IRB Advisor – February 1, 2010
February 1, 2010
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NCI's Central IRB saves time, money
Using the National Cancer Institute's Central IRB (CIRB) saved affiliated institutions money, staff time and time spent on review, according to a recent study of the costs and benefits associated with the CIRB.Human protection practices honored at three institutions
Three institutions recently were honored by the Health Improvement Institute for their contributions to enhancing the protection of research subjects.QA program checks consent form accuracy
For more than 30 years, the National Surgical Adjuvant Breast and Bowel Project has collected copies of every consent form signed by the more than 130,000 patients enrolled in its clinical cooperative group trials.Language database makes consent forms consistent
When an institution conducts IRB reviews of hundreds of protocols, it can be hard to maintain consistency on such details as language used in informed consent to describe potential risks and adverse events.Series helps IRBs, researchers wrestle with tough ethical issues
Some of the thorniest questions that IRBs face are those for which there are no clear-cut answers opinions may vary, arguments on both sides may be compelling, regulatory guidance may be scanty.Considering a new model for community research
The current system of regulating community-based participatory research (CBPR) doesn't truly engage or protect communities as it should and fails to follow up on promises made by researchers to IRBs and to those whom they study, says one community researcher.Training helps overcome community resistance
Tufts University researchers studying immigrant workers in a nearby community engaged local leaders and teens to help them create a survey and recruit and translate for the immigrant population. It was an example of community-based participatory research (CBPR), involving the community from start to finish.Clarifying alternatives to research participation
While federal regulations require that subjects be informed of the possible alternatives to their participation in a clinical trial, often subjects don't learn enough about those alternatives to make an informed decision, says a bioethicist who has studied the issue.