OHRP Compliance Letters

ETHICAL AND POLICY ISSUES IN RESEARCH INVOLVING HUMAN PARTICIPANTS

National Bioethics Advisory Commitee (NBAC) Final Report, 2001

Exhibit 3.1: Office of Protection from Research Risks (OPRR) Compliance Oversight Investigations Resulting in Restrictions/Actions to Institutions that have Multiple Project Assurances (MPA) between January 1990 – June 2000

Year, Institution and Action by OPRR

1990 Massachusetts Eye and Ear Infirmary. Certain research was excluded under the existing MPA pending negotiation of a renewed MPA. New participant accruals were suspended pending re-review by appropriately convened IRB and notification of former participants about inadequate informed consent.

1991 NIH. Certain collaborative research was excluded under the existing MPA. Designation of a signatory official with authority to ensure institutional human participant protections, modification of institutional policies and procedures to ensure IRB review of all human participant research, and development of an education program were required.

University of California – San Francisco. New participant accruals in all pediatric oncology research were suspended pending modification of informed consent documents and revised consent for all current pediatric oncology participants, and mechanisms to ensure regulatory compliance in such research were required.

1992 State University of New York College of Optometry. Use of expedited IRB review procedures was suspended. Suspension of human participant involvement in certain research, re-review of research by an appropriately convened IRB, modification of IRB review and record keeping procedures, and designation of a signatory official with authority to ensure institutional human participant protections were required.

Florida State University. Use of expedited IRB review procedures was suspended. Re-review of research by an appropriately convened IRB, modification of IRB review, and record keeping procedures were required.

1993 NIH. Progress reports on implementation of education program were required.

1994 University of California – Los Angeles. Schizophrenia research was excluded under the existing MPA. Modification of informed consent documents, information materials, and record keeping for schizophrenia research, the addition of participant representatives to the IRB, and the establishment of a Data and Safety Monitoring Board for psychiatric disorders research were required.

West Virginia University. Special monitoring of urology department research and modification of IRB review and record keeping procedures were required.

Memorial-Sloan Kettering Cancer Center. Special monitoring of melanoma immunization research, modification of IRB review and record keeping procedures, verification of completeness of informed consent documents, development of handbook of guidelines for investigators, and designation of a signatory official with authority to ensure institutional human participant protections were required.

Medical University of South Carolina. Review of research by appropriately convened IRB, modification of institutional mechanisms to ensure IRB review of human participant research, and development of an education program were required.

1994 University of California – San Diego. Human participant involvement in certain research was suspended, and re-review of research by an appropriately convened IRB, modification of IRB review and record keeping procedures, and designation of a signatory official with authority to ensure institutional human participant protections were required.

University of Florida. Use of expedited IRB review procedures was suspended. Re-review of research by an appropriately convened IRB, modification of IRB review and record keeping procedures, and revision of IRB guidelines for investigators were required.

University of Minnesota. Research conducted by the Department of Surgery was excluded under the existing MPA, and human participant involvement in certain research was suspended. Re-review of research by an appropriately convened IRB, modification of IRB review, and record keeping procedures were required.

54

1995 University of Virginia. Behavioral and educational research were excluded under the existing MPA, and human participant involvement in behavioral and educational research and certain medical sciences research was suspended. Re-review of research by appropriately convened IRBs, modification of IRB review and record keeping procedures, provision of an enhanced educational program and materials, review of staff support and resources for IRBs, designation of a signatory official with authority to ensure institutional human participant protections, and comprehensive review of IRB policies and procedures were required.

Centers for Disease Control and Prevention. Provision of updated information to measles research participants, development of conflict of interest guidelines for IRB members, review of staff support and resources for IRBs, development of an educational program, a proposal for a mechanism to ensure performance site assurances for international research, and a comprehensive review of IRB policies and procedures were required.

University of California – Los Angeles. Development of an educational program, revised IRB guidelines for investigators and the procedures manual, review of staff support and resources for IRBs, provision of a locked filing system and computerized tracking system to ensure confidentiality of IRB records, and development of mechanisms to ensure that all human participant research receives IRB review were required.

