Belmont Report and Code of Federal Regulations

Belmont Report and Code of Federal Regulations

Investigators must assure that each member of the research team carries out all research procedures in accordance with ethical principles of research. These principles of Justice, Autonomy and Beneficence were set forth in the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research report “Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” known more commonly as the Belmont Report, and codified as regulations in Title 45 Code of Federal Regulations Part 46.

Northeastern University has a Federal Wide Assurance (FWA #00004630), which is approved by the U.S. Department of Health & Human Services. This is a requirement in order to receive federal funding for research with human participants. The University has elected to apply the protections of the federal regulations (45 CFR 46) to all of our human subject research regardless of its source of support, or lack thereof.

Investigators are strongly encouraged to read these and other relevant documents available at the U.S. Dept. of Health & Human Services Office for Human Research Protections (OHRP) policy guidance and international issues web sites.

As an integral part of ethical conduct of research, federal guidelines require an independent review of protocols involving human subjects before an investigator can begin the study. This independent review process provides an unbiased evaluation of the risks, promotes the safety of research participants and documents that the research, when conducted as approved, will be in accordance with federal regulations. At Northeastern, the Office of Human Subject Research Protection and the Institutional Review Board (IRB) serve this independent review function.

It is the policy of Northeastern University that no activity involving human subjects be undertaken until those activities have been reviewed and approved by the University’s Institutional Review Board (IRB).