| 1. |
Is
there an intervention or an interaction with a living person that
would not be occurring or would be occurring in some other fashion
but for this research? Examples: videotaping people, observing children
using software, surveying manufacturing personnel during a pilot test
of new equipment, gathering tissue or cells from human donors. |
| |
|
 |
Yes—Human
subjects are involved. Go to question 3. |
| |
|
|
No—Go to
question 2. |
| 2. |
a. |
Will
data/information/specimens collected originally from people or about
people be used in this research? Examples: broadcast video, Web-use
logs, medical information, cells or tissues, survey questions. |
| |
|
|
Yes—Identifiable
human subjects may be involved. Go to question 2.b.. |
| |
|
|
No—Go to
question 6. It appears that human subjects may not be involved in
the project. However, an exemption determination may be required.
Please review question 3 for additional information about research
that may require an exemption determination. |
| |
b. |
Does
that information contain private information in a form in which the
identity of the subject is or may readily be ascertained from the
information? Examples: medical records, donor name or address, sales
transaction records. |
| |
|
|
Yes—Identifiable
human subjects are involved. Go to question 3 to see if an exemption
may apply. If you know that an exemption does not apply, proceed to
question 5. |
| |
|
|
No—Go to
question 3. The research may not be within the scope of 15 C.F.R.
Part 27; however, it may require an exemption determination to be
made due to the use of data, recordings, or specimens that could be
linked to humans without appropriate safeguards. |
| 3. |
Do
you think the research may either not be within the scope of 15 C.F.R.
Part 27 or qualify for an exemption under 15 C.F.R. § 27.101(b)?
The following questions will help you evaluate whether to request
an exemption determination by ATP or provide documentation that the
research may not be within the scope of 15 C.F.R. Part 27: |
| |
a. |
Will
the task involving human subjects use only existing data, recordings
(audio or visual), or specimens? Examples: patient records, a company’s
customer data, Web-use logs, cells, or tissue. |
| |
|
|
Yes—Go to
question 3.d. |
| |
|
|
No—Go to
question 3.b. |
| |
b. |
Will
the research plan involve normal educational practices such as instructional
strategies or comparison of instructional techniques, curricula, or
classroom management methods? Examples: observation of student-teacher
interactions, video of instruction. |
| |
|
|
Yes—Go to
question 3.d. |
| |
|
|
No—Go to
question 3.c. |
| |
c. |
Will
the research plan involve educational tests (cognitive, diagnostic,
aptitude, achievement), survey procedures, interview procedures, or
observation of public behavior? Examples: broadcast video, software
usage testing. |
| |
|
|
Yes—Go to
question 3.d. |
| |
|
|
No—Go to
question 5. This research is probably not exempt and will require
Institutional Review Board (IRB) review and approval. |
| |
d. |
Do
any of the data, recordings, specimens, or practices/procedures involve
or come from a protected class? Protected classes include prisoners,
children, pregnant women, human in vitro fertilization, fetuses, and
nonviable fetuses or fetal sources of data, cells, or tissue. Examples:
testing educational software with children, surveys of obstetric patients. |
| |
|
|
Yes—Go to
question 5. This research is probably not exempt and will require
IRB review and approval. |
| |
|
|
No—Go to
question 3.e. |
| |
e. |
Are
the data, recordings (audio or visual), or specimens publicly available?
NOTE: Publicly available may include items for sale, items that are
freely available to the public, or items that reside in the public
domain. Examples: customer data sets, catalog orders of cells or tissues,
donations of pathological specimens, shareware. |
| |
|
|
Yes—Go to
question 4. This research may be exempt under 15 C.F.R. § 27.101(b). |
| |
|
|
No—Go to
question 3.f. |
| |
f. |
Will
the data, recordings (audio or visual), or specimens be stripped of
all identifiable information that could be linked to a human subject
prior to being received by the investigator? |
| |
|
|
Yes—Go to
question 4. This research may not be within the scope of 15 C.F.R.
Part 27, or this research may be exempt under 15 C.F.R. § 27.101(b). |
| |
|
|
No—Go to
question 3.g. |
| |
g. |
Will
information be recorded by the investigator in such a way that it
can be linked to the human subject? Examples: Web-use logs tied to
e-mail address, patient records, or specimens that include patient
identifiers. |
| |
|
|
Yes—Go to
question 5. This research is probably not exempt and will need an
IRB review. |
| |
|
|
No—Go to
question 4. This research may be exempt under 15 C.F.R. § 27.101(b). |
| 4. |
An
exemption under 15 C.F.R. § 27.101(b) may apply to the task,
or the task may not be within the scope of 15 C.F.R. Part 27. In order
to complete the necessary requirements for research considered exempt
under 15 C.F.R § 27.101(b), please review this booklet. Complete
Appendix 3 and/or Appendix
4 as required and submit with Gate 1 proposal. |
| 5. |
An
exemption probably does not apply to the proposed research and further
documentation is required. Please review this booklet. See Appendix
5 for required documentation list. |
| 6. |
It
appears that human subjects are not involved in this project. This
checklist is only a tool for general guidance and does not constitute
a final legal opinion from NIST on whether human subjects are involved,
or whether an exemption determination under the regulations is needed.
If, upon NIST/ATP review of your proposal, it is determined that additional
documentation is needed to reach a final determination, and your proposal
is selected as a semifinalist (Gate 3), you will be asked to provide
the additional documentation prior to an oral review. |
| |
|
|
|
