 Some
links will work for NIAID staff only.
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This SOP is for grants only.
Standard Operating Procedure Table of Contents
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Purpose
To ensure that investigators protect human
subjects by having their applications reviewed by an institutional
review board (IRB) for domestic applications or independent
ethics committee (IEC) for foreign applications.
Procedure
NIH sets policies for human subjects research according to federal
law 45
CFR 46, Protection of Human Subjects. All domestic and international
grantees funded by NIH and conducting human
subjects research must comply.
To determine whether your project qualifies as human subjects
research, go to Decision
Trees for Human Subjects Requirements and read the following:
If your application proposes human subjects research, you must
comply with human subjects requirements. Once awarded, NIH considers
your institution engaged in human subjects research even if another
institution performs the human subjects activities for you.
Applicants
- If your human subjects application falls within the fundable
range, and you have not yet received IRB or IEC approval, submit
a request for IRB or IEC approval immediately.
- NIAID will require certification of IRB or IEC approval when
it requests your just-in-time information. Include the title and number of your application to avoid a delay in making your award. See the Just-in-Time SOP.
- The other certification you will need is for training in the
protection of human subjects. See the Human
Subjects Certifications: Training SOP.
- To learn more about certification and assurance requirements
take a look at the Human Subjects SOPs.
- Be prepared to provide IRB clearance for study protocols should your program officer request it.
IRBs and IECs
Often residing in local institutions, IRBs and IECs independently
determine whether projects are human subjects research or are exempt
according to 45
CFR Part 46.101(b).
Their responsibilities include the following:
- Review research protocols, grant applications, informed consent documents, and related materials
to determine if the research complies with human subjects policies.
See HHS regulation 45
CFR 46.118, 119, 120, 122, and 123 for details on materials reviewed.
- Perform annual reviews of protocols.
The IRB or IEC chairperson or designated member reviews the research,
retaining all authority except disapproval, which requires the
full IRB or IEC. In May 2004, HHS issued guidance for IRBs, IECs, investigators,
and research institutions to avoid financial conflicts of interest
that could harm human subjects. See Financial
Relationships and Interests in Research Involving Human Subjects.
Grantees
- Register IRBs or IECs with the Office for Human Research Protections (OHRP) and update the registration
information as changes occur and at least once every three years.
- Get IRB or IEC approvals for the grantee and performance sites.
- Obtain annual recertification of IRB or IEC approval before
submitting each noncompeting progress report as well as any time you change your research protocol.
- Send NIAID documentation of IRB or IEC review.
- Submit with just-in-time information
for competing applications.
- Submit with your progress report, unless you are submitting
it electronically.
- Note: Annual IRB or IEC reviews may be out of
sync due to the timing of the initial approval, the award
date, or a changed anniversary
date. Make sure the approval date will be in effect
after the start date of the next budget
period.
- Keep approvals for performance sites ready for NIAID review
in case they are requested.
- If you are not planning to do human subjects research immediately,
you will get a restricted award
for a delayed onset:
- Do not conduct human subjects research until the IRB
or IEC approves it and NIAID issues a revised, unrestricted
award. If you do, NIAID will reduce the award, and you
cannot use any human subjects data you obtained during
that time for any activity related to the NIAID grant.
- Make sure you comply with NIAID
Clinical Terms of Award, if included in the Notice
of Award.
- For help on planning to request IRB or IEC approval, see Plan
for IRB or IEC Approval in the All
About Grants tutorials.
- Register in OHRP's
Electronic Submission System for Federalwide Assurances and
IRB/IEC Registrations.
Program Staff
- For cooperative agreement clinical trials, review annual IRB
and IEC approvals.
- Review progress reports to see if the protocol has changed.
- If it has, review the IRB or IEC approval, and indicate
whether it is acceptable or unacceptable on the PO worksheet
in IMPAC.
- If it is unacceptable, work with the PI to resolve.
- Work with the grants management specialist when the grantee
has conducted human subjects research without IRB or IEC approval.
Determine what human subjects research was involved,
and confer with the PI and specialist about reducing the budget.
Grants Staff
- Do not issue awards without the grantee's certification
of IRB or IEC approval.
- Documentation of IRB or IEC approval of entities other than
the grantee is not required unless program or grants
staff feel it is necessary.
- Issue a restricted award at the end of the fiscal year if there
is not enough time to get the certifications.
- Follow up on restricted awards and issue a revised award
once the required certifications have been approved.
- If human subjects activity was conducted during the
restricted period, contact the program officer to determine
what unallowable research the grantee conducted,
and decide what aspects of the budget to adjust.
- For progress reports, ensure that annual IRB or IEC approval
is in place only for non-eSNAP applications.
Contacts
Grantees: Contact the appropriate program officer or grants management
specialist listed on your Notice
of Award.
For questions about using OHRP's electronic submission system,
contact your regional
or country coordinator.
If you have knowledge to share or want more information on this
topic, email deaweb@niaid.nih.gov.
Links
FAQs on IRB Registration OHRP
Web page
How to Write a Human Subjects Grant Application, an All About Grants tutorial
Human Subjects questions and answers
Human Subjects Research Requirements SOP and other Human Subjects SOPs
Guidance
on Informed Consent for In Vitro Diagnostic Device Studies Using
Leftover Human Specimens that are Not Individually Identifiable, FDA
document
NIAID's Human Subjects,
Clinical Research Web page
OHRP:
Assurances & IRB Registration and Guidance Topics, section
of OER Web page
OHRP's Step-by-Step
Instructions for Registering an IRB or IEC
Policy Guidance, OHRP
Web page
Trans-NIAID Clinical Research Toolkit |
