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 Backdoor to Eugenics. The term "vulnerable population" is also problematic, for it reinforces a false binarypeople are either members of a vulnerable population or not. 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 2001, 357: 1432-1433. Read more at feedproxy.google.com Eisenberg, Leon 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. Safeguarding is an integral part of our overarching research ethics. 5. . ): Cognitive or communicative vulnerability Institutional vulnerability Deferential vulnerability Medical vulnerability In research, vulnerability typically focuses on the possibility that some people might be taken advantage of and harmed through research efforts. In some cases, vulnerable populations are the people who are not able to protect their rights, their interests, or their well-being. 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). 2 The implication is that a person or population might be vulnerable to exploitation or to undue burdens of research participation. And therefore, the importance of additional research on diseases typical for older people is becoming increasingly . Body Duster, Troy. Click on the links below to learn more about what is required for each of the populations. Vulnerable populations need advocates. Population at risk definition: Groups of people who are at a greater risk of exposure to a specific negative outcome than the general population. Procedural ethics such as those maintained by the Institutional Review Board require researchers to literally "do no harm" to participants. (New York: Routledge Press, 1990). 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. Vulnerable Populations and Sensitive Topics. 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. Carleigh B Krubiner Ruth R Faden. APPROVAL: Any changes in objectives, scope, or membership of work group members must be approved by the Under Secretary for Health. 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 . Fisher CB. physical, sexual, emotional, neglect. Vulnerable subjects require additional protections. But collecting that data could present ethical issues. The idea of vulnerable populations falls under the ethical construct of respect for persons. The categories of individuals that constitute Vulnerable Populations are outlined under The Common Rule (45 CFR 46, Subparts A-D). Office for Human Research Protections 1101 Wootton Parkway, Suite 200 Rockville, MD 20852 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 . research with vulnerable populations. We sometimes forget that the source of their vulnerability is not intrinsic. The National Bioethics Advisory Committee (NBAC 2001) defines vulnerable subjects as persons who "have difficulty providing voluntary, informed consent arising from limitations in . A relational perspective on ethics-in-science decisionmaking for research with vulnerable populations. Ethics of research involving vulnerable populations. "Vulnerable" or "special" classes of subjects include: Pregnant women, human fetuses and neonates, Prisoners, Children, Surrogate Consent/Use of a Legally Authorized Representative (LAR) 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 . 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. Research ethics are based on three fundamental principles: . As seen on Figure 1, European population is projected to continue to age. 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. The University of Sheffield Research Ethics Policy Note no. These policies generally recognize vulnerable populations to include pregnant women, fetuses, neonates, children, prisoners, persons with physical handicaps . vulnerable population framework serves a vital practical and ethical function in research practice and oversight. . 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. Ethical Questions. Moreover, within research ethics policy and guidelines, vulnerable populations have been defined in relation to 'reasons for vulnerability' , which can be divided into two broad groups'respect for persons-based accounts' and 'justice-based accounts' [12 p. 2]. The vulnerable individuals' freedom and capability to protect one-self from . For Vulnerable Populations, the Thorny Ethics of Genetic Data Collection Republish To be equitable, genetics research needs more diverse samples. This collection of open-access articles explores qualitative studies with vulnerable individuals and communities. Introduction Communities worldwide are affected by an increasing number of natural and technologi-cal (man-made) disasters (Myers & Wee, 2005). The definition of what is a vulnerable population . 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. 2008;3(1):15-24. [ 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 Acts of Commission. 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. It is decidedly extrinsic. Participants in the workshop argued that a vulnerable population is one that has a compromised ability to protect its interests and provide informed consent. 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. Deliberate and intentional--intentionality only applies to ACTS . 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]. (2009). 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. Vulnerabilities often characterize the availability of immigrant populations of interest in social behavioral science, public health, and medical research. 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 . 45 CFR 46. The focus is on protecting people from research participation that . Ethics in working with vulnerable populations should include a detailed explanation throughout all study phases from gaining access through project completion. As noted earlier, the term " vulnerable populations " refers to a wide range of persons who may be at risk in a research setting not only because of their intrinsic characteristics but also as a result of their life situation or circumstances. Causes of Undernutrition: The reasons are diverse- for instance, before birth, intrauterine growth restriction can be an essential basis. 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. 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. 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. 