IRB Advisor – September 1, 2008
September 1, 2008
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Successful accreditation process requires close attention to details
The very first step to becoming accredited is to collect all of your institution's policies and procedures related to the human research protection program in a searchable electronic format, an expert advises. -
The right to withdraw: What does it really mean?
Every study participant has seen some variation of this assurance in informed consent documents: "You are free to participate in this research or to withdraw at any time without penalty or loss of benefits you are entitled to receive." -
Withdrawing from a biobank brings special challenges
The growing field of biobanking has added new wrinkles to issues of withdrawal from research. Withdrawing from participation in a biobank or a large cohort study is a very different matter from withdrawing from a clinical trial. Because of the technology involved, it may not be possible to completely remove one's information from the research. -
NIH working group to help IRBs assess risk properly
Two or more IRBs reviewing the same study might reach strikingly different conclusions about the study's risks and suitability for human subjects. -
Ethics Corner: When is an inducement 'undue?' Is a payment ever coercive?
From a bioethical perspective, payments to research participants are complicated, an expert says. -
Expert offers suggestions for standardizing subject payments
Ethicists and others continue to find it troubling that payments to research participants are part of the recruitment process. -
FDA amended rule on non-IND foreign trials criticized
The FDA's amended rule for acceptance of foreign clinical studies not conducted under an investigational new drug (IND) application has drawn fire from health advocates who say it weakens ethical protections.