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 IRB
or IEC approval. Before NIAID can issue a human subjects award, your
organization must comply with the following:
Your certification
of IRB or IEC approval
is due "just-in-time," i.e., just before
we are ready to issue an award. Nevertheless, we recommend that you
start the approval process early -- well before the application's
due date -- because revisions and final approval can take time. If
the certification of IRB or IEC approval is
ready, include it in the application.
Your organization's IRB or IEC
performs many functions. It reviews research to make sure human subjects
are protected, may
require
modifications
or disapprove the research, looks at privacy issues, and determines
the need for informed consent. If you need
informed consent, the IRB or IEC must approve the informed consent
form, unless the IRB or IEC waives appropriately
the requirements for documenting informed consent.
For details about informed consent, read 45
CFR 46.116, 45
CFR 46.117, and 45
CFR 46.115. Also visit the Informed
Consent section of Human
Research Questions and Answers on the Office
for Human Research Protections' Web site.
Before you enroll subjects, your
organization must certify to
NIAID that an IRB or IEC designated under your organization's
FWA has reviewed and approved your research project. There
are two types of review: full board and expedited. For more information,
see 46.107, 46.110,
and 46.111 of 45 CFR Part 46, the Research on
Human Specimens NIH brochure, and NIAID's Human
Subjects Certifications: IRB or IEC SOP.
Grants supporting human subjects research usually
require you to obtain IRB or IEC approval before award. Certain
grant mechanisms, such as training grants (T32), do not require
IRB or IEC approval before an award is made but do require a grantee
to submit certification of IRB or IEC approval before beginning any
nonexempt human subjects research. For other grant types,
contact your SRO or program officer to find out if IRB or IEC approval is required.
To register an IRB or IEC for the first time
or to update or renew
an existing IRB or IEC registration online, go to Electronic
Submission System for Federalwide Assurances and IRB/IEC Registrations.
Also, if you're planning to use a clinical trials Web site to advertise for clinical trial subjects, you may need IRB
or IEC approval.
Under certain circumstances, when a site goes beyond listing basic
descriptive information, approval is required. For details, read "OHRP's
guidance on Institutional Review Board (IRB) Review of Clinical Trial
Websites."
If you're performing clinical
research at a foreign or domestic site,
your organization will
need to
obtain a Federalwide
Assurance before
your work can be funded. For information about
obtaining an assurance, see the following:
In very limited circumstances, some collaborators
may not be required to obtain their own FWA, including a collaborating
individual investigator who operates under
another institution's FWA. See Guidance
on Extension of an FWA to Cover Collaborating Individual Investigators
and Introduction of the Individual Investigator Agreement.
If you're applying from a foreign
country or plan to include a foreign research site in your domestic
application, you should also read IRB,
IEC, and FWA Requirements for Foreign Countries in this tutorial. For
additional information, see IRBs and IECs
Have Ongoing Requirements.
Additional Resources
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