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In the 60+ years that the modern concept of informed consent has been around, researchers in various fields of practice, especially medical ethics, have developed new models to overcome theoretical and practical problems. While (systematic) literature reviews of such models exist within given fields (e.g., genetic screening), this article breaks ground by analyzing academic literature on consent models across fields. Three electronic research databases (Scopus, Google Scholar, and Web of Science) were searched for publications mentioning informed consent models. The titles, abstracts, and if applicable, full publications were screened and coded. The resulting data on fields, models, and themes were then analyzed. We scanned 300 sources from three databases to find 207 uniquely named consent models, and created a network visualization displaying which models occur primarily in one field, and which models overlap between fields. This analysis identifies trends in the consent debate in different fields, as well as common goals of consent models. The most frequently occurring consent models are identified and defined. The analysis contributes toward a cross-disciplinary "consent design toolkit" and highlights that there are more interrelationships between models and fields than are acknowledged in the literature. Where some models are designed to solve distinctively field-specific issues and are specific to biomedical ethics, some may be adaptable and applicable for other fields including engineering and design., (© 2022. The Author(s).)

Purpose: There is a persistent HIV epidemic among sexual and gender minority adolescents in the U.S. Oral pre-exposure prophylaxis (PrEP) is an efficacious prevention strategy, but not yet approved for minors. Minors' access to biomedical HIV prevention technologies is impeded by the ethical and legal complexities of consent to research participation. We explore autonomous consent and study experiences among minor and adult participants in Project PrEPare, a Phase II safety study of PrEP for HIV prevention., Methods: Data for this mixed-methods descriptive study were collected via self-administered web-survey and in-depth telephone interviews in early 2016. Eligible participants were previously enrolled in Project PrEPare. We attempted to contact 191 participants; 74 were reached and expressed interest in participating and 58 enrolled., Results: Participants nearly universally felt well informed, understood the study, and freely volunteered with the clear understanding they could withdraw any time. All felt supported by study staff, but a small minority wished for more support during enrollment. Minors were more likely than adults to indicate a wish for more support in decision-making, and adults expressed higher satisfaction with their decision compared to minors. There was no association between elements of consent and Project PrEPare study outcomes., Conclusions: Participants had an overwhelmingly positive experience in a Phase II safety study of PrEP for HIV prevention. Some minors wished for more support during the decision-making process, but none consulted their parents about the decision. Our results support the inclusion of decisional supports in consent processes for adolescents, while also protecting their privacy., (Copyright © 2017 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: To describe the development and testing of a module to improve consent administrators' skills when obtaining research consent from culturally and linguistically diverse and low literacy populations., Design: Development and psychometric testing of video module including community vignettes., Methods: Following initial content, face, and construct validity testing by experts, a field trial was conducted with pre- and postknowledge tests and satisfaction surveys completed by 112 consent administrators., Results: Mean score out of a possible 10 on pretest was 8.6 (±standard deviation [SD], 1.55) and on posttest was 9.1 (±SD, 1.2; paired t-test 95% confidence interval of difference: -0.18 to -0.88; two-tailed p = 0.003). The average years of experience with obtaining consent was 6.42 years (range: 0-35), but years of experience was not significantly associated with either pre- or posttest scores (p = 0.82 and 0.44, respectively). Most user evaluations were positive, although suggestions for improvements were made., Conclusion: Although pretest scores were relatively high, training needs of research consent administrators for consenting diverse and low literacy populations may be unmet. We urge that institutional review boards, researchers, policymakers, educators, and bioethicists address the training needs of research consent administrators and we offer this training module as one potential resource and adjunct to such training., (© 2015 Wiley Periodicals, Inc.)

Politicians, employers, courts, and health insurance companies are often discussed as problematically preventing access to birth control. However, doctors have more direct control over women's health and quietly have been much more effective at preventing patients' access to contraception. Obstetrician/Gynecologists routinely deny their patients access to contraception ostensibly in the name of health by withholding birth control until patients undergo yearly pap smears. I argue that those in the medical field are motivated by similarly sexist concerns as those in other major institutions in the United States, but that they are often overlooked in discussions of biomedical ethics. After providing background, I argue that using birth control as a bargaining chip to control patients is morally impermissible, is paternalistic, and is contrary to consent. I next argue that sexism explains, though does not justify, this practice. I discuss the medical harms of routine pap smears and withholding birth control. These claims make medical malpractice likely. Withholding birth control to coerce individuals seeking medical care is medical malpractice, paternalistic, violates autonomy, and is contrary to consent. [ABSTRACT FROM AUTHOR]

