Some links will work for NIAID staff only.
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Standard Operating Procedure Table of Contents
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Purpose To strengthen
NIAID oversight of clinical
trials and studies by requiring applicants to provide additional
information with their competing and noncompeting renewal
applications.
Procedure
Incorporated into the Notice of Award, the NIAID Clinical
Terms of Award specify a grantee's responsibilities and deadlines
for providing documentation and approvals when starting and during
a study. We may ask applicants to send us some or all
of this information.
The terms apply to all NIAID-supported grants conducting human
subjects research. There may be additional terms for certain countries; for example, see the NIAID Clinical Terms of Award Restriction for China.
Grant applications must follow human subjects instructions in either
the Grant
Application Guide (for an electronic application) or PHS
398 (for a paper application).
NIAID can award applications only if they provide information showing that they comply
with all policies.
For grants, certain human
subjects codes, 20 or 44, in IMPAC
II and on an application's summary
statement indicate a bar
to award that must be resolved before funding. Bars are placed
on grants if no assurance exists or if applicants did not clearly follow
the application instructions. For a list of codes, go to Human
Subjects Inclusion Codes.
Find more information on human subjects requirements at NIAID
human subjects resources on the Funding
Web site.
Applicant and PI
- Read the NIAID Clinical Terms of Award for details on what to do.
- Contact the program officer early on. Before you can begin patient accrual,
you will need to send NIAID some or all of the information listed in
the terms document.
- Before and during your award, you'll need to provide information
to your program
officer.
- Make sure you are gathering the data you will need for reporting
during the award.
Program Staff
Grants Staff
Contacts
If you have questions, contact your Contact Staff for Help.
See GMP
Assignments by Geographic Region and Program Code for the appropriate
GMP specialist.
If you have knowledge to share or want more information on this topic, email deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. Thanks for helping us clarify and expand our knowledge base.
Links
NIAID's Grant Application portal
Grant Application, Electronic SOP
Grant Application, Paper SOP
How to Write a Human Subjects Grant Application Web page
Human Subjects Research Requirements SOP and other Human Subjects SOPs
IMPAC
and CRISP SOP
Noncompeting Progress Reports and Program Officer Approval SOP
Program Officer Checklist SOP
Protection
of Human Subjects: Assurance Identification/IRB Certification/Declaration
of Exemption Form
Required
Clinical Training -- Frequently Asked Questions Web page
Trans
NIAID Clinical Research Toolkit
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