Advancing informed consent for vulnerable populations.
Ontology highlight
ABSTRACT:
SUBMITTER: Heerman WJ
PROVIDER: S-EPMC4338326 | biostudies-literature | 2015 Mar
REPOSITORIES: biostudies-literature
Publications
Advancing informed consent for vulnerable populations.
Heerman Willliam J WJ White Richard O RO Barkin Shari L SL
Pediatrics 20150301 3
Similar Datasets
Project description: Not available
| S-EPMC7392325 | biostudies-literature
Project description:BackgroundLittle is known about patient characteristics associated with comprehension of consent information, and whether modifications to the consent process can promote understanding.ObjectiveTo describe a modified research consent process, and determine whether literacy and demographic characteristics are associated with understanding consent information.DesignDescriptive study of a modified consent process: consent form (written at a sixth-grade level) read to participants, combined with 7 comprehension questions and targeted education, repeated until comprehension achieved (teach-to-goal).ParticipantsTwo hundred and four ethnically diverse subjects, aged > or = 50, consenting for a trial to improve the forms used for advance directives.MeasurementsNumber of passes through the consent process required to achieve complete comprehension. Literacy assessed in English and Spanish with the Short Form Test of Functional Health Literacy in Adults (scores 0 to 36).ResultsParticipants had a mean age of 61 years and 40% had limited literacy (s-TOHFLA<23). Only 28% of subjects answered all comprehension questions correctly on the first pass. After adjustment, lower literacy (P=.04) and being black (P=.03) were associated with requiring more passes through the consent process. Not speaking English as a primary language was associated with requiring more passes through the consent process in bivariate analyses (P<.01), but not in multivariable analyses (P>.05). After the second pass, most subjects (80%) answered all questions correctly. With a teach-to-goal strategy, 98% of participants who engaged in the consent process achieved complete comprehension.ConclusionsLower literacy and minority status are important determinants of understanding consent information. Using a modified consent process, little additional education was required to achieve complete comprehension, regardless of literacy or language barriers.
| S-EPMC1831581 | biostudies-literature
Project description:BackgroundTrauma is highly prevalent among vulnerable populations, including those who are incarcerated, in treatment for substance use, or seeking mental health services. Trauma-informed yoga seeks to create a safer yoga practice for individuals with a trauma history and may improve emotional and physical wellbeing. Thus, we conducted an evaluation of a trauma-informed yoga program to gain insight into participant experiences.MethodsTrauma-informed yoga classes were led by trained volunteers and held in three sectors that work with vulnerable populations: corrections and reentry, substance use treatment and recovery, and community and mental health. Data were collected via anonymous survey using a retrospective pre-post design. The survey instrument captured reasons for student participation and perceived effects of yoga on emotional and physical wellbeing.ResultsStudents were motivated to participate in yoga classes by expectations of physical, mental, and spiritual benefit. Students reported perceived improvements in emotional and physical wellbeing and greater use of self-regulation skills after starting yoga.ConclusionOur findings suggest trauma-informed yoga is perceived as beneficial by vulnerable individuals, especially those in the correctional system or recovering from substance use. Our results support the value of offering trauma-informed yoga in institutionalized and community settings. Improvements in emotional and physical wellbeing warrant formal study.
| S-EPMC8325936 | biostudies-literature
Project description:BackgroundA topic of great concern in bioethics is the medical research conducted in poor countries sponsored by wealthy nations. Western drug companies increasingly view Latin America as a proper place for clinical research trials. The region combines a large population, modern medical facilities, and low per capita incomes. Participants from developing countries may have little or non alternative means of treatment other than that offered through clinical trials. Therefore, the provision of a valid informed consent is important.MethodsTo gain insight about some aspects of the informed consent procedure in a major cancer centre in Mexico, we conducted a three-step evaluation process: 1) a ten point multiple choice survey questionnaires, was used to explore some aspects of the patients' experiences during the informed consent process, 2) researchers' knowledge about specific aspects of the informed consent was evaluated in this study using survey questionnaires; and 3) the comprehensibility, readability and number of pages of the consent forms were analysed. The socioeconomic and educational level of the patients, were also considered. Results were reported using a numerical scale.ResultsThirty five patients, 20 doctors, and 10 individuals working at the hospital agreed to participate in the study. Eighty three percent of the patients in the study were classified as living in poverty; education level was poor or non existent, and 31% of the patients were illiterate. The consent forms were difficult to understand according to 49% of the patients, most doctors agreed that the forms were not comprehensible to the patients. The average length of the IC documents analysed was 14 pages, and the readability average score was equivalent to 8th grade.ConclusionThe results presented in this work describe some relevant characteristics of the population seen at public health care institutions in Mexico. Poverty, limited or no education, and the complexity of the information provided to the patients may question the validity of the informed consent procedure in this group of patients.
