The National Science Foundation supports research involving human subjects when the project has been certified by a responsible body to be in compliance with the federal government's "Common Rule" for the protection of human subjects.
The official NSF version of Code of Federal Regulations 45 CFR 690.101-124
is available at
The regulations give grantee institutions the responsibility for setting up
"Institutional Review Boards" (IRBs) to review research protocols and designs and
ensure the protection of the rights of human subjects.
Basic principles of human subjects protection
The fundamental principle of human subjects protection is that people should not
(in most cases) be involved in research without their informed consent, and that
subjects should not incur increased risk of harm from their research involvement,
beyond the normal risks inherent in everyday life. The regulations are designed
mainly to pertain to biomedical research, based on the philosophical principles
contained in a key document, "The Belmont Report: Ethical Principles and
Guidelines for the Protection of Human Subjects of Research".
Exempt Research, Expedited, and Full IRB Review
Social and behavioral scientists are subject to the same regulations as their biomedical colleagues, but the Common Rule gives discretion to institutions and
IRBs to match the severity of the review to the potential risk of harm to subjects.
Institutions have two forms of considering proposals: Full (the entire IRB reviews the
proposal) and Expedited (the IRB chair or a designee reviews the proposal for the
committee). In addition the Common Rule specifies broad classes of research
involving human subjects as Exempt from the policy's oversight (in 45 CFR 690.101).
- Institutions determine whether the research is Exempt or qualifies for expedited or full-board
review. Researchers or department chairs should not have the authority
to make this designation themselves.
- Research using surveys, observational or ethnographic methods, cognitive and educational tests, etc. is "Exempt" unless two things apply:
- The information would allow subjects to be identified, AND
- Disclosure of the data would reasonably place the subject at risk of harm. (see details at 45 CFR 690.101).
Timing of IRB review
While a proposal can be reviewed without IRB approval, projects involving human
subjects cannot be recommended for funding until this certification or its equivalent is filed in the
- Researchers should file their proposal with their local IRB at the same time they submit it to NSF, so that the approval procedure will not delay the award processing.
Waiver or alteration of informed consent
While informed consent is an important process of communication between
researchers and the public, the Common Rule provides conditions for waiving or
altering informed consent: when the research could not be practicably carried out
without the waiver, such as minimal risk social science surveys or ethnographic
studies where the request for written consent might offend or raise unwarranted
suspicions among respondents. (see details at 45 CFR 690.116).
Multiple Site and Foreign Research
In general each institution where research takes place should have an IRB review
the project for human subjects implications. In some cases the review of the lead
grantee institution's IRB can serve, so long as the principles inherent in the review,
involving knowledgeable and diverse representation, are respected (see
45 CFR 690.107).
Links to relevant sites:
The Department of Health and Human Services' Office for Human Research Protection (OHRP, formerly the NIH Office for Protection from Research Risks, OPRR) is charged with overseeing human subjects issues in the biomedical sciences supported by the National Institutes of Health. Since it is the largest
federal government office dealing with human subjects issues, it takes a de facto
lead in the area. http://www.hhs.gov/ohrp/
These notes represent the personal opinion of the Human Subjects Research Officer, Jeffrey Mantz (email: firstname.lastname@example.org), and do not supersede the official documents referred to. Researchers with specific questions should contact their NSF program officer first, as the program officer is the lead actor in recommending actions about specific research projects.