Institutional Review Board
The Institutional Review Board (hereafter referred to as the IRB) at Tallahassee Memorial HealthCare, Inc. (hereafter referred to as TMH) was established in accordance with Federal regulations pertaining to the Protection of Human Subjects under the National Research Act of 1974, Title 21 CFR Parts 50, 54 and 56, and Title 45 CFR Part 46 (as amended).
The primary goal of the IRB is to assure that the rights and welfare of the human subjects involved in research at TMH are adequately protected and that human subjects are not exposed to inappropriate risks. To achieve this goal, the IRB will:
- review all planned research involving human subjects prior to initiation of the research
- approve research that meets established criteria for protection of human subjects as well as their private health information, to the extent possible
- monitor approved research to ensure that human subjects have given informed consent to participate in the research and that human subjects remain protected during the course of the study.
Scope of the IRB
Any systematic investigation that is designed to develop or contribute to generalizable knowledge, and which involves living humans about whom an investigator obtains information through intervention or interaction or obtains identifiable private information, qualifies as human subjects research. Also, any activity whose data will be submitted to the FDA or held for their inspection, qualifies as human subjects research.
IRB approval is required whenever human subjects are involved in the following:
- Research is to take place on the premises of any TMH facility;
- Research is to take place elsewhere, and involves an employee / affiliate of TMH
- Research is to take place elsewhere, utilizing data collected on current patients, research subjects or staff / affiliate of TMH or related facilities, including those data stored in any form, off the premises of TMH or related facilities.
All study documents involving human subjects at TMH must be submitted electronically and approved by the IRB.