In their continuing and, um, not super expeditious campaign to harmonize regulations between their agencies, the Office for Human Research Protections and the Food and Drug Administration have issued a joint guidance about written procedures for IRBs. We encourage you to take a look at them to get an idea of the breadth of the […]
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D.I.Y. Gene Editing — is this for real?
Apparently, making and re-engineering DNA in the privacy of your very own lab, which may well be in your garage at home, is becoming a thing, according to a recent New York Times piece. The implications of such unmonitored tinkering are potentially huge. The story includes mention of a recent journal article describing the recreation […]
“Emergency contacts” and research — Research Ethical Worry Number 2,359
Remember that recent news story about investigators using publicly available family tree information to identify a criminal suspect? Well, family relationships are also of interest to researchers. A recent New York Times story discussed a trend of using the emergency contact information patients give their healthcare providers to conduct research. As the story puts it, […]
A cautionary tale about research irregularities
Sometimes we think these regulations and requirements are all just too much. And then we read something like this, and think to ourselves, “Thank goodness we take steps to minimize the chance that this happens here!” (With the tiniest hint of “There but for the grace of the research gods go we” mixed in.) In […]
When should I have my study documents translated during the new submission process?
Investigators studying non-English speaking populations usually plan ahead and get any documents subjects will see translated before the study begins. The IRB sometimes receive new submissions with study documents already submitted in both English and the language of interest. While the IRB will eventually need to see both versions, it may save you some time/hassle […]
Genomics research and identifiability webinar May 10 at noon
The thought of genomics research fills us with both wonder (Think of all the interesting possibilities!) and fear (Think of all the new ethical and identifiability concerns!). Of particular note is the changing concept of “identifiability.” Rapid knowledge and technological advances mean genomic data that’s not identifiable now may be identifiable someday soon. And genetic […]
Discussion of a thorny ethical issue
A recent New York Times article about human research ethics piqued our interest. The story addresses an ongoing discussion about the ethics of a proposed research study in which the participants are to be infected with the Zika virus. What struck us about the article is that it is basically a summation of that unavoidable […]
It’s (almost) official — Revised Common Rule likely to be delayed again
You may recall that in January, the federal Department of Health and Human Services (HHS) announced a 6-month delay in the implementation of the Revised Common Rule. Part of the intent of that delay was to allow stakeholders to formally request a longer delay. Well, we’re now one step closer to that longer delay period. […]
Enrolling the elderly in clinical trials
As Americans age, are clinical trials keeping up with patients’ changing demographics? According to a recent article in the New York Times, no. Please click on the link to read more about the barriers to enrolling older adults in research and the implications for clinical practice. A recent NIH policy aims to ensure clinical trials […]
Revising an informed consent form — will you reconsent?
When you revise an informed consent form, the IRB will consider whether you need, or plan, to addressing the following items in your modification form will allow the IRB to review and approve your revised form more quickly: –Does the change affect any subjects currently on study? The IRB needs to know whether current subjects might […]