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.

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 […]

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 (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 […]

Should an institution consider a proposal’s scientific or scholarly validity when reviewing research? Yes, according to the Association for the Accreditation of Human Research Protection Programs (AAHRPP). You may recall a) AAHRPP is the organization that accredits us and b) we are in the throes of a reaccreditation process right now. Specifically, AAHRPP expects us to […]

Workloads, member qualifications, and potential conflicts of interest are concerns when assessing the performance of institutional review boards, according to a recent article in Modern Healthcare. This scrutiny of IRB operations coincides with the announced proposal to revise the Common Rule, which is the federal regulation that outlines the requirements for research involving human subjects. […]

An informed consent process note is distinct from the informed consent process form. While the form documents the information that is to be exchanged during the consent discussion (and is typically required by federal regulations), the process note documents that an actual consent process occurred. While the regulations don’t require separate process notes, UAMS IRB […]

We’ve overhead members say in the IRB meetings that they’re not able to see the tracked changes in a document that’s labeled as the tracked-changes version, or that a particular change the PI says has been made in a document hasn’t been made. Here are some tips when you’re not able to see the changes in […]

AAHRPP is coming! AAHRPP is coming! Eventually, anyway – we’re expecting an AAHRPP site visit in the months ahead as part of our reaccreditation process, and some IRB members will likely be asked to meet with the AAHRPP site visitors. To help you prepare, our IRB Members Blog will review some elements that AAHRPP will […]

The proposed revisions to the Common Rule (known as the Notice of Proposed Rulemaking, or NPRM) is still working its way through the public comment process.  You may recall that it took about 4 years for the NPRM to be released after the Office for Human Research Protections (OHRP) announced its intent to revise it […]