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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.
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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).
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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.
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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.
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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.
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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.
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Perhaps the best way research enterprises can thank the volunteers who participate in studies is by sending them the study's findings in clear, simple lay terms.
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As the scrutiny and duties of IRBs steadily increase, demanding ever more time from IRB members, it has become clear to some research universities and hospitals that there should be a change in whether and how IRB members are compensated for their time.
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In this issue of IRB Advisor, we are starting a new column designed to answer reader questions. If you have questions regarding IRB responsibilities, federal regulations, adverse event reporting, day- to-day functions, anything related to clarifying the duties and responsibilities of your IRB, wed like to know.
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Current federal research regulations in the United States limit efforts to study emerging infectious diseases, and an alternative model is needed to allow a rapid response to immediate threats to public safety, a top U.S. researcher claims.
