Human Subjects Research

Human Subjects Research

Assurances and certifications

The regulations require that each institution, defined in the regulations as “any public or private entity or agency (including federal, state, and other agencies),” engaged in the conduct of covered research activities have an approved Assurance of Compliance on file and provide Certification that the Institutional Review Board designated in the Assurance has reviewed and approved the proposed activity in accordance with the regulations, or that is has provided approval on condition that all covered research activities will be reviewed and approved before they are initiated and that appropriate Certification will be submitted. The Assurance sets forth the commitment of the institution to employ the basic ethical principles of the Belmont Report and to comply with the regulations. [34 CFR 97.103] (An independent investigator proposing to conduct covered research must be affiliated through a written Agreement with an organization that has an Assurance of Compliance and has accepted responsibility for the research activities of the individual.)

Policies & Guidelines Concerning Human Subjects in Research

DSU Institutional Review Board

Office of Human Research Protections (OHRP)

Belmont Report: Ethical Principles and Guidelines for Protection of Human Subjects of Biomedical and Behavioral Science Research (1979)

Code of Federal Regulations Title 45 Part 46 – Protection of Human Subjects
HHS Guidance on Engagement of Institutions in Human Subjects Research

NIH: Frequently Asked Questions

NSF Grants Administration Guidelines: Protection of Human Subjects

U.S. Department of Education Policy on Human Subjects Research