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PubMedDate not supplied

Recruiting vulnerable populations for research: revisiting the ethical issues.

The successful recruitment of participants is essential to the research process. 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. These well-meaning professionals may limit subject participation in a study involving vulnerable populations under the guise of protecting these individuals from harm. We describe some of the characteristics of vulnerable populations affecting their recruitment into research studies. We examine the ethical conflicts that occur when health care professionals control access to these subjects during recruitment for research studies. Finally, we discuss the implications for practice and research designed to protect the rights of vulnerable populations participating in research. We identify collaboration and dialogue between researchers, health care providers, and members of the potential subject populations as most important in recruiting sufficient numbers of subjects to ensure the scientific merit of the study.

Ethics, Research↗

PubMed1993

Collecting data to evaluate the effect of health policies on vulnerable populations.

Public health policies often have disproportionate effects on the poor and other vulnerable groups. Standard survey techniques are often difficult to apply to these vulnerable populations, and many data bases systematically omit such individuals. The purpose of this paper is to review our experience in collecting primary survey data from public hospital, mentally ill, HIV-infected, and non-English-speaking patients. Important issues in conducting research on these populations include proper selection of subjects and comparison groups and difficulties involved in recruitment and enrollment of subjects. Maintaining longitudinal data on these populations is difficult and often requires tracking, secondary contacts, home visits and community outreach, and the use of organizations, institutions, and networks. Investigators must also pay careful attention to ethical issues involved in conducting research on vulnerable populations.

Data Collection↗

PubMedDate not supplied

Physicians' understanding of consent requirements for phase I clinical trials in cognitively impaired or highly vulnerable populations.

We investigated physicians' attitudes about entering patients who cannot give informed consent or who are of a vulnerable population into clinical trials. A survey instrument asked a nationwide sample of practicing physicians about whether ten hypothetical patients could be enrolled in a phase I clinical trials. The impact of demographic variables on the number of scenarios viewed as completely or somewhat acceptable was analyzed via student's T tests or analysis of variance (ANOVA) as applicable. All significant (p<0.01) variables were entered into a multiple logistic regression model. Eighty-four percent of respondents indicated that at least one case scenario was acceptable. A majority of those who conduct clinical trials (62%), who had training in the ethics of clinical research (78%), and who sit on institutional review boards (IRBs) (83%) approved of at least one case scenario. Physicians approved of the entry of some patients who cannot give informed consent or who are of a vulnerable population into clinical trials. More effective education on the guidelines involving clinical research should be available to practicing physicians, residents, and medical students. There should also be assurance that physicians who conduct clinical trials or who sit on IRBs have the requisite knowledge about the ethics of clinical research.

Attitude of Health Personnel↗

PubMed1997

Monitoring the impact of the Medicare Fee Schedule on access to care for vulnerable populations.

Implementation of the Medicare Fee Schedule (MFS) introduced concerns about the potential for reduced access to care, especially for vulnerable populations. These analyses show differences in access before and after the MFS that cannot be explained by health status. In particular, those without private or public supplementary insurance, those with low incomes, African Americans, and the oldest old had lower utilization before the MFS. The impact after implementation of the MFS on vulnerable populations was similar, for the most part, to that for other beneficiaries: reduced utilization in areas with fee increases and increased utilization in areas with fee decreases. An exception was that African Americans, those without supplemental insurance, and those with low incomes in areas of fee decrease saw reductions in the use of surgical services relative to their counterparts in areas with no fee change.

Ethnicity↗

PubMed2000

Vulnerable populations and health insurance.

This study provided a national profile of health insurance of certain vulnerable populations including children, racial/ethnic minorities, low-income families, non-metropolitan statistical area (MSA) residents, and those with poor health status. The study shows an increase in the proportion of uninsured nonelderly population. While public insurance helped reduce the employment- and health-related disparities in private coverage, it has not overcome other disparities related to vulnerable characteristics including race/ethnicity, wages, education, and area of residence. Comparison between health maintenance organization (HMO) and fee-for-service insurance indicates that younger although not much healthier people, racial/ethnic minorities, MSA residents, and those residing in the West and Northeast regions were more likely to have HMO coverage. To reduce significant disparities in health insurance coverage, policy makers will have to consider expanding public insurance coverage, targeting vulnerable groups, particularly those with multiple vulnerable characteristics rather than merely the economically distressed. Expecting managed care to achieve cost containment for services provided to vulnerable populations may be unrealistic.

Adolescent↗

PubMed2006

Telehomecare for vulnerable populations: The evaluation of new models of care.

The use of telehomecare has the potential to facilitate access to healthcare services for vulnerable populations. However, evidence on the implications of telehomecare on various aspects related to patients, healthcare professionals, organizations, and healthcare systems is still limited. Assessing the various effects of telehomecare for these different groups of stakeholders is thus an essential step to ensure future integration of this technology into mainstream healthcare services. A synthesis of lessons learned from the evaluation of three telehomecare experimentations targeting specific vulnerable groups is proposed. This paper presents the various models that were implemented to assess telehomecare services for vulnerable populations, explores issues related to conducing telehomecare evaluations, and provides a reflection on key factors that might influence the success of telehomecare projects. Lessons learned from these three experimentations provide valuable insights to orient the development of telehomecare services for various vulnerable groups in the population.

