Policies and Regulations

Institutional Review Board

Research involving human subjects conducted by faculty members and students under the auspices of Niagara University must be reviewed and approved by the Niagara University Institutional Review Board (IRB) prior to its commencement. The IRB is charged with developing policies and guidelines in compliance with 45 CFR 46.101 for research involving human subjects conducted in the United States and either the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (2010), or the Tri-Agency Framework: Responsible Conduct for Research (2016) for research conducted in Canada. The IRB is a University-wide Academic Board that reports to the Provost.

45 CFR 46 (Protection of Human Subjects)

Based on The Belmont Report and issued by the US Department of Health and Human Services (HHS), 45 CFR 46 is the primary federal regulation that governs research on human subjects as well as the activity of the IRB.

Known as "The Common Code," Subpart A outlines the Department's basic policy on the protection of human subjects. Among other things, it:

  • Defines research that is exempt from IRB review (46.101)
  • Defines the authority and duties of the IRB (46.101, 103, 107-110, 113-115)
  • Defines key regulatory terms, such as "research" and "human subject" (46.102)
  • Defines the criteria for reviewing an IRB application (46.111)
  • Defines the general requirements for informed consent (46.116-117)

Subparts B, C, and D address research involving vulnerable subjects, including pregnant women and fetuses, prisoners,  and children.

Tri-Council Policy Statement

Parallel to the  American 45 CFR 46, the Tri-Council Policy Statement is the governing document for research involving humans in Canada. On February 1, 2010, the IRB of Niagara University formally adopted the Tri-Council Policy Statement for all IRB applications involving Canada.

This RCR Framework sets out the responsibilities and corresponding policies for researchers, institutions, and the Agencies, that together help support and promote a positive research environment. It specifies the responsibilities of researchers with respect to research integrity, applying for funding, financial management, and requirements for conducting certain types of research, and defines what constitutes a breach of Agency policies.