Abstract Is Institutional Review Board (IRB) approval and a rigorous informed consent
process enough? It is our view that this is no longer the case. Conventional research ethics …

Integrity and ethical issues play a role throughout all phases of clinical research. First,
policies and decisions that determine the research agenda, prioritizing some topics above …

People have debated the ethics of clinical trials for as long as trials have been conducted.
The arguments have changed over the years and perhaps become more sophisticated, but …

Objectives—To assess the relationship between the approval of trials by a research ethics
committee (REC) and the fact that informed consent from participants (ICP) was obtained …

Clinical research has resulted in significant benefits for society, yet continues to pose
profound ethical questions. This chapter briefly describes: five overlapping but distinct eras …

The ethical analysis of research with human subjects has been greatly developed over the
last 20 years, with input from researchers and statisticians as well as philosophers. That all …

Researchers have been charged with the task of undertaking methodologically rigorous and
ethically acceptable clinical trials with human subjects. Guidance to produce proposals of …

Research involving human volunteers has been the subject of previous review to examine
ethical standards and codes of conduct.'There is need for codified ethical standards to …

We commend Shamy and Fedyk for their thoughtful commentary [1] on the ethical and
scientific justification for clinical trials and accompanying cross-sectional study of De …

Until recently there has been no formal law covering many aspects of clinical research,
making the ethical and scientific guidelines more important. Rapidly changing law gives …