by Krystal Bradford, CIP, research compliance specialist at Cincinnati Children’s Hospital Medical Center
Since my last blog post, I have tried to pay closer attention to things discussed at the 2014 AER Conference that I have incorporated into my everyday work. Several items that stand out to me might be considered minor, but there is payoff in the end. One example is documentation.
If you have read any post-site visit letters from OHRP or FDA, there is almost always a reference to documentation that should have occurred but didn’t. Accurate research study [...] Read more
by Caroline Slymon, executive coordinator
In January, PRIM&R welcomed two new members to its board of directors, including Bruce Gordon, MD. Dr. Gordon is professor of pediatrics in the section of pediatric hematology/oncology and stem cell transplantation at the University of Nebraska Medical Center (UNMC). Dr. Gordon has been a member of the UNMC institutional review board (IRB) since 1992, served as chair since 1996, and served as executive chair since 2011. He also organized, and is first chair of, a joint pediatric IRB with the Children's Hospital and Medical Center in Omaha. He has served on a variety of national committees and [...] Read more
by Anita Pascoe, MS, CIP, project coordinator at Intermountain Healthcare
Time has flown by since December’s 2014 AER Conference. The holidays came and went, and, believe it or not, spring has announced its extremely premature arrival here in Salt Lake City. Two months post-conference, I am, however, still contemplating several of the key themes discussed during the four days in Baltimore. Topping my list of memorable conference moments is John Wilbanks’ keynote address, which hit home for me on a personal as well as a professional level.
Wilbanks noted that the nature of our global research enterprise has forever been altered because of the [...] Read more
by Michael (Mike) Kraten, PhD, CPA, IRB chair at Providence College
As the chair of our college's institutional review board (IRB), you can only imagine how frequently I am asked questions about the 45 CFR Part 46 federal regulations regarding the requirements of human subjects research.
What types of questions? For instance:
- I'm not sure whether my study is contributing to "generalizable knowledge." How can I tell whether it's doing so?
- How can I possibly know whether I'm potentially damaging someone's "financial standing, employability, or reputation" with my work?
- When does a "practicable" study become impracticable?
These questions, though tricky, are certainly not impossible to answer. [...] Read more
by Krystal Bradford, CIP, Research Compliance Specialist at Cincinnati Children’s Hospital Medical Center
Now that we have settled back into our daily lives, and the frantic time constraints of the holidays are over, I've started to reflect on the 2014 AER Conference. I asked myself 'What did I learn that I want to start incorporating into my work processes?' And here is the funny and sad, but true, answer: 'I don’t remember!' Uh oh. Really?? Then anxiety started to set in, 'How do I not remember?' Looking back to the first line of this paragraph, I realize the answer: [...] Read more