Conduct Of Clinical Research Research Articles

The CARE (Curiosity, Attentiveness, Respect and Responsiveness, and Embodiment) Model: Operationalizing Cultural Humility in the Conduct of Clinical Research.

Cultural competence training has been criticized for reinforcing existing stereotypes, ignoring intersectionality and inadvertently marginalizing some individuals and groups. In contrast, cultural humility offers the possibility of transformational learning, requiring individuals to pursue a lifelong course of self-examination. This approach makes authentic engagement with others possible. We review the premises underlying cultural competence and cultural humility, as well as proposed models for the integration of cultural humility into the clinical context. We propose a new model for the integration of cultural humility into clinical research: CARE, signifying Curiosity, Attentiveness, Respect and Responsiveness, and Embodiment. We conclude that the concept of cultural humility can be integrated into the conduct of clinical research.

Guidance on the Conduct of Clinical Research within OECD Countries during the Early Stages of the COVID-19 Pandemic: A Systematic Review

In response to the COVID-19 pandemic, member countries of the Organisation for Economic Co-operation and Development (OECD) rapidly published guidance regarding the conduct of clinical research. A systematic review was conducted to explore the recommendations issued in relation to the commencement, continuation and termination of clinical research during the early phases of the pandemic. Searches consisting of the terms "COVID-19", "clinical research", and "guidance", were conducted in PubMed, Embase, MEDLINE, Trip, Guidelines International Network, and Google in April-May 2021 (up to 4 May 2021). Data were extracted from guidance published from OECD member countries and mapped to inductively-developed categories. 9419 references were systematically screened, resulting in the inclusion of 46 publications from 27 OECD countries. Thirty-three sources made recommendations regarding monitoring, risk-benefit assessments and information technology. There was limited specific recommendations made in relation to personal protective equipment (PPE) in the included guidance. Findings demonstrate that guidance differed by publication date demonstrating the rapidly evolving environment within which research was conducted. Importantly, many organisations opted to endorse existing guidance published by the United States' Food and Drug Administration and the European Medicines Agency rather than develop their own recommendations. Given the rapidly evolving nature of the pandemic, particularly in the early stages, findings demonstrate the global response in relation to clinical research conduct, thereby providing important insights for future public health emergencies.

Development and Validity Assessment of a Self-evaluation Questionnaire for Functional Dyspepsia: A Multicenter Prospective Study in Korea.

Background/AimsPatient-reported outcomes (PROs) are essential for clinical decision making, conduction of clinical research, and drug application acquisition in functional gastrointestinal disorders. The aim of this study is to develop a PRO instrument and to determine the respondents’ perception of the efficacy of therapeutic agents for functional dyspepsia (FD).MethodsA self-evaluation questionnaire for dyspepsia (SEQ-DYSPEPSIA) was developed and validated through a structured process. The 2-week reproducibility was evaluated, and the construct validity was assessed by correlating the scores of SEQ-DYSPEPSIA (including typical and major FD symptom subscales). Finally, the response to medication was assessed by comparing the changes after 4 weeks of treatment.ResultsA total of 193 Korean patients (age 48.5 ± 13.6 years, 69.4% women) completed the questionnaire. SEQ-DYSPEPSIA with 11 items had a good internal consistency (alpha = 0.770-0.905) and an acceptable test-retest reliability (intraclass correlation coefficient = 0.733-0.859). The self-evaluation questionnaire (SEQ)-major FD score highly correlated with the postprandial fullness/early satiety domain of the Patient Assessment of Gastrointestinal Symptom Severity Index (correlation coefficient r = 0.741, P < 0.001), Nepean Dyspepsia Index-Korean version (NDI-K) (r = 0.839, P < 0.001), and NDI-K quality of life (r = −0.275 to −0.344, P < 0.001). After medical treatment, decrease in the SEQ-typical FD and SEQ-major FD was significantly greater in the responder group than in non-responder group (P = 0.019 and P = 0.009, respectively).ConclusionThis study suggests that the Korean version of SEQ-DYSPEPSIA has good reliability and validity, and can be a useful PRO measurement tool in patients with FD.

Some Objectivity to the Ethical Aspects in Conduct of Clinical Research in Vulnerable Population

Some Objectivity to the Ethical Aspects in Conduct of Clinical Research in Vulnerable Population

Cultural Considerations in the Conduct of Clinical Research: The Guam Experience

Cultural sensitivity provides one of the foundations for a successful clinical research within tribal communities. Researchers involved in the efforts that cross paths with cultural practices of human subjects must be aware of the potential impact as well as the challenges these will pose to the clinical research process. These were some of the insights gained from the research experience of the biomedical research team from University of Guam (UOGCRC) and the University of Hawai’i (UHCC) after conducting a study in Guam which aimed to describe the betel nut chewing practices of its indigents and identify specific biomarkers that occur in the saliva of humans after betel nut (BN) mastication.

