional issues, such as in research on those who are bereaved (stroebe, stroebe, & schut, 2003) or who have experienced trauma (mudaly & goddard, 2009; newman & kaloupek, Vulnerable and Other Populations Requiring Additional Protections The Code of Federal Regulations outlines specific requirements to enhance protections for three groups. The APHA concluded that there was no evidence of harm to vulnerable populations, when aid in dying was available and adopted policy supportive of the option.1 At this point in time, significant support for the option of aid in dying has emerged from mainstream medical, health policy, patient advocacy communities. Bioethics first engaged with vulnerability in the context of participation in research and this continues to define how the value is typically understood. Vulnerabilities often characterize the availability of immigrant populations of interest in social behavioral science, public health, and medical research. The focus is on protecting people from research participation that . Vulnerable Populations and Sensitive Topics. The reality is that individuals and groups exist within a matrix of domination, and "all individuals and all groups possess varying amounts of penalty and privilege" (Collins, 2000, p. 246). Population ageing is a long-term trend which began several decades ago in Europe . The University of Sheffield Research Ethics Policy Note no. Click on the links below to learn more about what is required for each of the populations. The research involved a vulnerable population and did not offer the participants the prospect of direct health-related benefits. THE CENTER FOR ETHICS EDUCATION Lancaster University, which is the lead research institution . Subpart A, also known as the Common Rule, provides a robust set of protections for research subjects; subparts B, C, and D provide additional protections for certain populations in research; and subpart E provides requirements for . Individuals in vulnerable populations may have a higher risk of negative outcomes as a result of participating in a research study, they may have a reduced capacity or ability to give consent, or they may (for other reasons) have special legal protections. 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 ability to give informed consent to receive medical or surgical treatments or to participate in research. Deliberate and intentional--intentionality only applies to ACTS . In some cases, vulnerable populations are the people who are not able to protect their rights, their interests, or their well-being. Pregnant women should not be categorised as a 'vulnerable population' in biomedical research studies: ending a vicious cycle of 'vulnerability'. Research Involving Vulnerable Populations Celia B. Fisher Director, Center for Ethics Education Director, HIV and Drug Abuse Prevention Research Ethics Institute Fisher@Fordham.edu Center for Technology and Behavioral Health Dartmouth Psychiatric Research Center May 15, 2015. However, there is 10 Jeste, D.V., et al. 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. Control Groups in HIV Research Ruth Macklin, Ph.D., Albert Einstein College of Medicine Presented July 2011 at the Fordham HIV Prevention Research Ethics Training Institute Ethical Assessment of Ongoing Vaccine Trial: The Bangkok Experience Ruth Macklin, Ph.D., Albert Einstein College of Medicine Presented July 2011 at the Fordham HIV Prevention Research Ethics Training Institute Ethical If you would like to learn more about this, what you can do to help spread the word about safe and responsible research ethics, or if you just want to have a conversation about the critical work of IRBs, please reach out at virb@viableinsights.com or hit us up on social media @viableinsights. in the introduction to the cioms guidelines, issues of human rights are described as relating to two principles, one of which is the " protection of dependent or vulnerable persons and populations " ( [ 18 ], p. 11), while the principle of respect for persons is described as entailing " at least two fundamental ethical considerations ", including Vulnerable populations are those which are more susceptible to social, psychological, legal, economic and physical harm and will include such groups as children, drug users, runaways, prisoners, patients, victims of violence or the mentally ill. When bioethicists refer to vulnerable populations these persons might be minorities, women, children, the elderly, the imprisoned or other institutionalized persons. The first is that we must be willing to take the time and make the effort to be aware of and ask ourselves some of the difficult . This collection of open-access articles explores qualitative studies with vulnerable individuals and communities. Research ethics are based on three fundamental principles: . Learners will review definitions of vulnerability, relevant regulations in the United States, and their implications for special protections among various populations, including: This activity is co-provided by . In medical research ethics, the term Vulnerable Populations generally refers to individuals whose situations do not allow them to protect their own interests. Recruiting vulnerable populations for research: revisiting the ethical issues The successful recruitment of participants is essential to the research process. 