A description of new and revised exemption categories can be found here. Notable changes are also described below.
Minor revisions to existing categories
There have been some minor revisions to the following categories:
Exempt 1: Now includes a statement that the research cannot “adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction.”
Impact: Provides clarification on risk.
Exempt 2: Includes a clarification that the data may involve visual or audio recording as well as a carve-out that allows for the collection of sensitive, identifiable data to be collected as long as a “limited review” is conducted by the IRB.
Impact: Allows for sensitive, identifiable data to be determined as exempt.
Exempt 4: This category has been revised to also include biospecimens, as well as special carve-outs for HIPAA-covered data, federally conducted research, and federally generated data.
Impact: Provides greater clarity on what is allowable under this category.
Exempt 5: The revision provides further clarification about what are “research and demonstration projects that are conducted or supported by a Federal department or agency.” To note, research that is reviewed under this category has always been quite rare.
Impact: Provides clarification on what is allowable under this category.
New Exempt Categories
Exempt 3: This is a new category specific to “benign interventions” involving adults that allows for deception under certain conditions. Data may also be sensitive and identifiable as long as a “limited review” is conducted by the IRB.
Impact: “Benign interventions” are currently reviewed as expedited review, as there is no current exempt category that this activity would fit in. With the Common Rule, this type of research would be permitted as an exempt review.
Exempt 7: This new category is specifically for identifiable data and/or biospecimen repositories as long as a “limited review” is conducted by the IRB.
Impact: Repositories are currently reviewed as expedited review, as there is no current exempt category that this activity would fit in. With the Common Rule, this type of research would be permitted as an exempt review.
Exempt 8: This new category pertains to the use of identifiable data and/or biospecimens from a repository as long as certain conditions are met.
Impact: The review of secondary use of identifiable data is currently reviewed as expedited review, as there is no current exempt category that this activity would fit in. With the Common Rule, this type of research would be permitted as an exempt review.