The Revised Common Rule will bring some largely welcome changes to the Exempt categories of research. In general, the language changes expand the type of research to which the exempt status review will apply.
As a reminder, “exempt” does not mean the same thing in research-land as it does in real life. An “exempt” study is still subject to some UAMS IRB oversight. “Exempt” means that the project fits into one of the exempt status categories described in the regulations.
You may want to have UAMS IRB Policy 7.3 at hand when reading this blog post, as it lists the current exempt categories. Below are descriptions of the changes most closely related to research we see here at UAMS.
Exemption 1 deals with educational research, something we see a fair amount of at an academic institution. The revised rule clarifies that the research must not be likely to adversely impact either the students’ opportunity to learn required educational content or the assessment of educators who provide instruction. An example of something that might not qualify for this exemption is a study of a new way of teaching a particular topic that sharply reduces the amount of time left to teach other required topics. This doesn’t mean this research can’t be done; it just means that exemption 1 may not be applicable. Note that the UAMS IRB already considers these issues when reviewing educational research now.
Exemption 2 — The revised rule will clarify that this exemption applies to studies involving only surveys, educational tests, interviews, and observations of public behavior. This clarifies OHRP’s current position, rather than changing it. This exemption generally will not apply to research involving interventions; see Exemption 3 for benign behavioral interventions instead. An expansion of exemption 2 allows the use of identifiable information that might be sensitive, provided there is “limited IRB review”of privacy and confidentiality protections. This activity requires expedited review under the current rule. Now if only OHRP would issue guidance re what it wants that “limited IRB review” to involve, exactly.
Exemption 3 — This one is being totally rewritten to relate to studies involving “benign behavioral interventions.” Under the old rule, this exemption referred to candidates and public officeholders and a federal statute protecting confidentiality, which we don’t think we ever saw at the UAMS IRB. The revision will likely be helpful for many UAMS researchers. Research qualify for this exemption if it involves benign behavioral interventions with adults who prospectively agree to participate when information collection is limited to verbal or written responses or audiovisual recordings and one of the following applies: a) Information recorded cannot be readily linked back to subjects, or b) it is not sensitive or, c) it is identifiable and sensitive and undergoes “limited IRB review” for privacy and confidentiality protections. And what does “benign” mean? The intervention itself must be brief; harmless, painless, and not physically invasive; not likely to have a significant adverse lasting impact on subjects; and the investigator must have no reason to believe the subjects will find the interventions offensive or embarrassing. And while subjects must “prospectively agree” to the research, this doesn’t mean the full set of informed consent requirements applies. The UAMS IRB’s typical consent process required for exempt status studies would meet this “prospective agreement” requirement. This exemption may even apply to some research involving deception,if subjects are informed they will be deceived about some aspects of the research, and they agree to the deception.
Exemption 4 — This exemption expands in the RCR to allow the use of identifiable private information covered under HIPAA, and to allow the use of such information created in the future, i.e., it doesn’t have to be in existence at the time the study begins to be included. That sound you hear is the sound of the angels singing, as this exemption will cover many of the medical record review studies that currently must be reviewed using expedited procedures. This change means that forward-looking chart reviews will qualify for exempt status review, as will chart reviews in which investigators collect identifying information, if the data are covered under HIPAA (which medical records are, of course).
Exemptions 7 and 8 deal with something called broad consent, which, roughly translated, refers to storing and maintaining identifiable private information/samples for potential secondary research, such as in a tissue and data bank, and then using those data/specimens. We’re still working on what these exemptions may mean for how things are done at UAMS, so stay tuned for more on these exemptions and their possible applications here.