10.1016/S0140-6736(00)04572-4. There are a number of research populations described in the Federal regulations as "vulnerable" or that require additional consideration or protection. To increase the rate of subject participation, investigators have to rely on help from health care providers who often serve as gatekeepers to potential research study subjects. Carleigh B Krubiner Ruth R Faden. 5. . in the introduction to the cioms guidelines, issues of human rights are described as relating to two principles, one of which is the " protection of dependent or vulnerable persons and populations " ( [ 18 ], p. 11), while the principle of respect for persons is described as entailing " at least two fundamental ethical considerations ", including [ 1, 3] the vulnerable populations refers to but not limited to children, minors, pregnant women, fetuses, human in vitro fertilization, prisoners, employees, military persons and students in Social groups that have increased susceptibility and are at risk for health problems are referred to as "vulnerable populations." This paper seeks to briefly define the meaning of the term "vulnerable population,' describe its characteristics, identify some of the barriers to health care service, and look at cultural . . If the target is the general population, and one of these groups (except prisoners) will participate, they are not considered a "target" population. The IRB-SBS identifies eight categories where the potential for vulnerability exists in research ( modified from National Bioethics Advisory Committee, Ethical and Policy Issues in Research Involving Human Participants. Shows the return of scientific racism under the influence of genetic research and (mis)interpretations of findings. NUTRITION ISSUES &VULNERABLE POPULATIONS 4 like scarce natural resources, high and volatile food prices, conflicts, climate change as well as demographic changes and poor governance. With approximately 1% of US residents incarcerated as of 2013, the issue of research ethics in this . Population at risk definition: Groups of people who are at a greater risk of exposure to a specific negative outcome than the general population. The term "vulnerable population" is also problematic, for it reinforces a false binarypeople are either members of a vulnerable population or not. Title: PowerPoint Presentation Author: Alison Antes Research ethics is based on several main principles that underline . In research, vulnerability typically focuses on the possibility that some people might be taken advantage of and harmed through research efforts. In three reports issued during the 1970s, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research identified fetuses, pregnant women, children, and prisoners as vulnerable populations requiring special protections, and a 1998 report from the National Bioethics Advisory Commission identified dementias . It is essential in protecting researchers and research participants, and is defined as " protecting people's health, wellbeing and human rights, and enabling them to live free from harm, abuse and neglect .". As respect for personal autonomy, prevention of harm, and promotion of justice are widely accepted ethical principles of responsible research, the possibility that some communities and individuals may be susceptible to exploitation or harm due to their vulnerable circumstances raises important ethical concerns. Office for Human Research Protections 1101 Wootton Parkway, Suite 200 Rockville, MD 20852 Procedural ethics such as those maintained by the Institutional Review Board require researchers to literally "do no harm" to participants. IRB: Ethics & Human Research 1997;19:1-4. Over the past three decades, there has been a rapid Participants in the workshop argued that a vulnerable population is one that has a compromised ability to protect its interests and provide informed consent. In line with other contributions to this special issue, the article . These policies generally recognize vulnerable populations to include pregnant women, fetuses, neonates, children, prisoners, persons with physical handicaps . This manuscript aims to discuss the conditions that make a group vulnerable and the tools and requiremen Read more at feedproxy.google.com Recognizing the specific needs and considerations of a vulnerable population is an important step in putting appropriate research protections in place. Vulnerable population There are several definitions available for the term "vulnerable population", the words simply imply the disadvantaged sub-segment of the community requiring utmost care, specific ancillary considerations and augmented protections in research. Under Provision 8, nurses must advocate for all vulnerable populations to receive equal treatment despite sexual orientation, gender identity, socioeconomic status, immigration status or other factors. Ten lessons to successfully conduct research with vulnerable populations using the Belmont report Respect for persons The Belmont Report defines respect for persons in research as: honoring the choices of subjects capable of exercising autonomy and protecting subjects incapable of making their own decisions. The Ethics Center will submit a final report to the USH on October 31, 2008, summarizing the findings and recommendations of the Work Group on PTSD and Vulnerable Populations in Research. In a study of consent among vulnerable populations in Mexico , about half of patients found the consent forms difficult to understand; most of the doctors also confirmed that the forms were incomprehensible to patients. Ram Weiss and colleagues (Sept 20, p 951) report the results of clinical research involving obese children with and without impaired glucose tolerance. 