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 […]

As mentioned previously, one of the most contentious proposals in the current Common Rule draft requires the obtaining of informed consent for future research use of tissue specimens. Here’s one opinion on how this requirement might impact communities with limited access to health care – a concern relevant to many areas of Arkansas.

Author Paul McLean has probably given a lot of thought to medical ethics, both as an ethics fellow at Harvard Medical School, and as the parent of a child who directly benefited from medical research. And apparently he’s a dog person too. Read his family’s story at the link above.

The following research history trivia quiz should get us thinking both about just how long research has been going on, and why maintaining certain ethical standards is important. Q. Where would you look to find a description of the earliest known activity that might be described as research involving one or more human subjects? Published descriptions of […]