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. Bioethics first engaged with vulnerability in the context of participation in research and this continues to define how the value is typically understood. Participant recruitment and retention from vulnerable populations in clinical trials is a matter of trust October 2022 Contemporary Clinical Trials 123(5):106969 Annotated bibliogrpahy for the research ethics module covering the ethical issues that arise in doing research on vulnerable populations. Our goals are threefold: (1) to help researchers, research ethics committees (RECs), and other stakeholders to . Citing Literature They may lose their papers, documents of identification. Over the past three decades, there has been a rapid Vulnerable Populations. Populations in Research Requiring Additional Considerations and/or Protections. 3 , 4 The need to identify this population arose out of historical examples in which subjects were exploited for the purpose of medical experimentation. Pregnant women, human fetuses, and neonates Children Prisoners This learning activity provides an overview of ethical and regulatory principles of research with participants perceived as vulnerable. Recognizing the specific needs and considerations of a vulnerable population is an important step in putting appropriate research protections in place. You are here Research > Research Ethics > Research with vulnerable groups and sensitive topics. 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. vulnerable populations INTRODUCTION The concept of vulnerability is a cornerstone of the theoretical basis and practical application of ethics in human subjects research. Their links to their new community may still be fragile. 10 Jeste, D.V., et al. 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 .". Risks to humans participating in research must be minimized; that is, subjects must be offered protection from risks. However, later on in life, poor sanitation and hygiene, frequent infections . . Recruiting vulnerable populations for research: revisiting the ethical issues The successful recruitment of participants is essential to the research process. Other vulnerable populations may be those who are already dislocated from familiar settings, for instance, refugees, new immigrants, or minority groups. Content Authors Jeremy N. Block, PhD, MPP Baruch College Bruce Gordon, MD The University of Nebraska Medical Center Introduction. 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. 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 . Visual: Dan Kitwood/Getty Images By Adrian Pecotic 09.30.2019 4 Comments 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. 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). Lancaster University, which is the lead research institution . She has used modules such as the Study Guide to "Ethically Impossible" STD Research in Guatemala from 1946 to 1948 and Vulnerable Populations in Safeguarding Children: Pediatric Medical Countermeasure Research for courses on research ethics and clinical trials. Refugees, asylum seekers, and undocumented immigrants present unique vulnerabilities relevant to protocol development as well as ethics review procedures and criteria. The types of study populations that are likely to be vulnerable to coercion or undue influence may including but are not necessarily limited to: Children/minors Prisoners Employees Military persons and students/trainees in hierarchical organizations Terminally ill, comatose, physically and intellectually challenged individuals In medical research ethics, the term Vulnerable Populations generally refers to individuals whose situations do not allow them to protect their own interests. "Vulnerable populations" are groups of individuals who in one or more ways are at risk of harm through research; research ethics committees often use the term to identify groups that are at risk in particular research projects. The HHS regulations for the protection of human subjects in research at 45CFR 46 include five subparts. Title: PowerPoint Presentation Author: Alison Antes 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" However, there is 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). These people are exposed to various types of harm that includes social, economic, legal, psychological, or even physical challenge (Henry, 2012). An experimental strategy that is likely to be used by many types of people should be . Cognitively Impaired T o be considered a vulnerable population, the targeted group must be the focus of the research. research with this sub-segment of population is validated if reasonable direct benefits are foreseen, in compliance with local legal regulations. Journal of Medical Ethics 2017; 43 664-665 Published . Leaning J: Ethics of research in refugee populations. There are a number of research populations described in the Federal regulations as "vulnerable" or that require additional consideration or protection. 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 IRB: Ethics & Human Research 1997;19:1-4. 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, Ram Weiss and colleagues (Sept 20, p 951) report the results of clinical research involving obese children with and without impaired glucose tolerance. Pregnant women should not be categorised as a 'vulnerable population' in biomedical research studies: ending a vicious cycle of 'vulnerability'. Keywords: ethics, disasters, disaster research, research methodology, vulnerable populations 1. Guidance on the Mental Capacity Act notes that lack of capacity to make a decision may be permanent or temporary. 10.1016/S0140-6736(00)04572-4. 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. This particular page provides information on vulnerable populations in research. Research ethics is based on several main principles that underline . Journal of Empirical Research on Human Research Ethics. In particular, I want to point out Part 4 (pages 49-66) that is focused on protecting vulnerable populations. With approximately 1% of US residents incarcerated as of 2013, the issue of research ethics in this . 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.
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