This SOP is for grants only.
Standard Operating Procedure Table of Contents
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Purpose
To ensure that institutions receiving an HHS grant for activities involving human subjects comply with federal, HHS, and NIAID regulations.
Procedure
NIH sets policies for human
subjects research according to federal law 45
CFR 46, Protection of Human Subjects, which applies to all domestic
and international grants. Find NIH policies in these documents:
Is the Project Human Subjects Research?
Before preparing a grant application, first determine whether your project qualifies
as human subjects research.
Follow NIAID's Process for an Investigator-Initiated Clinical
Trials
If you are proposing to conduct
a clinical
trial, follow NIAID's two-step
approach for investigator-initiated clinical
trials.
First, apply for a Clinical Trial Planning Grant -- R34; then, as an NIAID R34 recipient, you may be able to apply for the next step, a Clinical
Trial Implementation Cooperative Agreement (U01). Read more in Investigator-Initiated
Clinical Trials Resources and the Investigator-Initiated
Clinical Trial Planning and Implementation Grants SOP.
Make sure you address protection of human subjects (risk, adequacy of protection against risks, potential benefits of the research to subjects, and importance of the knowledge gained), data and safety monitoring, and the inclusion of women, children,
and minorities.
Inadequate protection or inclusion plans may negatively affect your priority
score. See the PHS 398 instructions for more information.
If there is a scientific rationale for examining subpopulation differences in a foreign population, consider designing your study to accommodate those differences, and discuss inclusion of the groups in your application. For details, see NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research.
Be aware of financial conflicts
of interest. See Financial
Relationships and Interests in Research Involving Human Subjects and the Financial Conflict of Interest for Awardees SOP.
If you identify a conflict, find a way to reduce, eliminate, or manage
it, and notify the chief grants
management officer that you've taken those steps.
For more help in writing an application,
read our How to Write a Human Subjects Grant Application tutorial.
Get Human Subjects Certification, a Federalwide Assurance, and Training
Your institution must obtain a Federalwide Assurance and register its institutional
review board (IRB)
or independent
ethics committee (IEC) with the HHS Office for Human Research Protections. You must get IRB or IEC approval for your application.
You must also document training for investigators and key staff in the responsible conduct of clinical research.
Follow these links:
If You Get a Bar or Restriction
An application will receive a bar
to award if the scientific
review group is concerned about the protection of human subjects (a code 44 on the summary
statement) -- see Human Subjects Involvement Codes.
It can also get a bar for unacceptable
gender, minority, or children inclusion -- for a list of those codes, see Human
Subjects Inclusion Codes.
At the end of the fiscal year, an application may get a restriction -- code 48 -- instead.
For details, read Bars to Grant Awards -- Human Subjects SOP.
Contacts
For grant questions, contact Cindy McDermott, cm550v@nih.gov,
301-594-7456.
For review questions, contact Hortencia Hornbeak, hhornbeak@niaid.nih.gov,
301-496-8208.
If you have knowledge to share or want more information on this topic, email deaweb@niaid.nih.gov with this link and your message. Thanks for helping us clarify and expand our knowledge base.
Links
Clinical
Terms of Award at NIAID's Human Subjects Resources
Human Subjects SOP List
Trans
NIAID Clinical Research Toolkit
NIH Guide Notices
Data and Safety Monitoring and Further Guidance for Phase I and II
Other
45
CFR 46, Protection of Human Subjects, HHS
Guidance on
Informed Consent for In Vitro Diagnostic Device Studies Using
Leftover Human Specimens that are Not Individually Identifiable,
FDA
Guidance
on Research Involving Coded Private Information or Biological Specimens,
OHRP
HHS Provides Guidance on Financial Relationships and Interests in Research Involving Human Subjects
Research
Involving Human Subjects, NIH
Office of Biotechnology Activities,
NIH
NIAID
Clinical Terms of Award Restriction for China
NIH's Office of
Extramural Research
NIH
Grants Policy Statement, section on Human Subjects
Policies and
Guidelines,
HHS
Policy Guidance, OHRP
Protection
of Human Subjects: Assurance Identification/IRB Certification/Declaration
of Exemption form
Research Ethics Training Curriculum by Family Health International
Special Protections for Children as Research Subjects, OHRP
Privacy Act of 1974
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