6014.0: Thursday, November 16, 2000 - 9:10 AM

Abstract #10832

Incentives for research involving liver biopsy in HCV-infected injection drug users: ethical and practical considerations

Karen H. Seal, MD, MPH, Jennifer Lorvick, BA, Jeffry Moore, Robert Thawley, Jon Paul Hammond, BA, Donald Gann, BA, and Brian R. Edlin, MD. Urban Health Study, University of California, San Francisco, Box 1304, San Francisco, CA 94143-1304, (415) 502-1326, karene@itsa.ucsf.edu

Objective: To explore ethical and practical issues related to providing monetary incentives to a low-income, marginalized population for an invasive diagnostic procedure. The presentation will draw from our experience offering liver biopsies, with incentives, to injection drug users (IDUs) infected with hepatitis C virus (HCV).

IDUs are the population most affected by HCV infection. In many communities, over 90% of IDUs are HCV antibody-positive, yet studies regarding the natural history of HCV-related liver disease have not included active, street-recruited IDUs. In studies of non-IDUs, 80% of HCV-infected individuals develop chronic hepatitis and, of these, 20% progress to cirrhosis or hepatocellular carcinoma. Liver biopsy is considered the "gold standard" to assess liver disease progression and is important prognostically and in decision-making regarding treatment. The procedure is generally well-tolerated, but there is a risk of significant internal bleeding requiring transfusion or surgery (1/1000) and death (1/10,000).

In implementing one of the first HCV natural history studies among IDUs, we confronted the issues surrounding providing monetary incentives to compensate IDUs undergoing liver biopsy. We will discuss the controversies that arose in deciding to offer incentives for this invasive medical procedure. We will describe strategies developed by experienced HIV/hepatitis counselors to promote empowered decision-making by participants and mitigate the influences of incentives. Finally, we will present preliminary results from implementing these procedures with approximately 50 IDUs, discussing challenges, successes and participant responses.

Learning Objectives: Participants will: 1. Articulate the importance of liver biopsy as a diagnostic procedure for HCV-infected inviduals. 2. Assess the advantages and disadvantages of providing incentives to drug users who undergo liver biopsy. 3. Describe strategies to help patients balance incentives with sound decision-making about personal health issues

Keywords: Hepatitis C, Out-of-Treatment Drug Users

Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: None
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.

The 128th Annual Meeting of APHA