Human Subject Research

Human Subjects Research conducted at Northern Light Health member organizations must comply with 45 CFR Part 46 and 21 CFR Part 56 and is subject to review by an Institutional Review Board (IRB).

Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.

Northern Light Health holds a Federal Wide Assurance with the U.S. Department of Health and Human Service’s Office for Human Research Protections, and has one Institutional Review Board (IRB) registered under this Assurance. The IRB is composed of physicians, pharmacists, scientists, ethicists, and community members, who meet once a month. Each IRB member reviews research protocols guided by the ethical principles in:

The IRB reviews all protocols for scientific merit, assesses the risks and benefits to study participants, and reviews data collection materials and the informed consent documents to ensure that participants are provided with sufficient information to allow them to make an informed decision to participate in research.