April 2013  - Revised Investigational Drug Data Sheet

An updated version of the Investigational Drug Data Sheet (Revised 2/13) has been posted. All new and revised drug data sheets are required to be submitted on the updated template as of May 1, 2013. Investigational Drug Data Sheets received after May 1, 2013 on an outdated template will be returned and the application will not be processed until the correct drug data sheets are submitted. Please note that a separate IDDS must now be submitted for each site (HCGH, Sibley Memorial, Suburban, JHBMC) at which the IND will be dispensed.

The Institutional Official who has authority over the JHM Human Subjects Protection Program is the Vice Dean for Clinical Investigation. The current Vice Dean for Clinical Investigation is Dr. Daniel E. Ford.

The Johns Hopkins Medicine Institutional Review Boards (JHM IRBs) are responsible for protecting the rights and welfare of the human subjects of research conducted by faculty and staff at the Institutions. The JHM IRBs review all human subjects research projects conducted by Hopkins faculty and staff. To fulfill the agreement underlying the assurances, and to satisfy institutional policy, all faculty and staff at the Institutions must submit for JHM IRB review any human subject research project, regardless of funding source (or lack thereof) and/or location at which the research will be conducted.

[ Please Note: Part-time faculty are obliged to obtain JHM IRB approval of all human subjects activities conducted under the auspices of their Hopkins’ appointment ( which means “use of Hopkins’ personnel or space or the use of the faculty appointment in correspondence, agreements with sponsors, etc…”)].

The Institutions had been operating under Multiple Project Assurance # M-1011 for the period of 11/01/98 to 10/31/03. The MPA was replaced by Federal-Wide Assurances associated with each of the organizations linked to the JHM IRBs. List of JHM FWAs

For more information on the federal guidelines that determine the kind of research the JHM IRB is required to approve please visit http://www.hhs.gov/ohrp/policy/index.html.