Independent or Institutional Review Board (IRB) review serves an important role in the protection of the rights and welfare of human research subjects. The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. At Pearl, there has been a large increase in the number of diagnostic testing protocols submitted for review since the onset of the COVID-19 pandemic. The question that we receive most often is “how will my study be reviewed?” Unfortunately, the only answer we can provide to that question is “it depends.” When reviewing research protocols, an IRB must take several issues into consideration. For example, the route of sampling, the study population, and the risk involved to the subject.
Types of COVID-19 Tests
Currently, there are a few types of COVID-19 diagnostic tests being developed or currently on the market. These include molecular, antigen, and antibody tests. the particulars of these tests are shown below.
Expedited Review Categories
In order for an initial study of a diagnostic device to be reviewed via an expedited procedure, some conditions must be met. The study must be minimal risk and fall into one of the below expedited review categories.
- Category 1: Study of approved drug or device being used for its approved indication
- Category 2: Study involves blood sampling (defined, limited amounts)
- Category 3: Study involves noninvasive specimen collection
- Category 4: Study involves noninvasive, routine clinical procedures, such as MRI or EKG (no sedation, general anesthesia, x-rays or microwaves)
- Category 5: Study involves use of data or specimens collected for non-research or research purposes (e.g. chart reviews)
- Category 6: Study involves collection of data from voice, video, digital, or image recordings
- Category 7: Study involves low-risk behavioral research
Category 1 might apply to your research study if your study involves the testing of a device that is already approved. However, since the COVID -19 test market is relatively new, this scenario is unlikely.
Category 2 could apply if your COVID test is antibody-based and samples are taken via finger stick or blood draw.
Category 3 could apply to your study review if your test is molecular-based and saliva samples are to be collected.
Categories 3 and 4 are not applicable if your test involves collecting nasopharyngeal swabs. Per 21 CFR 812 (k), nasopharyngeal and mid-turbinate swabs are not considered noninvasive. “Noninvasive, when applied to a diagnostic device or procedure, means one that does not by design or intention: … enter the nose beyond the nares”. As such, if the sampling procedure is considered invasive, it is considered greater than minimal risk and must be sent to the full board for review.
Category 5 might apply if your study involves the use of leftover specimens collected as part of routine clinical testing by a licensed physician.
Typically, Categories 6 and 7 would not apply to these types of device studies so we can discard them from this conversation.
As usual, please contact Pearl IRB with any questions you may have before submitting your study for review.