Thursday – September 27, 2008
Elephants in the Room: Ethics and Research in HIV and Substance Abuse
John Lacks, Ph.D.
Centennial Professor of Philosophy
Vanderbilt University
Nashville, TN
Scientific work on HIV/AIDS and drug addiction is significantly hampered by strong feelings concerning the subjects of the research and its ultimate beneficiaries. Many believe that alcoholism, drug addiction and exposure to HIV are self-caused by individuals of weak will or bad habits who therefore deserve their fates.
These impressions are not borne out by the facts and should, in any case, be challenged. Our common humanity does not permit us to ask questions about the merit of the starving prior to feeding them. Similarly, those afflicted with HIV/AIDS and drug addiction need cures and not an examination of their value systems.
HIV/AIDS in the 21st Century: Past, Present and Future
Richard D’Aquila, M.D
Director, Center for AIDS Research
Vanderbilt University Medical Center
Nashville, TN
PowerPoint© Slides
Substance Abuse in the 21st Century: Past, Present and Future
Samuel A. MacMaster, Ph.D.
University of Tennessee, College of Social Work (Nashville)
PowerPoint© Slides
Incentives for Research Participation
Financial Incentives: Too Much, Too Little, or Just Right?
Elizabeth Ripley, M.D.
IRB Vice Chairman
Virginia Commonwealth University
PowerPoint© Slides
Panel Moderator: Elizabeth Ripley, M.D.
Financial Incentives: Reimbursements or Enabling
Frances Clark, Ph.D.
Director of Behavioral Health Services
Metro Public Health Department, Nashville, TN
Medication and Treatment Incentives
Mark Hubbard
Chair, Tennessee Association of People With AIDS
Nashville, TN
High costs, limited access, and waiting lists for HIV treatment often make HIV treatment trials the only option for HIV positive individuals. In an overburdened system do these and other factors constitute undue incentive to participation?
Paying Substance Users
Kevin Irwin, Ph.D.
Research Coordinator, Center for Interdisciplinary Research on AIDS
Yale University
PowerPoint© Slides
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IRB Mission Creep: What is Effective, What is Not?
Joan Sieber, Ph.D.
Editor - Journal for Empirical Research in Human Research Ethics
California State University (Hayward)
PowerPoint© Slides
Gregory A. Miller, Ph.D.
Professor of Psychology, Beckman Institute
University of Illinois, Urbana-Champaign
PowerPoint© Slides
Research on HIV/AIDS, other STDs, and substance abuse, by its very nature, challenges our ability to be ethical and rigorous. If we seek a risk-free approach, and depend on our ability to imagine the risks of harm that could arise in proposed research, we will never tackle the important problems that need to be studied, but will focus on the safe and trivial studies that might be deemed non-risky. There are better ways to identify risk and keep subjects safe.
Mission Creep occurs when IRBs operate out of fear that they will overlook a risk. It occurs when IRBs:
- Fail to expedite or exempt research or related activities as permitted by federal regulations. Make these determinations with IRB meetings.
- Make top-down judgments about what risk subjects may take, rather than describing those risks clearly and objectively in the informed consent and letting subjects decide for themselves.
- Fail to understand that risk of harm = (degree of harm x probability of occurrence); do faulty estimation of degree of harm or probability of harm; fail to seek data on possible degree of harm and probability.
- Disallow research that would trouble some subjects, rather than identifying the small percentage of subjects who would be troubled and encouraging them not to participate.
- Assume risks that do not exist.
- Fail to encourage empirical research on the ethical issues about which they guess, based on anecdote and conjecture; fail to use extant empirical data.
Later in the program, Jim Dubois will talk about finding, collecting and using data to solve ethical problems. We are going to talk about the kinds of issues that lend themselves to evidence-based ethical problem solving.
We will discuss specific aspects of the research process that lend themselves to evidence based ethical problem solving: cultural appropriateness of the research approach to the subject population, risk assessment, providing benefits that really are benefits and incentives that really are effective incentives, recruitment methods, learning how to communicate clearly and appropriately in the informed consent process (even if your institution’s lawyers require 20 page consent forms written at the 16th grade level), privacy and confidentiality, compensation, safety of the researcher, and training your research assistants and outreach people.
We will introduce important studies and research tools and challenge the audience to identify the issues that investigators and IRBs argue about and define empirically answerable questions that would elucidate or solve the issue.
The Long Shadow of Stanley Milgram
Misperceived Risks vs Legitimate Concerns in Social-behavioral Research
Grant Benham, Ph.D.
IRB Chairman
University of Texas – Pan American
Researchers and professional organizations are becoming increasingly vociferous regarding issues of mission creep and the unnecessarily burdensome review of human subjects research by IRBs. Social-behavioral researchers are particularly critical of the way in which the federal regulations appear to hamper low-risk research.
While I would argue that there exist legitimate potential risks in social-behavioral research, the risks of psychological harm may be overestimated during IRB review resulting in restrictive human subjects protection practices. Using Milgram’s infamous studies on obedience as a foundation, I examine this issue. In doing so, I suggest that empirical data rather than personal belief should be used to guide effective IRB review and argue that both researchers and IRBs can play a part in developing this information.
