XYZ MEDICAL CENTRE Boston

Sep 24th, 2006

MEMORANDUM

TO: Alex Adams, Ph.D., Director, Institutional Review Board XYZ Medical Centre XYZ Medical Centre at Boston Boston, Ma

FROM: John Johnson Investigator, Institutional Review Board (IRB) XYZ Medical Center at Boston Boston

SUBJECT: Violations observed during the FDA inspection of XYZ Institutional Review Board from August 21 to August 25 1, 2006

I am writing this letter to set out all the non- compliance issues identified during the FDA inspection of XYZ Institutional Review Board (IRB). These violations are pertaining to applicable provisions of Title 21, Code of Federal Regulations (21 C.F.R.) Part 56 Institutional Review Boards, Part 50-Protection of Human Subjects, and Part 812 Investigational Device. The compliance issues can be summarized as follow:
1- The IRB failed to establish, maintain, and follow adequate written procedures for conducting the review of research. (21 CFR 56.108, 21 CFR 56.110(c), and 21 CFR 56.115{a){6)]
2- The IRB failed to prepare and maintain adequate documentation of IRB activities. {21 CFR 56.115]
In regards to inadequate documentation, I would like to point out to some specific issues that have been ignored at the IRB, such as: - There was an inconsistency between the numbers of members present and the number of members voting and abstaining during IRB meetings for approval of the revised informed consent - There were missing records of continuing review approval for protocol research for 2003, 2004, and 2005 - A lack of adequate system to keep records of expedited review research and to notify all members of research proposals

The IRB should have implemented the following steps prior to the FDA’s inspection:

1- Establishing and maintaining a written quality policy and procedure for conducting its initial and continuing review of research 2- Determining which projects require immediate review 3- Keeping certain records as required by the HHS regulations for at least three years after completion of the study. 4- Documentation of IRB activities, including minutes of IRB meetings and records of expedited review research

I would like to bring your attention that immediate action is necessary to move forward. I am suggesting the following measures:

1- Creating and maintaining a quality management system 2- Setting up a standard operating procedure 3- Establishing roles and responsibilities of the IRB and the clinical investigator 4- Conducting internal routine and mock inspections 5- The IRB must conduct continuing review, at least once a year, of studies that it has approved 6- The IRB shall prepare and maintain adequate documentation of IRB activities, including but not limited to records of revised informed consent 7- IRB shall review proposed research at convened meetings at which a majority of the members of the IRB are present, and limit the use of expedited review procedures for initial or continuing review to specific research categories involving no minimal risks to human subjects.

If you have any questions, please feel free to contact me. And thank you for your continuous responsibility for safeguarding the welfare of research participants and ensuring that clinical studies involving human subjects comply with federal regulations at XYZ Medical Centre IRB at Boston.

Sincerely,

John Johnson Investigator (IRB)