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) […]
Community Based Participatory Research is Becoming More Common
Community based participatory research (CBPR) aims to allow the people affected by a particular issue to be involved in the development and carrying out of research related to that issue. In successful CBPR projects, the research involving community members means that the research findings both come from and go directly back to the people who need them […]
Update on upcoming CRS course offerings
The Spring 2016 calendar is filling up with educational opportunities for those seeking to obtain their Certified Research Specialist certification. Here are some upcoming live activities, so mark your calendars to earn some hours: Essentials of Quality Human Subject Research. Wednesday, February 10, 9am to 4pm; IDW 214A/B Developing a Research Protocol. Thursday, February 18, 1 […]
The mandated reporter language is mandatory in informed consent materials
Arkansas state law requires certain individuals to report suspected abuse or an intent to harm oneself or others. Healthcare providers and teachers are among these so-called “mandated reporters;” see IRB policy 15.1 for the full list (it’s surprisingly long) of reporters. This reporting requirement is a limit to the confidentiality of research data that must […]
Remember to affiliate with UAMS when taking CITI training
The UAMS IRB requires all study personnel who interact with subjects or with identifiable private information to be current on human subject protection training through citiprogram.org. Please note that not all CITI trainings are the same, and the IRB asks that you take the UAMS-specific training. To do this, please be certain to affiliate with […]