The new regulations include many changes to the exempt categories, which went into effect January 21, 2019. In most cases, they have been expanded to include research that previously could not be exempt. One of the most notable changes for UWM researchers is that “benign behavioral interventions” will now be considered exempt (see category 3).
The primary change you’ll see is in the I-Manager xForms, where the new Exempt categories are listed. Our process for reviewing and approving exempt studies hasn’t changed. Some researchers might see a faster turnaround time, if their research was previously typically expedited and now qualifies as exempt. This will mostly affect psychology and some linguistics faculty.
Expedited categories have not changed.
Specific changes to the Exempt categories
Below is a summary of the changes to the exempt categories. Click here to access full text for all categories (pdf).
Exempt Category 1: Educational research – Revised
Educational research: Minor changes were made, clarifying that the research must not disrupt students’ learning.
(1) Research, conducted in established or commonly accepted educational settings, that specifically involves involving normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most such as research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Exempt Category 2: Anonymous / non-sensitive surveys, interviews, etc. – Revised
Previously, this category only applied to anonymous or non-sensitive research. With the new regulations, there is a provision for certain kinds of sensitive data to remain identifiable or coded, if sufficient protections are in place to ensure data security.
Exempt Category 3: Benign behavioral interventions – New
The former exempt category 3 was eliminated completely and replaced with a category granting exemption to studies involving only “benign behavioral interventions” with adult subjects. The data must be anonymous or non-sensitive, or have sufficient protections in place to ensure data security.
(3)(i) Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection.
Benign behavioral interventions are defined as: “brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing.”
- having subjects play an online game
- having subjects solve puzzles under various noise conditions
- having subjects decide how to allocate a nominal amount of received cash between themselves and someone else.
If a study involves deception, it can be exempt under this category if the participants are told during the recruitment/consent process that there is an element of deception in the study, and they agree to participate knowing this.
Exempt Category 4: Secondary research on existing data or specimens – Revised
This category was completely revamped. Previously, the use of existing records or specimens could be exempt only if the data was recorded in a de-identified manner. The new regulations allow the use of identifiable data/specimens for secondary research, if at least one of the following conditions is met:
- The data/specimens are publicly available (although in most situations, this type of research would not require IRB review at all);
- The information is recorded in a way that there is no possible way to link the data to the subjects’ identities, the researcher does not have any contact with the subjects, and will not re-identify the data;
- The research involves only information regulated by HIPAA; or
- The research is conducted by or on behalf of a federal department or agency, and other specific conditions are met.
Exempt Category 5: Research conducted by federal agencies – Revised
This category has been altered/clarified, but it applies primarily to research conducted by departments in the federal government. The changes are not likely to affect UWM researchers.
Exempt Category 6: Food acceptance studies – Unchanged
This category, for food evaluation and acceptability studies, is unchanged.
Exempt Categories 7-8: Data and specimen banking with broad consent – New
These two new categories are used when broad consent is obtained for future, unspecified research. The two categories are related: Category 7 governs the setup of a data/biospecimen bank, while research using the banked data/biospecimens would fall under Category 8.