IRB Advisor – March 1, 2014
March 1, 2014
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More subjects enrolled than previously
Recruiting patients in many areas of clinical trial research is a very slow process, contributing to delays in getting new treatments through the research pipeline. -
Translation services may improve trial enrollment
Non-English speakers often are under-represented in clinical trials because of the language barrier and the lack of resources to provide clear and up-to-date translations of informed consent. This leads to questions of equity, an expert notes. -
Try this 30-second QI solution for IC
Informed consent templates are useful when an IRB office starts a new process or when there are new employees or new investigators submitting applications, but an experienced office can improve IC review quality by weaning its staff off of templates, an expert suggests. -
Essentials document defines protocol ethics
Developing a sound, ethical protocol is the top goal for any researcher or IRB. But the basic ethical elements and the considerations behind an investigator's choices may not always be clear, often resulting in back-and-forth discussions between investigators and IRBs reviewing the protocol. A group from Harvard University collaborated with other research stakeholders to develop an ethics reference tool for investigators. -
New HIPAA rules clarify authorizations
In March 2013, the Department of Health and Human Services (HHS) issued a final omnibus rule modifying various aspects of the Health Insurance Portability and Accountability Act (HIPAA) to implement provisions of the Health Information Technology for Economic and Clinical Health Act (HITECH). These rules include a few notable changes that affect research programs, including provisions related to compound authorizations and authorizations for future research use and disclosure of protected health information (PHI). -
"No more than minimal risk" for vaccine trial
The federal government would have to take multiple steps before anthrax vaccine trials with children could be ethically considered, according to a March 2013 report from the Presidential Commission for the Study of Bioethical Issues.