A procedure that fell somewhere between “research” and “treatment,” depending on who you ask, involving the injection of stem cells into the eye led to severe vision problems in three women, one of whom went blind as a result, according to a recent report in the New York Times. The article raises some interesting points. […]

You may remember the San people from the 1980s movie titled “The Gods Must Be Crazy.” That effort wasn’t the first time this community was under scrutiny. As a recent article in the online publication Quartz notes, the group has been studied and photographed for a long time, and “The traditional knowledge and culture of the […]

Here at the IRB, we see a fair number of social/behavioral studies that are designed with the help of community advisory boards or other representatives of the intended study population. However, that kind of patient involvement seems to be more rare in clinical studies, at least the ones we see. The NCI-MATCH study, per one […]

Researchers and health-care providers have long worried about how to ensure patients and potential subjects understand treatment and research options. Two medical doctors weigh in in a recent New York Times piece, acknowledging the shortcomings of current methods. (Example: “Over your lifetime of seeing us, we have trained you that we will look impatient and concerned if you […]

A study involving infecting people with the Zika virus in an attempt to develop an effective vaccine has been deemed to have too many ethical concerns to be carried out as currently proposed, STAT news reported on its website recently. The article indicates that “it is not uncommon for researchers to deliberately infect study participants […]

Does the average informed consent process adequately describe a research subject’s available options? Regulations require any “alternatives that might be advantageous to the subject” to be addressed. But can the few words in a consent form, which are sometimes limited to “ask your doctor about the other treatments available”, fully explain what the options are? A recent […]

No rule is every truly final – in fact, the Office for Human Research Protections (OHRP) issued a Final Rule on the protection of human subjects back in 1991, and now the agency’s back at it with the new Final* Final Rule, issued just last month. Elisa A. Hurley, the director of PRIM&R, one of […]

Recent discussions we’ve overheard lead us to think there are different ideas of what constitutes a “waiver of documentation of consent”. The concept is indeed a bit tricky, since the word “documentation” has a couple of different meanings in the consent context. The first thing we think of regarding consent documentation is the written consent […]

It ain’t over until the … publication appears in the Federal Register, and sure enough, today’s Federal Register contains the final* Final Rule. Since most people don’t have the daily Federal Register delivered to them at home, here’s a link to today’s publication. Note that much of this document is a discussion of the slow, […]

The updated final version of the Common Rule was made available for review Wednesday, January 18, with its publication in the Federal Register slated for Thursday, January 19. The Common Rule, you no doubt recall, is the federal regulation setting the basic requirements for the protection of human subjects in research. A proposal to revise […]