Law, Policy and Ethics Publications
Published by Yale University Center for Interdisciplinary Research on AIDS (CIRA), the views and perspectives expressed in these papers are those of the authors.
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Risk to Researchers? Safety issues and solutions for individuals involved in fieldwork and data collection (2009)
by Amy Smoyer, M.S.W., M.P.A.
While strong federal guidelines and institutional regulations exist to protect individuals who participate in medical and psychosocial research, very little oversight is provided to protect the people conducting the research from harm. Field work and data collection can carry substantial risk, and researchers are often unprepared to deal with these dangers.
This Policy Update reviews the existing literature on risk to researchers and suggests an agenda for future inquiry on this issue, especially as it relates to HIV care and prevention research.
Click here for the full update: Adobe Acrobat (.pdf)
Related Web sites:
The Chance For Us to Make That Change: How CIRA Science Can Support President Obama's Domestic HIV Agenda (2009)
by Amy Smoyer, M.S.W., M.P.A.
On the night of his election as the President of the United States of America, Barack Obama called on the people of the United States to join in his efforts to remake the country. It is in response to this collective call to action that the Yale Center for Interdisciplinary Research on AIDS (CIRA) has prepared this working paper in order to highlight key CIRA science findings that can inform Obama’s domestic HIV agenda.
Click here for the full update: Adobe Acrobat (.pdf)
American Indians/Alaska Natives & HIV/AIDS: An Annotated Bibliography (2008)
by Amy Smoyer, M.S.W., M.P.A.
There are over 4 million people in the US who identify as American Indian or Alaska Native (AI/AN), representing 1.5% of the population. In 2005, the CDC reported that 1,581 of these individuals were living with AIDS.
This annotated bibliography demonstrates several reasons why research about HIV prevention and care among AI/AN is important. Most obviously, this research provides information that can be used to design interventions to prevent transmission and improve care for AI/AN people living with the virus. Secondly, this literature offers a unique range of insight and knowledge that can inform HIV prevention and treatment work among other populations. Examples of these areas of expertise include trauma, prevention and treatment of alcohol abuse, and issues relating to cultural competence and community participation in research.
Building on the research presented in this annotated bibliography about HIV risk factors, prevention and treatment among AI/NA will serve to strengthen this population's defenses against the epidemic and inform strategies for other communities who face similar barriers to HIV prevention and care.
Click here for the full update: Adobe Acrobat (.pdf)
Compensation for Incarcerated Research Subjects: A State-by-State Analysis (2008)
by Amy Smoyer, M.S.W., M.P.A. and Brandis Belt, M.P.H.
This Policy Update focuses on the question of payment for individuals who volunteer to participate in behavioral or social research while incarcerated. Individuals who are living in the community are usually compensated for their time when they participate in behavioral research. Incarcerated subjects, however, are not always offered remuneration, as this state-by-state analysis reveals.
The policy update includes an historical overview of research with incarcerated subjects, a summary of state guidelines on compensation, and a discussion of the implications of this work with suggestions for future research.
Click here for the full update: Adobe Acrobat (.pdf)
Male Circumcision as HIV Prevention (2008)
by Amy Smoyer, M.S.W., M.P.A.
Male circumcision (MC) is a new and growing part of the HIV prevention landscape. Scientists should be familiar with the MC policy in the countries where they work in order to better understand the research environment. In addition, male circumcision policies, and the programs that they create, raise a broad range of research questions that could be explored to better understand the implications of this HIV prevention strategy.
This Policy Update offers a historical background on the prevalence and meaning of male circumcision, a summary of the current research relating to MC and HIV prevention and a discussion of emerging policy issues and national policy responses.
Click here for the full update: Adobe Acrobat (.pdf)
Related Article:
Can Microenterprise Programs Reduce HIV Risk in the United States? (2007)
by Amy Smoyer, M.S.W., M.P.A. and Helen Rose Patterson
Microenterprise is one of a collection of microfinance programs designed to alleviate poverty by helping low-income individuals acquire assets and achieve financial independence. Originally an economic development tool in the developing world, especially for women, these initiatives have become increasingly prevalent domestically. However, the performance of microenterprise programs in the United States is mixed. Evaluations find that these programs do not usually lift participants out of poverty, but they can offer a degree of financial independence and psycho-social benefits.
