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 […]
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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 […]
Reviewing the entire renewal period when looking at Continuing Reviews
Ongoing studies are required to undergo continuing review by the IRB at least once per year. Please keep the entire timeframe in mind when looking at a continuing review submission. In addition to reviewing the CR form and any documents submitted with the form, take a look at everything that has been submitted on the study […]
Describing coded data in a consent form
The IRB may require you to put information in the consent form describing how subject data will be stored. If you are storing all data with only a code rather than direct identifiers, you should include consent language saying something like, “Your personal information will be identified only with a code and will not include anything […]
Sorting comments on agenda items
So, you’ve gotten your assignments for the week, you’re logged into CLARA, you open the first study you’ve been assigned, and what do you find? Sometimes what greets you is a jumbled mess of comments and suggested contingencies from the IRB consent reviewer, IRB prereview, and maybe the other IRB reviewer as well. Use the […]
Formatting, word choice, white space — they all matter in consent forms
Think back to your high school days, when you’d try to tackle a reading assignment from, say, your history textbook. Did you look forward to the prospect of reading page after page of small text, arranged in long paragraphs? Or were you hoping for some illustrations, bulleted lists, and white space to break up all […]