Yes No
Yes No
Yes No
3. Research involving benign behavioral interventions in conjunction with the
collection of information from an adult subjects through verbal or written responses
or audiovisual recording if the subject prospectively agrees to the intervention and
information collection and at least one of the following criteria is met:
i. The information obtained is recorded by the investigator in such a manner that
the identity of the human subjects cannot readily be ascertained, directly or through
identifiers linked to the subjects;
ii. Any disclosure of the human subjects' responses outside the research would
not reasonably place the subjects at risk of criminal or civil liability or be damaging
to the subjects' financial standing, employability, educational advancement, or
reputation;
iii.The information obtained is recorded by the investigator in such a manner that
the identity of the human subjects can readily be ascertained, directly or through
identifiers linked to the subjects, and an IRB conducts a limited IRB review to make
the determination required by §46.111(a)(7).
4. Secondary research for which consent is not required: Secondary research uses
of identifiable private information or identifiable biospecimens, if at least one of the
following criteria is met:
i. The identifiable private information or identifiable biospecimens are publicly
available;
ii. Information, which may include information about biospecimens, is recorded
by the investigator in such a manner that the identity of the human subjects cannot
readily be ascertained directly or through identifiers linked to the subjects, the
investigator does not contact the subjects, and the investigator will not re-identify
subjects;
iii. The research involves only information collection and analysis involving the
investigator's use of identifiable health information when that use is regulated under
45 CFR parts 160 and 164, subparts A and E [HIPAA]; or
iv. The research is conducted by, or on behalf of, a Federal department or
agency using government-generated or government-collected information obtained
for nonresearch activities,...
5. Research and demonstration projects that are conducted or supported by a
Federal department or agency,... and that are designed to study, evaluate, or
otherwise examine: Public benefit or service programs; or procedures for obtaining
benefits or services under those programs; or possible changes in or alternatives to
those programs or procedures; or possible changes in methods or levels of
payment for benefits or services under those programs...
6. Taste and food quality evaluation and consumer acceptance studies,
1. if wholesome foods without additives are consumed, or
2. if a food is consumed that contains a food ingredient at or below the level and for
a use found to be safe, or agricultural chemical or environmental contaminant at or
below the level found to be safe, by the FDA or approved by the Environmental
Protection Agency or the Food Safety and Inspection Service of the U.S.
Department of Agriculture.
Samford does not implement federal exemptions 7 and 8.
Yes No
Yes No
Yes No
Yes No
Yes No
Yes No
Form Updated 11/19
