Welfare Of Subjects Research Articles

Medical Trainees Abroad: Neglected Human Rights Considerations.

Medical trainees (applicants, students, and house officers) often engage in global health initiatives to enhance their own education through research and patient care. These endeavors may concomitantly prove of value to host nations in filling unmet clinical needs. At present, healthcare institutions generally focus on the safety of the trainee and the welfare of potential patients and research subjects when sanctioning such programs. The American medical community has historically afforded less consideration to the ethics of engagement by trainees from the United States in nations known for serious human rights transgressions. This essay examines the ethics of such endeavors and argues for increased consideration of these broader considerations when trainees engage in global health work abroad.

Institutional Review Board Considerations for Clinical Trials.

To protect subjects who participate in human research, Institutional Review Boards (IRBs) play an important role in reviewing research and determining the validity of a study by comprehensively examining it for ethical issues, including invasiveness and management of personal information. They conduct regular and independent reviews to protect the health, rights, and welfare of research subjects. When we as researchers conduct clinical research, we must obtain IRB approval and submit our research for investigation of ethical issues before we begin.

50 years of the first ethics commission in Germany: the Ulm Ethics Commission in an international perspective.

The creation of the legal framework to recognize rights of patients and participants in clinical trials began in Germany in the 19th century. However, the ethical review of medical research in terms of the protection of rights and welfare of human subjects has only become a widespread practice since the establishment of ethics commissions. The first ethics commissions emerged at the universities under the influence of the German Research Foundation. The widespread establishment of ethics commissions began in the Federal Republic of Germany in 1979, after the adoption of the recommendation of the German Medical Association for the establishment of ethics commissions. We analyzed unpublished archival documentation of the Ethics Commission of the University of Ulm and evaluated it based on a thorough review of research works on the history of international and German ethics commissions. For the examination of the sources, we implemented the historical-critical method. The first ethics commission in Germany was set up at the University of Ulm in 1971/72. The reason for that was that the German Research Foundation required grant applications for medical research involving human subjects to be reviewed by an ethics commission. Initially the commission was created at the Center for Internal Medicine and Pediatrics, its authority grew over time until in 1995 it became the central Ethics Commission for the entire University of Ulm. Before the adoption of the Tokyo revision of the Declaration of Helsinki in 1975, the Ulm Ethics Commission developed its own guidelines for the conduct of scientific investigations on humans based on international ethical principles. The Ethics Commission of the University of Ulm must have been established between July 1971 and February 1972. The German Research Foundation played a decisive role in the establishment of the first ethics commissions in Germany. The Universities had to create ethics commissions in order to be able to obtain additional funds from the Foundation for their research. Thus, the Foundation initiated the institutionalization of the ethics commissions in the early 1970s. The functions and composition of the Ulm Ethics Commission were similar to other initial ethics commissions of the time.

Responsible conduct of research: Preparedness for times of crisis

A live, virtual conference, "Driving Responsible Conduct of Research during a Pandemic," was held in April 2021, 13 months after the COVID-19 pandemic fundamentally altered the conduct of clinical research across the USA. New York was an early epicenter of the US pandemic, highlighting preexisting problems in clinical research and allowing us to assess lessons learned and to identify best practices for the future. Risks and opportunities were categorized broadly into three areas, protecting the welfare and safety of human subjects, ensuring trust in science and medicine, and implementing efficient, ethical, and compliant clinical research. Analysis of conference proceedings, and recent publications, shows a need for preparedness that is more effective, robust partnerships, and organizational systems and standards to strengthen the ethical and responsible conduct of research.

Prevalence of Psychoactive Substance Use and Associated Behavioral Risks among Secondary School Students in Tanzania

This study aimed to investigate the prevalence of psychoactive substance use and associated behavioral risks among secondary school students in Tanzania. The study adopted a qualitative research approach. Data generated from semi-structured interviews with Heads of school, focused group discussions with teachers and students and documentary reviews were subjected to thematic analysis. Credibility, dependability, confirmability and transferability were considered to ensure trustworthiness. Rights and welfare of research participants and subjects were considered by the researcher. The most commonly used psychoactive substances among secondary school students were marijuana (cannabis), cigarettes and alcohol. Peer pressure, the family environment, the availability of substances in students localities are some of factors that influenced students to use psychoactive substances. The study recommends that the government should take special priority in banning the use of cannabis, cigarettes and alcohol, especially among secondary school students in order to minimize the prevalence of the use of psychoactive substances among secondary school students. School management and government at large need to establish drug control and prevention clubs in secondary schools so as to equip students with the necessary skills of knowing to resist temptations related to the use of psychoactive substances.

