DHMH Institutional Review Board Research, Respect and Responsibility

DHMH IRB Staff Gay Hutchen, IRB Administrator Chante Tindal, IRB Coordinator Pamela Owens, Esq., Chief, Corporate Compliance Officer

DHMH DEPARTMENT OF HEALTH AND MENTAL HYGIENE

IRB 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? Funded by or through DHMH Patients or clients of DHMH Data held by or compiled for DHMH Investigator is employee or student in a residency program in DHMH

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? 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 RESPONSIBILITIES 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 consent 4. Report unanticipated problems and adverse events

STEPS TO PROTOCOL SUBMISSION Download IRB application packet for the IRB website at 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’t Send original proposal and fifteen copies to: Institutional Review Board 201 W. Preston Street, 5 th Floor Baltimore, MD 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 Submission 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? Should you have any questions as you prepare your proposal for submission, contact: Gay Hutchen Administrator, IRB (410)