IRB Advisor – October 1, 2013
October 1, 2013
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Informed consent, standard of care debated at OHRP meeting
A late-August Office of Human Research Protections (OHRP) public meeting in Washington, D.C. brought debate from researchers, physicians, and patient advocates on the subject of standard of care research and how IRBs should assess risks in randomized trials. -
Achieving accreditation through tough times
Seek help early and often -
IRB expert strategies for improving PIIRB relations
IRBs should ask themselves: Are we gatekeepers? Or are we collaborators, navigators, and concierges? -
Improve IC process by taking a subject’s view
IRBs and researchers could improve the informed consent (IC) process by looking at research participants from a different perspective, an expert says. -
Citizen science: a new frontier for IRB review
While private companies that conduct human subject research do not fall within the definition of regulated research, the decision whether to entirely forgo approval is not always clear.