Chi Van Dang, M.D., Ph.D./John Hopkins School of Medicine, IRB, FDA 483 Insp. Observations (Baltimore) 09/07/2001
FOOD AND DRUG ADMINISTRATION
|DISTRICT OFFICE ADDRESS AND PHONE NUMBER
900 Madison Avenue
Baltimore, MD 21201
|DATE(S) OF INSPECTION
7/17, 18, 19, 20, 24, 8/3, 16, 9/7/01
|NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED
TO: Chi Van Dang, M.D., Ph.D., Vice Dean for Research (Handwritten on original document)
Johns Hopkins School of Medicine, IRB
720 Rutland Avenue, Suite 36
|CITY, STATE AND ZIP CODE
Baltimore, MD 21205
|TYPE OF ESTABLISHMENT INSPECTED
Institutional Review Committee
DURING AN INSPECTION OF YOUR FIRM, WE OBSERVED:
Note: Although this FDA-483 is an accurate representation of the original FDA-483 issued to the firm, it is not an exact copy. Slight modifications to the original FDA-483 have been made to accommodate its conversion to the HTML format. A scanned copy of the original letter is available in PDF at the bottom of this page.
1. Failure to prepare and maintain adequate documentation of minutes for fully convened IRB meetings in sufficient detail for six (6) out of 21 meetings, occurring on 1/9/00, 1/23/00, 2/13/00, 3/13/00, 3/27/00, and 4/10/00.
2. Failure to prepare and maintain adequate documentation of IRB minutes in sufficient detail to determine if an IRB member, who had a conflicting interest in a project, participated in the initial review or voting for his project. For example, RPN #00-11-07-02 was approved by the fully convened IRB on 12/12/00. A co-investigator in that study, who was also an IRB member, was documented as being present at this meeting. There was no indication that this member did not participate in the initial review or voting.
3. Failure to follow written procedures for conducting the initial review of research. IRB guideline "IV. A. Full Board/Committee Review," provides that the protocol application packet, including the proposed consent document, will be distributed to all IRB members for review and comment. The procedure then requires that "significant issues, comments or questions" regarding the protocols be sent to the subcommittee and then forwarded to the investigator in writing for a response, prior to the fully convened IRB meeting. Some, but not all, comments or questions were forwarded to the investigator. For example:
4. Failure to review research at fully convened IRB meetings at which a majority of IRB members are present, in that reviews are conducted by individual IRB members and/or in subcommittees at which only a minority of the IRB membership is present. Multiple studies, approved by the subcommittee, are approved by block vote at fully convened meetings of the IRB. The meeting minutes do not always document that the IRB discussed, considered, or determined whether the various issues, comments and questions raised by individual members were addressed or resolved. For example,
5. Failure to require that information given to subjects as part of the informed consent minimizes the
On 4/14/98, the fully convened IRB reviewed and approved the consent form for RPN# 97-02-03-04. The consent form provided under "Benefits" that "you will receive treatment with an [redacted] which will be provided at no cost to you or your insurer (standard cost $[redacted] ) or [redacted], which is also expensive."
|SEE REVERSE OF THIS PAGE||EMPLOYEE(S) SIGNATURE||EMPLOYEE(S) NAME AND TITLE (Print or Type)
J. Diann Shaffer, Investigator
Gerald W. Miller, Compliance Officer
FORM FDA 483 (8/00) PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIONS