| 1. |
What
is the time frame (start and end dates) for human subject/data/image
involvement? |
| 2. |
State
the technical justification for human subject/data/image involvement
(i.e., Is there no other way to achieve an equivalent technical outcome?
Why?). |
| 3. |
Are
the data/images stripped of any identifiable information (e.g., personal
identifiers such as names or codes that can be traced back to the
human donor or source)? Explain. |
| 4. |
Are the data/images
publicly available from a named source? Explain and name the source(s)
being considered or planned, if appropriate.
NOTE: An answer
of “no” to either question 3 or question 4 may disqualify
the project from an exemption. In those cases, an appropriate IRB
approval may be required and should accompany the proposal if the
work is within the first year of the project.
|
| 5. |
Are
the data/images/recording preexisting, being collected for the express
purpose of the research, or being obtained by some combination of
the two? |
| 6. |
What
is the source of the data/images/recording (e.g., video archives,
proprietary database, security systems/records, medical records, video
conference records)? |
| 7. |
What
is the extent of data/images/recording handling by the Principal Investigator:
collecting, receiving, and/or sending data/images? |
| 8. |
What
is the extent of contact by the Principal Investigator with human
subjects: personal observation, image recording, survey questions? |
| 9. |
What
is the extent of control by the Principal Investigator of the environment
in which the human subjects will be monitored? |
| 10. |
Do
the data/images/recording come from individuals (e.g., minor children
or prisoners) who may need special safeguards? NOTE: An answer of
“yes” to question 10 disqualifies the project from exemption
under 15 C.F.R. Part 27. In these cases, the proposal protocol/task
descriptions MUST be reviewed and approved by an IRB that possesses
a current assurance appropriate for the research in question. The
assurance must be on file with the OHRP, and approved by OHRP for
federalwide use. This IRB approval MUST be submitted by the time of
oral review (Gate 3). |
| 11. |
Is
the image/recording in fact “public behavior”? Some indicators
of public behavior are the following: |
|
a. |
The
image of behavior does not give rise to any cause of action under
any legal theory protecting personal privacy. |
|
b. |
No
trade secrets or other confidential information pertaining to any
person are in the image or recording. |
|
c. |
No
copyright restrictions exist, or the copyright holder has granted
written permission to the proposer. |
|
d. |
The
image of behavior contains other matter the proposer deems germane
to this issue. |
| 12 |
If
the answer to question 11 is “yes”: |
|
a. |
Can
the human subjects be identified directly or through identifiers? |
|
b. |
If
the human subjects can be identified, would any disclosure reasonably
place the subjects at risk of criminal or civil liability, or would
it jeopardize standing, employability, or reputation? |
| 13. |
Has
the research been reviewed by an IRB? If yes, attach a copy of the
review. |
|
| The
following signed statement must accompany the answers to the above
questions: |
| This
is an accurate description of the proposed research involving human
subjects. Any changes in protocol or task descriptions will be submitted
in advance to the IRB as appropriate and to ATP before notification
of ATP award decisions. |
|
| ________________________________________________________ |
____________________ |
|
| Name
of Principal Investigator |
Date |
|
|
|
|