This policy update describes microenterprise programs, summarizes existing research on the subject, and explores the possibility that given both their economic benefits, however marginal, and their non-economic benefits, these programs may be an important structural intervention for reducing HIV risk among very low income, marginalized individuals in the United States.
Click here for the full update: Adobe Acrobat (.pdf)
Related Web sites:
- The Grameen Bank in Bangladesh, founded by economist Muhammad Yunus in 1976, is perhaps the most famous example of microfinance. Grameen has loaned more than 5 billion dollars since its inception, with a recovery rate of 98.82%. Ninety-seven (97%) of the borrowers are women. To learn more about this project, go to: www.grameen-info.org
- To learn more about microfinance in the United States and see examples of this type of work, visit:
Related article:
Can Microfinance Programs Reduce HIV Risk in Developing Countries? (2007)
Prepared by Sarah Hanck, Brooke West & Sharon Tsui, Project Parivartan and the Law, Policy and Ethics Core, Center for Interdisciplinary Research on AIDS, Yale University
This Policy Update defines microfinance and offers a history of these programs in developing countries, including the types of providers that manage them, different models of microfinance, and the programs' successes and challenges. The paper also describes the ways in which microfinance has served as a tool for HIV prevention in these settings.
Click here for the full update: Adobe Acrobat (.pdf)
Sixteen Year Old Adults: The Experiences of CT Teenagers in Adult Prison (2007)
by Kim Blankenship, Ph.D. and Amy Smoyer, M.S.W., M.P.A.
In the 2007 legislative session, Connecticut lawmakers passed a bill that will raise the age at which juveniles can be charged as adults from 16 to 18 years old. The bill will become law in January 2010. CT is one of three states in the US that considers people over 15 to be adults in the criminal justice system and the state leads the nation in the number of youth under 18 incarcerated as adults: 383 in 2005. Based on her research about the criminal justice system (Project SHARPP), Dr. Kim M. Blankenship worked with CIRA's Law, Policy and Ethics (LPE) Core to produce this brief document about the experiences of SHARPP participants who were incarcerated as adults while under the age of 18.
Click here for the full update: Adobe Acrobat (.pdf)
Related Web sites:
Understanding and Implementing the New National Institute on Drug Abuse (NIDA) Policy:
"HIV Education, Counseling, Testing, and Treatment for Research Subjects" (2007)
by Amy Smoyer, M.S.W., M.P.A.
In February 2007, the National Institute on Drug Abuse (NIDA) issued a revised policy on researcher's responsibilities to provide HIV education, counseling, testing, and treatment to research subjects. This CIRA Policy Update summarizes the new NIDA policy and suggests ways in which CIRA scientists might comply with these recommendations.
Click here for the full update: Adobe Acrobat (.pdf)
Related Web sites:
This NIDA policy is available on their Web site at http://grants1.nih.gov/grants/guide/notice-files/NOT-DA-07-013.html
Understanding the Utility of Certificates of Confidentiality in HIV Research (2007)
by Amy Smoyer, M.S.W., M.P.A.
The Certificate of Confidentiality (CoC) is a legal document issued by the National Institutes of Health (NIH) to protect scientists against involuntary disclosure of sensitive research data. Initiated in the 1970s, primarily to guard data collected in research about illicit drug use and mental health, the CoC's scope was expanded in 1988 to include a wide range of health issues. The CoC can play a critical role in facilitating HIV/AIDS research that solicits intimate details about subjects' HIV status, sexual behaviors and/or illegal activities, including drug use, by strengthening the protocol's assurances of confidentiality and subsequently boosting participants' willingness to share information.
This Policy Update reviews the current literature on CoCs and explores the exceptions to CoC protections, in addition to other issues that are important for researchers to consider when utilizing this document.
Click here for the full update: Adobe Acrobat (.pdf)
Related Web sites:
Institutional Review Boards in Developing Countries: Challenges and Opportunities in the Protection of Human Subjects (2006)
by Amy Smoyer, M.S.W., M.P.A. and Kaveh Khoshnood, Ph.D.