Chronic Disease↗

PubMed2004

Bridging the digital divide: reaching vulnerable populations.

The AMIA 2003 Spring Congress entitled "Bridging the Digital Divide: Informatics and Vulnerable Populations" convened 178 experts including medical informaticians, health care professionals, government leaders, policy makers, researchers, health care industry leaders, consumer advocates, and others specializing in health care provision to underserved populations. The primary objective of this working congress was to develop a framework for a national agenda in information and communication technology to enhance the health and health care of underserved populations. Discussions during four tracks addressed issues and trends in information and communication technologies for underserved populations, strategies learned from successful programs, evaluation methodologies for measuring the impact of informatics, and dissemination of information for replication of successful programs. Each track addressed current status, ideal state, barriers, strategies, and recommendations. Recommendations of the breakout sessions were summarized under the overarching themes of Policy, Funding, Research, and Education and Training. The general recommendations emphasized four key themes: revision in payment and reimbursement policies, integration of health care standards, partnerships as the key to success, and broad dissemination of findings including specific feedback to target populations and other key stakeholders.

Financing, Organized↗

PubMedDate not supplied

Health disparities among vulnerable populations: evolution of knowledge over five decades in Nursing Research publications.

BACKGROUND: Considerable attention has been focused recently on conducting research on the health disparities experienced by some Americans as the result of poverty, ethnicity, and/or marginalized social status. Nursing research has a major role to play in developing this body of knowledge. PURPOSE: The purpose of this paper is to review the contributions that Nursing Research made through its publications over the last five decades in developing the body of tested knowledge about health disparities in vulnerable groups and to analyze the progress made. METHODS: Criteria for reviewing the literature were established. All Nursing Research publications between 1952 and 2000 were searched manually, indexes of each year's bound volumes were reviewed, and computer searches were conducted. Included in the review were research reports, research briefs, and methodology articles. RESULTS: Seventy-nine papers were found that met basic criteria for inclusion. The number of relevant publications increased each decade, with a sizable increase in numbers since 1990, and may be related to the social, political, and economic climate of each decade. The research questions asked and the methods used became more complex over time. CONCLUSIONS: 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 associated with vulnerable populations research. Areas for future research are community-based studies, intervention studies that provide tangible resources, and methodologic approaches that involve participants in the research process.

Attitude to Health↗

PubMed1995

Humanitarian responses to mass violence perpetrated against vulnerable populations.

This multidisciplinary review links three areas of legitimate inquiry for practitioners of medicine and public health. The first is occurrences of mass violence or genocide perpetrated against vulnerable populations, with a focus on the failure of national and international mechanisms to prevent or predict such violence. The second is evolving concepts of national sovereignty and an emerging framework in which the imperative to assist vulnerable populations supersedes a state's right to self determination. The last is how medical, public health, and other systems of surveillance and rapid assessment of mass violence can accelerate public awareness and facilitate structured, consistent political decision making to prevent mass violence and to provide international humanitarian assistance.

Altruism↗

PubMed1995

High-risk vulnerable populations and volunteers: a model of education and service collaboration.

Extending our earlier work (Hutchison & Quartaro, 1993) describing a training program for volunteers caring for high-risk vulnerable populations, we identify and explicate factors contributing to the successful collaboration of education and service organizations. Addressing the management of linkages essential to mutual goal setting and shared responsibility for planning, implementation, and evaluation of patient/client outcomes, each factor is discussed with specific reference to improving caregiving to persons with AIDS and their families through well-trained volunteer services. The model has been applied to training for service to homeless persons and to the frail elderly and may be more broadly applicable to other high-risk vulnerable populations.

Acquired Immunodeficiency Syndrome↗

PubMed2004

The risk of child and adolescent mortality among vulnerable populations in Rio de Janeiro, Brazil.

This study investigated the importance of socioeconomic factors such as education, income, religion, family structure and residence in explaining the increased risk of mortality among vulnerable populations aged less than 20 years in Rio de Janeiro, Brazil. Data used were from the 1991 Brazilian Demographic Census and comprised 121,060 women aged 15-49 residing in Rio de Janeiro. Two alternative statistical methods were used to calculate the risk of death: the widely used Brass method (an indirect estimate which assesses population risks) and a case-control study (which assesses individual risks). The study also focused on the importance of indicators of human and social capital, the lack of which may explain the higher risk of death among children and adolescents. Lack of education was found to be a major determinant of mortality at young ages. Residence in a favela (shantytown), families in which mothers were the head of the family, and a lower median level of income were found to be significant determinants of mortality among vulnerable populations in Brazil. However, religion was not found to be as important a predictor of high mortality.

Adolescent↗

PubMed2006

From the streets to assisted living: perceptions of a vulnerable population.

