General Information

• Information About the Protection of Human Subjects in Research Supported by the Department -- Overview

• Information About the Requirements at the Application/Proposal Stage and After Award

• Where to Address Questions About the Protection of Human Subjects in Research

Regulations Governing the Protection of Human Subjects in Research

• 34 CFR Part 97, Protection of Human Subjects -also in RTF format (64K)
  Includes Subpart A (Basic Policy) and Subpart D (Additional Protections for Children).

• Research Activities Which May Be Reviewed Through Expedited Review Procedures
  The Department of Education's regulations authorize expedited review procedures for certain kinds of research appearing on the list established by the Secretary of Health and Human Services.

• Report on: Expedited Review of Social and Behavioral Research Activities




• Excerpts from 34 CFR Part 350 and 34 CFR Part 356, Disability and Rehabilitation Research
  Additional Institutional Review Board membership requirements in certain research projects.

• 34 CFR Part 98, the Protection of Pupil Rights Amendment (PPRA)
  PPRA is designed to protect the rights of parents and students in programs that receive funding from the Department.

• 34 CFR Part 99, the Family Educational Rights and Privacy Act (FERPA)
  FERPA is designed to protect the privacy of a student's education records at all public elementary and secondary schools and virtually all public and private postsecondary institutions.

Guidance and Educational Materials

• The Belmont Report
  Basic reference document. The Department of Education's Regulations for the Protection of Human Subjects embody the principles of the "Ethical Principles and Guidelines for the Protection of Human Subjects of Research," known as the Belmont Report, which was issued in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

• Institutional Review Board Guidebook
  Basic reference document. The guidebook is designed to help researchers and institutional review board members in understanding the policies and principles that underlie the regulations and in identifying the issues to which one needs to be sensitive in designing and reviewing research protocols.

Assurance Information and Other

• Human Subjects Research Narrative instructions. - also in MS Word format (26K)

• ED Guidance on "Engagement" of Institutions in Research - also in MS Word format (26K)

• HHS Office for Human Research Protections Procedures for Registering Instutional Review Boards

• HHS Office for Human Research Protections Procedures for Filing Federal-Wide Assurances

• List of Approved Assurances on file with Office for Human Research Protections and Registered Institutional Review Boards

• The U.S. Department of Education Sample Single Project Assurance - also in MS Word format (62K)

• Independent Investigator Agreement - also in MS Word format (53K)

• Guidance for Preparing the U.S. Department of Education Single Project Assurance and the Independent Investigator Agreement - also in MS Word format (62K)

• Assurance Identification/Certification/Declaration of Exemption (Formerly Form 310) (RTF format)

• ED Form 424 Application for Federal Education Assistance (link to the Grant Application Forms page)
  Includes grant application instructions regarding human subjects research.

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