A recent Washington Post article and podcast got us started looking around for more information about the notorious Tuskegee experiment, which, according to the Post author, “destroyed the trust many African Americans held for medical institutions – a legacy that persists today.” Clicking around the internet for more information led us to an American Scholar […]

Considerations and recommendations for returning individual results to human research participants are the focus of a newly released report by the National Academy of Sciences. The full report exceeds 300 pages, but the executive summary runs to a much more manageable 27 pages. The NIH’s Office of Science Policy has a blog item about the […]

Most of us working in research know the story of Henrietta Lacks, a woman whose cells were collected from her without her knowledge or consent in 1951. The so-called HeLa cells have been extensively used in research ever since, without her family’s knowledge or approval for much of that time. An attorney representing some members […]

Chicago Magazine recently published a piece about the AbbVie  Clinical Pharmacology Research Unit, a Illinois phase 1 clinical trial managed by a pharmaceutical company. Some of the issues mentioned make us wonder if they’re shared with our local study subject population. Some key take-aways: —“AbbVie touts altruism as a motive for volunteering. If chosen, “you […]

If you’re assigned to review a reportable new information report (RNI), here are a couple of reminders and resources that may be helpful: –Please look over the entire CLARA form and any additional documents submitted with it. If you’d like more information about the event before the meeting, you can either contact the study team […]

As a reminder to our reviewers, please remember to note any comments, contingencies, notes, or topics for discussion in CLARA before the meeting, keeping in mind the chair has asked for reviews to be completed by noon Monday. Having everything documented in CLARA provides a record for the IRB of topics discussed, makes everything visible to everyone […]

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, […]