NIH NCRR GCRC Guidelines

The NIH NCRR Division of Clinical Research (DCR) provides a set of guidelines for GCRCs which describes the purpose, scope, and nature of each DCR program, including funding eligibility and application requirements and instructions. These guidelines along with more recent modifications can be found at the following NIH NCRR website:

http://www.ncrr.nih.gov/clinical/cr_gcrc.asp

HIPAA

The Health Insurance Portability and Accountability Act (HIPPA) is a new set of federal regulations that among other things covers the handling of so-called Protected Health Information (PHI), which is information about the health of individuals that includes information that allows them to be identified. The benefits of these regulations will be to better protect the privacy of health information and reduce or eliminate abuse. A set of Privacy standards went into effect on April 14th, 2003 and a set of Security standards roughly a year later. Significant penalties are identified for violations of the regulations.

The Dept of Health and Human Services (HHS) has information regarding HIPAA from the Centers for Medicare & Medicaid Services (CMS) and from the Office for Civil Rights (OCR).

The Privacy Rule was first published in the Federal Register, Dec 28, 2000. Final modifcations to the Privacy Rule werepublished in the Federal Register, Aug 14, 2002. Both versions of the Privacy Rule can be found on the CMS website at http://www.hhs.gov/ocr/hipaa/finalreg.htm or on the CMS website at http://www.cms.hhs.gov/hipaa/hipaa2/regulations/privacy/default.asp.

Text of the final rule adopting HIPAA standards for the security of electronic health information as published in the Federal Register Feb 20, 2003 can be found on the CMS website at http://www.cms.hhs.gov/hipaa/hipaa2/regulations/security/default.asp.

The Federal Register is a legal newspaper published every business day by the National Archives and Records Administration (NARA). It contains Federal agency regulations; proposed rules and notices; and Executive orders, proclamations and other Presidential documents. NARA's Office of the Federal Register prepares the Federal Register for publication in partnership with the Government Printing Office (GPO), which distributes it in paper, on microfiche and on the World Wide Web.

NYU has established policies for managing PHI in the research setting. To conduct research on the GCRC researchers must have completed an approved "HIPAA training course" and then follow the NYU policies and procedures for patient privacy protection. The Clinical Trials Development Office distributes the appropriate templates of forms that will be required for signature by the patients.

The NYU SOM has a Policy Statement regarding Privacy, Information Security and Confidentiality which can be found at http://www.med.nyu.edu/it/helpdesk_support/cps.html. Everyone musts sign the Policy Statement before they can have accounts set up and access granted to computer and/or network services.

The NYU Medical Center's Notice of Privacy Practices describes how medical information may be used and shared.

The GCRC Informatics Core manager can help with advice about the management of data collected in a study to avoid pitfalls that might lead to HIPAA violations. Going forward, researchers will have to be sensitive to data security, particularly in regard to data stored on desktops and on removable media.

Financial Support and Patient Care Categories
The GCRC Program sets guidelines to designate the extent of financial support for investigators conducting clinical studies on the GCRC. Using a negotiated inpatient and outpatient routine per diem rate, the GCRC pays Bellevue Hospital Center or NYU Hospitals Center for patient care services, such as room, board, and ancillary services. An inpatient admission includes room and board, routine nursing care and ancillary services. An outpatient visit includes the visit procedure charges and ancillary services. Ancillary services are those services routinely available through the hospital for all patients. This also includes services purchased from sources outside the hospital for reasons of economy or efficiency.

The availability of financial support is based upon the priority score and the patient care category assigned to each research study. The GCRC Advisory Committee determines a study's score and its category. The patient care categories at the NYU SOM GCRC are A, B, D and scatter. Category A studies are generally given higher priority, especially if NIH funded.

Category A includes patients who are enrolled in an investigator-initiated study. These studies are usually federally funded (i.e NIH) or funded by a foundation or the medical school department. Category A classification can be for inpatient stays, outpatient visits or both. Hospitalization costs for the research-related inpatient stay are the financial responsibility of the GCRC or the investigator. The outpatient research visit is paid for by the grant. The Center's ability to pay for ancillary services beyond the negotiated rate is determined by its current utilization and the yearly grant award.

Category B includes patients admitted for routine medical care who are simultaneously participating in a research study. The patients or their insurer are responsible for those costs unrelated to research patient care charges.

Category D includes patients who participate in an industry-initiated study. All charges are paid by the industry through the responsible GCRC investigator. The investigator is expected to pay for the use of the GCRC facilities and for ancillary charges.

Scatter-bed studies are those inpatient studies that require patients be cared for in off-site areas (away from the GCRC) because the study cannot be done on the GCRC. Prior approval from the NIH is required for scatter-bed status.

Scatter research nurse hours may be requested if a study requires a GCRC nurse to perform the research component of the study on a patient who is located off the GCRC units but within the hospital system. Assistance with these type of studies can only be granted after prior discussion with the Nurse Manager.