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In the waning days of the comment period for the advance notice of proposed rule-making (ANPRM) for human subjects protection regulation, some of the IRB community's heavy hitters have weighed in.
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When investigators seek an exception from informed consent (EFIC) for emergency research, they must show that they have engaged in community consultation and public disclosure, informing the public that they may encounter an experimental intervention while being treated in an emergency setting.
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In the proposed revision of the Common Rule, the Department of Health and Human Services (HHS) responds to years of complaints about informed consent documents that they're too long, too complicated, too full of boilerplate and risk management language.
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Research ethicists and others have long described the value of recruiting more minorities in clinical research (CR) trials, but the question is whether or not IRBs have a role to play in advancing this goal.
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In assessing the recent revisions to the Common Rule proposed by the Department of Health and Human Services (HHS), the accrediting agency for human subjects protection programs suggests that HHS may lack the necessary information to move forward with a final rule.
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Most major corporations and business sectors have adopted business quality improvement (QI) measures like Six Sigma, Lean Process, and others. But in human subjects research, this type of QI approach is fairly new, an expert says.
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For years, federal regulations have deemed the research use of deidentified blood and tissue samples collected in clinical procedures to be non-human subjects research, and therefore, they have not required informed consent from the patients from whom they were taken.
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According to a study that appears in Archives of Surgery, between 85% and 94% of patients were willing to sign forms permitting medical residents to assist surgeons, but many will not consent to giving residents a major role during surgery.1 Fewer patients consented when the form offered more detailed information about the education level or role of the student.
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The manner in which investigators, research institutions, and review boards handle incidental findings has evolved in recent years, with a consensus now forming around the belief that research sites have an ethical responsibility when it comes to reporting certain incidental findings to research subjects.
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According to a follow-up study in the American Journal of Public Health, few states in the United States have properly addressed ethical issues surrounding pandemic flu preparedness in recent years.
