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 \u201cbenign behavioral interventions\u201d will now be considered exempt (see category 3).<\/p>\n
The primary change you\u2019ll see is in the I-Manager xForms, where the new Exempt categories are listed. Our process for reviewing and approving exempt studies hasn\u2019t 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.<\/p>\n
Expedited categories have not changed.<\/p>\n
Below is a summary of the changes to the exempt categories. Click here to access full text for all categories (pdf)<\/a>.<\/p>\n Educational research: Minor changes were made, clarifying that the research must not disrupt students\u2019 learning.<\/p>\n (1) Research, conducted in established or commonly accepted educational settings, <\/span>that specifically involves involving<\/span> <\/span>normal educational practices<\/span> 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<\/span> <\/span>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.<\/span><\/p>\n 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.<\/p>\n The former exempt category 3 was eliminated completely and replaced with a category granting exemption to studies involving only \u201cbenign behavioral interventions\u201d with adult subjects. The data must be anonymous or non-sensitive, or have sufficient protections in place to ensure data security.<\/p>\n (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.<\/span><\/p>\n Benign behavioral interventions are defined as: \u201cbrief 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.\u201d<\/p>\n Examples:<\/p>\n 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.<\/p>\n 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:<\/p>\n 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.<\/p>\n This category, for food evaluation and acceptability studies, is unchanged.<\/p>\n These two new categories are used when broad consent<\/a> 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.<\/p>\n","protected":false},"excerpt":{"rendered":"Exempt Category 1: Educational research \u2013 Revised<\/span><\/h4>\n
Exempt Category 2: Anonymous \/ non-sensitive surveys, interviews, etc. \u2013 Revised<\/span><\/h4>\n
Exempt Category 3: Benign behavioral interventions \u2013 New<\/span><\/h4>\n
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Exempt Category 4: Secondary research on existing data or specimens \u2013 Revised<\/span><\/h4>\n
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Exempt Category 5: Research conducted by federal agencies \u2013 Revised<\/span><\/h4>\n
Exempt Category 6: Food acceptance studies \u2013 Unchanged<\/span><\/h4>\n
Exempt Categories 7-8: Data and specimen banking with broad consent \u2013 New<\/span><\/h4>\n