On the Ill-Being of Animals

Animal welfare theorists tend to assume that most animals in captivity—especially those living in our homes and in sanctuaries—can, with sufficient care and environmental enrichment, live genuinely good lives. This misguided belief stems from the view that animal well-being should be assessed only in terms of the felt experiences of animals. Against this view, I argue that in assessing how well an animal’s life is going, we ought to consider two distinct kinds of welfare: experiential welfare and subject welfare. Once we take seriously the notion of subject welfare, which pertains to the non-sentient nature of animals, we will be forced to accept the unfortunate reality that most, if not all, animals in confinement—including those living in our homes and in sanctuaries—fare quite poorly and live lives that should be characterized as having overall ill-being.

Challenges of Clinical Research Administration During the COVID-19 Pandemic.

In early 2020, clinicians and researchers rushed to understand the SARS-CoV-2 virus and how to go about treating and preventing it. Caring for patients while simultaneously learning about a disease not seen before created challenges on several levels. Much of the spotlight was on the researchers doing this critical work; however, these narratives remind us of the enormous effort and commitment shown by IRB members and research administrators responsible for research infrastructure. Despite the sense of urgency and obligation to plan and conduct clinical research during the pandemic, IRBs guaranteed that researchers still adhered to the core ethical principles that protect the rights and welfare of human subjects so that critical research could continue. Many themes emerge in these stories, including the need for flexibility in processes for both staff and research participants and the perception that IRB members serve as "research gatekeepers." With approaches to clinical research evolving, the SARS-CoV-2 pandemic may be the catalyst needed to make sustainable improvements to our research processes, roles, and goals.

Should the Regulation of Research Misconduct Be Integrated with the Ethics Framework Promulgated in The Belmont Report?

The federal research misconduct regulations finalized in 2005 did not incorporate important principles regarding human subjects protections articulated in The Belmont Report, yet research misconduct can involve harms to research subjects and to subsequent patients whose treatments are based on false research findings. Consistency with the Belmont principles would require assuring regular monitoring to detect research misconduct, tracing effects of research misconduct on trial participants and informing them of these effects, and assuring timely correction of published reports of research findings if research misconduct related to the study was subsequently discovered. Research misconduct has historically been viewed as a matter for the scientific community to manage; it is actually a threat to the welfare of human subjects and ethically ought to be treated as such.

Health-Related Quality of Life in a Sample of Chronic Obstructive Pulmonary Disease Patients in AL-Diwanyia Province /Iraq.

The effect of mental and physical health on the feelings of subject welfare is known as health-related quality of life. The chronic obstructive pulmonary disease is a common respiratory diseases. Assessment of health-related quality of life is considered important in such chronic disease. The objective of the current study was to measure health-related quality of life in a sample of chronic obstructive pulmonary patients in AL- Diwanyia city/Iraq. This study was carried out on 150 already diagnosed COPD patients who attended to the Center of Respiratory Diseases/AL-Diwaniyah Teaching Hospital during September 2019 to January 2020. The Arabic version of St George’s Respiratory Questionnaire was used to assess the health-related quality of life. The mean symptoms score was 48.65 ±7.17, the mean activity score was 62.39 ±5.81, the mean impact score was 42.83 ±7.90 and the total score 49.58 ±4.82. Symptom score is predicted by disease duration (negatively) and hospital admission (positively), activity score and impact score cannot be predicted by any of independent variables and total score is predicted by forced expiratory volume in the first second (negatively) and hospital admission (positively).

Importance and Feasibility of Animal Welfare Measures from a Consumer Perspective in Germany

The subject animal welfare is increasingly in the public discourse. Consumers and policymakers are increasingly demanding products that are produced under increased animal welfare standards. The profession of the farmer involuntarily gets into disrepute. Many consumers want fundamental changes in pig farming, but are not aware of the consequences of implementation. In this representative study, consumers (n = 1101) were asked about their assessment of 33 animal welfare measures with regard to their importance and the feasibility of implementing those measures. With the help of a four-field matrix, both the perceived importance and the feasibility of the animal welfare measures surveyed were brought together. The results show four possibilities: important and easy to implement, important and not feasible, not important and easy to implement as well as not important and not feasible. The results show that any outdoor access to pasture ranks first, followed by any outdoor access to straw bedding. The results can make a significant contribution to future communication with critical consumers concerning the implementation of higher animal welfare levels, as it becomes clearer how realistic consumers are about the feasibility of several animal welfare measures. Furthermore, the results could prove useful for the design of animal welfare programs and could help famers making targeted decisions concerning stable construction and management.

Public Health Crises and the Human Subjects of Biomedical Research: A Focus on COVID-19

Public Health Crises and the Human Subjects of Biomedical Research: A Focus on COVID-19

Vulnerability in Research: Basic Ethical Concepts and General Approach to Review.

