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 […]
More background on why, exactly, we have IRBs and why they matter
Anyone who has done their basic human subject protection training is aware of some of the research-related abuses that led to the creation of ethics oversight boards. We recently came across a couple of publications about one fairly well-known study that involved feeding radioactive cereal to institutionalized children. While these publications aren’t new, they do […]
AAHRPP Site Visit Recap
Well, we made it through another site visit from our accrediting agency, the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Our two site visitors spent 2.5 days at UAMS reviewing records and policies and interviewing people from several components of our human research protection program. We are to receive a draft report […]
Simplifying consent forms, part 5 (and the Plain Language Consent Templates)
Consent form formatting and word choice can go a long way in making written consent forms easy to understand. While it may be tempting to cram as many words as possible onto a single page, in an effort to reduce the overall page count, having a bunch of gray text on a page will likely […]
If you see something, say something. Like when the minutes you’re to approve are for the wrong date.
We’ve noticed that if we’re not very, very careful, CLARA has the tendency to pull minutes from the wrong meeting to add to the agenda. The reason for this relates to a CLARA quirk involving the timing of agenda creation and meeting finalization in the CLARA system. CLARA is supposed to pull the minutes from […]
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 […]