Center for Molecular Medicine and Immunology. Modification of IRB review and record keeping procedures were required.

Veterans Affairs Medical Center, West Los Angeles. Modification of IRB review and record keeping procedures were required.

1996 Cook County Hospital Hektoen Institute for Medical Research. Participant enrollment in research not receiving valid initial or continuing IRB review and use of expedited review procedures were suspended. Revision of IRB review procedures was required.

Cornell University Medical Center. Enrollment in research not receiving adequate initial or continuing IRB review was suspended. Modification of IRB review and record keeping procedures, a plan for increased staffing, a plan for education of IRB members and investigators, and a mechanism for investigation of non-compliance were required.

University of Rochester. Enrollment in research not receiving appropriate initial or continuing IRB was suspended. Review and development of written operating procedures and an investigator handbook, a finalized organization structure of institutional human participant protections, and development of an education program for IRB members and investigators were required.

Wayne State University. Enrollment in research not receiving appropriate initial or continuing IRB review was suspended. Increased staffing and resources for the IRB, development of a mechanism for prompt review of adverse event reports, development of an educational program for IRB members and investigators, and review and revision of IRB policies and procedures were required.

1997 City University of New York. Development of an educational program for IRB members and investigators, review and revision of IRB policies and procedures, revision of sample informed consent documents to comply with DHHS regulations, and revision of IRB record keeping procedures were required.

1998 University of Maryland – Baltimore. Enrollment of participants in research not receiving appropriate initial or continuing IRB review was suspended. Review and revision of informed consent documents for psychiatric research to ensure compliance with DHHS regulations, development of an educational program for IRB members and investigators, and revision of IRB review procedures, including procedures for research involving vulnerable participant populations, were required.

University of California – Irvine. Modification of initial review process to ensure compliance with regulations, revision of continuing review and oversight procedures, increased documentation of IRB actions in accordance with regulations, enhanced education for investigators, IRB members, and staff, and increased support for social and behavioral sciences IRB were required.

Western Carolina Center. Due to limited DHHS support to the Western Carolina Center, Single Project Assurances (SPAs) were required for DHHS-supported human participant research, and the MPA was deactivated on October 30, 1998.

Rush Presbyterian St. Lukes Medical Center. OPRR suspended the MPA for five days pending development of adequate corrective action plans. The MPA was subsequently reinstated with restrictions. OPRR required correction of 17 identified deficiencies in systemic human participant protections, restructuring of systemic human participant protections including changes in leadership, enhanced institutional commitment, and expanded IRB membership, development of an education program for IRB members, IRB staff, and research investigators, suspension of new enrollments in all federally supported research pending review of all such protocols by the reconstituted, convened IRB, and suspension of IRB review of federally supported research by expedited review procedures.

Scripps Clinic and Research Foundation:The Scripps Research Institute. OPRR required correction of 20 identified deficiencies in systemic human participant protections, re-review of all DHHS-supported human participant protocols to include review of complete grant application, development of an educational program for IRB members, IRB staff, and research investigators, and quarterly progress reports.

Duke University. OPRR restricted the MPA and required several corrective actions.

Duke University Medical Center. OPRR restricted the Duke University Medical Center MPA and required several corrective actions.

1999 Friends Research Institute. OPRR removed from coverage under the existing MPA any performance sites outside the Maryland area, removed recognition of one IRB under the MPA, and withdrew approval of all inter-institutional and cooperative amendments to the MPA.

Mt. Sinai School Of Medicine. OPRR restricted the MPA and required satisfactory implementation of a series of corrective action plans.

Veterans Affairs, Greater Los Angeles Health Care System (Formerly Veterans Affairs Medical Center,West Los Angeles). OPRR deactivated the MPA on March 22, 1999. Enrollment of new participants in all federally supported research was suspended, and involvement of previously enrolled participants was allowed only when it was in the best interest of the participant.

