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Details

June 23, 2003 to June 24, 2003
Nashville, Tennessee

Sponsored by: National Institute on Drug Abuse

Meeting Summary

The Center on AIDS and Other Medical Consequences of Drug Abuse (CAMCODA) and Meharry Medical College co-sponsored and presented a meeting entitled: “Issues, Ethics, and You: A Community Discussion of HIV/AIDS and Substance Abuse, Research and Treatment”, Nashville, June 23-24, 2003. The objectives of the meeting were to discuss issues surrounding bioethics in HIV/AIDS among drug addicts with emphasis on minorities and underserved populations. Health care providers, scientists, clinicians, and field workers discussed a number of practical problems faced by the field workers. A field trip was organized by Meharry for bench scientists and other health scientists to see how community field workers [some were volunteers] in real world settings provide intervention/prevention messages to HIV-infected drug abusing poor people on the streets of Nashville. See below for a more detailed summary of the meeting.

Meharry Medical College Staff:  Linda D. Sander, Ph.D., Thomas Mether, Ph.D., Carolyn Szetela, Ph.D. and Susan DeRiemer, Ph.D.

Center on AIDS and Other Medical Consequences of Drug Abuse (CAMCODA), National Institute on Drug Abuse (NIDA)/NIH/DHHS Staff: Henry Francis, M.D., Jag H. Khalsa, Ph.D., Thomas Kresina, Ph.D.

Hosted by: 

The Program in Clinical and Research Ethics at Meharry Medical College, Academy for Educational Development, Alcohol and Drug Council of Middle Tennessee, First Response Wellness Center, IMANI Coalition, Metropolitan Health Department, Nashville CARES, National Minority AIDS Education and Training Center, Project COPE, Street Works, Vanderbilt University Medical Center HIV Vaccine Trials Unit, W.O.M.E.N.

The hosts (Meharry) and sponsor (CAMCODA/NIDA) developed and presented a highly interactive two-day colloquium addressing current ethical challenges and controversies in developing and maintaining government, academic, clinical, and community-based organization partnerships for addressing HIV/AIDS and substance abuse treatment and research. Minority community representatives, researchers, and government representatives, speakers and audience members confronted some of the ethical questions and regulatory issues that arise in the contemporary conduct of clinical research and treatment of HIV/AIDS and substance abuse.

The objectives of the conference were: 1) identify ethical challenges in developing and maintaining partnerships among government, academic, clinical and community-based organizations working on various aspects of HIV/AIDS and substance abuse; 2) identify ethical complexities facing a collaborative effort to address the issues of HIV/AIDS and substance abuse research and treatment; and 3) recognize regulatory and practical issues in the inclusion of minorities and underserved populations in HIV/AIDS and substance abuse research.

The approximately 150 participants included clinical researchers and members of clinical research teams, patient and human subjects advocates and community advisory board (CAB) members, clinicians not involved in research, mental health professionals, HIV/AIDS counselors, alcohol and drug abuse counselors, bioethicists, medical and graduate students, government officials (state and federal, public health and NIH), and staff and volunteers associated with community- and faith-based health service organizations.

The program included didactic presentations on rapid HIV testing kits, HIV vaccine trials, use of buprenorphine in a primary care setting and techniques for developing and maintaining working partnerships among seemingly unequal groups, i.e. community based organizations (CBOs), academic organizations and government funding bodies. These presentations formed the bases for interactive audience and panel discussions of case studies highlighting ethical issues related to rapid HIV testing in community settings and recruitment of minority participants for HIV vaccine trials and addiction studies. A roundtable discussion led by representatives of CAMCODA emphasized opportunities for research collaborations between community groups and NIDA. Additionally, participants were given the opportunity to accompany HIV outreach workers to provide a chance to compare real world conditions with those discussed in the conference sessions.

Invited speakers and conference participants highlighted the importance of:

  • Establishing relationships of trust between a community and academic research center before a community is approached for research participation;
  • Engaging the community of interest in all facets of research from protocol development to analyses of outcome rather than limiting their involvement to client recruitment, thus insuring informed consent by the community in addition to the individual;
  • Recognizing, rather than underestimating or minimizing, the distance from and, in some instances, hostility to medical research activities common in many minority communities;
  • Recognizing and developing means to deal with the conflicts within communities over ethical and stigma issues surrounding HIV/AIDS and substance abuse;
  • Recognizing the differences between the priorities of client-centered CBOs and the priorities of public health (whether Public Health Departments and/or CDC) on the relative importance of counseling in relation to some proposed rapid test protocols;
  • Acknowledging the significance of research findings on the ability of CBOs to serve their client populations successfully;
  • Developing and maintaining community, academic research centers, and government partnerships;
  • Recognizing when and how different groups may end up speaking at cross-purposes when trying to enter into dialogue with each other.
  • Understanding that the most important ethical component is not principles and case studies to guide decision-making and conduct of individuals in their separate walks of life but in the very creation and sustaining of community, researcher, and government partnerships and bonds of trust.

