Guidelines
and Documentation Requirements for Research Involving Human and Animal
Subjects
APPENDIX 5
Submission
Timeline for Required Documentation—Human Subjects
Determination
of Type and Date of Human Subjects Use Gate 1 Gate 3
As Indicated From Appendix 2 |
Gate
1
(Initial Proposal) |
Gate
3
(Oral Review) |
Year
1
Exempt
(Item 4 from Appendix 2)
|
Completed
answers to Appendix
3 and/or Appendix 4 as
required |
All other NIST
required materials
or clarifications as
requested in pre-oral-review
questions |
|
Year 1
IRB review required
(Item 5 from Appendix 2)
|
- Name of the
IRB that will
be reviewing the protocol
- FWA or MPA
number of the
“engaged” institution and
the expected date of IRB
review
|
- Signed copy
of the IRB
approved protocol
- Signed and
dated approval
letter from the IRB indicating
approval and expiration
dates
- Copy of all
IRB approved
consent forms and
advertisements
|
|
After year 1
Deferred exemption
or
deferred IRB review required
|
No
documents are required
to be submitted with the initial
proposal |
A projected date
of human
subjects use and a schedule
of when NIST required materials
will be submitted in accordance
with the categories
listed above |
FWA = Federalwide
Assurance
IRB = Institutional Review Board
MPA = Multiple Project Assurance
NIST = National Institute of Standards and Technology
Return to Table
of Contents or go to Appendix 6.
Date created: February
3, 2004
Last updated:
February 3, 2004
|
