Ethical Considerations for Clinical Research Collaborations

2008 ◽  
Vol 18 (3) ◽  
pp. 77-81
Author(s):  
Sherri M. Jones ◽  
Christina M. Figueroa

Abstract The definition of clinical research adopted by the National Institutes of Health (NIH) includes three areas, 1. patient-oriented research, 2. epidemiologic and behavioral studies, and 3. outcomes and health services research (DHHS, 2003). Extensive research training is not a core component of many clinical-degree programs, and clinicians may not have the requisite knowledge and skills to initiate a research program independently. However, clinicians and the clinical sites where they practice can play an integral part in collaborative research. This review discusses five areas for clinical supervisors to consider prior to initiating a research project, which include formal approvals, determining which aspects of the study to be involved in, subject recruitment and informed consent, data collection and storage, and dissemination of results. These are not the only areas that might be considered; however, mutual agreement on these issues before the project begins will facilitate successful collaboration and foster responsible conduct of research. The ethical conduct of research is paramount for the scientific base of our professions. Additionally, the information and guidelines presented are intended to facilitate discussion and offer resources for further study.

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 1679-1679
Author(s):  
Linda J Burns ◽  
Charles P Clayton ◽  
James N. George ◽  
Beverly S. Mitchell ◽  
Scott D. Gitlin

Abstract There is a recognized need to translate scientific discoveries to patient-oriented clinical research (POCR) in order to improve human health. To overcome obstacles that interfere with the recruitment and retention of physicians for POCR careers, in 2003 the American Society of Hematology (ASH) developed the Clinical Research Training Institute (CRTI), an enhanced and extensive mentored experience for early career POCR investigators. The ASH CRTI is limited to 20 trainees/year (senior fellows or junior faculty) with an equivalent number of faculty mentors. The year-long Institute includes a 1 week workshop with didactic sessions on a variety of POCR and career development topics, disease-specific small group sessions focusing on research protocol development with biostatistician participation, and one-on-one interactions with faculty and representatives with expertise in career-development awards from the U.S. National Institutes of Health. Trainees have additional interactions with their small groups and CRTI mentors throughout the ensuing year to promote career development and research collaborations. Communications between the trainees’ CRTI and home institution mentors are a vital component of the program. Evaluation of the POCR career development successes of the first 7 CRTI classes (140 trainees) was performed by reviewing trainees’ curriculum vitaes and their responses to an electronically distributed survey. Gender, racial and ethnic distributions were similar to that of U.S. Hematology/Oncology fellowship programs. The majority (66%) of trainees were senior fellows or graduates of adult hematology/oncology training programs, 31% of pediatric hematology/oncology programs and the remainder of other hematology-related programs. Eighty-six percent of trainees had self-described success establishing a POCR study and 85% considered themselves clinical investigators. Nearly half of trainees had positions that were primarily research focused. CRTI trainees received at least 144 external grant awards plus additional internal awards, and had published 1035 peer-reviewed manuscripts,173 chapters and 115 review articles. Over 95% of trainees were satisfied with their CRTI experience and testimonials supported their impression that CRTI had a significant impact on their career success. Enhancements introduced into the CRTI program, as a result of ongoing program evaluations, include broadening participant eligibility to include up to 5 international trainees per class to enhance global research collaborations and further enhancements to the trainee-mentor interactions. The outcomes of the ASH CRTI support the hypothesis that enhanced mentoring experiences contribute to the successful career development of physicians pursuing POCR careers. Disclosures: Clayton: American Society of Hematology: Employment.


2021 ◽  
pp. bmjspcare-2020-002609
Author(s):  
Donna Wakefield ◽  
Felicity Dewhurst ◽  
Jonathan Koffman ◽  
Charlotte Chamberlain

