As a Catholic institution of higher learning, The College of Saint Scholastica (CSS) recognizes the need for
research activities that involve human beings serving as participants. At the same time, The College of
Saint Scholastica is especially aware of its obligation to protect the rights of those individuals who
participate in human subject research studies. Consequently, CSS has established and empowered an
Institutional Review Board (IRB) to review all research investigations, externally funded or not,
conducted by its students, faculty, staff, and administration involving human beings as research subjects.
CSS, through its IRB, meets its responsibility for ensuring that the safety, welfare, and rights of all
subjects are adequately protected. The policies of CSS with respect to research, development, and
related activities involving human participants are based on the following principles:
- Participation of a human subject in any experiment must be voluntary and the information provided to gain subject consent must be adequate and appropriate. Potential participants must be informed that they are not obligated to participate and that appropriate alternatives to participation may be available.
- The risks to the subject must be acceptable when measured against any possible benefit and by the importance of the knowledge to be gained as a result of participation.
- Research and training activities involving human subjects must be supervised by qualified persons.
- Except for activities covered by the exemptions, all research programs which involve human subjects must be reviewed by, and receive the approval of, the CSS IRB prior to initiation of the protocol. Continuing research, if applicable, is subject to review.
These and other principles described in this document are based on the current U.S. Code of Federal Regulations, Title 45 Part 46, and 21 CFR part 50 and 56, and the following core historical reports:
● Nuremberg Code (1949)
● Declaration of Helsinki (1964)
● Belmont Report (1976)
The interpretation and implementation of these policies and procedures is the responsibility of the CSS IRB. Since all research applications (herein also referred to as “protocols”) require certification that proposed research and training programs involving human subjects comply with an accepted institutional review procedure, it will be necessary to follow the approved review procedure outlined in this document.