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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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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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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.
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In an ideal world, researchers working with mentally ill subjects would be able to present information about their studies in such clear, comprehensive, and organized ways that IRBs could be assured that participants know exactly what to expect.
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In the summer of 1971, Philip Zimbardo, PhD, was lead investigator on The Stanford Prison Experiment, a study designed to measure the psychological effects that imprisonment and authority would have on participants.
