IRB Advisor articles from September 2008

IRB Advisor archives from September 2008

Successful accreditation process requires close attention to details.
September 1, 2008... Successful accreditation process requires close attention to details Small committee and IRB chairs' cooperation are key The very first step to becoming accredited is to collect all of your institution's policies and procedures related...

The right to withdraw: What does it really mean?
September 1, 2008... The right to withdraw: What does it really mean? Review withdrawal procedures, language in consent Every study participant has seen some variation of this assurance in informed consent documents: "You are free to participate in this...

Withdrawing from a biobank brings special challenges.
September 1, 2008... Withdrawing from a biobank brings special challenges Consent must spell out limitations The growing field of biobanking has added new wrinkles to issues of withdrawal from research. Withdrawing from participation in a biobank or a...

NIH working group to help IRBs assess risk properly.
September 1, 2008... NIH working group to help IRBs assess risk properly NIH bioethicist cites lack of consistency Two or more IRBs reviewing the same study might reach strikingly different conclusions about the study's risks and suitability for human...

Ethics Corner: When is an inducement 'undue?' Is a payment ever coercive?
September 1, 2008... When is an inducement 'undue?' Is a payment ever coercive? Expert suggests IRBs pay closer attention From a bioethical perspective, payments to research participants are complicated, an expert says. "Partly because a lot of people...

Expert offers suggestions for standardizing subject payments.
September 1, 2008... Expert offers suggestions for standardizing subject payments Wage-payment model might work well Ethicists and others continue to find it troubling that payments to research participants are part of the recruitment process. "I think...

FDA amended rule on non-IND foreign trials criticized.
September 1, 2008... FDA amended rule on non-IND foreign trials criticized Some say it weakens ethical protections The FDA's amended rule for acceptance of foreign clinical studies not conducted under an investigational new drug (IND) application has drawn...

CNE/CME objectives/questions.
September 1, 2008... CNE/CME objectives The CNE/CME objectives for IRB Advisor are to help physicians and nurses be able to: *establish clinical trial programs using accepted ethical principles for human subject protection; *apply the mandated...