The issue of whether genetic information or material can be considered identifiable prompts a great deal of discussion among researchers and IRBs. On the one side are those who believe that nothing is more uniquely identifiable than an individual’s genetic information. On the other are those who say that genetic information by itself cannot readily […]

Ensuring the right steps are taken to prevent pregnancy can be an important part of research subject safety, particularly for drug studies, as the effects of a research intervention on an embryo or fetus are often unknown. But what’s the best way to describe the requirement to avoid pregnancy in a consent form? Quorum Review […]

Research involving human  materials is again in the news at The New York Times. A recent news article about fetal tissue researchers highlights some of the nuances involved in this type of research, and not just the ethics of it. The article highlights issues related not just to sourcing of fetal material, but also to concerns relevant to the broader […]

The decision to join a research study can have unpredictable long-term results. A man with autism who, at age 50, joined a study examining transcranial magnetic stimulation found the effects life-changing, in both positive and negative ways.

Many research studies involve multiple visits, with specific procedures to be carried out at each visit. Consent forms often describe this kind of research in visit-by-visit lists that include each procedure at every visit. This format can lead to a long consent form that includes a lot of repetition, if procedures will be repeated. We encourage […]

Genetic testing poses all kinds of questions for IRBs. Are genetic testing results potentially identifiable? Are they meaningful? Should they be returned to patients? Our current ability to do genetic testing may have outpaced our ability to answer these questions, at least for now. When reviewing research, we sometimes are asked to put ourselves in […]

Quorum Review IRB recently released an online resource recommending ways to shorten and simplify consent forms. Since overly long and convoluted consent forms are an ongoing headache for IRB members and researchers, we thought we’d share some of Quorum’s suggestions with you in a series of blog items. And we recognize that with industry sponsored […]

While we’re not exactly heading out to claim new territory, the weekly IRB meetings are set to move, beginning Tuesday, June 7. We are returning to our old space in the Biomed 1 building, rooms 205/207 on the second floor. You can enter these rooms from the atrium at the top of the stairs. Those […]

One of the IRB’s criteria for approval of research is “Risks to subjects are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk. While questions remain about the recent clinical trial in France that led to the death of one participant and serious adverse […]

It should come as no surprise that there are no quick answers to the question of what, exactly, went wrong in the clinical trial in France in which one participant has died and 5 others experienced other serious adverse events. A few more news articles about the study are here: An early report in Science A quick […]