The Maryland Department of Health (MDH) IRB was established in 1977 in response to the existing federal law and Code of Federal Regulations (CFR) that required that research receiving federal funds be reviewed to ensure that the rights and dignity of human subjects in research projects are protected. The IRB has been operating since that time, basing its decisions on the federal requirements as they are amended from time to time and/or expanded. The MDH IRB is registered with the federal Office for Human Research Protection and has a current Federal-wide Assurance (FWA00002813) that assures Health and Human Services (HHS) that MDHH will comply with the requirements in the HHS Protection of Human Subjects regulations at 45 CFR 46.
The purpose of the IRB is to protect the rights and welfare of human research subjects recruited to participate in research activities that are funded with federal, State, or other funds available from or through MDH. The IRB also reviews research that involves patients or clients of MDH, data held or compiled by or for MDH, and if the researcher is an employee of MDH or a student in a residency program at MDH, if the employee or student is conducting the research as a function of his/her employment or training. The MDH IRB is responsible for reviewing and approving all proposed research projects involving human subjects, covered by 45 CFR Part 46, 21 CFR Parts 50 and 56 and Maryland Annotated Code, Health-General Article §13-2001, et seq. Additionally, the IRB is charged with the responsibility of determining if a project qualifies as being exempt from IRB review requirements.
