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 […]
Research News
Investigators, study staff, research administrators — keep up with research happenings in our Research News and Tips blog. Reminders for working with the Institutional Review Board, Clinical Research Administration (CLARA) tips, educational opportunities — we’ll post all that, and more, on this blog.
Screening adult populations for capacity to consent
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’re cracking down on form completion
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. […]
Enrollment v. accrual — how many subjects will I have?
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 […]
The difference between a “patient” and a “subject”
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 […]
Confidentiality: The one risk of just about all research
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 […]
Can the consent process be waived in prospective chart review studies?
Some studies involve reviewing patient charts for encounters that have not yet occurred. Investigators sometimes ask to waive the entire consent process for these prospective chart review studies. Please keep in mind that the IRB’s ability to waive the entire consent process is restricted by current regulations, and many prospective chart review studies would not […]
Collecting PHI in chart review studies
The CLARA new submission form asks investigators about the source of any protected health information (PHI) they may be using for the research. One query asks whether any PHI will be collected directly from subjects, and another asks whether you will access PHI from medical records. Please note that if you are doing a chart review […]
Listing the resources available to protect human subjects in record review studies
The CLARA new submission form’s Risks section starts with a question asking you to list the resources available to protect human subjects in the research setting. If you are doing a record review study, please go ahead and include an answer in this box, even though you won’t be interacting directly with living individuals. The […]
Describing your test article in a consent form
If your study involves a test article (drug or device), then you’ll need to let subjects know during the consent process about the test article’s approval status. Please note that the IRB will want the approval status stated very clearly. We’ve seen, for example, long lists of all the countries in which a particular test article […]