Research Projects Involving Social Services Administration of the State of Maryland Department of Human Resources Department of Social Services (Foster Children)

The procedures for enrolling children who are in the Department of Social Services custody have been posted on the IRB website. For complete details on which types of studies foster children may participate as subjects, click here: http://irb.jhmi.edu/Guidelines/fosterchildren.html. The instruction/submission form for these studies can be accessed here: (http://irb.jhmi.edu/Forms/DSS_Submission_Form.doc)


Application of GCP (Good Clinical Practice) to the Conduct of Clinical Research

The IRB website has clarification regarding the GCP requirements as they pertain to our researchers. Read the details here: http://irb.jhmi.edu/Guidelines/gcp.html. A sample Investigator checklist that research teams at JHM may use when a study is to be conducted in accord with ICH GCP requirements can be found at: http://irb.jhmi.edu/Monitoring/sample_gcp_checklist.doc


Questions about IRB Registration Requirements

Sponsors and CROs have been requesting documentation that the JHM IRBs have met the new FDA regulatory requirement for registration of IRBs

OHSR has confirmed with FDA staff that the database for registration is not yet available to organizations and organizations have until September 2009 to complete registration. Currently, all JHM IRBs are registered on the OHRP website. The registration number is provided on the membership page for each IRB. When the FDA registration is complete, confirmation of registration will be posted on the IRB website (http://irb.jhmi.edu).

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