The stress of aging

Although the evolutionary theories of aging are quite well established, our knowledge about how we age is still very limited. The abundance and heterogeneity of available mechanistic theories of aging implicitly suggest that this phenomenon is overly complex and unlikely to be explained by a single pathway. Moreover, although aging remains a unique process, it is characterized by heterogeneous manifestations, not only determining inter-individual variations, but even intra-individual diversities. Such heterogeneity renders the inner nature of the aging process of difficult evaluation in older persons due to the potential biases introduced by multiple age-related social, biological, and clinical factors (and responsible for the evidence-based issue in geriatrics). Moving from the difficulties in translating anti-aging preclinical interventions into clinical trials, an alternative approach is illustrated. We encourage moving to a holistic evaluation of aging by adopting specific and consequent modifications in the design and conduction of clinical research. Such approach is today commonly applied in the clinical setting where the complexity of older patients often requires multidimensional interventions to adequately target the geriatric syndromes. Consistently, interventions targeting the aging process may result ineffective if too focused on a single underlying causal mechanism and/or failing to capture the complexity of the phenomenon. In this context, frailty (a geriatric syndrome characterized by age-related declines occurring across multiple physiologic systems) may indeed represent a clinically relevant threshold throughout the continuum of the aging process and a promising benchmark to test multidomain interventions against age-related conditions.

Determining Risk in Pediatric Research with No Prospect of Direct Benefit: Time for a National Consensus on the Interpretation of Federal Regulations

United States federal regulations for pediatric research with no prospect of direct benefit restrict institutional review board (IRB) approval to procedures presenting: 1) no more than “minimal risk” (§ 45CFR46.404); or 2) no more than a “minor increase over minimal risk” if the research is commensurate with the subjects' previous or expected experiences and intended to gain vitally important information about the child's disorder or condition (§ 45CFR46.406) (DHHS 2001). During the 25 years since their adoption, these regulations have helped IRBs balance subject protections with the pursuit of scientific knowledge to advance children's welfare. At the same time, inconsistency in IRB application of these regulations to pediatric protocols has been widespread, in part because of the ambiguity of the regulatory language. During the past decade, three federally-charged committees have addressed these ambiguities: 1) the National Human Research Protections Advisory Committee (NHRPAC) (Washington, DC), 2) the Institute of Medicine (IOM) Committee on the Ethical Conduct of Clinical Research Involving Children (Washington, DC); and 3) the United States Department of Health and Human Services Secretary's Advisory Committee for Human Research Protections (SACHRP) (Washington, DC). The committees have reached similar conclusions on interpretation of language within regulations § § 45CFR46.404 and 406; these conclusions are remarkably consistent with recent international recommendations and those of the original National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1977) report from which current regulations are based. Drawing on the committees' public reports, this article identifies the ethical issues posed by ambiguities in regulatory language, summarizes the committees' deliberations, and calls for a national consensus on recommended criteria.

The Conduct of Clinical Research Under the HIPAA Privacy Rule

This article is the report of a work group of the American Academy of Orthopaedic Surgeons Council on Research, Quality Assessment, and Technology. The task assigned to the group by the Chair, Joshua Jacobs, MD, was to review, codify, and disseminate information for the Fellowship on the compliance requirements for conducting clinical research under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. The ethical conduct of clinical practice has an established precedent extending to ancient times and the beginnings of the healing professions, encoded in the Code of Hammurabi and the Hippocratic oath. These guides were intended to regulate the conduct and ethics of the purveyors of medical treatment in the ancient world. They also prescribed boundaries of behavior and penalties for transgressions, including corporal punishment. Comparatively, medical research does not have such a history and was largely without published standards of conduct until the twentieth century. The Nazi physician trials in 1946 exposed atrocities committed under the guise of experimental human medical research, which resulted in the 1947 Nuremberg Code for human research1. Included in the ten precedents that it established were the important requirements that subject participation be informed and voluntary and that human research must be scientifically valid and conducted solely for the benefit of society as a whole. The Nuremberg Code was accepted by the fifty-one signatory nations of the Charter of the United Nations. In 1953, the Clinical Center of the United States National Institutes of Health produced the first federal policy to protect human research subjects. The years after World War II saw an increase in scientific technology applied to medical treatment protocols. The new policy was consistent with the Nuremberg Code and gave special emphasis to the protection of healthy adult research volunteers. This policy established the beginning of …

Book Review Ethical Conduct of Clinical Research Involving Children Edited by Marilyn J. Field and Richard E. Behrman. 448 pp., illustrated. Washington, D.C., National Academies Press, 2004. $57. 0-309-09207-8

Book Review Ethical Conduct of Clinical Research Involving Children Edited by Marilyn J. Field and Richard E. Behrman. 448 pp., illustrated. Washington, D.C., National Academies Press, 2004. $57. 0-309-09207-8

Human Subjects in Medical Experimentation: A Sociological Study of the Conduct and Regulation of Clinical Research

This book by Bradford Gray will be a landmark for the clinical researchers in academic medicine. He has documented objectively the problem in communication and the discrepancies between standards and practice in the conducting of clinical research. The book comes across as a scientific evaluation, done by an individual sympathetic to medicine and clinical investigation who finds glaring defects in the mechanisms now utilized for protecting the individual and his rights. The paternalism of the medical profession and conflict between ethics and the career interests of the investigators in the academic system are highlighted by the findings of the study. There is no alternative but to admit we have done a poor job in actual performance despite meeting proper paper requirements. The author makes some definite recommendations for improving communication between investigator and subject and the monitoring, by the Clinical Research Committee, of the experimental process and the individual's rights.