-
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.
-
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.
-
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.
-
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.
-
The way investigators, research institutions, and IRBs 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.
-
Many research institutions now have quality assurance/improvement projects that include research site audits or quality checks. But how many have thought about performing such a quality check on the IRB's work?
-
When human subjects research directors finish sifting through the proposed Common Rule changes, they likely will find some things they can live with and plenty of others they'd like to modify.
-
In its proposed revision of the Common Rule, the U.S. Department of Health and Human Services is considering the most extensive changes to human subjects protection regulations in decades.
-
The most recent statistics gathered from the Association for the Accreditation of Human Research Protection Programs' (AAHRPP) client institutions don't look all that different from the baseline metrics released last year.
-
Researchers studying whether specially padded underwear protected elderly wearers from hip fractures came up with a one-sided garment design that allowed them to compare the results of a padded hip and an unprotected hip on the same person.
