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 […]

It’s becoming increasingly rare for us to transmit large chunks of information via pages and pages of printed text. One notable exception is the documenting of informed consent for research. While the research community continues to explore ways to make informed consent forms and processes easier for subjects to understand, relatively long and complex research consent forms […]

Researchers and IRB members are aware of the need to ensure study populations reflect the community. Careful attention to enrollment helps ensure  study results are valid and generalizable, and allows the IRB to determine that subject selection is equitable (which is one of the criteria for approval). A recent New York Times article addressed the […]

Can investigators also be research subjects in their own studies? Science Magazine recently published a piece discussing the regulatory and ethical issues about researchers doing their research on themselves. As the piece points out, self-experimentation can lead to results that are life changing, for better or worse – two scientists went on to win Nobel […]

Research subjects provide a tremendous service to subjects, at a sometimes not-negligible cost, in terms of time and inconvenience (and potentially needlesticks, radiation exposure, etc.) to them. Some research procedures may yield information important to the participant’s health, or that could minimize that person having to have the same procedures done as part of their regular […]