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Institutional Review Board (IRB)

The Maryland Department of Health and Mental Hygiene (DHMH) 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, occurring in any DHMH facility.

Projects involving data collection in which there is identifiable linkage to the subject or involving physical, social, psychological, or privacy risks to the subject require IRB review. The IRB is charged with the responsibility of determining if a project qualifies as being exempt from IRB review requirements.

The DHMH Institutional Review Board (IRB) has an approved Federalwide Assurance FWA00002813, approved through 05/17/2008.  The IRB must comply with the FWA Terms of Assurance.

IRB Proposal Application Process

Complete DHMH 2124, Attachment 3

• Research involving any DHMH 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 "DHMH program administrator" on IRB form 1 (DHMH 2124, Attachment 3).

Mental 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).  

IRB Review

• The deadline for proposals to be included for each meeting's agenda is 10 calendar days prior to the meeting date.

When your proposal has been scheduled for review, you will be informed of the date and approximate time of the review. Although it is not required that the principal investigator attend 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:

IRB Contact

 

Ms. Gay Hutchen

IRB Administrator,

410-767-8448

hutcheng@dhmh.state.md.us

IRB Forms

The following documents are available in PDF format. If you do not have Acrobat Reader, click here to download. 

  Application & Instructions  

     (Entire package)     

  Continuous Review Application

 

  Modification Request Form 

Microsoft Word Documents

Please note that some adjustments may need to be made when using the Microsoft Word format.  When opening this file information tends to shift.

Application & Instructions  

      (Entire package )

Continuous Review Application  

 

Modification Request Form