Biomedical Research and Human Research Subject Protection: Is There Need for Action in Germany and Austria?

2009 ◽  
Vol 16 (1) ◽  
pp. 45-68 ◽  
Author(s):  
Roland Staudinger ◽  
Gerhard Fortwengel ◽  
Magdalena Thoeni ◽  
Verena Stühlinger
BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e024534
Author(s):  
Ping Ji ◽  
Hongling Chu ◽  
Chao Zhang ◽  
Ping Xiao ◽  
Min Liu ◽  
...  

ObjectivesTo better understand the strengths and weaknesses, and to propose policy recommendations, regarding conducting high-quality clinical research in Shenzhen, China.DesignA qualitative study conducted from August to November 2016 using a semistructured interview format involving both focus group interviews and individual interviews.SettingShenzhen, China.ParticipantsStratified purposive and convenience sampling were used. Thirty individuals experienced in conducting and managing clinical research were selected from key stakeholder groups, comprising 11 from local hospitals, 14 from pharmaceutical/medical device companies and 5 from government agencies.MethodsA semistructured interview guide was developed by the study group and used by experienced interviewers in focus group discussions and individual interviews. The interviewees were encouraged to share their opinions freely and discuss their own topics of interest during the interviews. Thematic analysis was used for analysis and all data were coded and extracted using NVivo V.11.0 software.ResultsFavourable driving factors for clinical research in Shenzhen identified by all stakeholders included the recent trend of increased governmental funding for clinical research, supportive governmental policies, wide recognition of the value of clinical research and high demands from local industry. The major challenges include a lack of technical infrastructure, weak human research subject protection and a lack of capable research resources.ConclusionsDespite the established strengths, Shenzhen still needs to develop suitable technical platforms, human resources training programmes and strong human research subject protection programmes pertaining to clinical research. This would facilitate the establishment of a functional system that can be expected to lead to increased medical research innovation in Shenzhen.


2017 ◽  
Vol 27 (1) ◽  
pp. 93-108 ◽  
Author(s):  
LAINIE FRIEDMAN ROSS ◽  
J. RICHARD THISTLETHWAITE

Abstract:Although national guidelines exist for evaluating the eligibility of potential living donors and for procuring their informed consent, no special protections or considerations exist for potential living donors who are incarcerated. Human research subject protections in the United States are codified in the Federal Regulations, 45 CFR 46, and special protections are given to prisoners. Living donor transplantation has parallels with human subject research in that both activities are performed with the primary goal of benefiting third parties. In this article, we describe what special considerations should be provided to prisoners as potential living donors using a vulnerabilities approach adapted from the human research subject protection literature.


JAMA ◽  
1994 ◽  
Vol 271 (16) ◽  
pp. 1228-1229
Author(s):  
C. Marwick

2000 ◽  
Vol 6 (6) ◽  
pp. 37-47 ◽  
Author(s):  
Daniel R. Vasgird ◽  
Michelle Hensleigh ◽  
Alan Berkman ◽  
Erica Schachne ◽  
Chau Trinh

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