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Sparking and Sustaining the Essential Functions of Research: What Promotes Discovery?
Published in Thomas S. Inui, Richard M. Frankel, Enhancing the Professional Culture of Academic Health Science Centers, 2022
Mengfeng Li, Guoquan Gao, Minhao Wu, Hongmei Tan, Wenjun Xin, Xia Yang, Yi Yang, Kaihua Guo, Qiongzhu Chen
Some of the authors of this chapter are scholars who have worked as faculty members in both US and Chinese medical schools. Because of this international experience, we have been especially interested in identifying institutional issues, solutions to which might significantly improve the cost-effectiveness of research conducted in Chinese medical schools. These issues include: (1) efficient organizational structures; (2) effective cooperation mechanisms among researchers; (3) balanced infrastructure and its full utilization; (4) a sound academic assessment system; (5) a favorable environment for development of younger scientists; and (6) a highly functional science research funding and fund-management mechanism. In this chapter we discuss organizational structure, infrastructure development, and academic assessment in the scientific research system implemented by China’s medical schools, as well as their relevance to biomedical research.
Ethical issues concerning informed consent in translational/clinical research and vaccination
Published in Joseph Tham, Alberto García Gómez, Mirko Daniel Garasic, Cross-Cultural and Religious Critiques of Informed Consent, 2021
Regarding the way informed consent notion interacts with biomedical research, some of the key questions that we want to address here are: How much of the notion of informed consent is applied in one’s tradition? And in which way?Can or should we have different informed consent forms for differently vulnerable populations?Do all traditions agree with the general principles behind informed consent (i.e. the prioritization of individual autonomy)? If not, what alternative values/approach could support widespread vaccination, for example?
Clinical Trial Designs
Published in Gary L. Rosner, Purushottam W. Laud, Wesley O. Johnson, Bayesian Thinking in Biostatistics, 2021
Gary L. Rosner, Purushottam W. Laud, Wesley O. Johnson
An important goal of biomedical research is to discover the causes of diseases and find effective ways to treat them. Some diseases affect patients acutely, such as pneumonia or other infections. Other diseases may progress to become clinically symptomatic more slowly and last longer, requiring long-term therapy, sometimes for the rest of the person's life. In all cases, however, the research is driven by learning, then developing and testing theories. Sometimes the research is based in a laboratory, either with cell lines, yeast, or mammals. Eventually, though, the research will move to evaluate the therapy in clinical settings, both human and veterinary. Clinical trials are a class of experiments carried out as research in a clinical setting.
Optical coherence tomography angiography of retinal vasculature in recovered COVID-19 patients compared to age and ethnic matched controls
Published in Clinical and Experimental Optometry, 2022
Julie Rodman, Mariana Ferraz, Ariela Baran, Bin Zhang
This research was reviewed by an independent ethical review board and conforms with the principles and applicable guidelines for the protection of human subjects in biomedical research. The study was cross-sectional and prospective and was performed at Nova Southeastern University’s Eye Care Institute in Fort Lauderdale, Florida. Approval for this work was provided by the Institutional Review Board at Nova Southeastern University. Written informed consent was obtained from all enrolled patients. The study adhered to the tenants of the Declaration of Helsinki and the provisions of the Health Insurance Portability and Accountability Act. Patients previously diagnosed with mild COVID-19 infection between September 2020 and January 2021 who provided written consent for the study were included.
Fostering Relationships in Pediatric Oncology Research: A Relational Ethics Approach to Clinically Integrated Research
Published in The American Journal of Bioethics, 2021
Brittany M. Lee, Stephanie A. Kraft
Ethical issues in biomedical research are traditionally examined as distinct from those of clinical care. However, this traditional framing may obscure questions of equity and fairness in both research and clinical translation. This is particularly salient in fields like precision medicine and pediatric oncology, where an individual’s relationship with research may be woven throughout their experience of clinical care. Lee thoughtfully approaches these considerations in the context of precision medicine research in the target article (Lee 2021). She highlights that by separating the discussion of research and clinical care, we risk deepening existing health disparities and structural inequities in the application of the research. Lee argues that grounding our ethical obligations to precision medicine research participants in the reciprocity of research relationships supports equity and fairness in both data collection and clinical translation. In this commentary, we argue that conceptualizing research participation in pediatric oncology through a similar lens of reciprocity offers a broad grounding for our ethical obligations to participants that can help us work toward a goal of equity and justice in research and medicine.
Sub-acute oral toxicity study of aqueous extract of tobacco leaves (Nicotiana tabacum L.) on lipid profile, the tissue, and serum of the liver and kidney of male Wistar rats
Published in Biomarkers, 2021
Felix Atawal Andong, Ebele Augustina Orji, Ngozi Evelyn Ezenwaji, Augustine Okorie Nkemakolam, Temitope Dadewura Melefa, Antoinette Onyebuchi Chukwurah, Oguche Moses Ojonugwa, Faith Funmilayo Hinmikaiye, Arinze Ikechukwu Onwurah
The study was conducted at the Department of Pharmacology and Toxicology Laboratory, Faculty of Pharmaceutical Sciences, the University of Nigeria, under the approval of the University of Nigeria National Code of Conduct for Animal Research Ethics Committee. The study conformed with the International Guiding Principles for Biomedical Research Involving Animals. We purchased fifty-two (52) male Wistar rats (weight = 33 − 47 g; ∼ 2½ weeks old) from the animal house of the Department of Zoology and Environmental Biology, the University of Nigeria, Nsukka (6° 51′ 21” N, 7° 23′ 45” E). We monitored the rats under conducive environmental conditions (12/12 h light/dark cycle; temperature 28 ± °C), with free access to water and feed (pelleted rats’ growers mash diet; Vital feed, Jos, Nigeria) (Edeogu et al. 2009). The pelletised feed contained crude protein (13%), fat (8%), crude fibre (15%), calcium (0.9%), and 0.35% available phosphorus. Of the fifty-two (52) male Wistar rats grouped randomly into four groups (n = 10; A, B, C, D mg/kg), twelve (12) were used for acute toxicity testing. The study lasted for 30 days after 7 days of acclimatisation.