All scientific research involving human subjects that is funded by the United States government must be reviewed and approved by at least one federally-approved Institutional Review Board (IRB). Protocol for research that will be conducted outside of the United States by U.S. investigators must be approved by an IRB that is located in the country where the research will take place (the host country) and the IRB at the investigators U.S. institution. This policy update explores the existing literature about IRBs in developing nations, where the differences between the resources and culture of the host country and the U.S. are particularly acute, in order to understand the issues that these IRBs face and suggest an agenda for future research to better understand, and possibly improve, these critical systems.
Click here for the full update: Adobe Acrobat (.pdf)
The Effectiveness of Abstinence-Only Sex Education: A Review of the Evidence (2006)
by Amy Smoyer, M.S.W., M.P.A. and Kim M. Blankenship, Ph.D.
HIV and AIDS have added a new sense of urgency to what has always been a controversial topic in the United States: how best to educate adolescents about sex in order to prevent unplanned pregnancies and sexually transmitted infection. In the last decade, abstinence-only programs have received unprecedented federal support and have come to the forefront of discussions about sex education. This policy update reviews and analyzes the scientific research of abstinence-only sex education programs in school settings in the United States.
Click here for the full update: Adobe Acrobat (.pdf)
Related Web sites:
- A government-funded multi-year evaluation of abstinence education programs was released in May 2007. The evaluation found that the programs had no effect on the sexual abstinence of youth. It also found that youth in these programs were no more likely to have unprotected sex, a concern that has been raised by some critics of these programs. Click here to read more about this report.
- Emerging Answers 2007
Report about programs that work in preventing teen pregnancy and sexually transmitted diseases, including HIV, published by the National Campaign to Prevent Teen and Unplanned Pregnancy.
- No More Money
A coalition of organizations advocating for no more funding of abstinence-only until marriage programs. Site includes information about the abstinence only legislation, programs and evaluations.
Drug Policy and HIV Prevention in Russia: The Case of HIV/AIDS Prevention (2005)
by Kevin Irwin, MA, Robert Heimer, Ph.D. and Amy Smoyer, M.S.W., M.P.A.
In October 2004, CIRA convened a two-day conference to discuss the impact of drug policy on HIV prevention in Russia. The conference brought together experts in law, human rights, drug use and community research, harm reduction and biomedicine who have an abiding interest and experience in the Russian Federation. Conference participants came from the United States, Europe, and the Russian Federation. This conference report summarizes the major points of discussion and the recommendations that emerged from the event.
Click here for the full report: Microsoft Word (.doc)
Related Web sites:
Drug Policy: Definition, Discussion & State Variation (2004)
by Kim M. Blankenship, Ph.D. and Amy Smoyer, M.S.W., M.P.A.
Laws that criminalize the use of drugs and create sentencing guidelines for drug-related offenses determine what drug-related activities are prohibited and how long, and under what conditions, convicted offenders will be removed from their families and communities. As such, they have considerable potential to impact the health of individuals, families, communities and societies. HIV is one health outcome likely to be impacted by drug policy, both directly and indirectly.
This paper defines and discusses twelve different drug policies, and describes the variation that exists between states.
Click here for the full report: Adobe Acrobat (.pdf)
Related Web sites:
Public Health, Research, and Law Enforcement: The Case of HIV/AIDS Prevention (2004)
by Kim M. Blankenship, Ph.D. and Amy Smoyer, M.S.W., M.P.A.
In November 2003, CIRA convened a one-day conference to bring together public health researchers, criminal justice experts, and police professionals. The purpose of the meeting was to strategize about ways to increase the amount and effectiveness of research and interventions aimed at understanding (and possibly modifying) how police and other law enforcers behave towards legally marginalized populations. In particular, the event focused on HIV related health and behaviors, and on groups particularly vulnerable to HIV (especially IDUs and sex workers). This conference report summarizes the major points of discussion and the recommendations that emerged from the event.
Click here for the full report: Adobe Acrobat (.pdf)
Related Web sites:
- The Consensus Project is a national effort to help policymakers and criminal justice and mental health professionals improve the response to people with mental illness who become involved in, or are at risk of involvement in, the criminal justice system.
Patient Delivered Partner Treatment For Sexually Transmitted Disease: A Policy Approach to HIV Prevention? (2004)
by Amy Smoyer, M.S.W., M.P.A. and Linda Niccolai, Ph.D.
