Human Research Subject Protections Bills Being Developed in Both Houses of Congress

2002 ◽  
Vol 50 (04) ◽  
pp. 265
Author(s):  
N/A
Keyword(s):  
Research Subject ◽  
Human Research ◽  
Human Research Subject

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
Keyword(s):  
Biomedical Research ◽  
Research Subject ◽  
Human Research ◽  
Human Research Subject

scholarly journals How to strengthen clinical research in Shenzhen, China: qualitative study

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e024534
Author(s):  
Ping Ji ◽  
Hongling Chu ◽  
Chao Zhang ◽  
Ping Xiao ◽  
Min Liu ◽  
...  
Keyword(s):  
Focus Group ◽  
Qualitative Study ◽  
Clinical Research ◽  
Functional System ◽  
Research Subject ◽  
Semistructured Interview ◽  
Human Research ◽  
Individual Interviews ◽  
Human Research Subject ◽  
Training Programmes

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.

Prisoners as Living Donors: A Vulnerabilities Analysis

2017 ◽  
Vol 27 (1) ◽  
pp. 93-108 ◽  
Author(s):  
LAINIE FRIEDMAN ROSS ◽  
J. RICHARD THISTLETHWAITE
Keyword(s):  
Living Donor ◽  
The United States ◽  
Living Donors ◽  
Research Subject ◽  
Federal Regulations ◽  
Human Subject Research ◽  
National Guidelines ◽  
Human Research ◽  
Human Research Subject ◽  
Living Donor Transplantation

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.

Ethicist faults human research subject protection

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

Protecting the Uninsured Human Research Subject

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