|
Tests,
Surveys, Interviews, Observations
|
Basic
Exempt Criteria {§46.101b(2)
Research includes
evaluation of individuals using educational or cognitive tests,
surveys, questionnaires, structured or open-ended interviews, or
systematic observations of public behavior.
NOTE: Studies cannot be exempt if the participant's name (or other
identifiers like birth date and initials, social security number,
phone number, etc.) is linked to "private" or "sensitive"
information (i.e., any information that could possibly affect the
individual's reputation, employability, or financial standing).
For example, if questions about medical history, substance use,
mood state, sexual behaviors, and possible criminal activity are
asked, identifiers cannot be linked to responses. |
|
|
If
subjects are children, only educational tests and/or
passive observation of behavior is permitted; investigators cannot
interact with child subjects
|
|
|
If
subjects are adults, tests, surveys, interviews
or behavioral observations can be included
|
|
|
Data
should ordinarily be recorded without identifiers
|
|
|
If
appropriately justified, identifiers may be recorded, but
only if no sensitive information is collected
|
|
|
Subjects
(or their parents, if subjects are minors) should be provided
with overview of project ("script")
that contains basic elements of informed consent, but no formal
written consent is obtained.
|
|
Additional
Requirements or Considerations
|
|
|
If
subjects are followed over time and assessed repeatedly, written
informed consent should be obtained (and the study submitted for
expedited review) unless it is truly impracticable (e.g., the
only contact with subjects is over the phone)
|
|
|
Focus
groups can be considered to be open-ended interviews, and may
be approved for adults, provided the basic exempt criteria are
met
|
|
|
If children
are studied, investigators must provide a rationale for why a
particular age range was selected, indicate their expertise in
working with children, describe the adequacy of their facilities
for pediatric research, and indicate whether they will have sufficient
numbers of children to adequately address the research question.
This requirement reflects NIH policy, effective October 1998
|
|
|
Copies
of all measures must be attached for IRB review, unless they are
listed in Appendix
G
of the IRB Manual
|
|
When
studies are conducted in foreign countries, written authorization
to conduct the research at that location must be attached to this
application. If identifiers are collected as part of that research
activity, the investigator has the responsibility to ensure that
responses to questionnaires or interviews about political, economic,
cultural, or religious topic will not affect the participant's reputation,
employability, or financial standing. This may require additional
documentation from someone with first-hand familiarity with the
country's laws and mores. |
|
|
Request for Exempt Review Form: Tests,
Surveys or Observations of Public Behavior |
|
