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INSTITUTIONAL REVIEW BOARD (IRB)

Misericordia University (MU) established an Institutional Review Board (IRB) to review all research involving human subjects and to implement institutional policies and procedures regarding such research. The use of human subjects in research imposes both ethical and legal responsibilities upon the university, the IRB and those conducting the research to ensure that the rights and welfare of those subjects are adequately protected. The primary function of the IRB is to protect the rights of human subjects. Review and approval by the IRB is meant to aid both the subjects and the researchers by bringing scrutiny to research protocols by a group of peers who can objectively assess the potential risk and accommodations made to minimize them.


The Misericordia University IRB is located within the Office of the Vice-President of Academic Affairs (VPAA) and the University President serves as the Institutional Official (IO) to maintain a separation from real or perceived conflicts of interest at the University. The IRB must act autonomously as an objective body and uphold the highest ethical standards in the conduct of human subjects research.  

Applicability

According to 45 CFR 46, research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge, and a human subject means a living individual about whom an investigator (whether professional or student) conducting research:
1.        Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
2.        Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens

It is the responsibility of researchers to refer their protocols (planned research studies) to the IRB whenever human subjects are used in research, even if the researcher does not consider the subjects to be at risk. Current law places the burden for negligence and harm directly on the researcher and the university. These policies and procedures are executed for the specific purpose of protecting human subjects.

Once initiated, all human subjects research must be conducted in full compliance with IRB policies and procedures.  This includes research that is conducted on or off campus by University employees or students. Questionnaires, interviews, surveys, tests, observations, and experiments constitute research, even if the work is preliminary (pilot work) to a more extensive study.  

All research involving the use of human subjects under the auspices of Misericordia University conducted by Misericordia University's faculty, staff, or students and/or sponsored by the University, must be reviewed and approved prior to the start of the research.  Once initiated, the research must be conducted in full compliance with IRB policies and procedures.

If you have questions about these policies and procedures, please contact the IRB Office by emailing irb@misericordia.edu or clicking here.
If you are not sure if your project requires IRB oversight, click here to find the answer to Is my project human subjects research?