I.  Introduction

As noted in the University of Mary Washington’s Statement of Community Values and Behavioral Expectations, “Mary Washington is an academic community dedicated to the highest standards of scholarship, personal integrity, responsible conduct, and respect for the individual”.  To this end, the University of Mary Washington (UMW) has established an Institutional Review Board (IRB) to ensure that research involving human participants is conducted by bona fide members of the University community (i.e., students, faculty, staff) meet, to the fullest extent, the ethical and legal requirements for such research as set forth in federal guidelines.  The University of Mary Washington is dedicated to the protection of human participants in research.  All human subjects research at the University of Mary Washington must be carried out under the guidelines set forth in this document (Manual of Policies and Procedures for the Institutional Review Board at the University of Mary Washington, hereafter, “Manual”) and by relevant federal, state, and professional codes.  All University employees, students, and agents who are engaged in or planning such research must be prepared to adhere to the conditions outlined in this Manual in the course of conducting research that involves human participants.

A.    Ethical Treatment of Human Participants

The University supports fully the ethical principles set forth by the Nuremberg Code and the Belmont Report.  Some of the main points of these guidelines are outlined below (the complete documents are included in the Appendices section of this Manual).

1. Basic Precepts of the Nuremberg Code

a)   The voluntary consent of the human participants is absolutely essential.

b)  The research should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.

c)   The research should be so conducted as to avoid all unnecessary physical and mental suffering and injury.

d)   No reaearch should be conducted, where there is an a priori reason to believe that death or disabling injury will occur.

e)  The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the research.

f)  Proper preparations should be made and adequate facilities provided to protect the research participant against even remote possibilities of injury, disability, or death.

g)  The research should be conducted only by scientifically qualified persons.

h)  During the course of the research, the human participant should be at liberty to bring the study to an end.

i)  During the course of the study, the scientist in charge must be prepared to terminate the research at any stage.

2. Basic Precepts of the Belmont Report

a)     Respect for Persons.  The principle of respect for persons acknowledges the autonomy of human beings and provides for protections for persons with diminished autonomy (e.g., children, prisoners, and people who are limited in their ability to make conscious decisions).  The IRB seeks to ensure respect for persons by requiring informed consent by research participants.

b)     Beneficence.  Beneficence requires researchers to avoid bringing harm to research participants and to take steps to maximize the benefits of research and minimize risks.  The IRB assesses the risks and benefits of human research.

c)     Justice.  Justice requires fairness in the selection of participants in research.  The IRB reviews applications to make sure that the inclusion or exclusion of people in proposed research is fair and equitable.

B.    State, Federal, and Professional Mandates

Research involving human participants at UMW must be conducted in accordance with mandates set forth by the State Code of Virginia (Title 32.1, Chapter 5.1), the Federal Code (45 CFR Part 46), and any applicable codes set forth by a researcher’s professional organization.  State and federal codes are available in the Appendix section of this Manual.

C.    Definitions

1.  Research

Federal regulations (45 CFR 46.102(d)) define research as “ . . . a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”

2.  Human Subject

Federal regulations (45 CFR 46.102(f)) definea human subject as “ . . . a living individual about whom and investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable public information.”