Dr. Charles J. Paine
Chief Executive Officer
CHRISTUS Schumpert Health System
One Saint Mary Place Shreveport, LA 71101

Dear Dr. Paine:

Between April 21 and 25, 2008, Ms. Dana Daigle, representing the Food and Drug Administration (FDA), inspected the Institutional Review Board (IRB) at the CHRISTUS Schumpert Health System.  The purpose of this inspection was to determine whether the IRB procedures for the protection of human subjects complied with Title 21 of the Code of Federal Regulations (CFR), Parts 50 and 56.  These regulations apply to clinical studies of products regulated by FDA.  We are aware that at the conclusion of the inspection, our investigator presented and discussed with you, a Form FDA 483, Inspectional Observations.

From our review of the establishment inspection report and the documents submitted with that report, including the revised IRB written procedures provided at the closeout of the inspection, we conclude that the IRB did not adhere to the applicable statutory requirements and FDA regulations governing the protection of human subjects.  We wish to emphasize the following:

1.  The IRB failed to require that information given to subjects as part of the informed consent process is in accordance with 21 CFR 50.25 [21 CFR 56.109(b)].

When seeking informed consent, the regulations at 21 CFR 50.25 require that each
subject be provided with the basic elements of informed consent [21 CFR 50.25(a)],
and when appropriate, one or more of the additional elements of informed consent [21
CFR 50.25(b)].

a.  For research Project 1125 entitled, ^{(b) (4)}  [redacted] ”, our inspection
revealed the IRB failed to review and approve an informed consent form that was
in compliance with FDA regulatory requirements.  We note that the IRB reviewed
and approved only three general hospital consent forms for procedures related to
Project 1125.  None of these consent forms complied with the requirements of 21
CFR Part 50.25.

b.  Our inspection revealed the informed consent form approved by the IRB for
Project 1121 did not include an explanation of whom the subject should contact for
questions about their rights as a research subject, or whom to contact in the event of a research-related injury as required by 21 CFR 50.25(a)(7).

2.  The IRB failed to ensure that no member participated in the initial or continuing
review of a project in which the member had a conflicting interest, except to
provide information requested by the IRB [21 CFR 56.107(e)].

Our inspection revealed five instances in which an IRB member, who was serving as
the clinical investigator for a particular research study, voted on the initial or
continuing review of that study.  The following table lists the dates of the IRB
meetings and a brief summary of our findings:

3.  The IRB failed to follow its written procedures for conducting its initial and
continuing review of research [21 CFR 56.108(a)(1)].

The IRB written procedures require that information, including copies of schemas of
all proposals on the agenda, be sent to IRB members prior to the meeting.  The
meeting minutes indicate members were mailed outlines and consent forms for new
proposals prior to the meeting, but our inspection revealed that IRB members were not
provided copies of protocol schemas for new proposals for the IRB meetings of
February 7, 2007 and November 1, 2007.  During the inspection, the IRB Coordinator
indicated protocol schemas were no longer routinely distributed.

4.  The IRB failed to prepare and maintain adequate documentation of written
procedures for the IRB as required by 21 CFR 56.108(a) and (b) [21 CFR
56.115(a)(6)].

Specifically, the IRB does not have written procedures for reporting IRB findings and
actions to the institution as required by 21 CFR 56.108(a)(1), and does not have
written procedures for determining which projects require verification from sources
other than the investigator that no material changes have occurred since previous IRB
review as required by 21 CFR 56.108(a)(2).

5.  The IRB failed to review proposed research at convened meetings at which a
majority of the members of the IRB are present [21 CFR 56.108(c)].

The IRB meeting minutes for November 1, 2007, indicate that the membership of the
IRB consisted of ten voting members and three ex-officio (non-voting) members.
Accordingly, a minimum of six voting members were required to be present at the
meeting to review proposed research.  Our inspection revealed that the IRB reviewed
and approved research at the November 1, 2007, IRB meeting with only five voting
members present.

6.  The IRB failed to conduct continuing review of research at intervals appropriate
to the degree of risk, but not less than once per year [21 CFR 56.109(f)].

Project 1114 was initially approved by the IRB on February 7, 2007.  Our inspection
revealed there is no documentation in the IRB files that continuing review of Project
1114 was conducted at any time prior to April 25, 2008.

7.  The IRB failed to prepare and maintain adequate minutes of IRB meetings in sufficient detail to show actions taken by the IRB [21 CFR 56.115(a)(2)].

Our inspection revealed the minutes for the November 1, 2007, IRB meeting do not list Project 1051 as being reviewed for continuing review.  However, the IRB files for Project 1051 contain an IRB re-approval letter and a progress report signed by the IRB Chair as approved at the November 1, 2007 IRB meeting.

This letter is not intended to be an all-inclusive list of deficiencies for the protocols reviewed and approved by the IRB.  It is your responsibility to ensure that CHRISTUS Schumpert Health System IRB’s practices and procedures comply fully with all applicable statutes and regulations.

The FDA received the IRB’s response dated February 23, 2009 to the FDA Form 483 and noted that CHRISTUS Schumpert Health System planned to formally disband the IRB as of April 18, 2009.  We request written documentation within thirty (30) working days of receiving this letter of the status of the plan to disband the IRB and transfer any remaining studies to an external IRB.  Should CHRISTUS Schumpert Health System decide to re-establish the IRB at any time in the future, it is expected that IRB procedures comply with the protection of human subjects in accordance with Title 21 of the CFR, Parts 50 and 56.  These regulations apply to clinical studies investigations of products regulated by FDA.

If you have any questions, please contact me at 301-796-3707; FAX 301-847-8748.  Your response and any pertinent documentation should be sent to me at:

Division of Scientific Investigations
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Bldg 51, Room 5356
10903 New Hampshire Avenue
Silver Spring, MD 20993

Sincerely yours,

Kevin Prohaska, D.O., M.P.H. 
Acting Human Subjects Protection Team Lead
Division of Scientific Investigations
Office of Compliance
Center for Drug Evaluation and Research
 

cc:
Dr. Antonio Pizzaro
IRB Chair
CHRISTUS Schumpert Health System IRB
One Saint Mary Place
Shreveport, LA 71101

Ms. Sandee Phagan
IRB Coordinator
CHRISTUS Schumpert Health System IRB
One Saint Mary Place
Shreveport, LA 71101