1887

Abstract

Abstract

Public (government) oversight reflects the way society perceives and responds to risk, which is intrinsic to the conduct of experimental research. Such oversight typically takes the form of regulation, which combines organizations, rules and sanctions intended to produce desired behaviors in support of clear objectives. Ensuring a rigorous clinical trial process that also offers proper protections of research subjects requires a legal framework that features the following qualities: (1) must act, and be seen to act, in the public interest; (2) comprised of clear and explicit objectives and requirements; (3) fairness in its application and enforcement; (4) based on dialogue among regulators, the regulated community, and the beneficiaries of regulation; (5) sustains public confidence and trust; and (6) is more likely than other options to achieve its goals. While these features will be applied to stem cell clinical trials, they are also relevant in other areas where science and technology are perceived as posing risks to individuals and/or the larger society.

Loading

Article metrics loading...

/content/papers/10.5339/qproc.2012.stem.1.44
2012-02-01
2019-10-23
Loading full text...

Full text loading...

http://instance.metastore.ingenta.com/content/papers/10.5339/qproc.2012.stem.1.44
Loading
  • Received: 05 Mar 2012
  • Accepted: 29 Mar 2012
This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error