IRB Advisor – January 1, 2012
January 1, 2012
View Issues
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New guidelines put focus on research conflicts of interest
Conflicts of interest (COI) have been an important priority for IRBs and research institutions for decades. -
Here are COI final rule changes for research
The U.S. Department of Health and Human Services (HHS) recently published its final rule on research conflicts of interest, titled, "Responsibility of Applicants for Protecting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors," in the Federal Register, Vol. 76, No. 165, Aug. 25, 2011. -
How to write response after AAHRPP visits
When a human research protection office seeking accreditation finally has the site visit, the hard work that went into the process is not over. Now it's time to prepare the best possible response to the draft site visit report. -
Board seeks anthrax vaccine trial ethics review
An advisory board to the U.S. Department of Health and Human Services has recommended that a proposal to hold pediatric trials of the anthrax vaccine be reviewed by an ethics board before proceeding. -
Novel data-sharing plan gives tribes more say
One of the thorniest issues in tribal research is the question of who controls the use of the data taken from tribal members or tribal lands. Is it the researcher, who collected the data, or the tribe that gave permission for its collection and use? -
Averting low-enrolling studies benefits IRBs
When a study is terminated because of low enrollment, it wastes the institutional resources that allowed it to be started including those of the IRB that approved it. -
Videos help subjects, families understand trials
Some institutions have created informational videos that help potential research subjects and their loved ones make a more informed decision about whether to enroll in a clinical trial. -
Best Practices Spotlight: Improve the IRB with an annual evaluation
Serving on an IRB is a very important role that requires commitment and training. Yet, many research institutions that have very good training and evaluation programs for their staffs lack any sort of ongoing oversight of their IRB members.