Background: The concept of vulnerability is a cornerstone of the theoretical basis and practical application of ethics in human subjects research. Risks to humans participating in research must be minimized; that is, subjects must be offered protection from risks. Vulnerable subjects require additional protections.Methods: This paper reviews the ethical and conceptual basis of vulnerability within the context of human subjects research and suggests a basic approach that institutional review boards (IRBs) can use when considering if the research includes adequate safeguards to protect the rights and welfare of subjects who are likely to be vulnerable.Results: Two distinct approaches to describing the features that make a person vulnerable are the categorical approach and the contextual approach. The categorical approach considers certain groups or populations as vulnerable. This approach is not optimal because it does not address persons with multiple vulnerabilities, does not account for variation in the degree of vulnerability within the group based on individual characteristics, and classifies certain persons as vulnerable rather than identifying situations in which individuals might be considered vulnerable. The alternate contextual approach allows for a more nuanced understanding of the nature of the vulnerability than the categorical approach and therefore a more focused approach to safeguards. The IRB is charged with ensuring that additional safeguards to protect the rights and welfare of subjects who are likely to be vulnerable are included in the study under review. To make this determination, the IRB might be advised to consider two questions: (1) is inclusion necessary? and (2) if so, are safeguards adequate?Conclusion: Although vulnerability is often presented as a yes/no consequence related to some characteristic of a group, a more accurate approach is to consider vulnerability as occurring along a spectrum of seriousness and as a consequence of situations and context. With this idea in mind, investigators and IRBs are advised to take a stepwise approach to determining if the study meets the regulatory and ethical admonition to ensure that safeguards protect the rights and welfare of vulnerable subjects.

Behavioral Management is a Key Component of Ethical Research.

Behavioral management programs aim to enhance the welfare of animal subjects that participate in research, thereby enhancing our ability to conduct ethical research projects. Socialization strategies, environmental enrichment techniques, opportunities for subjects to voluntarily participate in research procedures, and the provision of Functionally Appropriate Captive Environments are 4 major components of most behavioral management programs. The appropriate implementation of behavioral management programs should provide animals with opportunities to engage in species-typical activity patterns, contributing to valid and reliable animal models that require the smallest number of subjects to achieve meaningful results. The role that socialization strategies, environmental enrichment techniques, and positive reinforcement training can play in maintaining and enhancing welfare through the stimulation of species-typical behavior and the prevention of abnormal behavior is discussed. The value of empirically assessing the effects of behavioral management techniques is emphasized. Additionally, the necessity of adjusting the relative prioritization of needs related to the convenience of human caregivers and the animals themselves is addressed. For the purposes of this discussion, research projects are considered to be ethical if they (1) involve animals with high welfare, (2) provide data that are reliable and valid, (3) involve appropriate numbers of subjects, and (4) involve animals that are appropriate models to test meaningful hypotheses.

Tuskegee Syphilis Study of 1932–1973 and the Rise of Bioethics as Shown Through Government Documents and Actions

One government source regarding clinical trials is Clinicaltrials.gov (https://clinicaltrials.gov), which is available to health information seekers as a resource to find information about past, current, and recruiting clinical trials. Currently, if you participate in a clinical trial you are required to provide your “informed consent.” This means you have been informed of the risks, benefits, purpose of the study, and your rights. This information is provided to you so that you, as the potential participant, can make an informed decision before deciding whether or not to participate. If you work with or in research, you will become very familiar with the term IRB, which stands for “Institutional Review Board.” An IRB is a panel intended to oversee the entire scope of one or more medical research studies including protecting the rights and welfare of human research subjects. Although it may seem like common sense that these two things are necessary, there was a time when they did not exist. A new approach to bioethics and the regulation of clinical trials and medical studies using living human subjects came about from public and governmental outrage over one study, known as the Tuskegee Syphilis Study. By looking specifically at this case, which led to the rise of bioethics at the federal-government level in the 1970s, the origin of IRBs and informed consent as they relate to medical studies and human subjects will be illuminated. The issues of IRBs, informed consent, and bioethics are important in the library and information science community because we often interact with a public that is impacted by the policies and regulations related to these issues. In addition, we are the very researchers, or hold relationships with researchers, that are held to the strict standards set in place by IRBs and bioethics in general.

Comités de ética en investigación con seres humanos: relevancia actual en Colombia

En este artículo se revisan los antecedentes históricos que propiciaron la aparición de los Comités de Ética de Investigación con Seres Humanos en el mundo, su fundamentación ética, la principal reglamentación a nivel internacional y la existente en Colombia. Enmarcado en ese contexto y por la relevancia que tienen en la actualidad, se hace un recuento de la creación, el desarrollo y las actividades del Comité de Ética en la Investigación de la Fundación Santa Fe de Bogotá. Este comité, creado en 1983, ha ejercido sus funciones durante 25 años con la búsqueda permanente de la excelencia en todas sus actividades dirigidas a la protección de la dignidad, los derechos y el bienestar de los sujetos que participan en investigaciones biomédicas y sociales

