IRB Advisor articles from July 2008

IRB Advisor archives from July 2008

Are parents willing to allow children to participate in clinical research?
July 1, 2008... Are parents willing to allow children to participate in clinical research? Studies show support for research, even when child won't benefit To achieve success in pediatric research, investigators need to reach and convince one vital...

Implementation research raises unique issues.
July 1, 2008... Implementation research raises unique issues Studies pose issues of who is the research subject IRBs ordinarily are concerned with studies that test a specific drug or intervention on patients, students, or other end-users of health...

FDA briefly suspends IRB's ability to do expedited reviews.
July 1, 2008... FDA briefly suspends IRB's ability to do expedited reviews Restrictions lifted after company changes SOPs The FDA briefly suspended the ability of an independent IRB to conduct expedited reviews after raising concerns over the conduct...

Legal compliance office and IRB work together to better protect subjects.
July 1, 2008... Legal compliance office and IRB work together to better protect subjects Office relies on not-for-cause audits Research institutions and officials increasingly are finding that extra layers of oversight are better than too few. While...

Improve informed consent: Use teach-back to catch language problems.
July 1, 2008... Improve informed consent: Use teach-back to catch language problems Expert offers suggestions to IRBs One of the most important ways IRBs can improve the informed consent process is by encouraging investigators to confirm comprehension...

Avoid IRB staff burn-out following these tips.
July 1, 2008... Avoid IRB staff burn-out following these tips Burnout stems from initial passion When IRB directors are coping with the repercussions of staff burnout, they should keep in mind that burnout typically only happens to people who have a...

CNE/CME objectives/questions.
July 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...