Questions about the findings of earlier research (from the New York Times) have led to the pause of an NIH-funded trial testing stem cell therapy in heart failure patients, the Washington Post reported Oct. 29. These reports are significant for several reasons. As the Post’s article notes, subject safety is of primary importance, and a research […]
Institutional Review Board Members
Reminders for our Institutional Review Board reviewers about policies, using Clinical Research Administration (CLARA), and other news. Feel free to click on this blog even if you aren’t on the Institutional Review Board. You may get some pointers about what the Institutional Review Board is looking for when it reviews your studies.
Online Revised Common Rule course now available
Can’t wait until the IRB’s Oct. 30th presentation to get familiar with the Revised Common Rule, slated to take effect in January? An online 10-module course on the Revised Common Rule is now available through citiprogram.org. Even better – you can earn Certified Research Specialist credit for successfully completing it. The exact credit amount is […]
Do we need to rethink our view of “privacy”?
While we worry about things such as how biological samples and paper data collection sheets are labeled, the world of genetic accessibility marches on. Recent articles in The New York Times and the journal Science point out that publicly available genealogy databases now allow the identification of about 60 percent of Americans of Northern European […]
Revised common rule to bring welcome changes to exempt status research categories
The Revised Common Rule will bring some largely welcome changes to the Exempt categories of research. In general, the language changes expand the type of research to which exempt status review will apply. As a reminder, “exempt” does not mean the same thing in research-land as it does in real life. An “exempt” study is […]
Revised Common Rule to bring changes* to informed consent
The Revised Common Rule (RCR), slated to go into effect Jan. 21, 2019, will bring some changes* to informed consent requirements. And that asterisk by “changes” is intentional, as the federal Office for Human Research Protections (OHRP) has said that it may issue guidance regarding some RCR consent requirements. Well, here we are, a mere […]
Revised Common Rule Resources
The Revised Common Rule, slated to take effect Jan. 21, 2019, will bring some significant changes to our UAMS/ACH policies and procedures related to human subject research. Note that we can’t accuse the federal Office for Human Research Protections (OHRP) of rushing through this rule-making process; this is the first major revision since the original […]
Publication bias in research
It’s great when your study results support your hypothesis. Less appreciated, but equally important is when your study results show your hypothesis wasn’t correct. Researchers tend to be more enthusiastic about publishing the former than the latter, we’ve noticed. Here’s a New York Times piece that discusses the importance of letting the world know about […]
Publication bias in research
Well-known food and decision-making researcher resigns — Sound Research Design questions
While the name “Brian Wansink” may not be immediately familiar, some of the research he’s known for probably is. Dr. Wansink’s research into how people make decisions about what and how much to eat gets a lot of play in the popular media. He’s one of those rock star scientists. At the end of the […]
No docs allowed with staff-only modification forms
When making changes to study staff, please keep in mind the IRB cannot and will not review any revised documents submitted with staff-only modifications. Many staff changes can be made without revising any documents, which is why we created the “staff-only” modification form option. These “staff-only” changes can be reviewed and acknowledged by the IRB […]