Clinicians or Researchers, Patients or Participants: Exploring Human Subject Protection When Clinical Research Is Conducted in Non-academic Settings

2014 ◽  
Vol 5 (1) ◽  
pp. 3-11 ◽  
Author(s):  
Ann Freeman Cook ◽  
Helena Hoas
2008 ◽  
Vol 56 (8) ◽  
pp. 975-984 ◽  
Author(s):  
Suzanne M. Rivera

ABSTRACTThe conduct of clinical trials is a complicated process involving a myriad of regulations and enforcement entities. To protect the rights and welfare of study participants, a system of oversight bodies called institutional review boards has been established in the US. This article describes how institutional review boards work and explains what clinical researchers need to know about federally mandated human subject protection requirements.


Author(s):  
Christine Moretto Wishnoff ◽  
Pamela Hayes-Shell ◽  
David Shore ◽  
Cheryl Anne Boyce

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13571-e13571
Author(s):  
Richard Scott Swain ◽  
Marjorie E. Zettler ◽  
Yolaine Jeune-Smith ◽  
Bruce A. Feinberg ◽  
Ajeet Gajra

e13571 Background: Many community-based oncologists in the US participate in clinical trials. These trials largely fall into two categories: trials run by cooperative (co-op) groups, funded and supported by the National Cancer Institute and trials developed, and supported by the pharmaceutical (pharma) industry. This study aimed to assess participation in, and perceptions regarding, co-op versus pharma trials among US community oncologists. Methods: We invited healthcare providers (HCP) across the continental US to attend 4 virtual meetings held between September and November 2020. Participants submitted their demographic information and responses to targeted questions regarding their opinions about co-op- and pharma-sponsored trials via a web-based pre-meeting survey. We evaluated participant HCP practice demographics and survey responses using descriptive statistics. Results: Of 259 surveyed participants, HCPs specialized in hematology-oncology (57%) and medical oncology (40%) with mean (median) 19 (18) years’ clinical experience. Most HCPs (178; 69%) reported participating in clinical research, and of these, 137 (77%) participated in co-op-led and 156 (88%) participated in pharma-led clinical research. HCPs preferred participating in both pharma and co-op (49%), pharma only (22%), and co-op only (11%) trials, while 18% preferred not to participate. Co-op trials were considered more prestigious to lead (86%), less likely to imply a conflict of interest (59%), and to address more pertinent questions (58%), while pharma trials had perceived advantages of better compensation (61%) and superior efficiency (48%). Co-op trials were perceived as not being financially sustainable (69%) and slower to accrue patients (85%) than pharma-led trials. Relatedly, in a hypothetical scenario of competing trials with identical design, the majority (60%) of HCPs preferred enrolling a loved one in a co-op trial. HCPs practicing in facilities with academic affiliation (34%) and in non-academic (66%) settings reported similar perceptions about co-op- and pharma-led trials; though, HCPs in academic settings were more likely to participate in clinical research compared to those in non-academic settings (82% vs. 62% [ P=0.001], respectively). Conclusions: In our survey of experienced HCPs, co-op-led clinical trials were perceived generally more favorably than pharma-led trials, even with concerns regarding cost, feasibility, and slower recruitment. However, despite their preference for co-op trials, HCPs were more likely to participate in pharma-led trials. Almost a third of surveyed HCPs are not participating in clinical trials and a fifth do not wish to. These findings can inform stakeholders (co-op trial leadership, pharma drug development teams, and patient advocacy groups) regarding appropriate education, design, and messaging regarding future clinical trials in oncology.


2009 ◽  
Vol 37 (1) ◽  
pp. 12-18 ◽  
Author(s):  
Carl H. Coleman

The concept of vulnerability has long played a central role in discussions of research ethics. In addition to its rhetorical use, vulnerability has become a term of art in U.S. and international research regulations and guidelines, many of which contain specific provisions applicable to research with vulnerable subjects. Yet, despite the frequency with which the term vulnerability is used, little consensus exists on what it actually means in the context of human subject protection or, more importantly, on how a finding of vulnerability should affect the process of research ethics review.The Common Rule, the centerpiece of the U.S. human subject protection regulations, uses the word vulnerable three times. First, it provides that institutional review boards (IRBs) that regularly review research involving a vulnerable category of subjects should consider including one or more individuals who are knowledgeable about and experienced in working with these subjects.


Author(s):  
Yali CONG

LANGUAGE NOTE | Document text in Chinese; abstract also in English.自從20世紀80年代末,隨著中國和其他國家在生物醫學科研上合作的增多,與之有關的倫理問題隨之增加。尤其是20世紀以來,如果說科研倫理學是生命倫理學領域的一顆新星不過分的話,那麼,赫爾辛基宣言就是科研倫理學的核心的說法是很恰當的。為了提高科研倫理學的意識,保護受試者的權益,預防潛在的倫理問題的發生,順著赫爾辛基宣言發展的歷史並找尋其中變遷的線索是非常必要的。具體來說,從紐倫堡法典產生的背景和內容開始,追溯1964、1975、1983、1989、1996、2000和2002年赫爾辛基宣言變化的原因,並把主要變化的內容單獨注出來,以利於讀者進行比較分析。探詢歷史發展的軌跡,是為了從中吸取經驗教訓,完善對受試者保護權益保護的機制。本文所有的材料都是為了這個目的服務的。關於國際前沿性的對最新的赫爾辛基宣言的爭論,讀者頭腦中要有各國對科研倫理學原則的多元化的理解這樣一個概念,同時要知道聲音最大的背後的原因,而且更重要的是要有結合中國實際情況的意識,以及是否適合中國的情況的分析,否則仍要停留在被動盲從的地位,不能真正實現科研倫理學應有的實踐性價值。Along with the development of biomedical research cooperation between China and other countries since late 1980s, many ethical issues have occurred. It is not exaggerating to claim that research ethics is a bright star in the field of bioethics, especially since the end of the 20th-century. It is also appropriate to say that the Declaration of Helsinki consists of the core of contemporary research ethics. This paper will trace the history of Declaration of Helsinki and seek for the clue for positive changes. To do so should be able to help to raise the consciousness of research ethics in people, to protect the rights and welfare of human subjects, and to prevent some potential ethical problems from happening.This article will describe in detail on the background from the Nuremberg Code to the Declaration of Helsinki and on changes happened in different versions of the Declaration of Helsinki in 1964, 1975, 1983, 1989, 1996, 2000 and 2002. The obvious and significant changes of different versions will be highlighted for the convenience of the reader. The aim of this historical review is to learn the experiences and related lessons in the West and thus to develop the system of human subject protection in China. All the materials of the article are directed to this aim. Regarding the current ethical debates on the latest version of the Declaration of Helsinki, we should be aware of the moral pluralism and plurality among different countries. It is important to analyze and understand the strongest voice in the debate and the background of this voice.Yet, the most challenging task is to find out what is suitable for our country- China- - and what is not. In other words, while we need to learn from the West about human subject protection such as the historic and influential document like the Declaration of the Helsinki, it is crucial to root Chinese research ethics in our particular conditions in China. Otherwise, we will always in the status of simply following the West blindly and cannot fulfill the practical significance of research ethics in Chinese reality.DOWNLOAD HISTORY | This article has been downloaded 22 times in Digital Commons before migrating into this platform.


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