IRB Advisor – December 1, 2012
December 1, 2012
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Report balances privacy versus whole genome sequencing
Medical and electronic data advances in the 21st century have made it possible to determine the entire DNA sequence of any individual on the planet. The first question that many bioethicists ask is, "How do you protect individuals' privacy from the misuse or unauthorized use of this information?" -
Consent is a major focus of commission's report
Whole genome sequencing research raises important informed consent issues for IRBs and investigators, and the recent report by the Presidential Commission for the Study of Bioethical Issues (PCSBI) addresses these in its recommendations. -
PCSBI makes these 12 recommendations
The Presidential Commission for the Study of Bioethical Issues (PCSBI) has made these 12 recommendations for how to better develop public trust and protect privacy in the era of whole genome sequencing in research: -
Compliance Corner: Complaints or just seeking answers?
Human research protection programs (HRPPs) often must balance the need to handle research complaints with the goal of conducting fair and reasonable investigations into any potential problem. HRPPs also must use staff time efficiently and not get bogged down in disputes that clearly are not pertinent to protecting research subjects, an expert says. -
Tips for handling study complaints
Research institutions should make their complaint process as accessible as possible to researchers, participants, and others, an expert says. -
Ensuring trial compliance? There's an app for that
With the smartphone application market seemingly exploding with apps for just about anything, it's no surprise that clinical research is starting to get in on the action. Technology companies and academic institutions are working on research apps and other programs to assist with clinical trial data reporting. -
Speaker: Greater diversity needed in clinical trials
More subject diversity is needed in clinical trials to reduce the risk of adverse outcomes, according to the keynote speaker at the Clinical Trials in Georgia conference.