SMA Policy Committee: background readings
HIV Prevention Trials Network Ethical Guidance for Research (pdf)
In response to on-going questions and concerns raised by HPTN investigators and collaborators faced with shifting ethical guidance at national and international levels, the HPTN Executive Committee charged the Ethics Working Group with developing guidance for ethical decision-making and practice.
Freimuth et al., African Americans' views on research and the Tuskegee Syphilis study. Social Science & Medicine 2(5) March 2001, 797-808.
The participation of African Americans in clinical and public health research is essential. However, for a multitude of reasons, participation is low in many research studies. This article reviews the literature that substantiates barriers to participation and the legacy of past abuses of human subjects through research.
Can transnational reseach be ethical in the
developing world?
Paul Farmer (published in The
Lancet, Oct. 26, 2002 - also available as pdf)
Are institutional review boards, irrespective of their constitution, capable of monitoring research across such steep grades of inequality? Is truly ethical research possible in poor communities?
A
new look at international research ethics (BMJ editorial) (pdf)
Solomon R Benatar & Peter A Singer, British Medical Journal
2000;321:824-6
The normal "standard of care" against which new interventions are tested in medical research has not been formally defined. It is usually taken to mean the "best proved treatment" for any condition under investigation in a trial. We reject the arbitrariness of this notion of the standard of care and offer a more comprehensive alternative. Use of this new standard invokes a new approach to international research ethics that focuses on reducing inequalities in global health.
Researchers
Say They Have Little Input in Studies Sponsored by Drug Companies, Survey
Indicates
re-posted from the Kaiser Daily Health Policy Report, Oct. 24, 2002
Most research contracts between academic institutions and pharmaceutical companies that fund clinical trials do not follow guidelines issued last year to prevent bias and conflict of interest in published research...
Globalizing Clinical Research by Sonia Shah, the Nation, July 1, 2002
By the end of July a US district court will decide whether drug giant Pfizer should stand trial in the United States for presiding over a coercive, botched 1996 experiment on Nigerian children with meningitis. In a class-action suit filed last August, thirty Nigerian families say the company violated the Nuremberg Code by forcing an unapproved, risky experiment on unwitting subjects who suffered brain damage, loss of hearing, paralysis and death as a result.
The Globalization of Clinical Trials: A Growing Challenge in Protecting Human Subjects (OEi-01-00-00190; 09/01), Office of the Inspector General, U. S. Dept. of Health and Human Services
Summary: In conducting this inquiry, we analyzed two FDA databases: one of clinical investigators conducting drug research and one of clinical investigators conducting drug research who have been inspected by FDA.
Comments
on the Draft Health and Human Services Inspector General's Report: The Globalization
of Clinical Trials (OEI-01-00-00190)(HRG Publication #1591)
by Peter Lurie, MD, Deputy Director and Sidney M. Wolfe, MD, Director
Public Citizen's Health Research Group, July 5, 2001
While this report highlights the important issue of the increasing internationalization of medical research, it is lacking in three regards: 1. The report fails to draw adequately upon prior research in this area; 2. It fails to adequately emphasize the deficiencies of the data collected by the U.S. Food and Drug Administration (FDA); 3. The recommendations are too weak, even falling below those of the National Bioethics Advisory Commission (NBAC).
Department of Health, Education, and Welfare, Office of the Secretary: Protection of Human Subjects: Ethical Principles and Guidelines for the Protection of Human Subjects of Research.
A Cure for Clinical Trials by Janice Cruz Rowe, Martin E. Elling, Judith G. Hazlewood, and Randa Zakhary. The McKinsey Quarterly 2002:2.
Clinical trials are a vital step in bringing new drugs to market. But while pharmaceuticals companies pay close attention to the scientific side of designing their clinical trials, few consider how they will get enough patients to participate. As a result, most trials are plagued by delays that can cost pharma companies millions of dollars in missed sales. The take-away: To recruit enough patients, pharma companies must approach clinical trials as a marketing exercise. Bringing marketers into the process early will not only prevent costly delays but also enhance the trials' efficiency.
Bad Blood: the troubling legacy of the Tuskegee Syphilis Study
An important starting point for the renewal of dialogue about the Tuskegee Syphilis Study was the symposium "Doing Bad in the Name of Good?: The Tuskegee Syphilis Study and its Legacy" convened on Wednesday, February 23, 1994 at The Claude Moore Health Sciences Library. The five-hour symposium undertook to apply historical perspective on the Tuskegee Study to the current problems of cultural difference in perceptions of health care workers and the appropriate nexus of scientific research and human rights.
Costs
of Human Use Clinical Trials: Surprising Evidence from the US Orphan Drug
Act
James Love & Michael Palmedo, Consumer Project on Technology
According to the US Internal Revenue Service (IRS), US taxpayers received Orphan Drug Tax Credits totaling $80.1 million in fy 1998, and $61.4 million in fy 1997, the most recent years for which data are available. The credit represents half the costs of qualified clinical testing on all drugs which are considered orphans under FDA and IRS rules, including both successful and unsuccessful products under development.
IRBs
and Anthropological Reseach
Patricia A. Marshall, Case Western Reserve University, Anthropology
News, April 2003
Responsible
Research: A Systems Approach to Protecting Research Participants
(pdf)
from the Institute of Medicine, October 2002
The Tuskegee
Syphilis Study: A Hard Lesson Learned
from the CDC's National Center for HIV, STD and TB Prevention, includes
timeline
Office for Human Research Protections. Informed Consent Checklist – Basic and Additional Elements. January 2002.
Madison
Ave. Plays Growing Role in Drug Research
the New York Times, Nov. 22, 2002