Challenge trials – in which human volunteers are deliberately infected with pathogens that can get them sick – have a long history, according to a recent New York Times opinion piece. The article describes a British research center where volunteers were deliberately infected with coronaviruses in a quest to find a cure for the common […]

Brazilian families who enrolled their children in research about Zika later had concerns about not having the research results returned to them, according to this article in the online magazine Undark. Although this article is specific to research done in Brazil, the challenge of returning study results to research participants will look familiar to researchers […]

Federal regulations include additional protection for certain so-called vulnerable populations, including pregnant women and fetuses. These restrictions run the risk of being unethical by discouraging, or disallowing, people who might benefit from research to participate in it, according to the author of a recent Washington Post opinion column. Sarah N. Cross writes that pregnant women […]

Is your study team participating in a multi-site study in which each site will undergo separate IRB review? If so, take advantage of the option to submit a “local protocol addendum” to add detail about the main protocol the main site sends you. The IRB knows that asking for a correction or an addition to […]

Ever wondered how to make a grown IRB office staffer cry? Easy – send them a protocol submission that almost but not quite meets the criteria for expedited review. An example – protocols that involve multiple teeny tiny blood draws done over a short period of time. Expedited category 2a allows a reasonable amount of blood to […]

ORC, which has worked wonders over the past 18 months to keep the education offerings coming during a pandemic, is asking for feedback about the Certified Research Specialist (CRS) and Advanced Certified Research Specialist (ACRS) programs! Please click this link to take a short (10-minutes-max or so) anonymous survey about these two educational programs. ORC […]

Although  it wasn’t easy – some behind-the-scenes server switching caused the IRB’s web page to go a little kablooie – we finally were able to get some updated IRB policies posted. All of the current policies can be found on the IRB’s webpage. Retired policies are archived on the policy archive webpage. The most notable […]

A recent blog entry on the Public Responsibility In Medicine & Research (PRIM&R) is a good reminder of some of the considerations associated with obtaining consent for research remotely. eConsent is becoming more common, both because of the growth of telemedicine in general, and also because of its ability to make research available across a […]

A recent Philadelphia Inquirer article indicates the dean of Penn Medicine has apologized for the work of a longtime faculty member (now deceased) for conducting medical research on inmates at a Philadelphia prison. The research led by dermatologist Dr. Albert Kligman was done at Philadelphia’s Holmesburg Prison, where most of the inmates were Black. The […]

We’ve been noticing, as we review studies that qualify for exempt status review, that sometimes it seems like the consent process is the longest and most daunting-to-subjects part of participation. We realized that we didn’t have any consent material templates geared for exempt status research readily available. At least that’s a problem we can solve […]