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 To
determine if your proposed study will be considered human subjects research by NIH,
carefully read the following:
- Electronic applications. Section 2, Scenarios, under Part II, Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan, in the Grant Application Guide for your Grant
Application Package.
- Paper applications. Section 2, Scenarios, under Part II, Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan, in the PHS 398.
Take note, the HHS regulations for Protection
of Human Subjects in 45 CFR Part
46 define
a human subject as a living person about whom
an investigator conducting research
obtains either: data through intervention or interaction with the
person, or identifiable private information.
Before concluding whether your research is human subjects, make sure
you understand NIH's Guidance
on Research Involving Coded Private Information or Biological Specimens.
NIH clarified its definition of human subjects research in that policy,
which is now reflected in the PHS 398 and Grant
Application Packages.
A number of terms are key to understanding this
policy, including:
In general if you're using coded private information, data,
or specimens, NIH will consider your research to
involve human subjects
unless it meets both of the following conditions:
- You are not collecting samples by interacting or intervening with
living people.
- None of the investigators or
collaborators listed
in the application can identify
the subjects through coded private information
or specimens (e.g., an investigator's
access to identity is prohibited
by a written
agreement).
If
any investigator involved in the research can determine a subject's identity
or has access
to identifiers,
the
research
is considered to involve human subjects and human subjects requirements
apply.
An application is not considered
to be human subjects research if none of the personnel listed in
the application can identify the subject or
have access to the subject identifiers. If one person listed has access,
the application may be subject to human subjects requirements.
To see in which category your research falls, check out the HHS Human
Subject Regulations Decision Charts and NIH's decision chart
for Research
Involving Private Information or Biological Specimens.
If you still have questions about whether or
not your application has human subjects, it's a good idea to run
them by your institutional
review board or independent
ethics committee before you submit
your application.
Keep in mind, NIH recommends that investigators
are
not given the
independent authority to determine whether their research involves
human subjects. For details, read the HHS Office
for Human Research Protections' Guidance
on Research Involving Coded Private Information or Biological Specimens.
For more help, see the following on NIAID's Web site:
Most requirements for protecting
human subjects are codified in the law, 45 CFR Part
46.
Also, if you're submitting a multiproject application, follow human
subjects instructions and complete the requirements for each component
of the application. Even if only one of the components includes human
subjects, you are considered to be applying for a human subjects research
grant.
To indicate you are applying for human subjects research you must
check "yes" for "human
subjects.
Additional Resources
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