Fordham University. Due to the limited number of DHHS-supported projects at Fordham University and persistent concerns about compliance with human participant protections requirements, SPAs were required for all DHHS-supported human participant research, and the MPA was deactivated on May 31, 1999. Duke University Medical Center. OPRR suspended the MPA for five days. OPRR reinstated the Duke University Medical Center MPA with restrictions and required several corrective actions, including re-review of DHHS-supported research by the IRB, implementation of a second IRB, and implementation of appropriate education programs for IRB members, IRB staff, and all investigators.

University of Illinois at Chicago. OPRR restricted the MPA and required corrective actions in response to 29 identified deficiencies, including revision of the MPA to indicate enhanced institutional commitment to the protection of human participants and development of an educational program for IRB members, IRB staff, and research investigators. New enrollments in all federally supported research pending re-review of all such protocols were suspended.

St. Jude Children’s Research Hospital. OPRR restricted the MPA and required submission of a progress report describing implementation of all corrective actions three months after the site visit.

Virginia Commonwealth University. OPRR restricted the MPA and required corrective actions, including development of an educational program for IRB members, IRB staff, and research investigators and submission of a list of all active IRB-approved protocols. New participant enrollments in all federally supported research pending re-review of all such protocols were suspended.

2000 Virginia Commonwealth University. OPRR suspended the MPA and required revised corrective action plans, including designation of a new signatory official and new IRB chairpersons.

University of Alabama at Birmingham. OPRR restricted the MPA and required suspension of new participant enrollments in all federally supported research that had not had appropriate initial or continuing review. Submission of corrective action plans to address all deficiencies and concerns related to systemic human participant protections and submission of an educational plan for all IRB members, all IRB staff, and all research investigators were required.

[Adapted from Compliance Oversight Investigations Resulting in Restrictions/Actions to Multiple Project Assurances, 1/90 – 11/99 (OPRR 2000).]

UPDATE: source: OFFICE OF HUMAN RESEARCH PROTECTION http://ohrp.osophs.dhhs.gov/detrm_letrs/lindex.htm

COMPLIANCE DETERMINATION LETTERS, July, 2000

07/07/2000 University of Oklahoma Health Sciences Center 07/10/2000 University of Nebraska Medical Center 07/10/2000 University of Texas Medical Branch at Galveston 07/12/2000 University at Buffalo, State University of New York 07/13/2000 University of Oklahoma Health Sciences Center 07/13/2000 University of Illinois at Chicago 07/17/2000 State University of New York 07/18/2000 University of Illinois at Chicago 07/21/2000 Encino-Tarzana Regional Medical Center 07/27/2000 Yale University 07/28/2000 University of Miami 07/31/2000 University of Miami 07/31/2000 University at Buffalo, State University of New York

Compliance Determination Letters, August, 2000

08/02/2000 The University of Alabama at Birmingham 08/04/2000 Northeast Georgia Health Services 08/07/2000 Good Samaritan Regional Medical Center 08/07/2000 INOVA Institute of Research and Education, Fairfax Hospital 08/07/2000 Morehouse School of Medicine 08/07/2000 University of Cincinnati 08/11/2000 University of Wisconsin – Madison 08/23/2000 University of Pennsylvania 08/25/2000 The Cleveland Clinic Foundation 08/28/2000 The University of Alabama at Birmingham 08/28/2000 Memorial Health University Medical Center 08/28/2000 St. Francis Health System 08/28/2000 The Miriam Hospital

Compliance Determination Letters September, 2000

09/07/2000 University of Florida 09/14/2000 University of Texas Medical Branch at Galveston 09/21/2000 University of Tennessee, Memphis 09/22/2000 Virginia Commonwealth University 09/26/2000 University of Texas Medical Branch at Galveston 09/28/2000 University of South Florida

