November 7, 2018
The Common Rule News – November 7, 2018
Issue 8: Exempt Research, Part 2 of 3
HSD’s Common Rule Webpage
Exempt Research, Part 2 of 3
What are the categories of research that can be granted exempt status, and how are those categories changing with the revised Common Rule?
Last week’s issue described what it means for a study to be exempt, the advantages associated with exempt status, and the changes coming for the most commonly-used exempt category.
Exempt Category 1
Research on normal educational practices in established or commonly accepted educational settings.
The revised Common Rule does not change this exempt category, except to add that the research should be “not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction”. This possible risk of harm is something that HSD reviewers have always considered for this exempt category. Bottom line: No change in the number of studies that will be exempt in this category.
Exempt Category 2
Educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior.
This category was described in last week’s issue of the Common Rule News. It is the most common category of exempt research; with the revised Common Rule’s expansion of this category, even more studies will qualify for exempt status. Bottom line: More research will be exempt in this category.
Exempt Category 3
Research involving benign behavioral interventions.
This new category of exempt research overlaps significantly with the current UW specific category 7 – but the big difference is that this new category can be used with federally-funded research. Bottom line: More research will be exempt in this category.
Specific requirements for this exempt category include:
- Benign. The behavioral interventions must be benign. See the Word of the Week, below.
- Adults only. Research with children does not qualify for this category.
- Data collection methods must solely consist of collecting information through verbal or written responses (or data entry) or audiovisual recording.
- Prospective agreement. Subjects must agree to participate. This is a much looser concept than the regulatory requirement for consent and can be tailored to the nature of the study. No documentation is required; the fact that the subjects are participating is often considered sufficient evidence of their agreement.
Categories 4, 7, and 8
These categories will be described in the next issue of the Common Rule News, due to length considerations. All three categories focus on the secondary use of information or biospecimens – such as medical records reviews.
Exempt Category 5
Federal research and demonstration projects designed to study, evaluate, improve or examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternative to the programs, or possible changes in methods or levels of payment for benefits or services under those programs.
The changes are minor and intended to slightly increase the number of studies that qualify, and to clarify the category’s scope and criteria (which are numerous). However, this type of research is vary rare at the UW; about one study every five years. The detailed criteria will be described in the revised WORKSHEET: Exempt Determination (late November release date). Bottom line: No change in the number of studies that will be exempt in this category.
Exempt Category 6
Taste and food quality evaluation and consumer acceptance studies.
The revised Common Rule makes no changes to the wording or interpretation of this exempt category. UW research that fits all of the criteria for this category is rare. Bottom line: No change in the number of studies that will be exempt in this category.
Exempt Category 101
Currently called category 7
Non-federally-funded research involving benign interventions, interactions, or observations of behavior.
This category is part of the UW’s Flexibility Policy for non-federally-funded research. It is not part of the original or the revised Common Rule. It overlaps significantly with revised Common Rule category 3 (benign behavioral interventions). Fewer studies will be classified as exempt in this category – because they will qualify instead for the new exempt category 3. Bottom line: Many studies that would previously have been considered exempt because of this category will now be considered exempt in category 3 (i.e., a re-distribution among categories).
Word of the Week
Benign behavioral interventions are a key concept for an important new category of research considered to be exempt (category 3) and for an existing UW-specific category (currently called category 7; renamed category 101 when the revised Common Rule is implemented). Benign means: brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the researcher has no reason to think that the subjects will find the interventions/interactions/observations to be offensive or embarrassing.
Question from Campus
Q. One of the new required consent elements is to inform subjects if the study might include whole genome sequencing. Can you clarify whether the whole genome sequencing this refers to is of HUMAN genomes? For example, I have a study where we are collecting bacteria from human biospecimens and then doing whole genome sequencing of the bacteria. Would that need to be included in the consent form?
A. The requirement is only for sequencing of human genomes, so it doesn’t apply to the procedure you describe. You could still describe this part of your research in the consent form, but it would be as part of your general description of the study’s purpose and procedures, not because of this new specific requirement. This is how the requirement is written in the regulations:
“For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).”
Summary of Changes
HSD’s Common Rule webpage has a summary of the changes. Each issue of this special newsletter will focus on one of these changes – providing in-depth details about how it will affect researchers, the IRB review process, consent forms, application forms, and the Zipline e-IRB system. It will also link to any resources that are available to help with the change. The schedule of topics and newsletter dates are posted on the HSD Common Rule webpage.
Issue 9: November 14, 2018
Focus: Exempt Research, Part 3 of 3
Back issues available on the HSD Common Rule webpage