Guidelines
and Documentation Requirements for Research Involving Human and Animal
Subjects
APPENDIX 4
Request for an Exemption
From 15 C.F.R. Part 27 for Research Involving Human Subjects in Biological
Studies
If the research may be
exempt under 15 C.F.R.27.§101(b), as indicated by your responses to
the questions in The Human Subjects Determination Checklist (Appendix
2), then responses to the following questions must be supplied along
with the initial proposal submission (Gate 1) to allow NIST and ATP to perform
an independent determination of whether the use of human subjects qualifies
for an exemption from 15 C.F.R. Part 27. For proposals involving the collection
of data from voice, video, or digital sources or involving other uses of
informatics, please complete Appendix 3.
| 1. |
What
is the time frame (start and end dates) for human tissue/subject involvement? |
| 2. |
State
the technical justification for human tissue/subject involvement (i.e.,
Is there no other way to achieve an equivalent technical outcome?
Why?). |
| 3. |
Are
the samples 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. |
Is the tissue
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. |
What
is the anatomical source of the cell or tissue (e.g., liver, skin)? |
| 6. |
What
is the extent of tissue handling by the Principal Investigator: collecting,
receiving, and/or sending specimens? |
| 7. |
Are
the samples preexisting, being collected for the express purpose of
the research, or being obtained by some combination of the two? |
| 8. |
Are the samples
“custom collected” from individuals who may need special
safeguards (i.e., minor children, pregnant women, human in vitro
fertilization, fetuses, or prisoners)?
NOTE: An answer
of “yes” to question 8 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).
|
| 9. |
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/tissues. 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 |
|
|
|
|
Return to Table
of Contents or go to Appendix 5.
Date created: February
3, 2004
Last updated:
February 11, 2004
|