Sisterhood and "Doing Good": Asymmetries of Western Feminist Location, Access and Orbits of Concern

There are a variety of discourses and practices that position Western feminists (and Western political subjects more generally) as people who have a moral and political obligation to concern themselves with the welfare, suffering, or empowerment of non-Western subjects, often women, and intervene to “do good” on their behalf. Conversely, there are virtually no discourses and practices that assign moral and political obligations to non-Western feminists (or non-Western political subjects more generally) to intervene in matters involving the welfare or suffering of Western subjects, including women. A central goal of my paper is to make this asymmetry explicit and distinguish it from charges such as “essentialism” more commonly made against Western feminist representations of their Others. I explore the consequences of discourses and practices that construct Western subjects as entitled to and obligated to concern themselves with the world entire, while not extending this global scope of concern to non-Western subjects. I critically examine, among other things, the roles assigned Western-funded NGOs in enabling Western subjects to engage in practices of “doing good” and I explore alternative possibilities that are more explicitly “political.” Along the way, I examine certain blind spots in Western political theory that appear connected to the picture of Western subjects as obligated to “do good” in distant places. My analysis engages substantially with Alison Jaggar’s essay, “Saving Amina,” drawing attention to matters of agreement and possible disagreement.

PEMBANGUNAN DAN PEMBERDAYAAN MANUSIA MELALUI DANA DESA: POLA DARI MASA LALU HINGGA SINERGITAS YANG RANCU

Nawa Cita requires the village as the core of development. Funds are rolled out for each village to support the development, empowerment, and welfare of some village subjects. The main assumption is that the synergy of infrastructure followed by community empowerment will produce sustainable welfare. This rationality is considered not running together because it provides a large portion of the infrastructure and understates human empowerment. This study tried to discuss village funds by reviewing past development patterns, community development, and correcting infrastructure-based development. The discussion in this paper has been supported by various journals, figures, and news from online media. All materials are read interactively, reduced, then the essence of reading is developed according to inductive reasoning. It was found that from the past, village programs always referred to the provisions of the central government. Even though the problems and needs of each village are very different. Then, the lack of understanding of the village apparatus about the program, it is not uncommon for programs to be rolled out to be replicas from other villages. This paper also discusses community-based development as a solution to village fund problems.

The Contribution of Ethics Review to Protection of Human Participants: Comment on "Measuring the Quality and Performance of Institutional Review Boards".

Measuring the quality and performance of IRBs requires clarity about what IRBs are supposed to do. Although many agree that IRBs are supposed to protect the rights and welfare of human subjects, exactly how review by an IRB contributes to protection is not always clear. Originally, ethics review was instituted as a way to check the interests, possible conflicts, and enthusiasm of investigators whose relationship to participants is different from physicians' relationship to patients. IRB performance might include evaluating how well IRBs do this.

Citizen Scientists as Human Subjects: Ethical Issues

An increasing number of human studies are asking participants to have substantial involvement in research. Citizens in human studies may contribute to various research activities, including study design, recruitment, data interpretation, and data and sample collection. Citizen involvement in research raises novel ethical issues for human studies, because individuals have traditionally occupied the role of researcher or subject, but not both at the same time. The confluence of these two different roles in the same person poses challenges for investigators and oversight committees because legal rules and ethical guidelines focus on protecting the rights and welfare of human subjects and do not address issues that fall outside this domain, such as study design, data quality and integrity, reporting misconduct, authorship, or publication. This article examines some of these issues and makes recommendations for investigators and oversight committees.

Cultivating inclusivity in precision medicine research: disability, diversity, and cultural competence.

Cultural competence is increasingly viewed as key for the inclusion of diverse populations in precision medicine research (PMR) in the USA. Precision medicine researchers and personnel are thus increasingly expected to undergo cultural competency trainings and to engage with relevant racial/ethnic communities to ensure that all research components are culturally and linguistically sensitive to these communities. However, the need for PMR enterprises to ensure competence with and understanding of disability rights, history, and needs (hereinafter disability culture competency) have not received attention. This article discusses the importance of disability inclusivity in PMR and the construct-and challenges-of disability as a cultural community. Reviewing and extrapolating from studies in healthcare settings, the article considers three interrelated issues that are likely to impact disability inclusivity in PMR: disability accessibility and accommodation; disability stigma and unconsious bias; and disability language and communication. Next, disability competency trainings that were developed in healthcare settings are surveyed and their applicability for PMR is discussed. The arguments advanced are that disability culture competency among precision medicine researchers, personnel, and oversight committees is essential to upholding the welfare and rights of human subjects with disabilities in PMR; that engagement with disability communities is imperative for this endeavor; and that such knowledge of disability culture is crucial for cultivating inclusivity of people with different (dis)abilities in PMR.