The practice of contemporary medicine has been tremendously influenced by western ideas and it is assumed by many that autonomy is a universal value of human existence. In the World Health Report 2000, the World Health Organization (WHO) considered autonomy a "universal" value of human life against which every health system in the world should be judged. Further in Western bioethics, patient autonomy and self -determination prevails in all sectors of social and personal life, a concept unacceptable to some cultures. In principle, there are challenges to the universal validity of autonomy, individualism and secularism, as most non-Western cultures are proud of their communal relations and spiritualistic ethos and, thereby imposing Western beliefs and practices as aforementioned can have deleterious consequences. Religion lies at the heart of most cultures which influences the practice patterns of medical professionals in both visible and unconscious ways. However, religion is mostly viewed by scientists as mystical and without scientific proof. Herein lies the dilemma, whether medical professionals should respect the cultural and religious beliefs of their patients? In this paper we aim to discuss some of the limitations of patient's autonomy by comparing the process of reasoning in western medical ethics and Islamic medical ethics, in order to examine the possibility and desirability of arriving at a single, unitary and universally acceptable notion of medical ethics. We propose a more flexible viewpoint that accommodates different cultural and religious values in interpreting autonomy and applying it in an increasingly multilingual and multicultural, contemporaneous society in order to provide the highest level of care possible. [ABSTRACT FROM AUTHOR]

This article argues that many forms of 'integrative' medicine (IM) offered in modern hospitals are both secular and religious. Practices such as yoga, t'ai chi, acupuncture, mindfulness meditation, biofeedback, chiropractic, homeopathy, aromatherapy, Reiki, Therapeutic Touch, and Healing Touch are premised on metaphysical assumptions about spiritual energy that are deeply informed by religions such as Hinduism, Buddhism, and Daoism, and Western metaphysical spirituality. In the hospital setting, religious, spiritual, and secular language, goals, and techniques often bleed into one another-not accidentally, but through calculated marketing and rhetorical maneuvering. The case of 'energy medicine' illustrates tactics that IM promoters use to gain entrance to the hospital by relabeling metaphysics as medicine. Intentionally blurring the boundaries between medical and religious therapies creates biomedical ethical and legal dilemmas through a lack of informed consent. [ABSTRACT FROM AUTHOR]

Objective: To describe the development and testing of a module to improve consent administrators' skills when obtaining research consent from culturally and linguistically diverse and low literacy populations. Design: Development and psychometric testing of video module including community vignettes. Methods: Following initial content, face, and construct validity testing by experts, a field trial was conducted with pre- and postknowledge tests and satisfaction surveys completed by 112 consent administrators. Results: Mean score out of a possible 10 on pretest was 8.6 (±standard deviation [SD], 1.55) and on posttest was 9.1 (±SD, 1.2; paired t-test 95% confidence interval of difference: -0.18 to -0.88; two-tailed p = 0.003). The average years of experience with obtaining consent was 6.42 years (range: 0-35), but years of experience was not significantly associated with either pre- or posttest scores ( p = 0.82 and 0.44, respectively). Most user evaluations were positive, although suggestions for improvements were made. Conclusion: Although pretest scores were relatively high, training needs of research consent administrators for consenting diverse and low literacy populations may be unmet. We urge that institutional review boards, researchers, policymakers, educators, and bioethicists address the training needs of research consent administrators and we offer this training module as one potential resource and adjunct to such training. [ABSTRACT FROM AUTHOR]

The executive order and issuance of federal guidelines for human embryonic stem cell research are positive developments and will produce long-term benefits by creating a new registry for hESC lines. But there may be short-term costs caused by regulatory uncertainty, procedural delay, and knock-on effects as national policies are adopted at state and local jurisdictions. Policymakers must ensure that national mechanisms of oversight for a new hESC registry are adequately funded, properly organized, transparent, and free of bureaucratic detail. [ABSTRACT FROM AUTHOR]

The article focuses on the concept of informed consent applied to clinical research that involves patients with chest disease in the U.S. after research abuses were documented in Nazi Germany. It states that the Federal regulations governing clinical research has required both the consent of subjects and peer review of research proposals by institutional review boards (IRBs). It discusses the subpart A of the Code of Federal Regulations that contains basic provisions of the issue.