Clinicaltrials.gov, a database maintained by the National Library of Medicine at the National Institutes of Health, lists research studies involving human subjects. Certain types of studies are required to be listed at clinicaltrials.gov, and, per the clinicaltrials.gov website, study registrations have increased as more sponsors and investigators voluntarily register their studies. But as interesting as […]

Fears of side effects, potential higher costs, or being assigned to the placebo group dissuade people from enrolling in clinical trials, according to a new study that was the subject of a recent stat.com article. Those of us who work in research know that we have to be careful when approaching potential subjects regarding studies. While […]

The new submission form may be the longest, most involved form in the CLARA system. When creating a new submission, you’ll be asked a lot of questions – everything from the number and age range of subjects to risks of the research to whether you’ll be collecting any biological samples. You may be tempted to […]

The target date to post our next Research News Blog quiz is June 30. That goal means you only have a few days left to get your 0.5 hours of Certified Research Specialist education credit on our current blog quiz. Go to learnondemand.org, and enter “IRB” in the search box at upper right to access […]

You may have noticed some new text at the end of your new submission approval letters, encouraging you to request a NICE review. New Investigation Consult and Education reviews are a free, voluntary service provided by the UAMS Office of Research Compliance (ORC) for newly approved studies. You can request a NICE review for any study that has just […]

Adult subjects are routinely assumed to be able to weigh the potential risks and benefits of joining a research study. However, functional abilities can vary depending upon the population, and can even fluctuate in a particular individual, due to mental or physical health changes. So what kind of things does the IRB look for when reviewing […]

We’ve been getting a close look lately from the Association for the Accreditation of Human Research Protection Programs (AAHRPP), a.k.a. our accrediting agency, as part of a reaccreditation application. One bit of feedback AAHRPP has provided is that we need to pay closer attention to the way our CLARA forms are filled out to ensure the forms are accurate and complete. […]

We’ve had some questions about how to answer a couple of questions related to a study’s planned number of subjects, and how to address enrollment in the consent form. See the questions below: The first question, “What is your enrollment goal?,” is asking “How many subjects to you need to have in your study to […]

You may have gotten an IRB contingency asking you to change the word “patient” to “subject” in an informed consent form. Is the IRB just being picky here? After all, a clinician may both see someone as a patient and also be an investigator on a study that person is considering joining. So what’s the […]

While some research studies pose very little risk to subjects, there’s no such thing as an entirely risk-free study. Even if a project involves nothing more complicated than looking at previously collected information to gather study data, there’s still a risk of loss of confidentiality of private information. This same risk applies to studies involving […]