IRB Advisor – March 1, 2005
March 1, 2005
View Issues
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New Congress, regulators could take up human subjects protection
From a renewed push for a mandatory clinical trials registry to a new secretary of Health and Human Services, the political landscape promises to keep IRBs and others involved in protecting human research subjects busy. -
Most Americans believe clinical research is safe
Two-thirds of Americans believe that clinical research is safe for people who participate in them, according to a survey by the Center for Information and Study on Clinical Research Participation (CISCRP) and Opinion Dynamics Corp. (ODC). -
NIH’s new ethics rules create controversy
New ethics guidelines rolled out by the National Institutes of Health (NIH), aimed at repairing a damaged public image, angered employees and could create internal problems for the organization. -
EPA postpones child pesticide study
The U.S. Environmental Protection Agency (EPA) has decided to delay the start of a controversial effort to study the effect of pesticides on children after some agency officials raised concerns about its recruitment procedures. -
Group questions value of vulnerability designation
Although IRBs are often charged with giving special consideration to research involving subjects deemed to be particularly vulnerable to exploitation, there is no standard definition of what this term means, and no guidance governing what additional protective measures it should prompt. -
Autonomy key to audit team effectiveness
An effective compliance oversight process can nip noncompliance problems in the bud acting quickly to handle small problems before they get bigger, even preventing future noncompliance from occurring. -
Reporting adverse events on e-form saves time
A pilot program of a web-based system for reporting adverse events in clinical trials already has shown itself to be a timesaver for study staff at the Dana Farber/Harvard Cancer Center.