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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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St Vincent Hosp And Hlth Care 11/27/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Silver Spring, MD 20993 

NOV 27, 2013

WARNING LETTER
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED                   
 
Ref: 13-HFD-45-11-03  
 
Ian Worden, MHA, MBA, CPA                               
Interim Chief Executive Officer
St. Vincent Health
2001 West 86th Street
Indianapolis, IN  46260

Dear Mr. Worden:
 
This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection of St. Vincent Hospital and Health Care Center Institutional Review Board (SVHHCC IRB) that was conducted between August 12, 2013, and August 26, 2013, by Ms. Myra Casey, representing FDA. 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 investigations of products regulated by FDA.
 
This inspection is a part of FDA’s Bioresearch Monitoring Program, which includes inspections designed to evaluate the conduct of FDA-regulated research to ensure that the data are scientifically valid and accurate, and to help ensure that the rights, safety, and welfare of the human subjects of those clinical investigations have been protected.
 
At the conclusion of the inspection, Ms. Casey presented the Interim Executive Director for Academic Affairs and Research, Dr. Niceta C. Bradburn, with a Form FDA 483, Inspectional Observations. We acknowledge receipt of the IRB’s September 11, 2013, written response to the Form FDA 483. 
 
From our review of the FDA establishment inspection report, the documents submitted with that report, and the IRB’s written response, 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 determine at the time of initial review that clinical investigations involving children were in compliance with 21 CFR part 50, subpart D, Additional Safeguards for Children in Clinical Investigations [21 CFR 56.109(h)].
 
Under 21 CFR 56.109(h), when some or all of the subjects in a clinical investigation are children, the IRB must determine that the clinical investigation is in compliance with 21 CFR part 50, subpart D (Additional Safeguards for Children in Clinical Investigations) at the time of initial review. Under 21 CFR 50.50, an IRB must review the clinical investigation and  approve only those clinical investigations that satisfy the criteria described in section 50.51 (clinical investigations not involving greater than minimal risk), section 50.52 (clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects), or section 50.53 (clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition). 
 
In order to determine if a clinical investigation involving children meets the criteria in 21 CFR part 50, subpart D, the IRB must make certain types of findings with respect to such investigations.  In addition, under 21 CFR 56.115, the IRB is required to document its activities, including actions taken during IRB meetings.  Our inspection revealed that in its review and approval of 31 active clinical investigations involving pediatric subjects, SVHHCC IRB failed to determine that the clinical investigation satisfied the criteria of subpart D. 
 
For example, on May 23, 2012, SVHHCC IRB reviewed and approved a pediatric clinical investigation titled “(b)(4).” However, there is no documentation, either in the meeting minutes or in any other IRB materials, of the IRB’s requisite determination at the time of initial review that the clinical investigation was in compliance with subpart D.
 
Your IRB’s written response dated September 11, 2013, acknowledges the violation listed above and includes a copy of a “Checklist for Research Involving Children.”  This checklist documents that, as a part of the IRB’s corrective action plan, a subpart D review was performed for the above-mentioned pediatric clinical investigation and for two other pediatric clinical investigations (Studies(b)(4) and (b)(4)) that were included in the Form FDA 483. Your IRB’s response also states that the IRB willperform a subpart D review for the remaining 28 of 31 active pediatric clinical investigations. Your IRB’s response is inadequate because it does not provide written assurance that a subpart D review has been completed for the remaining 28 active pediatric clinical investigations.   
 
Failure to determine that the additional safeguards for children in research are met may expose this vulnerable population to unnecessary risks, and may result in the child’s parent(s) or guardian(s) not being fully informed about the proposed research. 
 
2.  The IRB failed to fulfill membership requirements [21 CFR 56.107].
 
The IRB allowed nonmembers to vote on clinical investigations. Specifically:
 
a.    IRB meeting minutes from March 28, 2012, show that an attendee identified as (b)(6) participated in voting. According to the IRB membership roster, Ms. (b)(6) was not a member of the IRB when this meeting was conducted.
 
b.    IRB meeting minutes from June 29, 2011, show that an attendee identified as (b)(6) participated in voting.  According to the IRB membership roster, Ms. (b)(6) was not a member of the IRB when this meeting was conducted.
 
c.    IRB meeting minutes from June 23, 2010, show that an attendee identified as(b)(6) participated in voting.  According to the IRB membership roster, Ms. (b)(6) was not a member of the IRB when this meeting was conducted.
 
We acknowledge your IRB’s September 11, 2013, written response, stating that several corrective actions have been implemented. These include the restructuring of the attendance grid of IRB meeting minutes, as well as training for IRB members on Standard Operating Procedure (SOP) #403, “IRB Attendance Monitoring”; SOP #404, “IRB Meeting Minutes”; and SOP #803, “IRB Membership Addition.” If properly implemented and executed, these procedures/actions appear adequate to prevent recurrence of similar violations in the future. Please ensure that the IRB is adhering to its SOPs, including fulfilling membership requirements and updating the membership roster. 
 
IRB membership requirements described in 21 CFR 56.107 are in place to ensure that the IRB is qualified through its members’ experience, expertise, and diversity to protect human subjects. Allowing nonmembers to vote calls into question the IRB’s ability to fulfill this requirement.
 
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 SVHHCC IRB’s practices and procedures comply fully with all applicable statutes and regulations.
 
Within fifteen (15) business days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future. Your written response should include any documentation necessary to show that full and adequate correction will be achieved. Please include the projected completion dates for each action to be accomplished.  Failure to explain the violations noted above adequately and promptly may result in regulatory action without further notice. 
 
We recommend that you visit the following FDA Web page for information on human subject protections that may assist you in your efforts to bring the IRB into compliance with FDA regulations: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm.
 
We appreciate the cooperation shown to the FDA Investigator, Ms. Myra Casey, during the inspection. If you have any questions, please contact Catherine Parker, R.N., at 301-796-5553; FAX 301-847-8748. Your written response and any pertinent documentation should be addressed to:
 
Catherine Parker, R.N.
Team Lead, Human Subject Protection Branch
Office of Scientific Investigations
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Building 51, Room 5247
10903 New Hampshire Avenue
Silver Spring, MD 20993
 
              Sincerely yours,
 
{See appended electronic signature page}
 
              Thomas N. Moreno, M.S.
              Acting Office Director
              Office of Scientific Investigations
              Office of Compliance
              Center for Drug Evaluation and Research
              Food and Drug Administration
 
Cc:    Kyle DeFur, FACHE
President
St. Vincent Indianapolis Hospital
2001 West 86th Street
Indianapolis, IN  46260

Tina G. Noonan, MBA, CHRC
Director, Research & Regulatory Affairs
St. Vincent Research & Research Regulatory Affairs
8402 Harcourt Road, Suite 805
Indianapolis, IN  46260
 
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This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature.
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/s/
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THOMAS N MORENO
11/27/2013