Minority Health and Health Equity Archive
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Welcome to the Minority Health and Health Equity Archive (MHHEA), an electronic archive for digital resource materials in the fields of minority health and health disparities research and policy. It is offered as a no-charge resource to the public, academic scholars and health science researchers interested in the elimination of racial and ethnic health disparities.
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Item Human Challenge Studies to Accelerate Coronavirus Vaccine Licensure(Journal of Infectious Diseases, 2020-06-01) Eyal, Nir; Lipsitch, Marc; Smith, PeterControlled human challenge trials of SARS-CoV-2 vaccine candidates could accelerate the testing and potential rollout of efficacious vaccines. By replacing conventional phase 3 testing of vaccine candidates, such trials may subtract many months from the licensure process, making efficacious vaccines available more quickly. Obviously, challenging volunteers with this live virus risks inducing severe disease and possibly even death. However, we argue that such studies, by accelerating vaccine evaluation, could reduce the global burden of coronavirus-related mortality and morbidity. Volunteers in such studies could autonomously authorize the risks to themselves, and their net risk could be acceptable if participants comprise healthy young adults, who are at relatively low risk of serious disease following natural infection, if they have a high baseline risk of natural infection, and if during the trial they receive frequent monitoring and, following any infection, the best available care. [ABSTRACT FROM AUTHOR]Item Eighty Years of Bad Blood: The Evolution of Human Research after the Tuskegee Study(2012) Cook, Brett D.; Jackson, Tahmika RuthThe year 2012 marks the eightieth anniversary of the beginning of the U.S. Public Health Service’s (PHS) study on the effects of untreated syphilis in Tuskegee, AL, which lasted from 1932 to 1972. The research continued after penicillin became widely available and was known to be an effective treatment for syphilis. To justify the experiments, the PHS argued that the study was a never-to-be-repeated opportunity. Did the U.S. government continue to take advantage of never-to-be-repeated opportunities in medical research by using unethical justifications? This manuscript will explore how America’s growing understanding of human research and the rights of human subjects have mirrored the growth of regulatory law and jurisprudence since the Tuskegee Study. We will examine PHS human research experiments in Guatemala from 1946 to 1948, as well as the U.S. Department of Justice’s decision not to prosecute members of the Japanese Army despite having received information on human experiments they conducted on World War II Prisoners of War (POWs). We recognize that numerous events have contributed to current human research practices and it would be impossible to discuss every significant topic. We submit that society’s ethical considerations regarding human research have progressed over the past eighty years. In this article we concentrate on the growing protections of the right to informed consent. We contend that constant and consistent oversight by the three branches of U.S. government is necessary to ensure human rights protection of those classes least able to protect themselves and prevent another Tuskegee Study.Item Misinformation and misbeliefs in the Tuskegee Study of Untreated Syphilis fuel mistrust in the healthcare system.(2005) White, Robert MThe Tuskegee Study of Untreated Syphilis (TSUS) is an important issue in research, healthcare, ethics and race relations. The assumed consequences of knowledge of this study on the African-American community include mistrust of the healthcare system. In the July 2005 issue of the Journal of the National Medical Association, Brandon, Isaac and LaVeist (the authors), who were at the Center for Health Disparities Solutions, Johns Hopkins Bloomberg School of Public Health, reported the results of black-white differences in awareness of and knowledge about the TSUS and the effect of that awareness and knowledge on medical mistrust. The study surveyed blacks, whites and others in the Baltimore, MD community about their knowledge of and attitudes about the TSUS. The respondents who were aware of the TSUS were asked survey items to assess specific factual information about the TSUS. The respondents who were not aware of the TSUS were read a brief description of the TSUS taken from the CDC website. Both groups were asked if a similar study was possible today. The authors performed a regression analysis of mistrust of medical care based on race, knowledge of the TSUS and demographic variables. The editorial identified and explained challenges in the article, i.e., challenges in calculations, demographic analysis by race, knowledge of TSUS, cultural sensitivity and methodology. The authors miscalculated the "similar proportions" of blacks and whites who were aware of the TSUS; the recalculated proportions, favoring whites, were different than reported by others. There was no demographic analysis by race in their article--also different than other published reports. Most respondents--blacks and whites--who were aware of the TSUS at baseline answered incorrectly the author-selected questions about the TSUS, particularly the fact-based question of whether the TSUS researchers gave syphilis to the men-not dissimilar to one other report. The source for TSUS information (the CDC website) that was used to educate respondents who were not aware of the TSUS at baseline had contradictions, errors and challenges in black history, medical and public health history, and women's studies. The content of what was actually read to respondents was unknown. Proportionally more whites who were not aware of the TSUS but who were read author-selected information about the TSUS believed that a similar study could happen today-a belief and