Transcript DHMH Institutional Review Board

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 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’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
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
2)
Hospital, Spring Grove Hospital, Clifton T. Perkins
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) 767-8448