The rapid growth of assisted-living facilities is paralleled by the necessity to understand the needs of the people living in them. A hallmark challenge for individuals who are poor and disabled, and often marginalized from mainstream society, is maintaining integrity and being a whole person, rather than a sum of broken parts. A key to maintaining this integrity is the ability to find stable housing and support systems. The inner-city assisted-living facility in this study is unique in that all of its residents are funded by Medicaid. The residents have complex needs related to histories of homelessness, mental illness, drug and/or alcohol addiction, and chronic illness. The purpose of this study was to explore the needs of this vulnerable population as they adapt to a new home and a new concept of assisted, yet independent, living. Structured interviews with key informants and oral survey questionnaires with residents provided quantitative and qualitative data about physical and mental health status, social support, perception of control, psychological wellbeing, and life satisfaction. This study provided valuable insights into the challenges inherent in providing a high quality of life in assisted living for a vulnerable population with diverse needs.

Adaptation, Psychological↗

PubMedDate not supplied

eHealth technology and Internet resources: barriers for vulnerable populations.

Disparities in accessing health information exist for various vulnerable populations. Reviewing access issues for those seeking and/or needing health information suggests that there are many factors that may inhibit access. These include a wide diversity in the education, background, and needs of those seeking information, and the distribution of information among many disciplines and information sources. The most needy among this group may require extensive, multispecialty healthcare and may have particular problems with access, treatment adherence, and working within the healthcare system.

Access to Information↗

PubMed2000

Developing leadership and excellence with vulnerable populations in research, education, and practice.

The development of leadership and excellence in an area of nursing scholarship depends on the interactions among practice, research, theory, and education. This article describes the development of leadership at the UCLA School of Nursing through scholarship in the health-related problems of vulnerable populations. Leadership in scholarship began and continues in practice, influences education, generates theory, is tested in research, and returns to influence all of these areas. The vitality and creativity of scholarship and science with vulnerable populations depends on an ongoing infusion of knowledge from practice, research, theory, and education. While focusing on one school, there are many that have followed a similar course in developing scholarship and others that may wish to develop their scholarship based on this model.

Education, Nursing, Baccalaureate↗

PubMed2006

Vulnerable populations in research: the case of the seriously ill.

This paper advances a new criterion of a vulnerable population in research. According to this criterion, there are consent-based and fairness-based reasons for calling a group vulnerable. The criterion is then applied to the case of people with serious illnesses. It is argued that people with serious illnesses meet this criterion for reasons related to consent. Seriously ill people have a susceptibility to "enticing offers" that hold out the prospect of removing or alleviating illness, and this susceptibility reduces their ability to safeguard their own interests. This explains the inclusion of people with serious illnesses in the Belmont Report's list of populations needing special protections, and supports the claim that vulnerability is the rule, rather than the exception, in biomedical research.

Critical Illness↗

PubMedDate not supplied

How the new medicare drug benefit could affect vulnerable populations.

This study estimates how out-of-pocket drug costs could change for vulnerable populations (racial and ethnic minorities, the near-poor, and seniors with a greater burden of chronic conditions) who qualify for the standard Medicare drug benefit. Although the new benefit might be associated with modest-to-moderate declines in out-of-pocket spending for seniors who do not qualify for subsidies, the savings might not be shared equitably and therefore might not reduce financial barriers to medication use for these populations.

Aged↗

PubMed2005

Students' comfort level in treating vulnerable populations and future willingness to treat: results prior to extramural participation.

This study analyzed senior dental students' perceptions prior to extramural rotations for comfort and future willingness to treat patients with special needs and other vulnerable groups. The sample included 690 University of Iowa senior dental students who graduated from 1992 through 2004. These students completed a questionnaire concerning twelve vulnerable population groups. Logistic regression models were performed, using student comfort and future willingness to treat each group as the dependent variable. There was a wide percentage of range of comfort with these groups, yet there was no individual group that more than 60 percent of these students were willing to treat in their future practices. Generally, prior experience with the group had a positive impact on comfort level. When gender was included in the regression models, male students were more likely to express comfort. In all instances except one, experience had a positive influence on perceived future willingness to treat the associated group. However, younger graduates had a greater willingness to treat. When controlling for other variables within the future willingness to treat models, comfort was statistically significant only for HIV+/AIDS and non-English speaking groups. This study provides insight about comfort with and perceived future willingness to treat special needs and other vulnerable patient groups.

Acquired Immunodeficiency Syndrome↗

PubMedDate not supplied

Teaching residents to care for vulnerable populations in the outpatient setting.

Residency programs have an obligation to teach house officers to care for vulnerable populations. Such populations consist of those whom physicians tend to consider undersirable as patients, and thus who often lack adequate care, because they cannot pay for medical services, because they have medical problems that are difficult to manage, or because they have characteristics giving them low social status. The authors identify and discuss key aspects of learning to care for such populations. These aspects include obtaining appropriate experience caring for disadvantaged patients, developing sensitivity to pertinent sociocultural issues, exploring biases, acquiring relevant special skills, studying epidemiology of diseases in specific vulnerable groups, and learning about health care financing and health policy. Measures to help residents obtain more satisfaction from caring for vulnerable patients are among additional topics discussed.

Ambulatory Care↗