Clinical Trials Administrator Archives – January 1, 2004
January 1, 2004
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NJ stem cell research law sparks renewed ethics and legal debates
In January, New Jersey became only the second state in the union to pass legislation formally permitting research using embryonic stem cells. -
Pharmacogenetics trials offer new challenges
The brave new world of genetics and pharmacogenetics research provides some exciting possibilities as well as some major challenges to researchers. Recruiting subjects is top concern. -
Ways to improve genetic trials informed consent
While an argument could be made that collecting genetic information from individuals is no different from collecting any other type of health information, the fact remains that the very word genetic may raise additional concerns among potential research participants. -
Lawsuits can be a result of poor communication
The recent lawsuit against Abiomed Inc. of Danvers, MA, and others involved in clinical trials involving the AbioCor Implantable Replacement Heart shows that sometimes the best preparation and informed consent process still cannot prevent litigation. -
Do you have a plan for research-related injuries?
No investigator or coordinator wants to believe it could happen. But in clinical trials, injuries or adverse events are always a possibility. The question for many is, What will happen to study subjects who are injured in the course of their research participation?