VA administrators attempt to scuttle legislation to protect patients

VA administrators attempt to scuttle legislation to protect patients

Wed, 30 Apr 2003

The Alliance for Human Research Protection received the following confidential Veterans Affairs communication describing efforts by VA administrators to scuttle a congressional bill whose aim is to ensure that research conducted at VA facilities is overseen by an independent body such as the Office of Reseach Compliance and Assurance (ORCA). [See: http://www.ahrp.org/infomail/0403/10.php]

The legislation (HR 1585) introduced by Congressman Steve Buyer, Chair, Subcommittee on Oversight and Investigations, House Veterans Affairs Committee, states:

Section 1 (4) “The Director of the Office shall carry out the Following duties: (A) The conduct of periodic inspections and evaluations of research integrity at research facilities of the Department.”

The VA proposal to reorganize is not just a change of name–the VA proposal eliminates the pro-active approach–“periodic inspections”– which are a preventive measure to protect patients. Instead, the VA proposes to wait for allegations to be made before investigating. Such a post-mortem approach is wrong–especially in view of the widespread violations that have put patients’ lives at risk.

See: Death & Other Problems at Fargo VA Research Detroit http://www.ahrp.org/infomail/0403/21.php

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The following message was delivered over the Teleconference last Friday (4/25/03) to all central office and field healthcare officials in the Veterans Healthcare Administration (VHA):

Office of Human Research Oversight

The Secretary has approved the establishment of the Office of Human Research Oversight (OHRO).

This new office will be responsible for performing the oversight functions formerly performed by the Office of Research Compliance and Assurance (ORCA), which has been eliminated. It will investigate allegations of research misconduct and improprieties, develop event specific protocols as needed, and establish and implement procedures to report non-compliance with VA regulations and policies. In addition to staff in VA Central Office, OHRO will also operate five field based offices located at the former sites of the ORCA Regional Offices in Bedford, Massachusetts, Washington, D.C., Decatur, Georgia, Chicago, Illinois, and Moreno Valley, California.

Concurrently, the new Program for Research Integrity, Development and Education (PRIDE) has been established within the Office of Research and Development (ORD). PRIDE will have responsibility for the training, education, and policy development functions formerly accomplished by ORCA.

This new structure will enhance our ability to provide effective research oversight, while improving our ability to identify, communicate, and provide necessary training on complex issues in a timely and responsive manner. It will strengthen protection for our human research subjects, and the support and guidance we provide our research community.”

This ‘reorganization is effective immediately and Dr. David Weber has been approved as the Acting Chief Officer, OHRO. This new office, OHRO, re-constitutes ORCA under a different name with the same scope of responsibilities and size, without any responsibility for education. Further, under this re-organization, former ORCA staff with the exception of its chief, have been transferred to OHRO.