If a research project involves human subjects, the U.S. National Science Foundation requires that a responsible body has certified the project complies with the federal government's "Common Rule" for the protection of human subjects.
This page provides an overview of NSF's guidance on research with human subjects; it does not supersede the information provided in NSF's Proposal and Award Policies and Procedures Guide (PAPPG) II.E.5 or in the other official documents linked on this page.
On this page
Basic principle of human subjects protection
The basic 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 an increased risk of harm from their involvement in research, beyond the normal risks inherent in everyday life.
Exempt research, expedited, and full IRB review
The NSF version of Code of Federal Regulations 45 CFR 690.101-124 gives grantee institutions the responsibility for setting up "Institutional Review Boards," or IRBs. These boards review research protocols and designs and ensure the rights of human subjects are protected.
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." 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 intensity of the review to the potential risk of harm to subjects.
Institutions have two ways to consider proposals:
- Full review, where the entire institutional review board reviews the proposal.
- Expedited review, where the IRB chair or a designee reviews the proposal for the committee.
The Common Rule also specifies broad classes of research involving human subjects as exempt from the policy's oversight (in 45 CFR 690.104). Generally, research using surveys, observational or ethnographic methods, cognitive and educational tests, and similar is "exempt" unless both of the following apply:
- The information would allow subjects to be identified or information gathered in a manner that subjects' identities could be "readily ascertained."
- Disclosure of the data would reasonably place the subject at risk of harm (see details at 45 CFR 690.101).
Institutions determine whether a project's 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. For certain exempt research categories, limited IRB review may be required.
Timing of IRB review
When possible, 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.
If IRB review is not possible before the deadline to file an award recommendation, NSF will accept a determination notice from the IRB stipulating that no work with human subjects, including recruitment, will be conducted until full IRB approval is obtained. See PAPPG II.E.5 for additional details.
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 690.117).
Cooperative and international research
For projects taking place in the U.S. and not on tribal lands or in other contexts where other local laws would govern the oversight of human subjects research, Single IRB approval should be used for the NSF-funded project. This is true of all cooperative research unless the study meets one of the criteria for an exception described in 45 CFR 690.114(b)(2).
Questions about waivers from Single IRB requirements should be directed to the NSF Human Subjects Research Officer at jmantz@nsf.gov.
Questions?
Contact the NSF Human Subjects Research Officer at jmantz@nsf.gov if you have specific questions.