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Federal Policies

The University of Richmond has a federalwide assurance agreement (FWA) with the Office for Human Research Protections.  This assurance agreement is signed by the University of Richmond President and is on file with IRB records in the IRB Chair's Office in Richmond Hall, Rood 118 (in Suite 113). 

The University of Richmond's IRB Number is 00002441.  The University of Richmond's FWA number is 00002622.  The Signatory Official for the UR IRB is the University President. 

Please direct questions regarding the University's FWA to irb@richmond.edu.

The source of most UR-relevant federal policies relating to the protection of human subjects of research can be found at the website of the U.S. Office for the Protection of Human Subjects of Research (OHRP).  Specifically, the sections on Policy and Guidance and the regulations at Title 45, Part 46 (Human Subjects of Research) are most relevant to the human subject research usually performed at the University of Richmond.  These federal regulations are commonly known as 45 CFR 46, standing for Title 45 Code of Federal Regulations, Part 46. 

Subpart A of the 45 CFR 46 is often referred to as "The Common Rule" because many federal agencies have adopted the regulations in Subpart A in lieu of developing unique regulations of their own.  The University of Richmond has -- in its assurance agreement with OHRP -- agreed to apply The Common Rule to all of its research, whether or not that research is funded by the federal government.  It should be noted that the adoption of The Common Rule is standard practice among institutions of higher education in the United States.

The ethical principles of human subjects research in the United States are established in the Belmont Report.  The Belmont Report emphasizes the principles of “Respect for Persons,” “Beneficence,” and “Justice.”  Briefly stated, "respect for persons" recognizes the autonomy of the individual and the individual's right to know that they are participating in a research activity and that he or she has freely provided "informed consent" (approval) to participate in the study.  Insuring that research subjects are provided with the opportunity to provide or withhold informed consent is one of the major responsibilities of the IRB.  The "beneficence" principle essentially means that the research activity will provide more benefits than risks.  The IRB carefully considers the benefits and risks of a study before approving it.  In many cases, the principle benefit of a student's research is the knowledge that the student will gain by conducting the research.  Consequently the research must present "no more than minimal risks" for the IRB to provide approval.  Because of their knowledge and experience, university faculty members may conduct research that entails more than minimal risks.  However, the board must still determine that the benefits of the research outweigh the risks to research subjects.  The "justice" principle of the Belmont report ensures that subjects are treated equally and fairly.  Normally this means that research activities should be equally inclusive of different groups.  A research proposal is evaluated by the IRB to ensure that different populations do not experience different risks and/or different benefits.

September 8, 2015 Proposed Changes to the "Common Rule"

In the September 8, 2015 edition of the Federal Register, the U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies announced proposed revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991.  The Advance Notice of Proposed Rulemaking, (ANPRM) in the Federal Register can be accessed at: http://www.gpo.gov/fdsys/pkg/FR-2015-09-08/pdf/2015-21756.pdf.  The comment period for this policy has closed.  For additional information about the ANPRM, including a brief summary of the proposed changes, how to submit comments or browse posted comments, visit http://www.hhs.gov/ohrp/humansubjects/regulations/nprmhome.html.  Researchers should be aware that this marks the beginning of the revision review process.  The proposed changes to the Common Rule are not in effect at present.

Changes to Simplify Federal Regulations were also Proposed in 2011

In 2011, The Office of the Secretary of the Department of Health and Human Services (HHS) in coordination with the Office of Science and Technology Policy (OSTP)developed and invited comments on the document "Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators".  This document and the comment periods that followed led many researchers to expect simplification and clarification of federally required protections of human subjects of research. Action on this proposal has been delayed and there is little indication that action is imminent.  In the meantime, the regulations in place before 2011 remain in effect.