​The Maryland Department of Health (MDH) Institutional Review Board (IRB) is responsible for reviewing and approving all proposed research projects involving human subjects covered by 45 Code of Federal Regulations (CFR) Part 46 as well as, 21 CFR 50 and 56, occurring in any MDH facility or involving any MDH program. The primary purpose of the IRB is to protect the rights and dignity of individuals who volunteer to participate in human subject research. ​

The MDH IRB shall review all human subject research projects that fit into any of the following categories:​

• The project is f​unded with federal, State, or other funds available from or through MDH. 
• The human subjects are patients or clients of MDH. 
• ​The data sought by the investigator is held or compiled by or for MDH. 
• The investigator is an employee of MDH or a student in a residency program at MDH and is conducting the research as a function of their employment or training. 

The IRB is also charged with the responsibility of determining if a project qualifies as being exempt from IRB review requirements.​

Federal-Wide Assurance

The MDH IRB has an approved Federal-wide Assurance (FWA0002813 ), approved through 2/25/2026.

1. Complete IRB Application-2024.docx

• ​Research involving any MDH unit or facility must be signed off by the Director or Administrator of the unit or facility. 
• ​The Director's signature should appear on the line designated for the 'MDH program administrator' on IRB form 1 (MDH 2124, 'Attachment 3'). ​
  

2. ​Behavioral Health Institutions Research Approval Committee

Any proposal that involves research in one of these facilities must be approved by that facility's review board. (See Attachment 1​) 

 3. IRB Review 

The deadline for proposals to be inclu​ded for each meeting's agenda is 10 calendar days prior to the meeting date. 

When a proposal has been scheduled for review, the researcher will be informed of the date and approximate time of the review. Although it is not required that the principal investigator attends the IRB meeting, his or her doing so can facilitate the process should the Board members have questions regarding the protocol to be followed to carry out the proposal. 

For more information or questions preparing your proposal for submission, please feel free to contact the IRB office.​​​​​​​