Compliance Determination Letters, October, 2000

10/03/2000 The Johns Hopkins University 10/03/2000 State University of New York at Binghamton 10/03/2000 Brooke Army Medical Center 10/04/2000 Georgetown University 10/11/2000 Northeast Georgia Health Services 10/11/2000 Evanston Northwestern Healthcare Corporation 10/11/2000 St. Francis Health System 10/19/2000 University of Maryland 10/19/2000 Research Foundation for Mental Hygiene, Inc. 10/19/2000 East Tennessee State University 10/19/2000 The University of Oklahoma Health Sciences Center 10/23/2000 Kaiser Foundation Hospitals 10/24/2000 University of South Florida 10/26/2000 University of Colorado Health Sciences Center 10/26/2000 Toxicology Associates 10/27/2000 Louisiana State University Medical Center 10/27/2000 The Pennsylvania State University 10/27/2000 George Mason University

Compliance Determination Letters, November, 2000

11/03/2000 National Institutes of Health 11/06/2000 University of Arkansas for Medical Sciences 11/08/2000 Yale University 11/13/2000 University of Florida 11/22/2000 University of Missouri – Columbia 11/17/2000 University of South Florida 11/27/2000 University of Rochester 11/27/2000 RAND 11/27/2000 Evanston Northwestern Healthcare Corporation 11/27/2000 Case Western Reserve University 11/27/2000 Raritan Bay Medical Center 11/27/2000 Brown University 11/29/2000 Temple University 11/30/2000 Charles R. Drew University of Medicine and Science

Compliance Determination Letters, December, 2000

12/04/2000 University of South Florida 12/11/2000 Louisiana State University Medical Center of New Orleans 12/11/2000 The University of Alabama at Birmingham 12/11/2000 University of Wisconsin – Madison 12/12/2000 Yale University 12/12/2000 National Institutes of Health 12/12/2000 State University of New York 12/15/2000 Massachusetts Eye and Ear Infirmary 12/15/2000 Virginia Commonwealth University 12/18/2000 Vanderbilt University 12/20/2000 Yale University 12/20/2000 Washington University School of Medicine 12/22/2000 Wake Forest University 12/22/2000 The University of North Carolina at Chapel Hill

Office for Human Research Protections (OHRP)

—————————————————————————- —-

Compliance Determination Letters January, 2001

01/12/2001 Mary Bridge Children’s Hospital & Health Center 01/17/2001 National Institutes of Health 01/17/2001 University of Texas Medical Branch at Galveston 01/19/2001 University of Miami 01/22/2001 The John Hopkins University School of Medicine 01/22/2001 McMaster University 01/22/2001 University of Pennsylvania 01/22/2001 National Institutes of Health 01/23/2001 The University of Texas Southwestern Medical Center 01/23/2001 National Institutes of Health 01/24/2001 Garden State Cancer Center 01/24/2001 National Institutes of Health 01/25/2001 University of South Florida 01/25/2001 Cook Children’s Medical Center 01/25/2001 St. Francis Health System 01/26/2001 University of South Florida 01/31/2001 Morehouse School of Medicine 01/31/2001 St. Luke’s Medical Center 01/31/2001 The University of Memphis

Office for Human Research Protections (OHRP)

—————————————————————————- —-

Compliance Determination Letters February, 2001

02/08/2001 Children’s Hospital, Boston 02/12/2001 Louisiana State University Medical Center 02/15/2001 Baylor College of Medicine 02/15/2001 University of Cincinnati 02/15/2001 Department of Veterans Affairs Medical Center, Philadelphia 02/16/2001 Florida Dept. of Health/FDCF 02/22/2001 Yale University 02/28/2001 Raritan Bay Medical Center 02/28/2001 Brown University Graduate School

Office for Human Research Protections (OHRP)

—————————————————————————- —-

Compliance Determination Letters March, 2001

03/26/2001 University of Southern California Health Sciences 03/272001 Indiana University 
03/28/2001 Department of Veterans Affairs Medical Center 03/28/2001 The University of Texas Southwestern Medical Center 03/29/2001 RAND 
03/29/2001 Garden State Cancer Center 
03/29/2001 St. Jude Children’s Research Hospital 
03/30/2001 St. Jude Children’s Research Hospital 
03/30/2001 University of Utah 
03/30/2001 University of Illinois at Chicago

