Part 2: Exemption Criteria For Research Projects
Please select any and all categories that relate to your research. Research is exemptible when all research methods are
one or more of the following five categories. Check statements that apply to your study:
1. In education setting, research to evaluate normal educational practices.
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2. For research not involving vulnerable people [prisoner, fetus, pregnancy, children, or mentally impaired]: observe public
behavior (including participatory observation), or do interviews or surveys or educational tests:
The research must also comply with one of the following:
a) The participants cannot be identified, directly or statistically;
or that
b) The responses/observations could not harm participants if made public;
or that
c) Federal statue(s) completely protect all participants' confidentiality;
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3. For research not involving vulnerable people [prisoner, fetus, pregnancy, children, or mentally impaired]; observe public
behavior (including participatory observation), or do interviews or surveys or educational tests:
All respondents are elected, appointed, or candidates for public offices.
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4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic
specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that
subjects cannot be identified, directly or through identifiers linked to the subjects.
must also comply with one of the following:
The research
a) Subjects cannot be identified in the research data directly or statistically, and no-one can trace back from research
data to identify a participant;
or that
b) The sources are publicly available
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5. Research or demonstration service/care programs, e.g. health care delivery.
a) It is directly conducted or approved by the head of a US Govt. department or agency.
and that
b) It concerns only issues under usual administrative control (48 Fed Reg 9268-9).
e.g., regulations, eligibility, services, or delivery systems;
and that
c) Its research/evaluation methods are also exempt from IRB review.
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6. For research not involving vulnerable volunteers (see "2&3" above), do food research to evaluate quality, taste, or
consumer acceptance.
must also comply with one of the following:
The research
a) The food has no additives;
or that
b) The food is certified safe by the USDA, FDA, or EPA.