Attitudes about HIV/AIDS: Variations in Ethical Beliefs and Practices
Frederick A. Ernst, Ph.D.
Assistant Dean for Graduate Studies and Research
University of Texas – Pan American
PowerPoint© Slides
Compassion may be the most powerful element of a care provider’s ability to help alleviate suffering. Underpinning the ethical standards of all helping professions is compassionate care unimpeded by bias or prejudice. Contemporary approaches to cultural competency in the provision of health care must transcend attention to race and gender and include any personal characteristic potentially incompatible with compassion. It will be argued, and perhaps demonstrated in this presentation that even the slightest bias can impair a provider’s ability to exercise skills in support of a person in need.
The audience will be introduced to the notion of dynamic survey research methodology and data interpretation after which findings will be presented concerning the evolution of attitudes about HIV-related issues amongst health care professionals and employees of mental health care facilities in Tennessee. Two areas of research will be addressed: 1) attitudes about male homosexuality and 2) trust of medical professionals by their patients. Our data reveal a significant change over a two decade period in attitudes expressed by survey respondents concerning homosexuality but little change in the levels of trust concerning information provided by medical professionals about contagiousness of HIV.
Demographic comparisons indicate significant influences of race, gender, religious preference, and, most notably, educational level on each of the two areas investigated. Implications of these findings will be discussed with an emphasis on ethical issues in the provision of effective medical care.
Friday – September 28, 2008
Challenges: Ethical Research in HIV/AIDS and Substance Abuse
Sten Vermund, M.D.
Director, Institute for Global Health
Vanderbilt University Medical Center
When the Levees Break: What happens to Black America
when the HIV/AIDS safety net fails
Phill Wilson
Executive Director
Black AIDS Institute, Los Angeles, CA
Evidence in Research Ethics: Finding, Collecting and Using Data
to Solve Ethical Problems
James DuBois, Ph.D.
Center for Health Care Ethics
St. Louis University
PowerPoint© Slides
Federal research regulations actually provide researchers and IRBs with more discretion than is commonly acknowledged or used. This enables researchers and IRBs to engage in ethical reflection as they design and review studies. The ultimate aim of such reflection should be to treat participants ethically while conducting good research, rather than merely complying with rules. However, empirical data are essential tools in answering numerous ethical questions that arise as we design and review research, particularly research with vulnerable populations.
This presentation will review recent empirical studies in the fields of substance abuse and HIV/AIDS research that assist us in answering important ethical questions like: What are the pros and cons of using financial incentives; what are participant preferences regarding the informed consent processes; what enhances participant understanding of information; can reasonable retention and compliance rates be achieved in substance abuse research; what benefits do participants seek when participating in research; what are the actual risks of participating in various kinds of clinical trials?
While many empirical studies are easily found in the ethics literature (in journals such as JERHRE or Ethics & Behavior), much of it is “hidden” and unfamiliar to IRB members. This presentation will conclude by providing tips on finding published studies and conducting empirical research on research ethics.
Conflict Resolution for IRB / Researcher Differences
Panel Moderator: Eugene Gallagher
Institutional Review Board
Vanderbilt Medical Center
Research and Active Substance Users: Can They Connect?
Kevin Irwin, Ph.D.
Research Coordinator, Center for Interdisciplinary Research on AIDS
Yale University
Mark Kinzly
Research Associate, Yale School of Public Health
New Haven, CT
In this session we review a number of scenarios that we have encountered in field research with people actively misusing substances. We draw from intervention and non-intervention studies to frame and engage with key ethical issues that have arisen during formative research, in the course of field investigations, and following the conclusion of projects.
We will discuss: opportunities for, and challenges of involving drug users in research design; strategies for addressing unforeseen ethical challenges that arise during research; researcher training and support; and critical community-level dynamics that may not be evident or adequately addressed in the context of institutionalized procedures.
Panel Moderator: Linda D. Sander, Ph.D.
The Urgency and Benefits of Involving the Black Church
James Hildreth, M.D., Ph.D.
Director, Center for AIDS Health Disparities Research
Meharry Medical College
Can ‘Real People” Benefit from HIV/AIDS and Substance Use Research?
Ron Crowder, Director
Street Works, Inc.
Nashville, TN
A Win-Win Game: Successes and Strategies of the CAB Model
Mark Hubbard
Chair, Tennessee Association of People With AIDS
Nashville, TN
The Adult Clinical Trials Group has one of the most integrated and open community involvement models in research. What fundamental principles are the keys to its success?
A 2-Way Street: Substance Users in Research
Mark Kinzly
Research Associate, Yale School of Public Health
New Haven, CT
Outcomes for the Real World
Patrick Luther, MHS
Education Director, Nashville CARES
Nashville, TN
Reaching us:
Program in Clinical and Research Ethics
Meharry Medical College
1005 Dr. D. B. Todd, Jr., Blvd.
Nashville, TN 37208
(P) 615-327-5909 & 615-327-6635
Fax: 615-327-6154
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