Step 3: MDH Institutional Review Board (IRB) Process
Is there a link to the MDH IRB?
The link to the MDH IRB is available here
Who do I contact at Maryland Medicaid for assistance with the IRB process and approval?
John Parrish, Regulatory Economist III, is the point person at the MDH Planning Administration for starting the IRB application. Mr. Parrish can be contacted via email at email@example.com
or via phone at (410) 767-5808. Moreover, questions may be submitted to Ms. Gay Hutchen, IRB Administrator, firstname.lastname@example.org
What are the links to State policy and federal regulations governing IRB review policies and procedures?
At the home page of the MDH IRB, click on “Related Links.” The next web page provides links to relevant federal agencies, federal regulations and the MDH’s policy (01.03.02) on research involving human subjects. An overview of protocol submission and review procedures, approval criteria and board decisions is included in this policy statement.
Is my planned project likely to be deemed to be “research” or not? Does my research protocol qualify for expedited IRB review? Does my research protocol qualify for exemption from IRB review? Under what circumstances can the requirement for informed consent and/or HIPAA be waived?
To begin to address these questions, read the relevant sections of the MDH IRB policy statement located here
. All projects must be reviewed by the MDH IRB. The MDH IRB will make a determination if a project is deemed research and/or deemed exempt from further review or not. These waivers or lack of waivers will affect the Covered Data able to be provided to you by Maryland Medicaid for your project.
What do I need to do to put my protocol before the MDH IRB?
The initial IRB application packet, including both the application form and application instructions, is available in PDF and MS Word formats available here
To whom is the drafted MDH IRB application to be submitted?
The principal investigator submits the drafted MDH IRB application to John Parrish for review. Mr. Parrish can be contacted via email at email@example.com
or via phone at (410) 767-5808. Along with the completed initial MDH IRB application form MDH IRB Form 2124), the principal investigator must submit the required responses to the nine questions posed routinely by the MDH IRB; an executive summary (i.e., brief narrative description) of the study protocol; study instruments; and other required attachments (e.g., the most recent determination letter issued by the IRB of the principal investigator’s employer).
When will I receive the requested data?
The timeline to receive E-Medicaid data varies for each individual data request. Generally, the process timeline varies for each projects individual requests and needs.
If the principal investigator has questions, comments and concerns to be discussed with the MDH IRB administrator, what steps should be taken?
Contact the MDH IRB Office at either MDH.OIG@maryland.gov