Research involving prisoners entails several extra layers of regulatory oversight, due to prisoners’ status as a vulnerable population. Those regulatory restrictions stem from historical concerns about inmates’ abilities to make truly voluntary decisions about whether to join a study, and fears over exploitation of a readily available population. One group of would-be researchers suggests the prison […]

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 […]

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 […]

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, […]

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 […]

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 […]

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 […]

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. […]

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 […]

Does CLARA sometimes start sending you weird error messages, or seem to hang up while you’re working in it? If so, the first thing to do is check which browser you’re using. CLARA works best in the Chrome browser. It is prone to error messages and other weird actions when opened in other browsers. Also, while […]