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 […]
Blog
The contingencies about “fasting” — and how to avoid them
It’s not unusual for a study to require subjects to be fasting before a certain study procedure, such as a blood draw. What is unusual, we’ve noticed here at the IRB, is a new submission that adequately describes what is meant by “fasting” on the first go-around. Addressing the following items in the consent form and […]
A request for assistance for students, residents, and the like
Many UAMS programs require students, residents, or fellows to complete a research or quality improvement project. For many of these people, this will be the first time they’ve had to interact with an IRB. If you’ve been working in research for a while, you probably already know the ins and outs of submitting a project […]
Publications and the IRB
The IRB occasionally fields queries about writing up research results for publication. Please note that the IRB has no input or oversight of the content of manuscripts or other publications. It is the researcher’s ethical responsibility to accurately reflect their research in any publications. The one thing the IRB asks related to publications is that if […]
Some wise words on the Final* Final Rule
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 […]
What needs to be in the information sheet for an interview or survey study?
Many interview and survey studies can be reviewed as exempt status research. Even though no formal written consent is required for such projects, the IRB will typically require that some kind of informed consent process will occur. That process would typically involve a short information sheet, for a focus group or interview study, or asking […]
What a “waiver of documentation of consent” means, exactly
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 […]
The Final* Final Rule (and opportunities for CRS credit)
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 Final Rule (Revised Common Rule) finally shows up
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 […]
Keep it short and to the point when responding to modification contingencies
So you’ve submitted a modification, the IRB had a question on it that was returned to you as a contingency, and now you’re responding. And then you remember you just received some new information from the sponsor that the IRB needs to see, or that you need to make a change to a study document […]