Office for Human Research Protections (OHRP)

—————————————————————————- —-

Compliance Determination Letters April, 2001

04/13/2001 University of Texas – Houston Health Science Center 04/17/2001 Mary Bridge Children’s Hospital & Health Center 04/19/2001 University of South Florida 
04/20/2001 University of Washington 
04/23/2001 Wills Eye Hospital – Thomas Jefferson University 04/30/2001 University of Cincinnati, Department of Veterans Affairs Medical Center and Shriners Burns Institute 
04/30/2001 University of Cincinnati, Department of Veterans Affairs Medical Center and Shriners Burns Institute
04/30/2001 University of Cincinnati, Department of Veterans Affairs Medical Center and Shriners Burns Institute 
04/30/2001 NIH Cancer Therapy Evaluation Program – Eastern Cooperative Oncology Group

Compliance Determination Letters, May, 2001

05/03/2001 University of Colorado Health Sciences Center 05/07/2001 University of Pennsylvania 
05/10/2001 University of Missouri-Columbia 
05/29/2001 University of Colorado Health Sciences Center 05/31/2001 University of Texas M.D. Anderson Cancer Center 05/31/2001 Georgetoown University

Compliance Determination Letters, June, 2001

06/01/2001 Florida Department of Children and Families 06/01/2001 Michael Reese Hospital 
06/05/2001 Roswell Park Cancer Institute 
06/05/2001 Sturdy Memorial Hospital 
06/06/2001 University of Pennsylvania 
06/11/2001 Cleveland Clinic Foundation 
06/11/2001 Scientific Analysis Corporation 
06/11/2001 University of California, Irvine 
06/11/2001 University of Michigan 
06/14/2001 University of Arkansas for Medical Sciences & Arkansas Children’s Hospital

Compliance Determination Letters, July, 2001

07/11/2001 University of Missouri-Columbia
07/12/2001 University of Texas M.D. Anderson Cancer Center 07/12/2001 St. Elizabeth’s Medical Center of Boston 
07/13/2001 St. Jude Children’s Research Hospital 
07/19/2001 Johns Hopkins University School of Medicine and The Johns Hopkins Bayview Medical Center 
07/20/2001 University of South Florida 
07/22/2001 Johns Hopkins University School of Medicine and The Johns Hopkins Bayview Medical Center

Compliance Determination Letters, August, 2001

08/06/2001 Georgetown University
08/15/2001 Georgetown University 
08/15/2001 National Institutes of Health 
08/16/2001 University of Miami 
08/17/2001 Michael Reese Hospital 
08/17/2001 Rosewell Park Cancer Institute 
08/17/2001 University of California, Irvine 
08/17/2001 University of Michigan 
08/17/2001 University of Washington 
08/20/2001 University of Pennsylvania 
08/21/2001 University of Iowa 
08/21/2001 Okanagan Similkameen Health Region-Corporate 08/21/2001 South Georgia Medical Center 
08/22/2001 St. Jude Children’s Research Hospital 
08/22/2001 National Institutes of Health 
08/27/2001 University of California 
08/28/2001 The University of Texas Health Science Center at San Antonio 
08/29/2001 University of California, Davis 
08/29/2001 Minnesota Department of Health 
08/29/2001 State University of New York at Stony Brook 08/31/2001 Children’s Hospital Los Angeles

09/04/2001 Memorial Medical Center, New Orleans

SEPTEMBER, 2001 AUGUST, 2001

JULY, 2001 JUNE, 2001 MAY, 2001 APRIL, 2001 MARCH, 2001 FEBRUARY, 2001 JANUARY, 2001 DECEMBER, 2000 NOVEMBER, 2000 OCTOBER, 2000 SEPTEMBER, 2000 AUGUST, 2000 JULY, 2000