DHMHDHMHInstitutional Review BoardInstitutional Review Board

Research, Respect and Responsibility

DHMH IRB StaffDHMH IRB Staff

Gay Hutchen, IRB AdministratorChante Tindal, IRB Coordinator

Pamela Owens, Esq., Chief, Corporate

Compliance Officer

DHMHDHMH

DEPARTMENT OF HEALTH AND MENTAL HYGIENE

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

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

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

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

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

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

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

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

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