Patient delivered partner treatment (PDPT) is the practice of prescribing extra antibiotic drugs to patients with sexually transmitted diseases (STDs) to give to their sex partners who might not otherwise be treated. Studies have shown PDPT to be effective in preventing re-infections in the original patient. In the case of chlamydia, preventing re-infection can also mean preventing HIV transmission. One study found that women with chlamydia have a three to five fold increased risk of acquiring HIV, if exposed.
The use of PDPT, however, is not widespread. Low utilization of this treatment strategy may result, in part, from uncertainty about the legality of PDPT. In this paper, we discuss chlamydia and PDPT, and their relationships to HIV prevention, review legislative developments regarding PDPT, and suggest a research agenda.
Click here for the full report: Adobe Acrobat (.pdf)
Related Web sites:
Research Priorities on Children Orphaned and Made Vulnerable by HIV/AIDS (2004)
by Anna R. Dolinsky, B.A., Kim M. Blankenship, Ph.D., and Shelley Geballe, J.D., M.P.H.
On January 29, 2004, CIRA scientists and UNICEF representatives met to appraise the current state of research on children orphaned and made vulnerable (OVC) by AIDS. This meeting comes at a crucial point in the international effort against HIV/AIDS. The epidemic is ravaging the African continent and is emerging in most developing countries around the world. Over 70% of all children orphaned by AIDS are living in sub-Saharan Africa. Although estimates are hard to obtain, the numbers of vulnerable children in India, China, and Russia are rising rapidly.
Six research priorities were identified across all areas of care and support for orphaned and vulnerable children (OVC). They include:
- Implications of the 3 by 5 Initiative and the Mother-to-Child-Transmission (MTCT) prevention programs for OVCs and families.
- Variations in developmental experience and needs of children orphaned at different ages.
- Nature of the growing HIV/AIDS epidemic outside sub-Saharan Africa.
- Definitions of vulnerability.
- Analysis of national policies relating to children affected by AIDS.
- Assessment of the HIV-related risks of OVCs.
Click here for the full report: Adobe Acrobat (.pdf)
Related Web sites:
Access to Essential Medicines and University Research: Building Best Practices (2003)
by Amy Kapczynski, M.A., M.Phil., J.D.
In September 2002, CIRA hosted a conference to discuss what universities as intellectual property holders can do to promote access to essential medicines and medical technologies in developing countries. This report summarizes several key points that emerged from this discussion.
Click here for the full report: Adobe Acrobat (.pdf)
Ms. Kapczynski co-authored an editorial on this subject that was published in the September 19, 2003, issue of Science. The editorial was reprinted in the Autumn 2003 edition of CIRA notes (page 1): "Global Health and University Patents."
Related Web sites:
Criminal Prosecutions for HIV Exposure: Overview and Analysis (2003)
by Sarah J. Bray, J.D.
There is considerable debate over whether laws that criminalize conduct that exposes others to HIV, or causes the transmission of HIV, are useful interventions in preventing the spread of HIV, or if this criminalization actually increases rates of HIV transmission by discouraging testing and diverting funds from HIV prevention efforts. This paper analyzes a sample of 316 criminal prosecutions for HIV exposure in the United States and concludes that this type of prosecution is not likely to serve the public health purpose of reducing HIV transmission from those who know they are infected.
Click here for the full report: Adobe Acrobat (.pdf)
Related Web sites:
Sustainable Care and Support for Children Orphaned and Made Vulnerable by HIV/AIDS (2003)
by Anna R. Dolinsky, B.A., Shalini Kapoor, M.P.H., and Kim M. Blankenship, Ph.D.
On May 5, 2003, CIRA sponsored a mini-conference on issues facing children affected by AIDS. This meeting among academics, service providers and donors was meant to further discussion on strategic interventions, identify research gaps, and explore options for future collaboration. The conference focused on Africa, where AIDS has orphaned 11 million children. Support for families and communities was identified as the key in the healthy development and well-being all vulnerable children.
As the prevalence of HIV/AIDS in resource-poor settings rises, traditional safety nets for children (such as and extended family and foster care) are compromised. Research and interventions must be directed at helping communities identify the most vulnerable children and caregivers, and mobilizing and channeling sustainable funding. The impact of treatment, prevention and care interventions must be assessed in order to provide the most appropriate support for children, families and communities. Conference participants discussed ethical and practical issues of child participation in research and programming; dissemination of findings to benefit vulnerable communities; and context-specific and culturally appropriate interventions.