6 RESEARCH INVOLVING VULNERABLE PEOPLE . Acts of Commission. Vulnerable Populations. As seen on Figure 1, European population is projected to continue to age. Policies have been developed to protect vulnerable populations in clinical research, including the US federal research regulations (45 Code of Federal Regulations 46 Subparts B, C, and D). One of the recommendations from the workshop was that pregnant women in research trials should be defined as a "scientifically complex" rather than a "vulnerable" population 8. You are here Research > Research Ethics > Research with vulnerable groups and sensitive topics. The HHS regulations for the protection of human subjects in research at 45CFR 46 include five subparts. Ethics of research involving vulnerable populations. I wanted to share a favorite resource of mine - 100 Questions (and Answers) about Research Ethics by Emily E. Anderson and Amy Corneli (2018; SAGE). Since 1979, the number of legal and non-legal research ethics policies and guidelines has increased tremendously and, with them, the use and scope of the concept of vulnerabil-ity or vulnerable populations [2, 3]. 45 CFR 46.111(b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards should be included in the study to protect the rights and welfare of these subjects. Limited autonomy = vulnerable populations Vulnerable populations are so-named because: They are vulnerable to undue influence or coercion Undue Influence = "an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance" . Lancet. This particular page provides information on vulnerable populations in research. The idea of vulnerable populations falls under the ethical construct of respect for persons. 3 , 4 The need to identify this population arose out of historical examples in which subjects were exploited for the purpose of medical experimentation. Risks to humans participating in research must be minimized; that is, subjects must be offered protection from risks. People who are included in research should not be included merely because they are a population that is easy to access, available, or perhaps vulnerable and less able to decline participating. Keywords: ethics, disasters, disaster research, research methodology, vulnerable populations 1. Annotated bibliogrpahy for the research ethics module covering the ethical issues that arise in doing research on vulnerable populations. The Mental Capacity Act 2005 applies to 16-17 year olds and adults (18 years and over) who lack capacity to make decisions because of an impairment, mental disorder or 'disturbance in the functioning of the mind and brain'. The National Bioethics Advisory Committee (NBAC 2001) defines vulnerable subjects as persons who "have difficulty providing voluntary, informed consent arising from limitations in . And therefore, the importance of additional research on diseases typical for older people is becoming increasingly . research with vulnerable populations. APPROVAL: Any changes in objectives, scope, or membership of work group members must be approved by the Under Secretary for Health. Eisenberg, Leon These people are exposed to various types of harm that includes social, economic, legal, psychological, or even physical challenge (Henry, 2012). They may lose their papers, documents of identification. In this paper, we describe, illustrate through cases, and critically examine key ethical challenges that are more likely to arise because a research study focuses on health-related stigma or involves stigmatized groups or conditions. 45 CFR 46. 2008;3(1):15-24. Protection of Vulnerable Populations in Research In addition to vulnerable subject populations such as children, prisoners, and pregnant women (covered in the subparts of the federal regulations for human subjects research), there are special classes of subjects including students, employees, and cognitively impaired individuals who may be vulnerable in Journal of Medical Ethics 2017; 43 664-665 Published . Any act or series of acts of commission (abuse) or omission (neglect) by a parent or other caregiver that results in harm, potential for harm, or threat of harm to a child (under the age of 18) Four common types of abuse. It reflects the principles of anti-oppressive social work and the ethics of undertaking research with vulnerable populations. Remember that this principle is about autonomy, where an autonomous individual is capable of making decisions about their personal goals and beliefs. "Vulnerable" or "special" classes of subjects include: Pregnant women, human fetuses and neonates, Prisoners, Children, Surrogate Consent/Use of a Legally Authorized Representative (LAR) The vulnerable individuals' freedom and capability to protect one-self from . Refugees, asylum seekers, and undocumented immigrants present unique vulnerabilities relevant to protocol development as well as ethics review procedures and criteria. Thus, vulnerability is generally deployed to describe individuals (or populations), where real or perceived deficiencies limit the ability to function and to protect themselves from risks. role in research ethics thinking, drawing attention to situ-ations where these conditions may not be met [1]. Other vulnerable populations may be those who are already dislocated from familiar settings, for instance, refugees, new immigrants, or minority groups.
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