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Human Subjects

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 http://www.nsf.gov/bfa/dias/policy/docs/45cfr690.pdf.

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:

    1. The information would allow subjects to be identified, AND
    2. 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 proposal jacket.

  • 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: jmantz@nsf.gov), 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.