We see a great many protocols with statistical analysis sections that read as follows: Data will be analyzed using SPSS version 20 (SPSS Inc., Chicago, IL). Baseline characteristics will be described as means and standard deviations for continuous variables and percentages for discrete variables. Continuous variables will be compared using Student’s t test and categorical […]
Blog
Patients advise on a cancer study
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 […]
Informed consent from the physicians’ perspective
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 […]
NIH rejects plan to infect volunteers with Zika virus
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 […]
Do you need Good Clinical Practice training? You might, and here’s where to find it
If you work on NIH-funded research, take note. The NIH policy on Good Clinical Practice training that took effect Jan. 1 applies to you. Investigators and site staff responsible for the management, conduct and oversight of NIH-funded clinical trials will need to complete Good Clinical Practice training. Per information available on the Office of Research […]
Research from the subject perspective
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 […]
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 […]