Recommendations

Conference participants had the following recommendations:

  • There is a need for more conferences like this one that bring together all stakeholders (community, researchers, clinicians and government) in order to build and nurture the partnerships needed to address the complex ethical, medical, and practical issues surrounding research, prevention and treatment of HIV/AIDS and substance abuse;
  • To enhance the usefulness of such conferences, relatively short presentations should be included to provide common background information to individuals representing very different professional backgrounds, e.g. information on addiction for HIV researchers, information on clinical research procedures for drug counselors, etc.
  • To ensure the “real-world” applicability of conference recommendations, mechanisms should be developed to allow the legally protected participation of clients (individuals with active substance use) in conferences designed to address these issues;
  • Introduction of all conference participants at the beginning, rather than at the end of the conference would serve to break down barriers existing between participants with different professional backgrounds;
  • Future conferences should address the special needs of children and adolescents, health insurance, mental health and homelessness, stigma, domestic violence and hepatitis C as they impact HIV/AIDS and substance abuse;
  • Plans for recruitment of substance users into clinical trials, such as the HIV Vaccine Phase III Trials, should accommodate the ethical issues which differ for both participants and treatment providers depending on the individual's stage of treatment or recovery;
  • More effort should be devoted to informing the general public, particularly within minority communities, of 1) the protections afforded to human subjects in research such as IRBs, data monitoring boards, patient advocates, 2) the avenues available for community involvement in research such as community advisory boards and community membership on IRBs and 3) the relationship between research and treatment;
  • Mechanisms should be developed to allow and ensure community input into identifying and defining federal funding priorities when addressing the social determinants of disease and health disparities;
  • Funding mechanisms need to be more community-friendly;
  • Additional funding needs to be identified for community-based and community-originated research into the social, ethical, and political determinants of health and health disparities particularly involving issues of stigma, HIV/AIDS and substance abuse.

Program Faculty

Kimberly NeCole Bartlett, LPC, Founder and Counselor, Focus Family Services
Sandra Baxter, Public Affairs Specialist, Food and Drug Administration, Nashville Branch, New Orleans District
Brad Beasley, M.S., Supervisor of STD and HIV Unit, Metro Public Health Department, Disease Intervention Specialist, Centers for Disease Control (CDC).
Regina Beck, community advocate working with the community outreach organization Street Works.
Vladimir Berthaud, M.D., Chief of Infectious Diseases, Metro-General Hospital and Associate Professor of Medicine, Meharry Medical College. 
LaTasha Blissett, LPC, Co-Founder and Counselor, Focus Family Services
Victoria A. Cargill, M.D., M.S.C.E., Director of Minority Research, Director of Clinical Studies, OAR, NIH 
Joan Clayton-Davis, M.A., Program Manager, Social Change Group, Center for Social Marketing and Behavior Change, Academy for Educational Development.
Robert Currie, M.S.S.W., Executive Vice President, Alcohol and Drug Council of Middle Tennessee.
Henry Francis, M.D., Director, Center for AIDS and the Medical Consequences of Drug Abuse (CAMCODA).
Jaqueline Hampton, Ph.D., First Response Center
Alberta Hardison, Chair, HIV Vaccine Community Advisory Board (CAB), Vanderbilt University Medical Center. 
David Harris, Education Coordinator, SABONA Program, Nashville CARES.
Victoria Harris, Ed.D, Manager of the Clinical Research AIDS Clinical Trial Center, Division of Infectious Diseases, Vanderbilt University Medical Center.
Thomas F. Kresina, Ph.D, Deputy Director of Center for AIDS and the Medical Consequences of Drug Abuse (CAMCODA).
James Lavery, Ph.D., NIH Bioethics Committee and Fogarty International Center, NIH.
Ciuinal Jones Lewis, M.S., Dir. Public Health & HIV Related Services, Cermak Health Services Cook County Jail
Melvin Littles, Outreach Counselor, St. Johns Hospital Park Care Pavilion
Patrick Luther, M.H.S., Director of Prevention Education, for Nashville CARES.
Shirley Marks, M.C.J, M.A.C. Director of Women’s Services, Health Services, Lloyd C. Elam Center, Meharry Medical College.
Susan Montgomery, R.N., Research Clinical Specialist with the Vanderbilt HIV Vaccine Program. 
James Robertson, M.S., Program Director, Project Community Outreach Prevention Education (Project COPE), Lloyd C. Elam Center, Meharry Medical College.
Orlando Roman, Research Recruiter, GI/Immunology Research Unit
Rev. Ed Sanders, Executive Director, First Response Center and appointed by President George W. Bush to the Advisory Council on HIV/AIDS. 
Murray Smith, M.D., Medical Director, New Life Lodge.
Catherine Wyatt-Morley, M.A., Director, Women On Maintaining Education and Nutrition (WOMEN).

Program in Clinical and Research Ethics at Meharry Medical College

Linda D. Sander, Ph.D., Director, Program in Clinical and Research Ethics, Meharry Medical College.
Thomas Mether, Ph.D., Bioethicist, Program in Clinical and Research Ethics, Meharry Medical College.
Carolyn T. Szetela, Ph.D., Bioethicist, Program in Clinical and Research Ethics, Meharry Medical College.
Susan A. DeRiemer, Ph.D., Program Associate, Deputy Director, Research Centers in Minority Institutions program at Meharry Medical College. 

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