It should come as no surprise that there are no quick answers to the question of what, exactly, went wrong in the clinical trial in France in which one participant has died and 5 others experienced other serious adverse events. A few more news articles about the study are here: An early report in Science A quick […]
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Another $.02 on the proposed Common Rule revision
As mentioned previously, one of the most contentious proposals in the current Common Rule draft requires the obtaining of informed consent for future research use of tissue specimens. Here’s one opinion on how this requirement might impact communities with limited access to health care – a concern relevant to many areas of Arkansas.
Another reminder of why research matters
Author Paul McLean has probably given a lot of thought to medical ethics, both as an ethics fellow at Harvard Medical School, and as the parent of a child who directly benefited from medical research. And apparently he’s a dog person too. Read his family’s story at the link above.
A Research History Trivia quiz, and a reminder of why research ethics matter
The following research history trivia quiz should get us thinking both about just how long research has been going on, and why maintaining certain ethical standards is important. Q. Where would you look to find a description of the earliest known activity that might be described as research involving one or more human subjects? Published descriptions of […]
ACH employees and CLARA
Attention all Arkansas Children’s Hospital (ACH) staffers who use CLARA: CLARA is able to accommodate a change to an ACH email address! Reliable sources who work in ACH compliance tell us that ACH staffers are in the process of transitioning to ACH email addresses, which will be used instead of uams.edu addresses. CLARA automatically defaults […]
Determining risk levels in research involving adults
One of the IRB’s responsibilities in its research reviews is to assess a proposal’s risks and benefits. For each study, the IRB is to determine that risks to participants are minimized by using procedures consistent with sound research design, and risks to participants are reasonable in relation to anticipated benefits, if any, to subjects, and […]
A series of adverse events on a Phase 1 trial in France
The New York Times published a report Jan. 15 about six healthy volunteers falling gravely ill during their participation in a Phase 1 drug trial. We’ll add additional posts as more information becomes available.
Use the “find” function to locate the language referenced in contingencies
There has been some discussion recently about whether its helpful to include page numbers on the IRB office staff’s draft contingencies. We will try to include page numbers in the future. However, we have long made it a practice to include enough information in our draft contingencies for you to be able to use the […]
New Online CRS quiz is available
If you’re looking to earn credits for the Certified Research Specialist credential at the time and place most convenient to you, check out the latest online Research News Blog quiz that’s now available. To access the quiz, go to learnondemand.org and click on “login” at upper right. Then, once the login process is complete, type “IRB” […]
To whom does the right to use tissue belong?
Few aspects of Notice of Proposed Rulemaking regarding the Common Rule have generated as much discussion as the possible requirement to obtain informed consent for the future use of biological specimens, including those without identifiers attached. Rebecca Skloot’s book The Immortal Life of Henrietta Lacks (well worth a read if you haven’t gotten to it yet) […]