dhmh institutional review board research, respect and responsibility
TRANSCRIPT
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DHMHDHMHInstitutional Review BoardInstitutional Review Board
Research, Respect and Responsibility
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DHMH IRB StaffDHMH IRB Staff
Gay Hutchen, IRB AdministratorChante Tindal, IRB Coordinator
Pamela Owens, Esq., Chief, Corporate
Compliance Officer
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DHMHDHMH
DEPARTMENT OF HEALTH AND MENTAL HYGIENE
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IRB FUNCTIONSIRB FUNCTIONS
IRB Review
- Initial Review
- Prospective review of all modifications
- Review of Unanticipated Problems and Adverse Events
- Exemption determinations
- Continuing review at least annually
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What Do We Review?What Do We Review?
Funded by or through DHMHPatients or clients of DHMHData held by or compiled for DHMHInvestigator is employee or student in a
residency program in DHMH
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What Do We Review ?What Do We Review ?
Request for Data from DHMH Agencies– Medicaid– Vital Statistics Administration (VSA)– Maryland Cancer Registry (MCR)– Alcohol and Drug Abuse Administration
(ADAA)– Tuberculosis (TB) Registry
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What Do We Review?What Do We Review?
Follow-back to the next of kin from the Office of the Medical Examiner’s (OME) records
Subject Recruitment from:– Mental Health Administration (MHA) Facilities– County Health Departments
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INVESTIGATOR INVESTIGATOR RESPONSIBILITIESRESPONSIBILITIES
1. Obtain IRB approval PRIOR to:– Initiating research– Making ANY changes to an approved protocol
2. Ensure research is conducted according to the approved protocol within the period of IRB approval
3. Obtain informed consent4. Report unanticipated problems and adverse events
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STEPS TO PROTOCOL STEPS TO PROTOCOL SUBMISSIONSUBMISSION
Download IRB application packet for the IRB website at www.dhmh.state.md.us/oig/irb
Submit completed IRB Form I, DHMH 2124, an abstract summary, research plan, and supporting documentation for all proposals (DHMH Form 2125 for annual renewals)
Wait for IRB approval before beginning ANY portion of your research
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Steps con’tSteps con’t
Send original proposal and fifteen copies to:
Institutional Review Board
201 W. Preston Street, 5th Floor
Baltimore, MD 21201 Proposals should be submitted 10 calendar days
prior to the next scheduled meeting date Meetings are held third Thursday of every month
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Approvals Needed Prior to Approvals Needed Prior to SubmissionSubmission
The Director for EACH Administration involved in your research
Collaborating Institution or Agency that has an IRB If student researcher…advisor is PI Research conducted in one of the following facilities
must have: 1) approval of that facility’s review board prior to submission to
the IRB: Walter P. Carter, Springfield Hospital, Spring Grove Hospital, Clifton T. Perkins
2) Approval of MHA Director
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Need More Information?Need More Information? Should you have any
questions as you prepare your proposal for submission, contact:
Gay Hutchen
Administrator, IRB
(410) 767-8448