ObjectivesDespite the acknowledged benefits of research, Palliative Medicine receives minimal research funding and has few dedicated research training posts. This study investigated the opportunities and barriers to participating in research for the current cohort of UK Palliative Medicine Specialist Trainees (PMSTs), to better understand the opportunities to improve evidence-based practice within the specialty.MethodsTwo surveys, one for PMSTs and a second for training programme directors (TPDs), were developed. Surveys were piloted and then reviewed by the UK Palliative trainee Research Collaborative and the Palliative Medicine Specialty Advisory Committee (SAC) before distribution. All current PMSTs and TPDs representing all of the UK training regions (n=13) were invited to complete the appropriate survey.ResultsOverall, 85% (11/13) and 45% (102/225) of TPDs and PMSTs responded, respectively. Almost all (92%) PMSTs reported that they were either ‘very interested’ or ‘quite interested’ in taking part in clinical research. PMSTs generally felt that educationaland clinical supervisors were supportive of them taking part in research; however, few (35%) believed they had access to personnel with adequate research experience to provide practical support. Opportunity for appropriate research supervision varied considerably by training region. Where research was being conducted, it was often conducted in trainees’ personal time due to the wide regional variation in dedicated research time.ConclusionDespite significant interest in clinical research and support by TPDs and clinical supervisors, access to experienced researchers and equitable protected research time by region needs urgent attention to enhance progress in evidence-based palliative medicine.


2018 ◽  
Vol 20 (1) ◽  
pp. 4-8 ◽  
Author(s):  
Takashi Watari ◽  
Masahiro Hirose ◽  
Patrik Midlöv ◽  
Yasuharu Tokuda ◽  
Hideyuki Kanda ◽  
...  

Author(s):  
Loïc Dayon ◽  
Charlotte Macron ◽  
Sabine Lahrichi ◽  
Antonio Núñez Galindo ◽  
Michael Affolter

2021 ◽  
Vol 58 (5) ◽  
pp. 2102527
Author(s):  
Maarten van den Berge ◽  
Céline Genton ◽  
Elise Heuvelin ◽  
Anita K. Simonds ◽  
Marc Humbert ◽  
...  

PEDIATRICS ◽  
1992 ◽  
Vol 89 (4) ◽  
pp. 805-805
Author(s):  
ROBERT J. HAGGERTY

In Reply.— Drs Robinson and St. Peter raise an important issue. The General Pediatric Academic Development Program did not exclude projects on health services research; but its main emphasis clearly was by design on research training in clinically related issues, because it is clear that there are many clinical problems in General Pediatrics that have not been studied adequately. The basic research skills that most of the fellows in this program achieved were in epidemiology, biostatistics, and behavioral science, and these are the basic sciences of health sciences research.


Author(s):  
Susan M. Hailpern

The Clinical Research Training Program (CRTP) at the Albert Einstein College of Medicine at Yeshiva University is a two-year program for physicians leading to a Master of Science degree in Clinical Research Methods. Beginning in July 2004, the program began teaching data analysis using Stata 8 in order to better meet the advanced statistical needs of the students. This paper details the structure and content of the course, how Stata was introduced, and the problems we encountered. Student comments and suggestions on future enhancements to Stata are included. Although challenging, our first semester teaching Stata was a success: the students all learned Stata and, more importantly, continued to use it for the analysis of their own research data after the course was complete.


Author(s):  
Pierre-Yves Donzé ◽  
Rika Fujioka

The luxury business has been one of the fastest growing industries since the late 1990s. Despite numerous publications in management and business history, it is still difficult to have a clear idea of what “luxury” is, what the characteristics of this business are, and what the dynamics of the industry are. With no consensus on the definition of luxury among scholars and authors, the concept thus requires discussion. Luxury is commonly described as the high-end market segment, but the delimitation of the lower limit of this segment and its differentiation from common consumer goods are rather ambiguous. Authors use different terminology to describe products in this grey zone (such as “accessible luxury,” “new luxury,” and “prestige brands”). Despite the ambiguous definition of “luxury,” various companies have described their own businesses in this way, and consumers perceive them as producers of luxury goods and services. Research on luxury business has focused mostly on four topics: (1) the evolution of its industrial organization since the 1980s (the emergence of large conglomerates such as Moët Hennessy Louis Vuitton SE or LVMH, and the reorganization of small and medium-sized enterprises); (2) production systems (the introduction of European companies into global value chains, and the role of country of origin labels and counterfeiting); (3) brand management (using heritage and tradition to build luxury brands); and (4) access to consumers (customization versus standardization). Lastly, new marketing communication strategies have recently been adopted by companies, namely customer relations via social media and the creation of online communities.


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