possibly mistrust of medical care that appeared to be induced-compared to whites with prestudy awareness of the TSUS but not read information from the CDC website. Both black groups were not dissimilar from each other. The authors used a survey that measured a race difference in response to a medical event (TSUS) specific to only one racial group (blacks) when there were inclusive examples specific to other groups available. The authors used "Tuskegee" as a single-word sound bite for the TSUS--a misuse that was inappropriate in scientific and research discourse and that may fuel mistrust of medical care. Whether knowledge of the TSUS was a predictor of mistrust of the healthcare system was inconclusive based on the results in the authors' article. The core findings of the article made believing their case difficult. The editorial suggested that bias and misinformation in undertaking, analysis and reporting the study may in itself fuel mistrust in medical care in the community. Because of these challenges, the editorial urged caution with regard to any change in research direction or policy debate based on the results reported in the article.Item Information on Protection of Human Subjects in Research Funded or Regulated by U.S. GovernmentU.S. Department of Health and, Human ServicesToday, a researcher who is compliant with current Federal regulations would not be able to conduct a study, domestically or in another country, with the ethical violations present in the Sexually Transmitted Disease (STD) Inoculation Study. The history of biomedical research in the U.S., 1940-1970’s: There was tremendous growth in research around World War II. Human subjects research entered what some scholars have described as an “unashamedly utilitarian phase.” Subjects were often institutionalized individuals who were not always fully informed of the risks of the study or asked for consent. Infectious disease research, particularly venereal diseases, was a focus of the U.S. government because of the toll diseases like syphilis and gonorrhea were taking on the armed services. One method for studying infectious disease was by intentionally infecting subjects with the disease-causing pathogen. Prisoners were commonly used because they were easily monitored in a highly controlled environment. Dr. Cutler was a researcher on two such studies: infection of prisoners with gonorrhea at the United States Penitentiary at Terre Haute (1943) and with syphilis at Sing Sing Correctional Facility (1953).Item Intentional Infection of Vulnerable Populations in 1946-1948(2010) Frieden, Thomas R.; Collins, Francis S.Unethical uses of humans as research subjects represent appalling chapters in the history of medicine. 1 To ensure that effective protections against such abuses continue to evolve and improve, it is essential to continue to learn from historical examples. Sadly, a new example has recently come to light. While conducting research on the Tuskegee study of untreated syphilis, 2 Wellesley College Professor Susan Reverby recently reviewed the archived papers of John Cutler, a US Public Health Service (PHS) medical officer and a Tuskegee investigator. Instead of finding Tuskegee records, however, Reverby found the records of another unethical study. In this study, vulnerable populations in Guatemala—mentally incapacitated patients, prison inmates, sex workers, and soldiers—were intentionally exposed to sexually transmitted infections (syphilis, gonorrhea, and chancroid). The work was directed by Cutler and was done with the knowledge of his superiors, including then Surgeon General Thomas Parran Jr. Funded with a grant fromItem Records of Dr. John C. Cutler(2011) Cutler, John C.(From National Archives Press Release) From 1946-48, the U.S. Public Health Service (USPHS) Venereal Disease Research Laboratory (VDRL) and the Pan American Sanitary Bureau collaborated with several government agencies in Guatemala on U.S. National Institutes of Health-funded studies involving deliberate exposure of human subjects with bacteria that cause sexually transmitted diseases (STD). Guatemalan partners included the Guatemalan Ministry of Health, the National Army of the Revolution, the National Mental Health Hospital, and the Ministry of Justice. Studies were conducted under the on-site direction of John C. Cutler, MD in Guatemala City, under the supervision of R.C. Arnold MD and John F. Mahoney, MD of the USPHS VDRL in Staten Island, New York; the primary local collaborator was Dr. Juan Funes, chief of the VD control division of the Guatemalan Sanidad Publica. According to a “Syphilis Summary Report” and experimental logs in the archives, syphilis studies included Commercial Sex Workers, prisoners, and patients in the mental hospital. In the series of syphilis studies, a total of 696 subjects of individual experiments (some representing the same patients involved in several experiments) were exposed to infection (by sexual contact or inoculation).Item National Archives Releases John Cutler Papers Online(2011) UNSPECIFIEDAtlanta, GA…The National Archives at Atlanta announced that on March 29, 2011, it will release online the papers of Dr. John C. Cutler. Dr. Cutler, a former employee of the U.S. Public Health Service, 1942-1967, was involved in research on Guatemalan soldiers, prisoners, and mental health patients who were exposed to the syphilis bacteria. The collection is available online [http://www.archives.gov/research/health/cdc-cutler-records] and at the National Archives at Atlanta, located at 5780 Jonesboro Road, Morrow, Georgia, 30260. This collection which consists of approximately 12,000 pages of correspondence, reports, photographs, and patient records was donated in September of 1990 to the University of Pittsburgh by Dr. Cutler. In September 2010, the University contacted the Centers for Disease Control and Prevention to request the transfer of the material to the Federal government. After examining the material, it was determined that they were Federal records and they were