INSTITUTIONAL POLICIES AND PROCEDURES
- Binghamton University IRB Policies and Procedures (Updated October 2021)
- Accredited by: Association for the Accreditation of Human Research Protection Programs
ETHICAL CODES FOR HUMAN SUBJECT RESEARCH
HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS (OHRP)
OHRP is a government agency that provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). They accomplish this by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight, and providing advice on ethical and regulatory issues in biomedical and behavioral research.
- Federal Policy for the Protection of Human Subjects ("Common Rule")
- Regulation 45 CFR 46: Common Rule Requirements
- OHRP FAQ's
- Educational Videos About HSS Regulations
INTERNATIONAL RESEARCH STANDARDS
OTHER REGULATORY AGENCIES
Office for Civil Rights (OCR)
The U.S. Department of Health and Human Services (HHS) OCR enforces federal civil rights laws, conscience and religious freedom laws, the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Breach Notification Rules, and the Patient Safety Act and Rule, which together protect your fundamental rights of nondiscrimination, conscience, religious freedom, and health information privacy.
Department of Defense (DoD)
DoD Instruction 3216.02 “establish[es] policy and assign[s] responsibilities for the protection of human subjects in DoD-supported programs to implement … ‘the Common Rule. The DoD components include, but may not be limited to: Navy, Office of Naval Research, Naval Academcy, U.S. Naval Observatory, Army, U.S. Army Corps of Engineers, Military Academy (West Point), Air Force, Air Force Academy, Marines, Coast Guard, Coast Guard Academy, National Guard, Missile Defense Agency, Defense Advanced Research Projects Agency (DARPA), Petnagon Force Protection Agency, Defense Intelligence Agency, National Geospatial-Intelligence Agency, National Security Agency, National War College, and Tricare Health System.
Department of Education (DE)
Research funded through the Department of Education must comply with additional regulatory requirements under 34 CFR 98.3, 34 CFR 98.4, 34 CFR 99, 34 CFR 356.3.
Food and Drug Administration (FDA)
The FDA is a government agency operating under the U.S. Department of Health and Human Services (HHS). The FDA regulates clinical investigations of products under its jurisdiction, such as drugs, biological products, and medical devices.
- 21 CFR Regulations
- Comparison of FDA and OHRP Regulations
- Regulations Pertaining to Good Clinical Practice and Clinical Trials
- Information Sheets
National Institutes of Health (NIH)
The NIH is the primary agency of the U.S. government responsible for biomedical and public health research.
National Science Foundation (NSF)
The NSF is a U.S. government agency that supports fundamental research and education in all the non-medical fields of science and engineering. Its medical counterpart is the NIH.
Department of Veteran's Affairs (VA)
The VA’s Office of Research & Development has specific federal regulations for conducting research at VA hospitals and institutions. VHA Directive 1200.05 is the National VA Policy that describes the requirements for the protection of human subjects in VA research.