Research, health care, and science all keep racing ahead, and human research protection programs keep trying to keep up. Studies involving development and testing of machine learning/artificial intelligence projects that use software were just not on most institutional review boards’ radar 10-15 years ago, but now they’re here, and we are learning how to best […]

Institutional review board staff and reviewers (and plenty of others, too) lie awake at night thinking about the ethical implications of research involving genomic data. While we all tend to worry about the identifiability of such data, genomic research can create large, population-wide considerations. Population descriptors used in genomic research can be one factor leading […]

The distance between researchers in the lab and the patients who benefit from research findings used to feel like a Grand Canyon-sized gap. However, over the past few decades, at least as far back as the HIV/AIDS epidemic of the 1980s, patients have played an growing role in research development and making research results available […]

Because we try to keep things simple at the IRB (or maybe we’re just simple folk), we’re thrilled to announce that we have created a resource that contains information that industry sponsors and external IRBs tend to ask for as we start up our site in multi-site studies. We’ve collated the responses to the questions […]

We’ve talked to the IRB Blog Central Archivist, and given her a stern talking-to about posting the slides from our IRB member trainings. Below are slides from education sessions that have continuing relevance. (Yes, every topic is relevant, but some, such as courses related to preparation for the AAHRPP site visit, have less long-term relevance than […]

How many times have you heard a reference to “The Beecher Report”? This report is considered a foundational document underpinning human research ethics, but it’s unclear how many of us who work in human subject research have had a chance to actually read and discuss it. Because we want to give the UAMS human research […]

HIPAA regulations require certain safeguards for electronic access to and storage of Protected Health Information (PHI). The following platforms are HIPAA compliant, per a list provided by The People Who Handle These Things. (We got the list from the UAMS Office of Research Compliance (ORC), but we can’t remember who, exactly, gave the list to […]

Preliminary results from a COVID challenge trial involving 36 young adults should this trial design appears safe, according to a recent Reuters article. Challenge trials, in which participants are deliberately exposed to an agent that can make them ill, raise questions of whether such a trial design is ethical. One camp argues challenge trials are […]

The question of whether to return incidental findings to research subjects is tricky. If a study team notices, say, an anomaly on a CT scan, or a blood test result indicative of a potential problem, should the participant be told of the finding? The participant’s wishes, and whether anything could be done in response to […]

Gang Chen, the M.I.T. scientist who had been charged with failing to disclose ties to China only to see the charges dropped a year later, says he is uncertain if he will ever again feel safe applying for federal research grants, according to a recent New York Times story. He described what he experienced over […]