The news about the Tuskegee study became public 45 years ago this summer. The federally funded study, which involved leaving syphilis untreated in African-American men for decades to follow its course, even after effective treatment became available, is one of the seminal events leading to the development of human subject protection regulations, policy, and best […]

In IRB-land, we use a variation of what might be called “Notice and Choice” regarding subjects’ allowing access to their private information. We tell people up front what their private information might be used for, including in the future as well as for the current project, and then give them the choice to opt in […]

In a perfect world, clinical trial participant populations would perfectly reflect the population from which they’re drawn. Those of us living in the real world, however, know that attracting and retaining a truly representative can be difficult. Different populations face different barriers to joining clinical trials, and UAMS and ACH researchers encounter people of a […]

As noted in a recent IRB Research News and Tips blog item, the revised Common Rule will require some changes to the current way we present and document key elements of informed consent information. We have yet to hear specifics about how those new requirements, slated to take effect in January 2018, are to be […]

A couple of things happened recently that got us thinking about the IRB approval criterion that requires informed consent information to be provided “in language understandable to the subject.” First, we prereviewed some industry study consent forms that were between 20 and 40 single-spaced pages, full of big words about serious disease. If I had […]

Q. How can I search for a specific blog item that I know I’ve seen, but I don’t know when? A. Short answer: If you know of a way, do let us know, because we haven’t been able to figure one out.  Long answer: Someone had a great idea that we thought we’d share. If […]

The Journal of Medical Ethics blog has a recent entry addressing findings of a study that examined the extent to which IRB members were familiar with some basic study design concepts. (In summary: not very familiar.) The blog entry author writes that she would expect IRB members to know enough about research design to be […]

It seems as though everyone involved in human subject protections struggles with the informed consent process. The desire to provide complete information to subjects can collide with a need to keep informed consent forms and processes simple and understandable. Eliza Hurley, director of the research professional organization Public Responsibility in Medicine and Research (PRIM&R), recently […]

This Memorial Day weekend, we honoring those who served. And since this is a research blog, we’ll guide you to a Foundation for Biomedical Research article about the animals who have served our veterans on the battlefield and in the research lab. There’s no shortage of stories about the ties between military working dogs and […]

One goal for the revised Common Rule, according to its developers, was to streamline oversight requirements based on the risk level of proposed research. IRB oversight has caused its share of grousing among researchers here and elsewhere about overreach (a.k.a. mission creep) and focus on irrelevant details. Social and behavioral researchers are now weighing in in […]