Click here for the full report: Adobe Acrobat (.pdf)
Related Web sites:
Microbicides: Worthy of More Attention (2001)
by Laurie Sylla, BSW, MHSA
Microbicides are chemical substances that would interfere with transmission of sexually transmitted diseases, including HIV. They are especially important for providing options to women and men who are unable to insist that their sexual partners use condoms. Fifty-nine microbicidal products are in various stages of pre-clinical development and clinical research, but there are no such products approved for use and available on the market. This update describes the need and potential role of microbicides and funding issues related to their development.
Click here for the full report: Adobe Acrobat (.pdf)
Read about CIRA-affiliated research on this subject in the Autumn 2003 edition of CIRA notes (page 7): "Acceptability of Microbicides for HIV Prevention in High-risk Women: Project Protect."
Related Web sites:
Innovations in Substance Abuse Treatment and Policy: Conference Findings and Future Directions (2001)
by Sarah J. Bray, J.D., Kim M. Blankenship, Ph.D., and Joan Altman, B.A.
From the perspective of HIV prevention, drug treatment is a promising point of focus. In June 2000, CIRA's Law, Policy, and Ethics Core co-sponsored, with the Connecticut State Department of Mental Health and Addiction Services (DMHAS), a conference entitled "Recent Innovations in Substance Abuse Treatment: Implications for Connecticut and Beyond." The conference addressed four subjects: pharmacological innovations in substance abuse treatment, innovations in treatment delivery, diversionary programs, and integrative approaches that address not only substance abuse but also problems such as homelessness and mental illness. In addition, commissioners from DMHAS, the Department of Public Health, the Department of Children and Families, the Department of Correction, the Department of Social Services, and the Chief Court Administrator, discussed paradigmatic, economic, attitudinal, and political barriers to implementing innovative substance abuse policies and programs. The conferences proceedings are summarized in this update and important developments in substance abuse treatment policy that occurred in the months after the conference, most notably in the realm of alternatives to incarceration, are included.
Click here for the full report: Microsoft Word (.doc)
Related Web sites:
Expanding Public Capacity for Substance Abuse Treatment (2000)
by Mira Johri, Ph.D., M.P.H and Edward H. Kaplan, Ph.D.
This update examines the substance abuse policy know as "Treatment on Demand" which aims to offer all those seeking publicly funded substance abuse treatment immediate entry into a program. San Francisco's implementation of this policy is examined in an attempt to answer the critical question, "Is 'treatment on demand' a sound social investment, or an unattainable goal?" In spite of budgetary increases in San Francisco, and the creation of hundreds of new treatment slots, there are still hundreds of individuals waiting for treatment. Treatment "on demand" has proven surprisingly difficult to achieve, raising doubts as to the success and sustainability of this policy. The authors' model-based analysis points to the need for a clearer articulation of the aims of the policy, but support its general claim to be of economic and social benefit.
Click here for the full report: Microsoft Word (.doc)
Related Articles:
Related Web sites:
Community Input on HIV/AIDS Research Priorities and Collaboration: A Report on the CIRA Community Advisory Committee Focus Group Initiative (1999)
This report summarizes the results of a series of community focus groups conducted in March and April 1999 by the Community Advisory Committee of the Center for Interdisciplinary Research on AIDS (CIRA) at Yale University. The groups were convened to gather input from community-based organizations, AIDS service organizations, and people infected and affected by HIV/AIDS throughout the state of Connecticut, in an effort to identify HIV/AIDS research priorities, and to expand opportunities for community collaboration with CIRA researchers. This initiative was intended to be a first step in an ongoing effort by CIRA to identify and respond to the community's needs in the area of HIV/AIDS prevention research.
Click here for the full report: Microsoft Word (.doc)
Related Web sites:
New Approaches to HIV Surveillance: Means and Ends.
A Summary Report of the Law, Policy and Ethics Conference on HIV Surveillance May 21st and 22nd 1998 (1999)
by Mira Johri, Edward H. Kaplan, Jeffrey Levi and Alvin Novick
The objective of the "New Approaches to HIV Surveillance: Means and Ends" conference was to provide a forum for professionals and stakeholders to step back from the existing debate and to engage in open discussion of how our HIV surveillance system might optimally be restructured. This paper summarizes the conference proceeding including a detailed discussion of three different types of surveillance: surveillance based on named reporting, surveillance based on unique identifiers, and statistical estimation as a means of surveillance.
