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 […]

While reading our copy of Rigor Mortis: How Sloppy Science Creates Worthless Cures, Crushes Hopes, and Wastes Billions, we were reminded of some earlier discussions about whether published research findings hold up under scrutiny. The 2005 paper titled Why Most Published Research Findings are False by John P.A. Ioannidis is probably one of the most-discussed publications in this area. […]

There’s been no shortage of discussion about the validity of published research findings, and whether any apparent discrepancies can be attributed to honest errors or to research misconduct. We’ve found some additional chapters in that debate that we thought we’d share. They involve diet-related research overseen by well-known researcher Brian Wansink. You may not know […]

Large databanks, such as those created by ambitious, long-term study like the Framingham Heart Study or the Nurses’ Health Study, can be a real gold mine when other investigators use their previously collected data to do their own research. The National Institutes of Health is slated to start recruiting this spring for its proposed All […]

Study teams and IRBs need to pay close attention to the consent process when preparing (or reviewing) a study that may enroll people whose capacity to consent is impaired. Study team members may also encounter potential subjects whose ability to provide consent is questionable, for whatever reason. What are some of the things IRBs and […]