| S-EPMC1764745 | biostudies-literature
Project description: Not available
| S-EPMC1112854 | biostudies-literature
Project description: Not available
| S-EPMC1126664 | biostudies-literature
Project description: Not available
| S-EPMC1121943 | biostudies-literature
Project description:The practice of clinical informed consent in America is governed by over 100 years of case law. Although predominant ethics resources for behavior analysts offer some guidance regarding the provision of clinical informed consent, such guidance remains limited. The goal of this article is thus to expand the contemporary literature on clinical informed consent in behavior analysis by providing a historical and contemporary guide to relevant case law. The article will highlight seminal moments in the history of case law regarding clinical informed consent, discuss their applicability to the process of clinical informed consent in behavior analysis, and provide an enhanced understanding of the ethical and legal obligations related to informed consent in the therapeutic context.Supplementary informationThe online version contains supplementary material available at 10.1007/s40617-023-00902-0.
| S-EPMC11219615 | biostudies-literature
Project description:BackgroundThe informed consent process aims to provide potential participants with information about health research that enables them to make an informed decision as to whether they choose to participate, or not. However, it remains unclear as to whether the process is effective for those who are under-served in health research. It is a pivotal issue within health research that the diversity of people who participate is broadened. The National Institute for Health Research (NIHR) pledges to support equality, diversity and inclusion, actively creating opportunities for all citizens whom are eligible, to take part in health research.MethodsIn order to understand how the informed consent process for under-served populations in health research works, under what circumstances and in what respects, a realist review approach will be undertaken. Searches will be carried out using electronic databases (EMBASE, MEDLINE, Web of Science and PsycINFO), along with selected websites and grey literature. Development of initial rough programme theory(ies) will lead to a more refined programme theory that will provide an explanation of context, mechanism and outcomes. Stakeholder involvement by NIHR (Public) Research Champions, health professionals and clinical academics will provide expert opinion about concepts and programme theory.DiscussionFindings of this realist review will highlight how the informed consent process in health research affects the experience and decision-making process of potential participants from under-served populations. They will be written up in accordance with RAMESES guidelines and disseminated to patients and the public, health researchers, health professionals and policymakers through peer-reviewed publication, presentations and discussions. The review will contribute to our understanding of the mechanisms that cause both positive and negative outcomes in the informed consent process for those whom are often under-represented in health research to inform policy, study design and delivery.
| S-EPMC8034278 | biostudies-literature
Project description:The doctrine of informed consent, as opposed to medical paternalism, is intended to facilitate patient autonomy by allowing patient participation in the medical decision-making process. However, regrettably, the surgical informed consent (SIC) process is invariably underestimated and reduced to a documentary procedure to protect physicians from legal liability. Moreover, residents are rarely trained in the clinical and communicative skills required for the SIC process. Accordingly, to increase professional awareness of the SIC process, a brief history and introduction to the current elements of SIC, the obstacles to patient autonomy and SIC, benefits and drawbacks of SIC, planning of an optimal SIC process, and its application to cases of an unruptured intracranial aneurysm are all presented. Optimal informed consent process can provide patients with a good comprehension of their disease and treatment, augmented autonomy, a strong therapeutic alliance with their doctors, and psychological defenses for coping with stressful surgical circumstances.
| S-EPMC5544373 | biostudies-other