Click here for the full report: Microsoft Word (.doc)
Related Web sites:
Would Difficult to Reuse Needles Reduce the Spread of HIV? (1998)
by Edward H. Kaplan, Ph.D.
To prevent the transmission of HIV among injecting drug users (IDUs), some have suggested an "engineering" response via the design of single use, or more generally difficult-to-reuse (DTR), syringes. Lowering the number of times a particular needle can be reused will indeed lower the probability of that particular needle becoming infectious. However, the author creates a mathematical model which demonstrates that introducing DTRs into a population of needles could change HIV risks, and not necessarily for the better.
Click here for the full report: Microsoft Word (.doc)
Related Articles:
- Caulkins, J.P., Kaplan, E.H., Lurie, P., O'Connor, T., and Ahn, S-H. (1998) Can difficult-to-reuse syringes reduce the spread of HIV among injection drug users? Interfaces, 28, (3) 23-33.
Related Web sites:
Blood Safety in the Age of AIDS (1998)
by Eric A. Feldman, J.D., Ph.D. and Ronald Bayer
This paper traces the history of blood safety in the United States, focusing on the transmission of HIV through blood and blood products, which was a defining event. The authors discuss how threats to blood safety have been managed and summarize the issues relating to maintaining supply in a market based on voluntarism. Safety issues concerning the ideology of national self-sufficiency and justice and compensation for the victims of blood-borne pathogens are also reviewed. The authors maintain that this story of blood in the age of AIDS must be borne in mind as communities think about the demands that securing a safer blood supply should impose upon us and about the limits of public policy in securing that safety.
Click here for the full working paper: Microsoft Word (.doc)
Related Web sites:
HIV Case Reporting (1998)
by Alvin Novick, M.D.
Novick outlines the arguments for and against HIV case reporting. He concludes that he would support HIV case reporting if anonymous testing were widely available, records were held confidential and lists were encoded, and programs of linkage to health care and to prevention and other resources were implemented before or along with HIV case reporting.
Click here for the full update: Microsoft Word (.doc)
Related CIRA Conference:
Related Web sites:
Testing the Force: HIV and Discrimination in the Australian Military (1998)
by Eric A. Feldman, J.D., Ph.D.
Should the military require all service members to be tested for HIV? If so, should those who test positive be permitted to serve? In answering these questions, different nations have crafted diverse policies, responsive to domestic political pressures, legal precedents, and regulatory regimes. This article examines the controversy over HIV and the military in the US and other nations, focusing on Australia, which has been the site of a particularly bitter and prolonged debate over HIV and the military.
Click here for the full update: Microsoft Word (.doc)
Related CIRA Conference:
Related Web sites:
Was Israel's Ethiopian Blood Ban Justified? (1998)
by Edward Kaplan, Ph.D.
In 1996, it was revealed that blood donations from Ethiopian immigrants in Israel were discarded, without informing the donors, due to the high level of HIV infection in this community relative to other Israelis. This news prompted a violent protest by 10,000 Ethiopian immigrants that led to injuries in roughly 70 demonstrators and police officers. While Blood Bank officials defended the action as a public health measure, critics called the move "irregular, unethical and unfair." The author suggests that the answer to this debate depends upon whether the number of infectious donations (resulting from false negatives in the screening process) prevented by excluding Ethiopian donors was sufficiently large to justify the action. A mathematical model, which estimates how many infections may have been averted, suggests that Israeli society may not have been well served via the exclusion of Ethiopian donors.
Click here for the full update: Microsoft Word (.doc)
Related Articles:
- Kaplan, E.H. (1998). Israel's ban on use of Ethiopians' blood: How many infectious donations were prevented? The Lancet, 351, (9109), 1127-1128.
- Kaplan, E. H., Soskolne, V., Adler, B., Leventhal, A., Shtarkshall, R.A. (2002). A model-based evaluation of a cultural mediator outreach program for HIV+ Ethiopian Immigrants in Isreal. Evaluation Review, 26, (4), 382-394
Related Web sites:
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