Brescia University (BU) has determined that all human subject research must be reviewed and approved by the University’s Institutional Review Board when the research is sponsored by the University, or when the research is conducted by any employee or agent of the University in connection with institutional responsibilities, or while using properties or facilities of the University. The university’s policies and procedures regarding research with human subjects are designed to protect individuals from harm, provide equitable selection of subjects, maximize benefits, and minimize the risks of research participation.
The protection of human subjects is based on internationally recognized ethical principles originally conveyed in the Belmont Report. Published in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, the Belmont Report articulates three fundamental principles:
Individuals should be treated as autonomous agents with the right to make decisions for themselves. Those with diminished autonomy (e.g. minors, prisoners, persons who are mentally disabled) are entitled to additional protections. Further, human subjects are enrolled into research studies only under the conditions of effective informed consent. This involves a process in which participation in the research is acknowledged by the research subject (or by a legally authorized representative) as a voluntary act free from coercion or undue influence from the investigator or members of the research team.
Research studies must be designed and implemented to 1) do no harm, and 2) maximize possible benefits and minimize possible harms. A risk/benefit analysis must demonstrate that any risks to subjects must be reasonable compared to the potential for benefit either to subjects directly or to society. Risk evaluation must include the consideration of both the probability and magnitude of harm, including psychological, physical, legal, social, and economic harm.
The possibility for benefits and the potential burdens of the research should be equitably distributed among the potential research subjects. The enrollment process must ensure that particular classes (welfare patients, racial and ethnic minorities, or persons confined to institutions) are not selected for their compromised position or convenience to the investigator, nor are they systematically excluded.
In 1966, the National Institute of Health developed Policies for the Protection of Human Subjects. The first formal requirements for the establishment of Institutional Review Boards became effective in 1974 under the auspices of the U.S. Department of Health, Education, and Welfare (DHEW). On June 18, 1991, fifteen Federal Departments and Agencies adopted a common set of regulations known as the Federal Policy for the Protection of Human Subjects, often referred to as the “Common Rule”. Updates to this policy went into effect on July 19, 2018. The “Common Rule” requires that any institution requesting and receiving funds from a federal department or agency for research involving human subjects must ensure that the research is reviewed and approved by the University’s Institutional Review Board. Brescia University has determined that all human subject research, whether funded or not funded, or subject to Federal regulations or not, must be reviewed and approved by the University’s Institutional Review Board. The IRB reviews all research projects involving humans to ensure that the ethical considerations contained in the federal regulations are met and that research procedures do not infringe upon the safety, health, or welfare of participants.
The welfare and rights of human subjects are adequately protected, and informed consent given, if required.
As such, the mission of the Brescia University IRB is to protect the community and individual participants. In the process, the IRB ensures that the research activity of all Brescia University affiliates complies with federal regulations and meets the highest ethical standards. All persons participating as a subject in a research study are entitled to informed consent, privacy, and confidentiality with respect to the research data collected.