transferred to the National Archives at Atlanta in October, 2010.Item Marshfield Clinic Personalized Medicine Research Project (PMRP): design, methods and recruitment for a large population-based biobank(2005) McCarty, Catherine A.; Wilke, Russell A.; Giampietro, Philip F.; Wesbrook, Steve D.; Caldwell, Michael D.Objectives: The objective of this paper is to summarize the planning for Phase I of the Marshfield Clinic Personalized Medicine Research Project (PMRP) and to describe the recruitment efforts in the first 2 years. Methods: The purpose of Phase I of the PMRP was to develop a large population-based biobank with DNA, plasma and serum samples to facilitate genomics research. Planning and consultation was facilitated with three external boards: the Ethics and Security Advisory Board; the Scientific Advisory Board; and the Community Advisory Group. Commencing in September 2002, residents aged 18 and above who resided in 1 of 19 zip codes surrounding Marshfield, WI, USA, were invited to participate. After providing written informed consent, participants completed brief questionnaires that included questions about demographics, some environmental exposures, family history of disease, and adverse drug reactions, as well as family members living in the study area. Participants provided 50 ml of blood from which DNA was extracted and plasma and serum samples were stored. The informed consent document allowed access to electronic medical records and included language about non-disclosure of personal research results. A tick-off box was also included so that participants could either allow or decline subsequent recontact for future research studies. Results: A total of 17,463 subjects were enrolled during the first 23 months of recruitment (44.3% of the residents who the Research Project Assistants were able to contact). The participants ranged in age from 18 to 98.5 years (mean = 48.9, median = 48); 57.2% (n = 9986) were female. Self-reported race in the study cohort was similar to the year 2000 census for Wood County, WI, USA, with the majority (98%) reporting themselves to be White Caucasian. The majority of subjects (n = 13,391, 76.7%) indicated that they had German ancestry. Only 142 participants (< 1%) opted out on the consent form for contact for future studies. The majority of the cohort reported that their current area of residence was a suburb, city or village (n = 10630, 60.87%); the remainder reported residence in a rural home or hobby farm (n = 5365, 30.72%), or a working farm or ranch (n = 1451, 8.31%). More than half the cohort (n = 9409, 53.88%) had lived on a working farm at some point in their life. Conclusion: The PMRP database will allow research in three areas: genetic epidemiology, pharmacogenetics, and population genetics. The size and the stability of the population as well as the relative ethnic homogeneity will help facilitate longitudinal studies with valid research results that are not biased by population stratification.Item Are Racial and Ethnic Minorities Less Willing to Participate in Health Research?(2005) Wendler, David; Kington, Raynard; Madans, Jennifer; Wye, Gretchen Van; Christ-Schmidt, Heidi; Pratt, Laura A.; Brawley, Otis W.; Gross, Cary P.; Emanuel, EzekielBackground: It is widely claimed that racial and ethnic minorities, especially in the US,are less willing than non-minority individuals to participate in health research. Yet,there is a paucity of empirical data to substantiate this claim. Methods and Findings: We performed a comprehensive literature search to identify all puublished health research studies that report consent rates by race or ethnicity. We found 20 health research studies that reported consent rates by race or ethnicity. These 20 studies reported the enrollment decisions of over 70,000 individuals for a broad range of research,from interviews to drug treatment to surgical trials. Eighteen of the twenty studies were single-site studies conducted exclusively in the US or multi-site studies where the majority of sites (i.e., at least 2/3) were in the US. Of the remaining two studies, the Concorde study was conducted at 74 sites in the United Kingdom, Ireland, and France, while the Delta study was conducted at 152 sites in Europe and 23 sites in Australia and New Zealand. For the three interview or non-intervention studies, African-Americans had a nonsignificantly lower overall consent rate than non-Hispanic whites (82.2% versus 83.5%; odds ratio [OR] ¼ 0.92; 95% confidence interval [CI] 0.84–1.02). For these same three studies, Hispanics had a nonsignificantly higher overall consent rate than non-Hispanic whites (86.1% versus 83.5%; OR ¼ 1.37; 95% CI 0.94–1.98). For the ten clinical intervention studies, African-Americans’ overall consent rate was nonsignificantly higher than that of non-Hispanic whites (45.3% versus 41.8%; OR¼1.06; 95% CI 0.78–1.45). For these same ten studies, Hispanics had a statistically significant higher overall consent rate than non-Hispanic whites (55.9% versus 41.8%; OR¼1.33; 95% CI 1.08–1.65). For the seven surgery trials, which report all minority groups together, minorities as a group had a nonsignificantly higher overall consent rate than non-Hispanic whites (65.8% versus 47.8%; OR ¼ 1.26; 95% CI 0.89–1.77). Given the preponderance of US sites, the vast majority of these individuals from minority groups were African-Americans or Hispanics from the US. Conclusions We found very small differences in the willingness of minorities, most of whom were African-Americans and Hispanics in the US, to participate in health research compared to non-Hispanic whites. These findings, based on the research enrollment decisions of over 70,000 individuals, the vast majority from the US, suggest that racial and ethnic minorities in the US are as willing as non-Hispanic whites to participate in health research. Hence, efforts to increase minority participation in health research should focus on ensuring access to health research for all groups, rather than changing minority attitudes.