Policy and Guidance

NSF Regulations (45 CFR, Chapter VI)

• 45 CFR 602, Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments
• 45 CFR 605, Nondiscrimination on the Basis of Handicap in Programs and Activities Receiving or Benefiting from Federal Financial Assistance
• 45 CFR 611, Nondiscrimination in Federally Assisted Programs of the National Science Foundation
• 45 CFR 612, Availability of Records and Information
• 45 CFR 613, Privacy Act Regulations
• 45 CFR 614, Government in the Sunshine Act Regulations of the National Science Board
• 45 CFR 617, Nondiscrimination on the Basis of Age in Programs or Activities Receiving Federal Financial Assistance from NSF
• 45 CFR 620, Governmentwide Debarment and Suspension (Nonprocurement) and Governmentwide Requirements for Drug-Free Workplace (Grants)
• 45 CFR 640, Compliance with the National Environmental Policy Act
• 45 CFR 650, Patents
• 45 CFR 660, Intergovernmental Review of National Science Foundation Programs and Activities
• 45 CFR 689, Misconduct in Science and Engineering Research

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Grant Proposal Guide (GPG)

• Frequently Asked Questions (FAQs) regarding Electronic Signatures
• FAQs: Proposal Preparation and Award Administration
• NSF CFDA Numbers

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Grant Policy Manual

• FAQs: NSF Investigator Financial Disclosure Policy
• FAQs: Proposal Preparation and Award Administration

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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 45CFR690.101-124 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" http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm

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. IRBs have two forms of reviewing 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 45CFR690.101).

• All research proposals must be inspected by the IRB, which decides 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 45CFR690.101).

Timing of IRB review

While a proposal can be reviewed without IRB approval, projects involving human subjects can not be funded 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 45CFR690.116).

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 45CFR690.107).

• Frequently Asked Questions regarding Human Subjects

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://ohrp.osophs.dhhs.gov/

These interpretive notes have been prepared by NSF's Human Subjects Research Officer Stuart Plattner, email: splattne@nsf.gov. These notes represent the personal opinion of the Human Subjects Research Officer 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.

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OMB Circulars

Type of Organization

Educational

• OMB Circular A-21, Cost Principles for Educational Institutions
• OMB Circular A-89, Federal Domestic Assistance Program Information
• OMB Circular A-110, Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals and Non-Profit Organizations
• OMB Circular A-133, Audits of States, Local Governments, and Non-Profit Organizations

Non-Profit

• OMB Circular A-89, Federal Domestic Assistance Program Information
• OMB Circular A-110, Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals and Non-Profit Organizations
• OMB Circular A-122, Cost Principles for Non-Profit Organizations
• OMB Circular A-133, Audits of States, Local Governments, and Non-Profit Organizations

Profit Organizations

• OMB Circular A-89, Federal Domestic Assistance Program Information
• OMB Circular A-110, Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals and Non-Profit Organizations

State/Local Government

• OMB Circular A-87, Cost Principles for State, Local and Indian Tribal Governments
• OMB Circular A-89, Federal Domestic Assistance Program Information
• OMB Circular A-102, Grants and Cooperative Agreements With State and Local Governments
• OMB Circular A-133, Audits of States, Local Governments, and Non-Profit Organizations

To obtain OMB Circulars contact the Office of Management and Budget:
Phone: (202) 395-7332
Internet Address:http://www.whitehouse.gov/omb/

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FAR Part 31, Cost Principles

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Federal Register

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Grant and Agreement Conditions

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Federal Demonstration Partnership

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NSF Outreach

• Regional Grants Conference
• Future Regional Grants Conference
• Presentations from Recent Events
• NSF Regional Grants Conference at Washington University - October 4-5, 2004
• BFA/Experimental Programs to Stimulate Competitive Research(EPSCoR)

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