Human Subjects
The U.S. Department of Health and Human Services, which encompasses the National
Institutes of Health (NIH), regulates the treatment of human subjects
through a set of internationally recognized ethical principles.
These principles are designed to safeguard a research participant's
rights and welfare. These regulations are contained in a document
called 45
CFR 46-Protection of Human Subjects.
The Office for Human Research
Protections (OHRP), a part of the NIH, oversees and enforces
the requirements of 45 CFR 40. The OHRP recently issued revisions
to its guidelines for researchers. As a result of these changes,
researchers must provide specified information regarding human subjects
in their funding applications. When you propose a study for funding
by any institute within the NIH, you must write a section in the
proposal demonstrating your willingness to abide by these regulations
as you conduct your research and detailing how you will protect
the study participants. You will also need to demonstrate that your
study will include sufficient representation of women and minorities.
Each human subjects section will contain different information,
based on the type of study you are proposing. It is recommended
that you seek guidance from your Project Officer or Program Official,
or from the OHRP.
To receive funding, you will be expected to comply with all regulations mandated
by the OHRP, including the requirement to obtain a Federalwide Assurance
(FWA) for the Protection of Human Subjects in Research. The OHRP
Website provides specific
instructions for preparing an application for a FWA.
Human Participant Protections Education for Research Teams
In addition, all investigators who apply for or receive NIH funds
for research involving human subjects must complete appropriate
training. Two Internet-based courses are available through NIH:
Protection
of Human Research Subjects, developed by the Office of Human
Subjects Research, and the National Cancer Institute’s Human
Participant Protections Education for Research Teams course.
These courses were created by the NIH to assure that research activities
involving human participants are conducted in a way that promotes
their rights and welfare. The courses incorporate interactive modules,
case studies, and exercises in topics including ethical principles,
federal regulations, privacy, confidentiality, and informed consent.
Additional Resources
Applying for a Small Business Innovative Research (SBIR) or Small Business
Technology Transfer Research (STTR) grant or contract? The human
subjects requirements for both SBIRs and STTRs have expanded considerably.
Follow this
link for an NIH resource on human subjects sections for these
funding mechanisms.
Vertebrate Animals
The vertebrate animals section is the equivalent of the human subjects section for a scientist who uses laboratory animals in the course of his or her research. This section describes how you will treat your laboratory animals ethically and humanely. In this case, the research organization must file a written Animal Welfare Assurance with the OHRP. For additional information, see the Office of Animal Care and Use.
Note: This sample grant is available
for downloading in Adobe Acrobat (PDF) format, which allows
the document to be downloaded, viewed, and printed with
all of its original formatting. To view files in this format,
you must first download
a copy of Adobe Acrobat Reader and follow the instructions
for installation.
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