-
The Belmont Report has withstood the test of time as a framework for ethical decision making about human subjects research, experts in research ethics say.
-
In this Q&A, Bernard Schwetz, DVM, PHD, director of the Office of Human Research Protections (OHRP), discusses the Belmont Reports successes and challenges as the 25th anniversary of its launching has passed.
-
The St. Louis-based genomic medicine development company GenoMed is taking a novel approach to testing its hypothesis that inflammation-reducing heart medications can be effective in treating severe complications of influenza.
-
Disappointed by a funding gap in the federal support of stem cell research, the citizens of California have made the decision to directly involve the State in the research effort.
-
Researchers are finding the HIPAA to be a significant barrier to recruiting research participants, in part because of the inconsistent way in which IRBs deal with requests for HIPAA waivers.
-
Reacting to allegations that clinical trials showing unfavorable results often go unpublished, two states are proposing legislation that would require clinical researchers to register their studies with the NIHs clinical trials database if they involve studies designed to evaluate a drugs safety or effectiveness.
-
Should a terminally ill 10-year-old have a say in determining her end-of-life care? Can a teenager make an informed consent to treatment? Questions of this type will be the mainstay of the Center for Pediatric Bioethics, the nation first center for bioethics solely dedicated to pediatrics, which will be located at Childrens Hospital and Regional Medical Center in Seattle.
-
Public opinion of FDA sliding in Vioxx wake; CAM therapies must meet standards.
-
Patients with psychiatric illness pose a particular problem to researchers and to the IRBs that review studies involving them. They can have widely varying capacity to give informed consent and that capacity can wax and wane depending upon the progression of the illness and the patients current treatment. Issues such as the use of placebo and the role of surrogates can be thorny.
-
A video created to dispel patient misconceptions about clinical trials benefited from a diverse array of viewpoints everyone from physicians and nurses to subjects and even those who decide not to take part in clinical trials, says the woman who spearheaded the effort.
